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What changed in Seer, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Seer, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+404 added−474 removedSource: 10-K (2026-03-02) vs 10-K (2025-03-03)

Top changes in Seer, Inc.'s 2025 10-K

404 paragraphs added · 474 removed · 290 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

94 edited+80 added−149 removed103 unchanged
Biggest changeWe have validated our NP technology and the principle of protein corona formation as a robust and reproducible method to deeply and broadly profile the proteome in a high-throughput manner. We have characterized our technology and its performance in three peer-reviewed publications: Nature Communications (Blume et al. ), PNAS (Ferdosi et al. ), and Advanced Materials (Ferdosi et al. ).
Biggest changeWe have characterized our technology and its performance in three peer-reviewed publications: Nature Communications (Blume et al. ), PNAS (Ferdosi et al. ), and Advanced Materials (Ferdosi et al. ). 9 Table of Contents Our third-generation assay, Proteograph ONE, launched in May 2025, significantly increases sample throughput across both the Proteograph workflow and downstream MS analysis, delivering more than a 3.6x increase compared to the Proteograph XT assay launched in 2023 and approximately a 10x increase compared to the original Proteograph assay launched in 2021.
Our NP technology, SP100 automation instrument, and software are protected by numerous issued patents and pending patent applications worldwide, covering improvements in NPs, assay methods and ways to leverage proteomic data and information for life sciences research, clinical diagnostic and drug discovery applications.
Our NP technology, automation instrument, and software are protected by numerous issued patents and pending patent applications worldwide, covering improvements in NPs, assay methods and ways to leverage proteomic data and information for life sciences research, clinical diagnostic and drug discovery applications.
Medical devices to be commercially distributed in the United States must receive from the FDA either clearance of a premarket notification, known as 510(k), or premarket approval pursuant to the FDC Act prior to marketing, unless subject to an exemption. 26 Table of Contents We label and sell our products for RUO and expect to sell them to academic institutions, life sciences and research laboratories that conduct research, and biopharmaceutical and biotechnology companies for non-diagnostic and non-clinical purposes.
Medical devices to be commercially distributed in the United States must receive from the FDA either clearance of a premarket notification, known as 510(k), or premarket approval pursuant to the FDC Act prior to marketing, unless subject to an exemption. 20 Table of Contents We label and sell our products for RUO and expect to sell them to academic institutions, life sciences and research laboratories that conduct research, and biopharmaceutical and biotechnology companies for non-diagnostic and non-clinical purposes.
Furthermore, the CCPA could mark the beginning of a trend toward more stringent state privacy legislation in the U.S., which could increase our potential liability and adversely affect our business. 30 Table of Contents Furthermore, the collection, use, storage, disclosure, transfer, or other processing of personal data regarding individuals in the European Economic Area (EEA), including personal health data, is subject to the GDPR, which became effective on May 25, 2018.
Furthermore, the CCPA could mark the beginning of a trend toward more stringent state privacy legislation in the U.S., which could increase our potential liability and adversely affect our business. 24 Table of Contents Furthermore, the collection, use, storage, disclosure, transfer, or other processing of personal data regarding individuals in the European Economic Area (EEA), including personal health data, is subject to the GDPR, which became effective on May 25, 2018.
For further discussion of the risks relating to intellectual property, see the section titled “Risk factors—Risks Related to our Intellectual Property.” 32 Table of Contents Collaboration and License Agreements The Brigham and Women’s Hospital In December 2017, we entered into an exclusive patent license agreement with BWH, pursuant to which we obtained an exclusive, royalty-bearing, sub-licensable (with approval from BWH) license to certain U.S. and foreign patents and patent applications in one patent family related to methods for identifying a biological state using nanoparticle and biosensor compositions and other nanoparticle compositions to develop, manufacture, use and commercialize products and processes in all fields, including but not limited to therapeutic, diagnostic, or other uses, on a worldwide basis.
For further discussion of the risks relating to intellectual property, see the section titled “Risk factors—Risks Related to our Intellectual Property.” Collaboration and License Agreements The Brigham and Women’s Hospital In December 2017, we entered into an exclusive patent license agreement with BWH, pursuant to which we obtained an exclusive, royalty-bearing, sub-licensable (with approval from BWH) license to certain U.S. and foreign patents and patent applications in one patent family related to methods for identifying a biological state using nanoparticle and biosensor compositions and other nanoparticle compositions to develop, manufacture, use and commercialize products and processes in all fields, including but not limited to therapeutic, diagnostic, or other uses, on a worldwide basis.
Subject to an applicable cure period, BWH may terminate the agreement if we fail to comply with applicable payments or diligence obligations or upon a breach of our obligation under the agreement, or for certain insolvency-related events. 33 Table of Contents PrognomiQ In August 2020, we entered into an intellectual property transfer and license agreement and, in October 2020, we entered into an intellectual property sublicense agreement, in each case with PrognomiQ in connection with the spin-out of PrognomiQ.
Subject to an applicable cure period, BWH may terminate the agreement if we fail to comply with applicable payments or diligence obligations or upon a breach of our obligation under the agreement, or for certain insolvency-related events. 27 Table of Contents PrognomiQ In August 2020, we entered into an intellectual property transfer and license agreement and, in October 2020, we entered into an intellectual property sublicense agreement, in each case with PrognomiQ in connection with the spin-out of PrognomiQ.
The de novo classification route is generally less burdensome than the PMA approval process. 27 Table of Contents Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices, or those deemed not substantially equivalent to a legally marketed predicate device, are placed in class III. Class III devices typically require PMA approval.
The de novo classification route is generally less burdensome than the PMA approval process. 21 Table of Contents Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices, or those deemed not substantially equivalent to a legally marketed predicate device, are placed in class III. Class III devices typically require PMA approval.
We entered a non-exclusive agreement with Hamilton that covers the manufacturing of the SP100 automation instrument and its continued supply on a purchase order basis. Starting in January 2025, we renewed the agreement under an extended term through December 2027. Following this extended term, the agreement will automatically renew annually for a maximum of two one-year renewal periods.
We entered a non-exclusive agreement with Hamilton that covers the manufacturing of the SP200 automation instrument and its continued supply on a purchase order basis. In January 2025, we renewed the agreement under an extended term through December 2027. Following this extended term, the agreement will automatically renew annually for a maximum of two one-year renewal periods.
Current companies that provide proteomics products include Agilent Technologies, Bio-Techne, Bruker, Danaher, DiaSorin and Thermo Fisher Scientific. There are also a number of companies that provide proteomic analysis services. In addition, multiple emerging growth companies have developed, or are developing, proteomics products, services and solutions, such as Alamar Biosciences, Nautilus Biotechnology, Quanterix, Quantum-Si and Standard BioTools.
Current companies that provide proteomics products include Agilent Technologies, Bio-Techne, Bruker, Danaher, DiaSorin, Illumina and Thermo Fisher Scientific. There are also a number of companies that provide proteomic analysis services. In addition, multiple emerging growth companies have developed, or are developing, proteomics products, services and solutions, such as Alamar Biosciences, Nautilus Biotechnology, Quanterix and Quantum-Si.
If the FDA or other regulatory authorities assert that any of our RUO products are subject to regulatory clearance or approval, our business, financial condition, or results of operations could be adversely affected. 28 Table of Contents For example, in some cases, our customers may use our RUO products in their own laboratory-developed tests (LDTs) or in other FDA-regulated products for clinical diagnostic use.
If the FDA or other regulatory authorities assert that any of our RUO products are subject to regulatory clearance or approval, our business, financial condition, or results of operations could be adversely affected. For example, in some cases, our customers may use our RUO products in their own laboratory-developed tests (LDTs) or in other FDA-regulated products for clinical diagnostic use.
Our scientific advisory board is composed of Robert Langer, Sc.D., Charles Cantor, Ph.D., Steven Carr, Ph.D., Joshua Coon, Ph.D., Luis Diaz, M.D., Vivek Farias, Ph.D., Chris Mason, Ph.D., Mark McClellan, Ph.D., Gary Patti, Ph.D., Jennifer Van Eyk, Ph.D., M.D., and Bruce Wilcox, Ph.D. 34 Table of Contents Employees Our employees are guided by our mission to imagine and pioneer news ways to decode the biology of the proteome to improve human health.
Our scientific advisory board is composed of Robert Langer, Sc.D., Charles Cantor, Ph.D., Joshua Coon, Ph.D., Luis Diaz, M.D., Vivek Farias, Ph.D., Chris Mason, Ph.D., Mark McClellan, Ph.D., Gary Patti, Ph.D., Jennifer Van Eyk, Ph.D., M.D., and Bruce Wilcox, Ph.D. 28 Table of Contents Employees Our employees are guided by our mission to imagine and pioneer news ways to decode the biology of the proteome to improve human health.
The Proteograph is not limited to a defined set of proteins, and samples across the dynamic range of proteins and protein variants that may be present in biosamples.
The Proteograph ONE assay is not limited to a defined set of proteins, and samples across the dynamic range of proteins and protein variants that may be present in biosamples.
The horizontal dashed lines indicate the expected fold changes. • Reproducibility of measurement in large studies. Reproducibility, also referred to as precision, is a measure of the consistency of protein abundance measurements (i.e., MS measured intensity) between repeated measurements of the same sample.
The horizontal dashed lines indicate the expected foldchanges. • Reproducibility of measurement in large studies. Reproducibility, also referred to as precision, is a measure of the consistency of protein abundance measurements (i.e., MS measured intensity) between repeated measurements of the same sample.
We conduct vendor and component qualification for components provided by third-party suppliers and quality control tests on our NPs. 25 Table of Contents Automation Instrument We designed the SP100 automation instrument and have outsourced its manufacturing to Hamilton Company, a leading manufacturer of automated liquid handling workstations.
We conduct vendor and component qualification for components provided by third-party suppliers and quality control tests on our NPs. 19 Table of Contents Automation Instrument We designed the SP200 automation instrument and have outsourced its manufacturing to Hamilton Company, a leading manufacturer of automated liquid handling workstations.
As of December 31, 2024, we had 134 employees based in North America, the European Union and the United Kingdom. Many of our employees are highly educated, holding masters and doctorate degrees. None of our employees is represented by a labor union or covered under a collective bargaining agreement.
As of December 31, 2025, we had 124 employees based in North America, the European Union and the United Kingdom. Many of our employees are highly educated, holding masters and doctorate degrees. None of our employees is represented by a labor union or covered under a collective bargaining agreement.
Importantly, in each sample, we measured tens of thousands of data points at the peptide level, providing information on thousands of proteins. We believe this extensibility offers researchers a powerful and flexible tool to utilize across a variety of applications and sample types.
Importantly, in each sample, we measured tens of thousands of data points at the peptide-level, providing information on thousands of proteins. We believe this extensibility offers researchers a powerful and flexible tool to utilize across a variety of applications and sample types. • Discovery Proteomics & Proteome Characterization .
Against neat, the Proteograph has slightly worse reproducibility, but does so while quantifying almost 8-fold greater number of proteins including low abundance proteins. 14 Table of Contents Figure 13: (A) Across six technologies and methods tested, the Proteograph provides the highest performance in protein identification across all replicates and within each replicate.
Against neat, the Proteograph has slightly worse reproducibility, but does so while quantifying almost eight-fold greater number of proteins including low abundance proteins. Figure 14: (A) Across six technologies and methods tested, Proteograph XT provides the highest performance in protein identification across all replicates and within each replicate.
The Proteograph Product Suite enables rapid and large-scale proteomic sample processing in an approximately eight-hour workflow, compared to other unbiased solutions that can take days to weeks. With our current assay, we can process 40 samples in a single run of the Proteograph SP100 instrument.
The Proteograph Product Suite enables rapid and large-scale proteomic sample processing in an approximately five-hour workflow, compared to other unbiased solutions that can take days to weeks. With our current assay, we can process 80 samples in a single run of the Proteograph SP200 instrument.
For example, when we compared the performance of the Proteograph Product Suite workflow with that of neat biological samples across model organism plasma, urine, cerebral spinal fluid, and conditioned media, we noted superior protein group identification by the Proteograph of 4x, 1.5x, 1.5x, and 8.6x, respectively.
For example, when we compared the performance of the Proteograph Product Suite workflow with that of neat biological samples across model organism plasma, cerebral spinal fluid, and conditioned media, we noted superior protein group identification by the Proteograph ONE workflow of 8x, 1.8x, and 6x, respectively.
The Proteograph Product Suite The Proteograph Product Suite is an integrated solution consisting of consumables, an automation instrument, and data analysis software to perform unbiased, deep proteomic analysis at scale in a matter of hours.
Our Product and Technology The Proteograph Product Suite is an integrated solution consisting of consumables, an automation instrument, and data analysis software designed to enable unbiased, deep proteomic analysis at scale in a matter of hours.
Ferdosi, S. et al . Engineered nanoparticles enable deep proteomic studies at scale by leveraging tunable nano-bio interactions. PNAS . 119(11) (2022). Ferdosi, S. et al . Enhanced competition at the nano-bio interface enables comprehensive characterization of protein corona dynamics and deep coverage of proteomes. Advanced Materials . 34, 2206008 (2022). Keshishian, H. et al .
Engineered nanoparticles enable deep proteomic studies at scale by leveraging tunable nano-bio interactions. PNAS . 119(11) (2022). Ferdosi, S. et al . Enhanced competition at the nano-bio interface enables comprehensive characterization of protein corona dynamics and deep coverage of proteomes. Advanced Materials . 34, 2206008 (2022). Olinger, B., Banarjee, R., Dey, A. et al.
Importantly, the Proteograph protein data is obtained using an MS detector, which is the gold standard for proteomics, and data is conventionally reported with a less than one percent False Discovery Rate (FDR). This means that the reported proteins are identified with over 99% confidence. • Depth of coverage .
Importantly, the Proteograph ONE assay protein data is obtained using an MS detector, which is the gold standard for proteomics, and data is conventionally reported with a less than one percent False Discovery Rate (FDR). This means that the reported proteins are identified with very high confidence. 11 Table of Contents • Depth of coverage .
While other solutions have been introduced since our commercial launch, we believe none can replicate the performance delivered by the Proteograph Product Suite. • Provides unique insight into protein variation at the peptide level, with a depth and scale that sets a new standard for unbiased and deep proteomics.
While other solutions have been introduced since our commercial launch, we believe none can replicate the performance delivered by the Proteograph Product Suite, particularly the scale, depth, accuracy, and reproducibility to enable population-scale studies in an unbiased manner. • Provides unique insight into protein variation at the peptide level, with a depth and scale that sets a new standard for unbiased and deep proteomics.
These studies are not a part of this prospectus and are not incorporated by reference in this Annual Report. Backman, J.D. et al . Exome sequencing and analysis of 454,787 UK Biobank participants. Nature 599, 628–634 (2021). Beimers W, Overmyer K, et al . A Technical Evaluation of Plasma Proteomics Technologies. (bioRxiv). Bludau, I. et al .
These studies are not a part of this prospectus and are not incorporated by reference in this Annual Report. Backman, J.D. et al . Exome sequencing and analysis of 454,787 UK Biobank participants. Nature 599, 628–634 (2021). Beimers W, Overmyer K, et al . Technical Evaluation of Plasma Proteomics Technologies. J. Proteome Res . 2025, 24, 6, 3074–3087.
We expect that these COEs will actively promote the Proteograph solution and its capabilities, help us further raise awareness, and increase the accessibility of the Proteograph to a wider range of customers. • Channel Partners: We continue to expand geographically to enable access in key international markets.
We expect that these COEs will actively promote the Proteograph solution and its capabilities, help us further raise awareness, and increase the accessibility of the Proteograph to a wider range of customers. • Channel Partners: We continue to expand geographically to enable access in key international markets, including China, Australia, Eastern Europe, Israel, Japan, and South Africa.
Item 1. Busi ness Overview Our mission is to imagine and pioneer new ways to decode the biology of the proteome to improve human health. Through our product, the Proteograph TM Product Suite (Proteograph), we provide researchers with unbiased, deep, rapid and large-scale access to the proteome.
Item 1. Busi ness Overview Our mission is to imagine and pioneer new ways to decode the biology of the proteome to improve human health. Through our product, the Proteograph® Product Suite (Proteograph), we provide researchers with unbiased, deep, rapid and large-scale access to the proteome, enabling biological discovery that has historically been impractical.
The measurement of the true abundance of a large number of proteins at the protein variant level at scale is not possible, so we use the ratio of abundances in two samples to demonstrate the accuracy of protein abundance measurement.
This capability measures how close the measured abundance of a protein is to the true abundance in a sample. The measurement of the true abundance of a large number of proteins at the protein variant level at scale is not possible, so we use the ratio of abundances in two samples to demonstrate the accuracy of protein abundance measurement.
Proteomic and interactomic insights into the molecular basis of cell functional diversity. Nat Rev Molec Cell Biol 21, 327–340 (2020). Blume, J.E. et al . Rapid, deep and precise profiling of the plasma proteome with multi-nanoparticle protein corona. Nat.
Bludau, I. et al . Proteomic and interactomic insights into the molecular basis of cell functional diversity. Nat Rev Molec Cell Biol 21, 327–340 (2020). Blume, J.E. et al . Rapid, deep and precise profiling of the plasma proteome with multi-nanoparticle protein corona. Nat. Commun. 11 (2020). 29 Table of Contents Ferdosi, S. et al .
Although there is a trend towards harmonization of quality system, standards and regulations in each country may vary substantially which can affect timelines of introduction. 29 Table of Contents In the future, to the extent we or our partners develop any medical devices subject to FDA regulation, failure to comply with applicable regulatory requirements can result in enforcement action by FDA, which may include warning letters, untitled letters, fines, injunctions, consent decrees, and civil penalties; withdrawal, administrative detention, refunds, recall or seizure of products; operating restrictions, partial suspension or total shutdown of production; refusing or delaying requests for 510(k) clearance, de novo authorization, or PMA approval of new products or modified products; withdrawing 510(k) clearance, de novo authorization, or PMA approvals already granted; refusal to grant export approvals; or criminal prosecution.
In the future, to the extent we or our partners develop any medical devices subject to FDA regulation, failure to comply with applicable regulatory requirements can result in enforcement action by FDA, which may include warning letters, untitled letters, fines, injunctions, consent decrees, and civil penalties; withdrawal, administrative detention, refunds, recall or seizure of products; operating restrictions, partial suspension or total shutdown of production; refusing or delaying requests for 510(k) clearance, de novo authorization, or PMA approval of new products or modified products; withdrawing 510(k) clearance, de novo authorization, or PMA approvals already granted; refusal to grant export approvals; or criminal prosecution.
Given the success of and strong demand for STAC, in May 2024, we announced the opening of our second STAC location in Bonn, Germany, in partnership with LIFE & BRAIN GmbH. • Centers of Excellence (COE): We have partnered with eight select service facilities and core labs globally to be COEs for the Proteograph.
In May 2024, we announced the opening of our second STAC location in Bonn, Germany, in partnership with LIFE & BRAIN GmbH. • Service Providers: We have partnered with eight select service facilities and core labs globally to be service providers for the Proteograph.
In recent work, Karsten Suhre and colleagues in collaboration with our team conducted the first deep, large-scale mass spectrometry (MS)-based genome-wide association search (GWAS) for protein quantitative trait loci (pQTLs) (Suhre et al. ).
In a study published in Nature Genetics in November 2025, Karsten Suhre and colleagues in collaboration with our team conducted the first deep, large-scale mass spectrometry (MS)-based genome-wide association search (GWAS) for protein quantitative trait loci (pQTLs) (Suhre et al. ).
Therefore, a single Proteograph Product Suite coupled with one MS instrument can process hundreds of samples per week and approximately 10,000 samples annually, for unbiased and deep proteomic analysis. In comparison, the unbiased workflows developed by leading proteomics labs can take weeks for sample preparation and MS measurement to reach an equivalent depth of proteomic coverage.
Therefore, a single Proteograph Product Suite can process over 1,000 samples per week and over 50,000 samples annually. In comparison, the unbiased workflows developed by leading proteomics labs can take weeks for sample preparation and MS measurement to reach an equivalent depth of proteomic coverage.
In addition to our reliance on patent protection for our inventions, products and technologies, we also rely on trade secrets, know-how, confidentiality agreements and continuing technological innovation to develop and maintain our competitive position.
Consequently, we may not obtain or maintain adequate patent protection for any of our products or technologies. 26 Table of Contents In addition to our reliance on patent protection for our inventions, products and technologies, we also rely on trade secrets, know-how, confidentiality agreements and continuing technological innovation to develop and maintain our competitive position.
Each well of the XT assay contains uniquely engineered NPs that selectively capture thousands of distinct intact proteins from a biosample based on their abundance and affinity for the NP surface. This sampling capability is particularly strong in complex biofluids such as plasma.
The Proteograph ONE assay contains uniquely engineered NPs that selectively capture thousands of distinct intact proteins from a biosample based on their abundance and affinity for the NP surface. This sampling capability is particularly strong in complex biofluids such as plasma. Our unique NPs capture significantly more proteins than current methods of unbiased proteomic analysis.
Our owned or exclusively licensed patents and patent applications, if issued, are expected to expire between 2023 and 2045, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. 31 Table of Contents We exclusively license U.S. patents and patent applications, as well as ex-U.S. patents and pending patent applications from The Brigham and Women’s Hospital (BWH).
Our owned or exclusively licensed patents and patent applications, if issued, are expected to expire between 2023 and 2045, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
These patents and patent applications are directed to methods for identifying a biological state, including classification and early detection of cancers and other diseases, using nanoparticle and biosensor compositions, as well as other nanoparticle compositions.
We exclusively license U.S. patents and patent applications, as well as ex-U.S. patents and pending patent applications from The Brigham and Women’s Hospital (BWH). These patents and patent applications are directed to methods for identifying a biological state, including classification and early detection of cancers and other diseases, using nanoparticle and biosensor compositions, as well as other nanoparticle compositions.
The Proteograph is uniquely capable of generating robust, reproducible, deep and unbiased proteomic data. As this data is used by more customers to generate insights, we believe this cycle will fuel further adoption of the Proteograph Product Suite.
This capital-efficient and labor-efficient model has high operating leverage potential. • Presents a solution with sustainable differentiation. The Proteograph is uniquely capable of generating robust, reproducible, deep and unbiased proteomic data. As this data is used by more customers to generate insights, we believe this cycle will fuel further adoption of the Proteograph Product Suite.
The Proteograph’s ability to capture protein variations at scale enables synergistic insights when combined with genomic variations, yielding informative individualized models of biology at population scale. • Allows for wide adoption by customers in both decentralized and centralized settings.
By measuring >77,000 peptides per sample, the Proteograph has a differentiated ability to capture protein variations at scale to enable synergistic insights when combined with genomic variations, yielding informative individualized models of biology at population scale. 15 Table of Contents • Allows for wide adoption by customers in both decentralized and centralized settings.
We have established several channels for customers to access the Proteograph either through our direct sales team, STAC services, COEs service provides, international channel partners, and strategic commercial partnerships. • Direct Sales: In North America, the United Kingdom and select countries of the European Union, we have direct sales and customer experience personnel, including Regional Business Managers (RBM), Field Application Scientists and Field Service Engineers.
We continue to invest in and expand multiple access channels, including our direct sales organization, STAC services, centers of excellence service providers, international channel partners, and strategic commercial partnerships. • Direct Sales: In North America, the United Kingdom, select countries of the European Union, and the Asia Pacific, we have direct sales and customer experience personnel, including Regional Business Managers (RBM), Field Application Scientists and Field Service Engineers.
The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and their implementing regulations, which impose obligations, including mandatory contractual terms, with respect to safeguarding the transmission, security and privacy of protected health information by covered entities subject to HIPAA, such as health plans, health care clearinghouses and healthcare providers, and their respective business associates that access protected health information.
Changes in healthcare regulatory policies could also increase our costs and subject us to additional regulatory requirements that may interrupt commercialization of our products, decrease our revenue and adversely impact sales of, and pricing of and reimbursement for, our products. 23 Table of Contents The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and their implementing regulations, which impose obligations, including mandatory contractual terms, with respect to safeguarding the transmission, security and privacy of protected health information by covered entities subject to HIPAA, such as health plans, health care clearinghouses and healthcare providers, and their respective business associates that access protected health information.
The Proteograph Product Suite is an integrated solution that includes consumables, an automation instrument and data analysis software, and was designed to deliver ease-of-use, efficiency, robustness and reproducibility of results and to complement existing laboratory infrastructure. Its simple and integrated workflow enables the customer to use their own MS instrument or leverage a widely available installed base of MS instruments.
The Proteograph Product Suite is an integrated solution that includes consumables, an automation instrument and data analysis software, and was designed to deliver ease-of-use, efficiency, robustness and reproducibility of results and to complement existing laboratory infrastructure.
We believe that by leveraging our understanding of NP surfaces, software and analytics capabilities, we can rapidly develop new products. Our NP manufacturing process uses well-characterized inputs and methods, which require relatively modest investments in capital equipment and space. This capital-efficient and labor-efficient model has high operating leverage potential. • Presents a solution with sustainable differentiation.
NP-based products are efficient to design, develop and manufacture. We believe that by leveraging our understanding of NP surfaces, software and analytics capabilities, we can rapidly develop new products. Our NP manufacturing process uses well-characterized inputs and methods, which require relatively modest investments in capital equipment and space.
In genomics, unbiased sequencing of the genome enabled discovery of novel content, creating new end-market opportunities in basic research and discovery, translational research and clinical applications, including early cancer detection, recurrence monitoring and non-invasive prenatal testing. Similar to genomics, we believe that peptide-level resolution is crucial to the discovery of novel content and new biological insights.
In genomics, unbiased sequencing of the genome enabled discovery of novel content, creating new end-market opportunities in basic research and discovery, translational research and clinical applications, including early cancer detection, recurrence monitoring and non-invasive prenatal testing. Similar to genomics, researchers are using the Proteograph to discover and access novel proteomic content that was previously inaccessible.
We are using machine-learning techniques and conducting large-scale analyses to understand relationships between NP surfaces and protein binding to design future products. 15 Table of Contents • Provides core technology with significant operational leverage in research and development, manufacturing and commercialization. NP-based products are efficient to design, develop and manufacture.
Our diverse library of NP surfaces can support the development of new products catering to various applications and customer needs. We are using machine-learning techniques and conducting large-scale analyses to understand relationships between NP surfaces and protein binding to design future products. • Provides core technology with significant operational leverage in research and development, manufacturing and commercialization.
For the first time, scientists will be able to generate peptide-level molecular data from large cohorts, which we believe will unlock new biological insights and help usher in the next era of multi-omics driven precision medicine. • Innovate continuously to develop and commercialize additional transformative products to break down MS proteomic workflow barriers, access the proteome, and accelerate our understanding of biology.
For the first time, scientists will be able to generate peptide-level proteomic data from large-scale cohorts, which we believe will unlock new biological insights and help usher in the next era of multi-omics driven precision medicine.
While some of these reagents and components are currently sourced from a single supplier, these products are readily available from numerous suppliers. While we currently perform some filling and packaging of the Proteograph assay and the related consumables, we may eventually have our filling and packaging outsourced to a third party.
While we currently perform some filling and packaging of the Proteograph assay and the related consumables, we may eventually have our filling and packaging outsourced to a third party.
Even if our pending patent applications are granted as issued patents, those patents may be challenged, circumvented or invalidated by third parties. Consequently, we may not obtain or maintain adequate patent protection for any of our products or technologies.
Even if our pending patent applications are granted as issued patents, those patents may be challenged, circumvented or invalidated by third parties.
This final rule is being challenged in federal courts. In June 2024, the U.S. Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous.
In June 2024, the U.S. Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous. This landmark Supreme Court decision may invite various stakeholders to bring lawsuits against the FDA to challenge longstanding decisions and policies of the FDA.
We use a variety of intellectual property protection strategies, including patents, trademarks, trade secrets and other methods of protecting proprietary information. As of December 31, 2024, we owned or exclusively licensed over 200 issued patents and patent applications worldwide. Our intellectual property portfolio includes patents and patent applications directed to proteomic assays, nanoparticle chemistry, data analysis and automation instruments.
We use a variety of intellectual property protection strategies, including patents, trademarks, trade secrets and other methods of protecting proprietary information. 25 Table of Contents As of December 31, 2025, we owned or exclusively licensed over 230 issued patents and patent applications worldwide.
In addition, regulatory agencies may introduce new requirements that may change the regulatory requirements for us or our customers, or both. As noted above, although our products are currently labeled and sold for research purposes only, the regulatory requirements related to marketing, selling, and supporting such products could be uncertain and depend on the totality of circumstances.
As noted above, although our products are currently labeled and sold for research purposes only, the regulatory requirements related to marketing, selling, and supporting such products could be uncertain and depend on the totality of circumstances. This uncertainty exists even if such use by our customers occurs without our consent.
As we continue to improve and extend our product portfolio, we expect to continue to expand the capabilities and features in the PAS as well. Proteograph Product Suite Performance The Proteograph Product Suite provides five essential capabilities: (i) broad protein sampling with peptide-level resolution; (ii) deep coverage; (iii) accurate and precise measurement; (iv) reproducibility and (v) scalability for high-throughput studies.
Proteograph Product Suite Performance The Proteograph Product Suite provides five essential capabilities: (i) broad protein sampling with peptide-level resolution; (ii) deep coverage; (iii) accurate and precise measurement; (iv) reproducibility and (v) scalability for high-throughput studies. We believe that our integrated solution is the only product in the market that combines all these technical and operational capabilities.
Available Information We make our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports, available free of charge at our website as soon as reasonably practicable after they have been filed with the SEC. Our website address is http://seer.bio. Information on our website is not part of this report.
Widespread Expansion of Protein Interaction Capabilities by Alternative Splicing. Cell. 164(4):805-17 (2016). Available Information We make our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports, available free of charge at our website as soon as reasonably practicable after they have been filed with the SEC.
The PAS also includes a dedicated proteogenomics workflow that maps peptide-level data to genomic data to identify sample-specific variant peptides not captured in canonical reference databases. The workflow provides interactive tables and plots, enables visualization of identified peptides’ relationship to gene structure, protein domain information and functional regions, and creates amino acid-level browsable peptide data maps.
It also includes a dedicated proteogenomics workflow that maps peptide-level data to genomic data to identify sample-specific variant peptides not captured in canonical reference databases. PAS provides interactive visualizations and tables to support data exploration, including views of peptide-to-gene relationships, protein domains, and functional regions.
In January 2024, FDA announced its plans to reclassify certain high-risk in vitro diagnostics, including companion diagnostics, as Class II devices. All medical devices, including IVDs, that are regulated by the FDA are also subject to the quality system regulation.
In January 2024, FDA announced its plans to reclassify certain high-risk in vitro diagnostics, including companion diagnostics, as Class II devices.
The Proteograph can quantify the proteome across a wide dynamic range of protein abundance. Figure 10 compares the depth of coverage of our assay with that of plasma.
The Proteograph can quantify the proteome across a wide dynamic range of protein abundance. Figure 8 compares the depth of coverage of our assay with that of neat plasma and demonstrates that the Proteograph assay detected >4-fold more proteins cataloged in the Human Plasma Proteome Project (HPPP).
Utilizing a $2 million Small Business Innovation Research grant to the Company and Massachusetts General Hospital (MGH) from the National Institute on Aging (NIA), researchers from the Company and MGH conducted a study that analyzed 1,800 plasma samples comprising both controls and individuals diagnosed with cognitive decline, including Alzheimer’s Disease (AD) (Lacar et al.) .
Using funding from a Small Business Innovation Research grant from the National Institute on Aging, researchers from Seer and Massachusetts General Hospital conducted a longitudinal study analyzing approximately 1,800 plasma samples from individuals with cognitive decline, including Alzheimer’s disease, and matched controls.
We believe that our integrated solution is the only product in the market that combines all these technical and operational capabilities. Furthermore, we rigorously measure and evaluate each of these technical attributes, as we describe below. • Breadth of protein sampling . This capability refers to conducting unbiased, highly parallel sampling of the proteome.
Furthermore, we rigorously measure and evaluate each of these technical attributes, as we describe below. 10 Table of Contents • Breadth of protein sampling . This capability refers to conducting unbiased sampling of the proteome.
Suhre, K. et al . Nanoparticle enrichment mass-spectrometry proteomics identifies protein-altering variants for precise pQTL mapping. Nat Commun, 15, 989 (2024). Suhre, K. et al. A genome-wide association study of mass spectrometry proteomics using the Seer Proteograph platform (bioRxiv). Yang X. et al . Widespread Expansion of Protein Interaction Capabilities by Alternative Splicing. Cell. 164(4):805-17 (2016).
Suhre, K. et al . Nanoparticle enrichment mass-spectrometry proteomics identifies protein-altering variants for precise pQTL mapping. Nat Commun, 15, 989 (2024). Suhre, K., Chen, Q., Halama, A. et al. A genome-wide association study of mass spectrometry proteomics using a nanoparticle enrichment platform. Nat Genet 57 , 2987–2996 (2025). Yang X. et al .
Additionally, to reduce customer capital investment barriers, we launched the Strategic Instrument Placement Program (SIPP) in 2023 to enable customer access to our Proteograph without the need for an upfront capital investment.
In addition to these direct personnel, we have marketing, customer experience and technical support personnel located in our offices in Redwood City and San Diego, California. 18 Table of Contents Additionally, to reduce customer capital investment barriers, we launched the Strategic Instrument Placement Program (SIPP) in 2023 to enable customer access to our Proteograph without the need for an upfront capital investment.
Recently, the European Parliament voted to extend the transition timelines for IVDR. Outside of the EU, regulatory approval needs to be sought on a country-by-country basis in order to market medical devices.
In 2025, the European Commission published its proposals on amendments to the IVDR as well as new transparency requirements. Outside of the EU, regulatory approval needs to be sought on a country-by-country basis in order to market medical devices.
The SEC maintains a website that contains the materials we file with the SEC at www.sec.gov. 36 Table of Contents
Our website address is http://seer.bio. Information on our website is not part of this report. The SEC maintains a website that contains the materials we file with the SEC at www.sec.gov. 30 Table of Contents
We believe that the Proteograph will be attractive to researchers who are looking for an easy-to-use, scalable approach with a unique combination of attributes spanning breadth, depth, accuracy, reproducibility and precision of measurement, and the speed and throughput necessary for large-scale proteomics studies.
The Proteograph is increasingly being adopted by large-scale studies seeking an easy-to-use, scalable approach with a unique combination of attributes spanning breadth, depth, accuracy, reproducibility and precision of measurement.
(B) Distribution of observed fold changes of bovine proteins for three selected comparisons of spiked-in samples. The color indicates the data source: (i) neat digestion (gray), or (ii) Proteograph workflow constrained to proteins also identified in neat (dark blue) or (iii) Proteograph workflow all proteins (teal).
( Bottom ) Distribution of observed fold-changes of bovine proteins for 3 selected comparisons of spiked-in samples. The color indicates the data source: protein identifications unique to direct digestion (gray), protein identifications shared between the Proteograph ONE workflow and direct digestion (purple), or protein identifications unique to the Proteograph ONE workflow (teal).
We are currently manufacturing using our production-scale and pilot lines and continue to build out our manufacturing capabilities to support the broad commercial availability of our products. We obtain some of the reagents and components used in the Proteograph workflow from third-party suppliers.
We procure certain components of our consumables from third-party manufacturers, which includes the commonly-available raw materials needed for manufacturing our proprietary engineered NPs. We are currently manufacturing using our production-scale lines and continue to build out our manufacturing capabilities to support the broad commercial availability of our products.
Almost all highly reliable pQTLs are scored highly by Seer data; conversely, pQTLs that are scored low are likely to be false discoveries, potentially due to epitope effects induced by the presence of protein allelic variants that alter the binding of the affinity reagent to the protein surface. 5 Table of Contents Our Proprietary Engineered Nanoparticle Technology The Proteograph Product Suite leverages our proprietary engineered NP technology to overcome the limitations of existing methods, and enable an easy-to-use workflow for unbiased, deep, rapid and scalable proteomic analysis.
Almost all highly reliable pQTLs are scored highly by Seer data; conversely, pQTLs that are scored low are likely to be false discoveries, potentially due to epitope effects induced by the presence of protein allelic variants that alter the binding of the affinity reagent to the protein surface. 5 Table of Contents Biomarker discovery in multi-omic diagnostic test development.
In another study performed by PrognomiQ, a 2021 spinout of Seer, across a set of 2,840 plasma samples, approximately 13,000 proteins were identified. Figure 9: Proteograph XT demonstrates an 8.0x expansion in depth of coverage compared to neat plasma. In a study performed by PrognomiQ across 2,840 plasma samples, approximately 13,000 proteins were identified.
Figure 10: Proteograph ONE demonstrates a 7.0x expansion in depth of coverage compared to neat plasma. In a recent customer study across more than 800 plasma samples, approximately 9,000 proteins were identified.
Considering these additional sources of protein variants, the actual number of protein variants at both individual and population-wide levels is significantly higher. These findings emphasize the unmet need to understand protein variants at the peptide level and underscore how little is currently known about the complexity of the proteome.
These findings emphasize the unmet need to understand protein variants at the peptide-level and underscore how little is currently known about the complexity of the proteome. We believe understanding protein variation at this level could revolutionize how we diagnose, treat, and monitor diseases.
For example, non-invasive prenatal testing and precision oncology currently make up a significant part of the current genomics market, which would have been difficult to predict a decade ago. We anticipate that the same dynamic of new market creation will occur in proteomics, with one such application for proteomics being early disease detection.
Like the commercial impact of broadened access to genomics products, we believe the Proteograph will enable novel applications and insights, leading to new end-markets. For example, non-invasive prenatal testing and precision oncology currently make up a significant part of the current genomics market, which would have been difficult to predict a decade ago.
Joshua Coon, a professor at University of Wisconsin, demonstrates the performance of the Proteograph Product Suite against five other plasma proteomic technologies and methods (Beimers et al .). Using five technical replicates of the same plasma sample (BioIVT) on each method, the study shows the Proteograph assay provides the greatest proteomic depth across the six technologies and methods tested.
Using five technical replicates of the same plasma sample (BioIVT) on each method, the study shows the Proteograph assay provides the greatest proteomic depth across the six technologies and methods tested. While providing much higher numbers of proteins, the Proteograph assay also provides the greatest reproducibility of all methods except neat.
Changes to the current regulatory framework, including the imposition of additional or new regulations, could arise at any time during the development or marketing of our products. This may negatively affect our ability to obtain or maintain FDA or comparable regulatory clearance or approval of our products in the future.
Without timely regulatory approval, we will not be able to launch or successfully commercialize such diagnostic products. Changes to the current regulatory framework, including the imposition of additional or new regulations, could arise at any time during the development or marketing of our products.
The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026. Obtaining the requisite regulatory approvals, including the FDA quality system inspections that are required for PMA approval, can be expensive and may involve considerable delay.
Obtaining the requisite regulatory approvals, including the FDA quality system inspections that are required for PMA approval, can be expensive and may involve considerable delay. The regulatory approval process for such products may be significantly delayed, may be significantly more expensive than anticipated, and may conclude without such products being approved by the FDA.
If our products become subject to FDA regulation as medical devices, we would need to invest significant time and resources to ensure ongoing compliance with FDA quality system regulations and other post-market regulatory requirements. It is unclear how future legislation by federal and state governments and FDA regulation will impact the industry, including our business and that of our customers.
Further, the changes under the current, including new leadership at the FDA, reduced staff, funding for certain programs, and new executive and Congressional actions may result in new policies and regulations that can impact the compliance status of our products or that of our customers. 22 Table of Contents If our products become subject to FDA regulation as medical devices, we would need to invest significant time and resources to ensure ongoing compliance with FDA quality system regulations and other post-market regulatory requirements.
Diversity, equality and inclusion awareness were a part of our 2024 human capital strategy. As of December 31, 2024, 57% of our employees were women and/or people of color. Our human capital resources objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
Our human capital resources objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
On the individual level, each participant had on average 9,506 protein variants, of which 2,945 were potentially deleterious and 214 were loss-of-function variants. However, these variants were only identified at the genomic level and did not account for alternative splicing or post-translational modifications.
However, these variants were only identified at the genomic level and did not account for alternative splicing or post-translational modifications. Considering these additional sources of protein variants, the actual number of protein variants at both individual and population-wide levels is significantly higher.
Basic Research and Discovery Applications We believe that the Proteograph is a valuable tool for researchers across a wide range of basic research and discovery applications, including cataloging protein diversity, proteogenomics and exploring the interactome.
We believe the Proteograph is a valuable tool for basic research and discovery applications focused on comprehensive characterization of the proteome.
However, we believe that the capabilities of the Proteograph Product Suite may enable other applications in the future, including clinical and applied applications. Like the commercial impact of broadened access to genomics products, we believe the Proteograph will enable novel applications and insights, leading to new end-markets.
We currently sell and market the Proteograph Product Suite for research use only (RUO). However, we believe that the capabilities of the Proteograph Product Suite may enable other applications in the future, including clinical and applied applications.
A study by Backman et al. published in Nature revealed the genomic variation identified in a cohort of approximately 455,000 participants of the UK Biobank exome sequencing study. The study identified a vast amount of protein variation, including almost nine million protein variants, of which more than six million are potentially deleterious and 915,289 are protein loss-of-function variants.
The study identified a vast amount of protein variation, including almost nine million protein variants, of which more than six million are potentially deleterious and 915,289 are protein loss-of-function variants. On the individual level, each participant had, on average, 9,506 protein variants, of which 2,945 were potentially deleterious and 214 were loss-of-function variants.
To accommodate varying customer needs and scalability, we have designed the PAS to be cloud-based and, in the future, to be available via more localized solutions that accommodate different customer types and geographies. The PAS offers a predefined workflow for data management and analysis, leveraging publicly available MS data analysis tools as well as our own proprietary analysis tools.
PAS is currently offered as a cloud-based solution and, in the future, may be made available through localized deployment options to accommodate different customer requirements. PAS provides a predefined and scalable workflow that integrates publicly available MS data analysis tools with our proprietary analysis capabilities.
For example, two isoforms of the protein encoded by CD99L2 have different interacting proteins and those two proteins’ networks are related to distinct diseases (Yang et al. ). An example of a protein that has tissue-specific isoform abundance is FOX1, which has differential isoform presence in muscle and brain tissue (Nakahata and Kawamoto).
For example, two isoforms of the protein encoded by CD99L2 have different interacting proteins and those two proteins’ networks are related to distinct diseases (Yang et al. ). 2 Table of Contents A study by Backman et al. published in Nature revealed the genomic variation identified in a cohort of approximately 455,000 participants of the UK Biobank exome sequencing study.
The Proteograph XT assay employs two wells of NPs, assay buffers and reagents for protein lysis and digestion, peptide purification, peptide quantification and the reconstitution of lyophilized materials. The current product allows for the interrogation and processing of up to 40 samples in parallel on a single 96-well plate in approximately eight hours.
Proteograph ONE uses a single well of NPs along with assay buffers and reagents for protein lysis and digestion, peptide purification, peptide quantification, and reconstitution of lyophilized materials.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn addition, our restated certificate of incorporation and restated bylaws contain provisions that may make the acquisition of our company more difficult, including the following: • any transaction that would result in a change in control of our company requires the approval of a majority of our outstanding Class B common stock voting as a separate class; • our multi-class common stock structure provides our holders of Class B common stock with the ability to significantly influence the outcome of matters requiring stockholder approval, even if they own significantly less than a majority of the shares of our outstanding Class A common stock and Class B common stock; • certain amendments to our amended and restated certificate of incorporation require the approval of stockholders holding two-thirds of the voting power of our then outstanding capital stock; • any stockholder-proposed amendment to our amended and restated bylaws require the approval of stockholders holding two-thirds of the voting power of our then outstanding capital stock; • our stockholders may only be able to take action at a meeting of stockholders and may not be able to take action by written consent for any matter; • our stockholders are able to act by written consent only if the action is first recommended or approved by the board of directors; • vacancies on our board of directors may be filled only by our board of directors and not by stockholders; • only the chair of the board of directors, chief executive officer or a majority of the board of directors are authorized to call a special meeting of stockholders; • certain litigation against us can only be brought in Delaware; 83 Table of Contents • our restated certificate of incorporation authorizes undesignated preferred stock, the terms of which may be established and shares of which may be issued, without the approval of the holders of our capital stock; and • advance notice procedures apply for stockholders to nominate candidates for election as directors or to bring matters before an annual meeting of stockholders.
Biggest changeIn addition, our restated certificate of incorporation and restated bylaws contain provisions that may make the acquisition of our company more difficult, including the following: • certain amendments to our amended and restated certificate of incorporation require the approval of stockholders holding two-thirds of the voting power of our then outstanding capital stock; • any stockholder-proposed amendment to our amended and restated bylaws requires the approval of stockholders holding two-thirds of the voting power of our then outstanding capital stock; • our stockholders may only be able to take action at a meeting of stockholders and may not be able to take action by written consent for any matter; • our stockholders are able to act by written consent only if the action is first recommended or approved by the board of directors; • vacancies on our board of directors may be filled only by our board of directors and not by stockholders; • only the chair of the board of directors, chief executive officer or a majority of the board of directors are authorized to call a special meeting of stockholders; • certain litigation against us can only be brought in Delaware; • our restated certificate of incorporation authorizes undesignated preferred stock, the terms of which may be established and shares of which may be issued, without the approval of the holders of our capital stock; and • advance notice procedures apply for stockholders to nominate candidates for election as directors or to bring matters before an annual meeting of stockholders. 78 Table of Contents These anti-takeover defenses could discourage, delay, or prevent a transaction involving a change in control of our company.
Any of the above could cause investors to lose confidence in our reported financial information or our Class A common stock listing on Nasdaq to be suspended or terminated, which could have a negative effect on the trading price of our common stock.
Any of the above could cause investors to lose confidence in our reported financial information or our Class A common stock listing on Nasdaq to be suspended or terminated, which could have a negative effect on the trading price of our Class A common stock.
We have relied and expect to rely heavily on trade secrets and confidentiality agreements to protect our unpatented know-how, technology and other proprietary and confidential information, including parts of the Proteograph Product Suite and related services, and to maintain our competitive position. However, trade secrets and know-how can be difficult to protect.
We have relied and expect to rely heavily on trade secrets and confidentiality agreements to protect our unpatented know-how, technology and other proprietary and confidential information, including parts of the Proteograph Product Suite and related services, to maintain our competitive position. However, trade secrets and know-how can be difficult to protect.
In particular, we anticipate that with respect to our technologies, these trade secrets and know how will over time be disseminated within the industry through independent development, the publication of journal articles describing the methodology, and the movement of personnel between academia and industry.
In particular, we anticipate that with respect to our technologies, these trade secrets and know how will over time be disseminated within the industry through independent development, the publication of journal articles describing the methodology, and the movement of personnel in and between academia and industry.
As a result, the demand for the Proteograph Product Suite and related services depends upon the research and development budgets of these customers, which are impacted by factors beyond our control, such as: • decreases in government funding of research and development; • changes to programs that provide funding to research laboratories and institutions, including changes in the amount of funds allocated to different areas of research or changes that have the effect of increasing the length of the funding process; 47 Table of Contents • changes in strategy and funding by commercial companies in their efforts around therapeutic and diagnostic product development and their adoption and use of the Proteograph Product Suite; • macroeconomic conditions; • opinions in the scientific community, including researchers’ opinions of the utility of the Proteograph solution; • citation of the Proteograph Product Suite in published research; • potential changes in the regulatory environment; • differences in budgetary cycles, especially government- or grant-funded customers, whose cycles often coincide with government fiscal year ends; • competitor product or service offerings or pricing; • market-driven pressures to consolidate operations and reduce costs; and • market acceptance of relatively new technologies, such as the Proteograph Product Suite.
As a result, the demand for the Proteograph Product Suite and related services depends upon the research and development budgets of these customers, which are impacted by factors beyond our control, such as: • decreases in government funding of research and development; • changes to programs that provide funding to research laboratories and institutions, including changes in the amount of funds allocated to different areas of research or changes that have the effect of increasing the length of the funding process; 41 Table of Contents • changes in strategy and funding by commercial companies in their efforts around therapeutic and diagnostic product development and their adoption and use of the Proteograph Product Suite; • macroeconomic conditions; • opinions in the scientific community, including researchers’ opinions of the utility of the Proteograph solution; • citation of the Proteograph Product Suite in published research; • potential changes in the regulatory environment; • differences in budgetary cycles, especially government- or grant-funded customers, whose cycles often coincide with government fiscal year ends; • competitor product or service offerings or pricing; • market-driven pressures to consolidate operations and reduce costs; and • market acceptance of relatively new technologies, such as the Proteograph Product Suite.
New hires typically require significant training and, in many cases, take significant time before they achieve full productivity. Our failure to successfully integrate these key personnel into our business could adversely affect our business. In addition, competition for qualified personnel is intense, particularly in the San Francisco Bay Area and San Diego.
New hires typically require significant training and, in many cases, take significant time before they achieve full productivity. Our failure to successfully integrate these key personnel into our business could adversely affect our business. In addition, competition for qualified personnel is intense, particularly in the San Francisco Bay Area.
To determine the priority of these inventions, we may have to participate in interference proceedings, derivation proceedings or other post-grant proceedings declared by the USPTO, or other similar proceedings in non-U.S. jurisdictions, that could result in substantial cost to us and the loss of valuable patent protection. The outcome of such proceedings is uncertain.
To determine the priority of these inventions, we may have to participate in derivation proceedings or other post-grant proceedings declared by the USPTO, or other similar proceedings in non-U.S. jurisdictions, that could result in substantial cost to us and the loss of valuable patent protection. The outcome of such proceedings is uncertain.
We have limited experience producing and supplying our products, and we may be unable to consistently manufacture or source our SP100 automation instruments and consumables to the necessary specifications or in quantities necessary to meet demand on a timely basis and at acceptable performance and cost levels.
We have limited experience producing and supplying our products, and we may be unable to consistently manufacture or source our SP100 and SP200 automation instruments and consumables to the necessary specifications or in quantities necessary to meet demand on a timely basis and at acceptable performance and cost levels.
Use of open source software may also present additional security risks because the public availability of such software may make it easier for hackers and other third parties to compromise or attempt to compromise our technology platform and systems. 76 Table of Contents Although we review our use of open source software to avoid subjecting our proprietary software to conditions we do not intend, the terms of many open source software licenses have not been interpreted by United States courts, and there is a risk that these licenses could be construed in a way that could impose unanticipated conditions or restrictions on our ability to commercialize our products, services and proprietary software.
Use of open source software may also present additional security risks because the public availability of such software may make it easier for hackers and other third parties to compromise or attempt to compromise our technology platform and systems. 71 Table of Contents Although we review our use of open source software to avoid subjecting our proprietary software to conditions we do not intend, the terms of many open source software licenses have not been interpreted by United States courts, and there is a risk that these licenses could be construed in a way that could impose unanticipated conditions or restrictions on our ability to commercialize our products, services and proprietary software.
Other factors in achieving commercial market acceptance, include: • our ability to market and increase awareness of the capabilities of the Proteograph Product Suite; • the ability of the Proteograph Product Suite to perform intended use applications broadly in the hands of customers; • our customers’ willingness to adopt new products and workflows; 42 Table of Contents • the Proteograph’s ease of use and whether it reliably provides advantages over other alternative technologies; • the rate of adoption of the Proteograph Product Suite by academic institutions, laboratories, biopharmaceutical companies and others; • the prices we charge for the Proteograph Product Suite; • our ability to develop new products, services and solutions that achieve commercial market acceptance; • if competitors develop and commercialize products that perform similar functions as the Proteograph; and • the impact of our investments in product innovation and commercial growth.
Other factors in achieving commercial market acceptance, include: • our ability to market and increase awareness of the capabilities of the Proteograph Product Suite; • the ability of the Proteograph Product Suite to perform intended use applications broadly in the hands of customers; 36 Table of Contents • our customers’ willingness to adopt new products and workflows; • the Proteograph’s ease of use and whether it reliably provides advantages over other alternative technologies; • the rate of adoption of the Proteograph Product Suite by academic institutions, laboratories, biopharmaceutical companies and others; • the prices we charge for the Proteograph Product Suite; • our ability to develop new products, services and solutions that achieve commercial market acceptance; • if competitors develop and commercialize products that perform similar functions as the Proteograph; and • the impact of our investments in product innovation and commercial growth.
Any delay or failure by us to develop and release the Proteograph Product Suite or new products or product enhancements would have a substantial adverse effect on our business and results of operations. Our sales have been concentrated in a small number of customers.
Any delay or failure by us to develop and release new versions of or enhancements to the Proteograph Product Suite or new products or product enhancements would have a substantial adverse effect on our business and results of operations. Our sales have been concentrated in a small number of customers.
If operations at our facilities were disrupted, it may cause a material disruption in our business if we are not capable of restoring functionality on an acceptable timeframe. 87 Table of Contents In addition, our information technology systems, and those of our vendors, partners and customers, are potentially vulnerable to data security breaches, whether by internal bad actors, such as employees or other third parties with legitimate access to our or our third-party providers’ systems, or external bad actors, which could lead to the loss or exposure of personal data, sensitive data and confidential information to unauthorized persons.
If operations at our facilities were disrupted, it may cause a material disruption in our business if we are not capable of restoring functionality on an acceptable timeframe. 82 Table of Contents In addition, our information technology systems, and those of our vendors, partners and customers, are potentially vulnerable to data security breaches, whether by internal bad actors, such as employees or other third parties with legitimate access to our or our third-party providers’ systems, or external bad actors, which could lead to the loss or exposure of personal data, sensitive data and confidential information to unauthorized persons.
To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated bylaws also provide that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. 82 Table of Contents Any person or entity purchasing or otherwise acquiring or holding or owning (or continuing to hold or own) any interest in any of our securities shall be deemed to have notice of and consented to the foregoing bylaw provisions.
To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated bylaws also provide that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. 77 Table of Contents Any person or entity purchasing or otherwise acquiring or holding or owning (or continuing to hold or own) any interest in any of our securities shall be deemed to have notice of and consented to the foregoing bylaw provisions.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours, which could have a material adverse effect on our business, financial condition and results of operations. 69 Table of Contents We may become involved in lawsuits to defend against third-party claims of infringement, misappropriation or other violations of intellectual property or to protect or enforce our intellectual property, any of which could be expensive, time consuming and unsuccessful, and may prevent or delay our development and commercialization efforts.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours, which could have a material adverse effect on our business, financial condition and results of operations. 64 Table of Contents We may become involved in lawsuits to defend against third-party claims of infringement, misappropriation or other violations of intellectual property or to protect or enforce our intellectual property, any of which could be expensive, time consuming and unsuccessful, and may prevent or delay our development and commercialization efforts.
Moreover, there could be public announcements regarding any cybersecurity incidents and any steps we take to respond to or remediate such incidents, and if securities analysts or investors perceive these announcements to be negative, it could, among other things, have a material adverse effect on the price of our Class A common stock. 88 Table of Contents The cost of protecting against, investigating, mitigating and responding to potential breaches of our information technology systems and data security breaches and complying with applicable breach notification obligations to individuals, regulators, partners and others can be significant.
Moreover, there could be public announcements regarding any cybersecurity incidents and any steps we take to respond to or remediate such incidents, and if securities analysts or investors perceive these announcements to be negative, it could, among other things, have a material adverse effect on the price of our Class A common stock. 83 Table of Contents The cost of protecting against, investigating, mitigating and responding to potential breaches of our information technology systems and data security breaches and complying with applicable breach notification obligations to individuals, regulators, partners and others can be significant.
Such challenges may be brought either in court or by requesting that the USPTO, European Patent Office (EPO), or other foreign patent offices review the patent claims, such as in an ex-parte reexamination, inter partes review, post-grant review proceeding, opposition or other comparable proceeding.
Such challenges may be brought either in court or by requesting that the USPTO, European Patent Office, or other foreign patent offices review the patent claims, such as in an ex-parte reexamination, inter partes review, post-grant review proceeding, opposition or other comparable proceeding.
Furthermore, individuals executing agreements with us may have pre-existing or competing obligations to a third party, such as an academic institution, and thus an agreement with us may be ineffective in perfecting ownership of inventions developed by that individual, which could have a material adverse effect on our business, financial condition, results of operations, and prospects. 72 Table of Contents Furthermore, we or our licensor have been, or may be, subject to claims by former employees, consultants or other third parties asserting an ownership right in our owned or licensed patents or patent applications.
Furthermore, individuals executing agreements with us may have pre-existing or competing obligations to a third party, such as an academic institution, and thus an agreement with us may be ineffective in perfecting ownership of inventions developed by that individual, which could have a material adverse effect on our business, financial condition, results of operations, and prospects. 67 Table of Contents Furthermore, we or our licensor have been, or may be, subject to claims by former employees, consultants or other third parties asserting an ownership right in our owned or licensed patents or patent applications.
Without protection for the intellectual property we license, other companies might be able to offer substantially identical products and technologies for sale, which could materially adversely affect our competitive business position and harm our business prospects, financial condition or results of operations. 73 Table of Contents If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights necessary for developing and protecting our technologies, services and products, including the Proteograph Product Suite and related services, or we could lose certain rights to grant sublicenses.
Without protection for the intellectual property we license, other companies might be able to offer substantially identical products and technologies for sale, which could materially adversely affect our competitive business position and harm our business prospects, financial condition or results of operations. 68 Table of Contents If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights necessary for developing and protecting our technologies, services and products, including the Proteograph Product Suite and related services, or we could lose certain rights to grant sublicenses.
If we are unable to commercialize products or generate sufficient revenue, or if our operating results fall below the expectations of analysts or investors or below any guidance we may provide, or if the guidance we provide is below the expectations of analysts or investors, it could cause the market price of our Class A common stock to fluctuate or decline substantially. 40 Table of Contents The size of the markets for the Proteograph Product Suite may be smaller or different from estimated, and new market opportunities may not develop as quickly as we expect, or at all, limiting our ability to successfully sell our products.
If we are unable to commercialize products or generate sufficient revenue, or if our operating results fall below the expectations of analysts or investors or below any guidance we may provide, or if the guidance we provide is below the expectations of analysts or investors, it could cause the market price of our Class A common stock to fluctuate or decline substantially. 34 Table of Contents The size of the markets for the Proteograph Product Suite may be smaller or different from estimated, and new market opportunities may not develop as quickly as we expect, or at all, limiting our ability to successfully sell our products.
If our assumptions regarding these risks and uncertainties, which we use to plan and operate our business, are incorrect or change, or if we do not address these risks successfully, our results of operations could differ materially from our expectations, and our business, financial condition and results of operations could be adversely affected. 38 Table of Contents Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations of investors or security analysts or any guidance we may provide, and which may cause the price of our Class A common stock to fluctuate or decline substantially.
If our assumptions regarding these risks and uncertainties, which we use to plan and operate our business, are incorrect or change, or if we do not address these risks successfully, our results of operations could differ materially from our expectations, and our business, financial condition and results of operations could be adversely affected. 32 Table of Contents Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations of investors or security analysts or any guidance we may provide, and which may cause the price of our Class A common stock to fluctuate or decline substantially.
In addition, we may seek to obtain additional licenses from our licensor(s) and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensor(s), including by agreeing to terms that could enable third parties, including our competitors, to receive licenses to a portion of the intellectual property that is subject to our existing licenses and to compete with our products. 74 Table of Contents In addition, the agreements under which we currently and in the future license intellectual property or technology from third parties are complex and certain provisions in such agreements may be susceptible to multiple interpretations.
In addition, we may seek to obtain additional licenses from our licensor(s) and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensor(s), including by agreeing to terms that could enable third parties, including our competitors, to receive licenses to a portion of the intellectual property that is subject to our existing licenses and to compete with our products. 69 Table of Contents In addition, the agreements under which we currently and in the future license intellectual property or technology from third parties are complex and certain provisions in such agreements may be susceptible to multiple interpretations.
Congress of a new comprehensive federal data privacy law to which we would become subject if it is enacted. 89 Table of Contents Furthermore, regulations promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), establish privacy and security standards that limit the use and disclosure of individually identifiable health information (known as “protected health information”) and require the implementation of administrative, physical and technological safeguards to protect the privacy of protected health information and ensure the confidentiality, integrity and availability of electronic protected health information.
Congress of a new comprehensive federal data privacy law to which we would become subject if it is enacted. 84 Table of Contents Furthermore, regulations promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), establish privacy and security standards that limit the use and disclosure of individually identifiable health information (known as “protected health information”) and require the implementation of administrative, physical and technological safeguards to protect the privacy of protected health information and ensure the confidentiality, integrity and availability of electronic protected health information.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on our business, financial condition, results of operations and prospects. 71 Table of Contents Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on our business, financial condition, results of operations and prospects. 66 Table of Contents Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
If our sales and marketing efforts, and logistics capability, or those of any third-party sales and distribution partners, are not successful, the Proteograph may not gain market acceptance, which could materially impact our business operations. 43 Table of Contents Even if the Proteograph Product Suite is successfully commercialized and achieves broad scientific and market acceptance, if we fail to improve it or introduce compelling new products and services, our revenues and our prospects could be harmed.
If our sales and marketing efforts, and logistics capability, or those of any third-party sales and distribution partners, are not successful, the Proteograph may not gain market acceptance, which could materially impact our business operations. 37 Table of Contents Even if the Proteograph Product Suite is successfully commercialized and achieves broad scientific and market acceptance, if we fail to improve it or introduce compelling new products and services, our revenues and our prospects could be harmed.
Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects. 75 Table of Contents Certain of our in-licensed patents are, and our future owned and in-licensed patents may be, subject to a reservation of rights by one or more third parties, including government march-in rights, that may limit our ability to exclude third parties from commercializing products similar or identical to ours.
Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects. 70 Table of Contents Certain of our in-licensed patents are, and our future owned and in-licensed patents may be, subject to a reservation of rights by one or more third parties, including government march-in rights, that may limit our ability to exclude third parties from commercializing products similar or identical to ours.
The principal factors and uncertainties that make investing in our company risky include, among others: • we are an early-stage life sciences technology company with a history of net losses, which we expect to continue, and we may not be able to generate meaningful revenues or achieve and sustain profitability in the future; • we have a limited operating history, which may make it difficult to evaluate our current business and the prospects for our future viability, and to predict our future performance; • our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide; • the size of the markets for the Proteograph Product Suite may be smaller than estimated, and new market opportunities may not develop as quickly as we expect, or at all, limiting our ability to successfully sell our products; • we are in the early stages of our commercialization plan, and we may not be able to commercialize the Proteograph Product Suite as planned; • our commercialization success depends on broad scientific and market acceptance of the Proteograph, which we may fail to achieve; • even if the Proteograph Product Suite is successfully commercialized and achieves broad scientific and market acceptance, if we fail to improve it or introduce compelling new products or services, our revenues and our prospects could be harmed; • health epidemics could adversely impact our business and operations; • if we are unable to obtain and maintain sufficient intellectual property protection for our products and technology, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be impaired; 37 Table of Contents • if we are unable to identify and recruit qualified employees, and retain or maintain our employee base, it may adversely impact our business and operations; and • if we fail to maintain an effective system of internal controls, or otherwise fail to comply with the Sarbanes-Oxley Act of 2002, we may not be able to accurately and timely report our financial results, which may adversely affect our business and investor confidence in us and, as a result, the value of our Class A common stock.
The principal factors and uncertainties that make investing in our company risky include, among others: • we are a commercial-stage life sciences technology company with a history of net losses, which we expect to continue, and we may not be able to generate meaningful revenues or achieve and sustain profitability in the future; • we have a limited operating history, which may make it difficult to evaluate our current business and the prospects for our future viability, and to predict our future performance; • our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide; • the size of the markets for the Proteograph Product Suite may be smaller than estimated, and new market opportunities may not develop as quickly as we expect, or at all, limiting our ability to successfully sell our products; • we may not be able to commercialize the Proteograph Product Suite as planned; • our commercialization success depends on broad scientific and market acceptance of the Proteograph, which we may fail to achieve; • even if the Proteograph Product Suite is successfully commercialized and achieves broad scientific and market acceptance, if we fail to improve it or introduce compelling new products or services, our revenues and our prospects could be harmed; • health epidemics could adversely impact our business and operations; • if we are unable to obtain and maintain sufficient intellectual property protection for our products and technology, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be impaired; • if we are unable to identify and recruit qualified employees, and retain or maintain our employee base, it may adversely impact our business and operations; and 31 Table of Contents • if we fail to maintain an effective system of internal controls, or otherwise fail to comply with the Sarbanes-Oxley Act of 2002, we may not be able to accurately and timely report our financial results, which may adversely affect our business and investor confidence in us and, as a result, the value of our Class A common stock.
As a public company, we continue to bear all of the internal and external costs of preparing and distributing periodic public reports in compliance with our obligations under the securities laws. 84 Table of Contents In addition, regulations and standards relating to corporate governance and public disclosure, including SOX, and the related rules and regulations implemented by the SEC and Nasdaq have increased legal and financial compliance costs and make some compliance activities more time-consuming.
As a public company, we continue to bear all of the internal and external costs of preparing and distributing periodic public reports in compliance with our obligations under the securities laws. 79 Table of Contents In addition, regulations and standards relating to corporate governance and public disclosure, including SOX, and the related rules and regulations implemented by the SEC and Nasdaq have increased legal and financial compliance costs and make some compliance activities more time-consuming.
Although we possess insurance for damage to our property and the disruption of our business, and self-insure for earthquake risk, this insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all. 86 Table of Contents If we, or our vendors, partners or customers, experience a significant disruption in our information technology systems or breaches of data security, our business could be adversely affected.
Although we possess insurance for damage to our property and the disruption of our business, and self-insure for earthquake risk, this insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all. 81 Table of Contents If we, or our vendors, partners or customers, experience a significant disruption in our information technology systems or breaches of data security, our business could be adversely affected.
Due to the complex and technical nature of our products and technology and the dynamic market in which we compete, any failure to attract, train, retain and motivate qualified personnel could materially harm our business, results of operations, financial condition and prospects. 46 Table of Contents We expect to be dependent upon revenue generated from the sale of the Proteograph Product Suite and related services for the foreseeable future.
Due to the complex and technical nature of our products and technology and the dynamic market in which we compete, any failure to attract, train, retain and motivate qualified personnel could materially harm our business, results of operations, financial condition and prospects. 40 Table of Contents We expect to be dependent upon revenue generated from the sale of the Proteograph Product Suite and related services for the foreseeable future.
In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license intellectual property, or develop or commercialize current or future products. 66 Table of Contents We may not be aware of all third-party intellectual property rights potentially relating to our products or services.
In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license intellectual property, or develop or commercialize current or future products. 61 Table of Contents We may not be aware of all third-party intellectual property rights potentially relating to our products or services.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations or prospects. 70 Table of Contents We have, and may in the future, choose to challenge, including in connection with any allegation of patent infringement by a third party, the patentability, validity or enforceability of any third-party patent that we believe may have applicability in our field, and any other third-party patent that may be asserted against us.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations or prospects. 65 Table of Contents We have, and may in the future, choose to challenge, including in connection with any allegation of patent infringement by a third party, the patentability, validity or enforceability of any third-party patent that we believe may have applicability in our field, and any other third-party patent that may be asserted against us.
Failure to implement sufficient standards and practices for responsible corporate citizenship, support for local communities, employee diversity and human capital management, health and safety practices, supply chain management, and corporate governance can increase our costs of production, decrease our revenue, and negatively affect our reputation, employee retention, and the general willingness of customers and suppliers to do business with us and investors to invest in us.
Failure to implement the appropriate standards and practices for responsible corporate citizenship, support for local communities, employee diversity and human capital management, health and safety practices, supply chain management, and corporate governance can increase our costs of production, decrease our revenue, and negatively affect our reputation, employee retention, and the general willingness of customers and suppliers to do business with us and investors to invest in us.
Such mechanisms include ex parte re-examination, inter partes review, post-grant review, derivation and equivalent proceedings in non-U.S. jurisdictions, such as opposition proceedings. For example, on October 7, 2024, PreOmics GmbH and Biognosys AG filed a petition for Inter Partes Review before the USPTO (Case No. IPR2024-01473) challenging the validity of U.S.
Such mechanisms include ex parte re-examination, inter partes review, post-grant review, derivation and equivalent proceedings in non-U.S. jurisdictions, such as opposition proceedings. For example, on October 7, 2024, PreOmics GmbH and Biognosys AG filed a petition for Inter Partes Review before the USPTO (Case No. IPR2024-01473), challenging the validity of select claims of U.S.
In addition, courts outside the United States may be less willing to protect trade secrets. 67 Table of Contents We also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is possible that these security measures could be breached.
In addition, courts outside the United States may be less willing to protect trade secrets. 62 Table of Contents We also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is possible that these security measures could be breached.
Repurchasing our Class A common stock reduces the amount of cash we have available, and we may fail to realize the anticipated long-term stockholder value of any share repurchase program. 81 Table of Contents We have not paid dividends in the past and do not expect to pay dividends in the future, and, as a result, any return on investment may be limited to the value of our stock.
Repurchasing our Class A common stock reduces the amount of cash we have available, and we may fail to realize the anticipated long-term stockholder value of any share repurchase program. 76 Table of Contents We have not paid dividends in the past and do not expect to pay dividends in the future, and, as a result, any return on investment may be limited to the value of our stock.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects. 68 Table of Contents We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest thereby harming our competitive position.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects. 63 Table of Contents We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest thereby harming our competitive position.
To perform sales, marketing, distribution, and customer service and support successfully, we will face a number of risks, including: • our ability to attract, retain and manage the sales, marketing and customer service and support force necessary to commercialize and gain market acceptance for our technology; • the time and cost of establishing a specialized sales, marketing and customer service and support force; and • our sales, marketing and customer service and support force may be unable to initiate and execute successful commercialization activities.
To perform sales, marketing, distribution, and customer service and support successfully, we face a number of risks, including: • our ability to attract, retain and manage the sales, marketing and customer service and support force necessary to commercialize and gain market acceptance for our technology; • the time and cost of establishing a specialized sales, marketing and customer service and support force; and • our sales, marketing and customer service and support force may be unable to execute successful commercialization activities.
We have only recently initiated the broad commercialization of the Proteograph Product Suite and related products and services, and we may not be able to successfully execute on this phase as planned due to: • the inability to establish the capabilities and value proposition of the Proteograph Product Suite with key opinion leaders and other customers in a timely fashion; • delays or longer-than expected lead times in the sales cycle to establish customer contacts, complete responsive presentations including platform evaluations tailored to specific requests, and move expeditiously 41 Table of Contents from quote to order to revenue to receipt of payment due to budgetary or other constraints of academic organizations, laboratories, biopharmaceutical companies and others; • changing industry or market conditions, customer requirements or competitor offerings during broad commercialization; • delays in continuing the build-out of our sales, customer support and marketing organization as needed for broad commercialization; • delays in ramping up manufacturing, either internally or through our suppliers, to meet the expected demand for broad commercialization; and • the impact of health epidemics on the economy and research industries, our business operations, and resources and the operations of our customers, suppliers and supply chain, and distributors.
We have undertaken the broad commercialization of the Proteograph Product Suite and related products and services, and we may not be able to successfully execute on this phase as planned due to: • the inability to establish the capabilities and value proposition of the Proteograph Product Suite with key opinion leaders and other customers in a timely fashion; 35 Table of Contents • delays or longer-than expected lead times in the sales cycle to establish customer contacts, complete responsive presentations including platform evaluations tailored to specific requests, and move expeditiously from quote to order to revenue to receipt of payment due to budgetary or other constraints of academic organizations, laboratories, biopharmaceutical companies and others; • changing industry or market conditions, customer requirements or competitor offerings during broad commercialization; • delays in continuing the build-out of our sales, customer support and marketing organization as needed for broad commercialization; • delays in ramping up manufacturing, either internally or through our suppliers, to meet the expected demand for broad commercialization; and • the impact of health epidemics on the economy and research industries, our business operations, and resources and the operations of our customers, suppliers and supply chain, and distributors.
If we do not successfully manage our growth or financial resources, our business, results of operations, financial condition and prospects will be harmed. 45 Table of Contents We depend on our key personnel and other highly qualified personnel, and if we are unable to recruit, train and retain our personnel, we may not achieve our goals.
If we do not successfully manage our growth or financial resources, our business, results of operations, financial condition and prospects will be harmed. 39 Table of Contents We depend on our key personnel and other highly qualified personnel, and if we are unable to recruit, train and retain our personnel, we may not achieve our goals.
The outcome of patent litigation or other proceeding can be uncertain, and any attempt by us to enforce our patent rights against others or to challenge the patent rights of others may not be successful, or, regardless of success, may take substantial time and result in substantial cost, and may divert our efforts and attention from other aspects of our business.
The outcome of patent litigation or other proceedings can be uncertain, and any attempt by us to enforce our patent rights against others or to challenge the patent rights of others may not be successful, or, regardless of success, may take substantial time and result in substantial cost, and may divert our efforts and attention from other aspects of our business.
If our sales force is less successful than anticipated, we may not be successful in commercializing the Proteograph Product Suite. We have limited experience as a company in sales and marketing and our ability to successfully commercialize depends on our being able to attract customers for the Proteograph Product Suite.
If our sales force is less successful than anticipated, we may not be successful in commercializing the Proteograph Product Suite. We have limited experience as a company in sales and marketing and our ability to successfully commercialize and grow our revenue depends on our being able to attract customers for the Proteograph Product Suite.
Should any of these events occur, they could materially adversely affect our business, financial condition, results of operations and prospects. 77 Table of Contents Risks Related to Ownership of Our Class A Common Stock An active trading market for our Class A common stock may not be sustained.
Should any of these events occur, they could materially adversely affect our business, financial condition, results of operations and prospects. 72 Table of Contents Risks Related to Ownership of Our Class A Common Stock An active trading market for our Class A common stock may not be sustained.
Hallal’s appointment resolved any potential non-compliance with the applicable Nasdaq Listing Rules. There can be no assurance that we will be successful in maintaining the listing of our Class A common stock on the Nasdaq Global Select Market, or, if transferred, on the Nasdaq Capital Market.
Ro’s appointment resolved any potential non-compliance with the applicable Nasdaq Listing Rules. There can be no assurance that we will be successful in maintaining the listing of our Class A common stock on the Nasdaq Global Select Market, or, if transferred, on the Nasdaq Capital Market.
Although members of our management team have considerable industry experience, we need to expand our sales, marketing, distribution and customer service and support capabilities with the appropriate technical expertise during the commercialization of the Proteograph Product Suite and related products and services.
Although members of our management team have considerable industry experience, we need to enhance our sales, marketing, distribution and customer service and support capabilities with the appropriate technical expertise during the commercialization of the Proteograph Product Suite and related products and services.
These fluctuations may occur due to a variety of factors, many of which are outside of our control, including, but not limited to: • our ability to successfully commercialize the Proteograph Product Suite on our anticipated timeline; • our ability to offer high-quality services, including customer service; • the timing and cost of, and level of investment in, research and development and commercialization activities relating to the Proteograph Product Suite, including our SP100 automation instrument, proprietary engineered nanoparticle (NP) technology and Proteograph Analysis Suite software, which may change from time to time; • the level of demand for any products we are able to commercialize, particularly the Proteograph Product Suite, which may vary significantly from period to period; • our ability to drive adoption of the Proteograph in our target markets and our ability to expand into any future target markets; • our relationship with third-party distributorships, the quantity of our products they elect to hold in inventory, and their ability to promote and sell our products; • the prices at which we will be able to sell the Proteograph Product Suite and related services; • the volume and mix of our sales between the Proteograph Product Suite and associated consumables, or changes in the manufacturing or sales costs related to our products; • the length of time and unpredictable nature of the sales cycle; • the lead time needed to procure SP100 automation instruments from our third-party contract manufacturer; • the success of our sales force, which if less than anticipated, could significantly impair our ability to generate revenue; • the failure of customers to exercise Proteograph purchase options; • the effective and efficient use of our financial and other resources, including the timing and amount of expenditures that we may incur to develop, commercialize or acquire additional products and technologies or for other purposes, such as the expansion of our facilities; • changes in governmental funding of life sciences research and development or changes that impact budgets and budget cycles; • seasonal spending patterns and the ability to collect on the accounts receivable of our customers; • the timing of when we recognize revenue; 39 Table of Contents • future accounting pronouncements, changes in accounting rules and regulations, or modifications to our accounting policies; • the outcome of any future litigation or governmental investigations involving us, our industry or both; • higher than anticipated service, replacement and warranty costs; • the impact of health epidemics on the economy, investment in life sciences and research industries, our business operations, and resources and operations of our customers, suppliers, and distributors; • global supply chain interruptions; and • general industry, economic and market conditions such as inflation, interest rates, bank failures and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
These fluctuations may occur due to a variety of factors, many of which are outside of our control, including, but not limited to: • our ability to successfully grow revenue generated from sales of the Proteograph Product Suite on our anticipated timeline; • our ability to offer high-quality services, including customer service; • the timing and cost of, and level of investment in, research and development and commercialization activities relating to the Proteograph Product Suite, including our SP100 or SP200 automation instrument, proprietary engineered nanoparticle (NP) technology and Proteograph Analysis Suite software, which may change from time to time; • the level of demand for any products we are able to commercialize, particularly the Proteograph Product Suite, which may vary significantly from period to period; • our ability to drive adoption of the Proteograph in our target markets and our ability to expand into any future target markets; • our relationship with third-party distributorships, the quantity of our products they elect to hold in inventory, and their ability to promote and sell our products; • the prices at which we will be able to sell the Proteograph Product Suite and related services; • the volume and mix of our sales between the Proteograph Product Suite and associated consumables, or changes in the manufacturing or sales costs related to our products; • the length of time and unpredictable nature of the sales cycle; • the lead time needed to procure SP100 and SP200 automation instruments from our third-party contract manufacturer; • the success of our sales force, which if less than anticipated, could significantly impair our ability to generate revenue; • the failure of customers to exercise Proteograph purchase options; • the effective and efficient use of our financial and other resources, including the timing and amount of expenditures that we may incur to develop, commercialize or acquire additional products and technologies or for other purposes, such as share repurchases, investments or the expansion of our facilities; • changes in governmental funding of life sciences research and development or changes that impact budgets and budget cycles; • seasonal spending patterns and the ability to collect on the accounts receivable of our customers; 33 Table of Contents • the timing of when we recognize revenue; • future accounting pronouncements, changes in accounting rules and regulations, or modifications to our accounting policies; • the outcome of any future litigation or governmental investigations involving us, our industry or both; • higher than anticipated service, replacement and warranty costs; • the impact of health epidemics on the economy, investment in life sciences and research industries, our business operations, and resources and operations of our customers, suppliers, and distributors; • global supply chain interruptions; and • general industry, economic and market conditions such as inflation, tariffs and trade relations, interest rates, government shutdowns, bank failures and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
Any of these occurrences, and any new epidemics, could significantly harm our business, results of operations and financial condition. 44 Table of Contents Unfavorable U.S. or global economic conditions could adversely affect our ability to raise capital and our business, results of operations and financial condition.
Any of these occurrences, and any new epidemics, could significantly harm our business, results of operations and financial condition. 38 Table of Contents Unfavorable U.S. or global economic conditions could adversely affect our ability to raise capital and our business, results of operations and financial condition.
Any of the foregoing events could have a material adverse effect on our business, financial condition and results of operations. 63 Table of Contents The U.S. law relating to the patentability of certain inventions in the life sciences technology industry is uncertain and rapidly changing, which may adversely impact our existing patents or our ability to obtain patents in the future.
Any of the foregoing events could have a material adverse effect on our business, financial condition and results of operations. The U.S. law relating to the patentability of certain inventions in the life sciences technology industry is uncertain and rapidly changing, which may adversely impact our existing patents or our ability to obtain patents in the future.
If we are unable to enter or maintain such distribution arrangements on acceptable terms, or at all, we may not be able to successfully commercialize our products in certain countries. 53 Table of Contents Furthermore, distributors can choose the level of effort that they apply to selling our products relative to others in their portfolio.
If we are unable to enter or maintain such distribution arrangements on acceptable terms, or at all, we may not be able to successfully commercialize our products in certain countries. Furthermore, distributors can choose the level of effort that they apply to selling our products relative to others in their portfolio.
In addition, if an acquired business fails to meet our expectations, our operating results, business and financial condition may suffer. 56 Table of Contents We also may make investments in early-stage companies that we believe are advancing or developing new technologies applicable to our businesses. These investments are generally illiquid at the time of investment.
In addition, if an acquired business fails to meet our expectations, our operating results, business and financial condition may suffer. We also may make investments in early-stage companies that we believe are advancing or developing new technologies applicable to our businesses. These investments are generally illiquid at the time of investment.
We also compete with a number of companies that have developed, or are developing, proteomic products and solutions, such as Alamar Biosciences, Nautilus Biotechnology, Quanterix, Quantum-Si and Standard BioTools.
We also compete with a number of companies that have developed, or are developing, proteomic products and solutions, such as Alamar Biosciences, Nautilus Biotechnology, Quanterix, and Quantum-Si.
Given the complexity of this automation instrumentation, individual units may occasionally require additional installation and service time prior to becoming available for customer use. We leverage well-established unit operations to formulate and manufacture our NPs at our facilities in Redwood City, California.
Given the complexity of this automation instrumentation, individual units may occasionally require additional installation and service time prior to becoming available for customer use. 43 Table of Contents We leverage well-established unit operations to formulate and manufacture our NPs at our facilities in Redwood City, California.
The occurrence of any one or more of the foregoing could negatively affect our business, financial condition, and results of operations. As we commercialize the Proteograph Product Suite outside of the United States, our international business could expose us to business, regulatory, legal, political, operational, financial, and economic risks associated with doing business outside of the United States.
The occurrence of any one or more of the foregoing could negatively affect our business, financial condition, and results of operations. 46 Table of Contents As we commercialize the Proteograph Product Suite outside of the United States, our international business could expose us to business, regulatory, legal, political, operational, financial, and economic risks associated with doing business outside of the United States.
What constitutes a “sufficient” additional feature is uncertain. Furthermore, in view of these decisions, since December 2014, the USPTO has published and continues to publish revised guidelines for patent examiners to apply when examining process claims for patent eligibility. In addition, U.S.
What constitutes a “sufficient” additional feature is uncertain. Furthermore, in view of these decisions, since December 2014, the USPTO has published and continues to publish revised guidelines for patent examiners to apply when examining process claims for patent eligibility. 58 Table of Contents In addition, U.S.
Some of the factors that may cause the market price of our Class A common stock to fluctuate include, but are not limited to: • the degree to which our launch and commercialization of our products meets the expectations of securities analysts and investors; • actual or anticipated fluctuations in our operating results, including fluctuations in our quarterly and annual results; • revenue being less than anticipated or operating expenses being more than anticipated; 78 Table of Contents • the failure or discontinuation of any of our product development and research programs; • changes in the structure or funding of research at academic and research laboratories and institutions, including changes that would affect their ability to purchase our instruments or consumables; • the success of existing or new competitive businesses or technologies; • announcements about new research programs or products of our competitors; • developments or disputes concerning patent applications, issued patents or other proprietary rights; • the recruitment or departure of key personnel; • litigation and governmental investigations involving us, our industry or both; • regulatory or legal developments in the United States and other countries; • volatility and variations in market conditions in the life sciences technology sector generally, or the proteomics or genomics sectors specifically, including volatility in the stock prices of publicly held companies in our industry; • investor perceptions of us or our industry; • the level of expenses related to any of our research and development programs or products; • actual or anticipated changes in our estimates as to our financial results or development timelines, variations in our financial results or those of companies that are perceived to be similar to us or changes in estimates or recommendations by securities analysts, if any, that cover our Class A common stock or companies that are perceived to be similar to us; • whether our financial results meet the expectations of securities analysts or investors; • short-selling strategies that may drive down the price of our Class A common stock; • the announcement or expectation of additional financing efforts; • sales of our Class A common stock by us or sales of our Class A common stock or Class B common stock by our insiders or other stockholders, or future stock issuances; • the perceived solvency of financial institutions with which we have financial deposits or investments in excess of insurance limits; • general economic, industry and market conditions; and • health epidemics such as the COVID-19 pandemic, natural disasters or major catastrophic events. 79 Table of Contents Stock markets in general, and the market for life sciences technology companies in particular, have experienced significant price and volume fluctuations that have often been unrelated or disproportionate to changes in the operating performance, financial condition, or tangible asset value of the companies whose stock is experiencing those price and volume fluctuations.
Some of the factors that may cause the market price of our Class A common stock to fluctuate include, but are not limited to: • the degree to which our launch and commercialization of our products meets the expectations of securities analysts and investors; • actual or anticipated fluctuations in our operating results, including fluctuations in our quarterly and annual results; • revenue being less than anticipated or operating expenses being more than anticipated; 73 Table of Contents • the failure or discontinuation of any of our product development and research programs; • changes in the structure or funding of research at academic and research laboratories and institutions, including changes that would affect their ability to purchase our instruments or consumables; • the success of existing or new competitive businesses or technologies; • announcements about new research programs or products of our competitors; • developments or disputes concerning patent applications, issued patents or other proprietary rights; • the recruitment or departure of key personnel; • litigation and governmental investigations involving us, our industry or both; • regulatory or legal developments in the United States and other countries; • volatility and variations in market conditions in the life sciences technology sector generally, or the proteomics or genomics sectors specifically, including volatility in the stock prices of publicly held companies in our industry; • investor perceptions of us or our industry; • the level of expenses related to any of our research and development programs or products; • actual or anticipated changes in our estimates as to our financial results or development timelines, variations in our financial results or those of companies that are perceived to be similar to us or changes in estimates or recommendations by securities analysts, if any, that cover our Class A common stock or companies that are perceived to be similar to us; • whether our financial results meet the expectations of securities analysts or investors; • short-selling strategies that may drive down the price of our Class A common stock; • the announcement or expectation of additional financing efforts; • sales of our Class A common stock by us or sales of our Class A common stock by our insiders or other stockholders, or future stock issuances; • the perceived solvency of financial institutions with which we have financial deposits or investments in excess of insurance limits; • general economic, industry and market conditions, including government shutdowns or changes in tariffs or trade restrictions or relationships; and • health epidemics, natural disasters or major catastrophic events. 74 Table of Contents Stock markets in general, and the market for life sciences technology companies in particular, have experienced significant price and volume fluctuations that have often been unrelated or disproportionate to changes in the operating performance, financial condition, or tangible asset value of the companies whose stock is experiencing those price and volume fluctuations.
Risks Related to Our Business and Industry We are an early-stage life sciences technology company with a history of net losses, which we expect to continue, and we may not be able to generate meaningful revenues or achieve and sustain profitability in the future.
Risks Related to Our Business and Industry We are a commercial-stage life sciences technology company with a history of net losses, which we expect to continue, and we may not be able to generate meaningful revenues or achieve and sustain profitability in the future.
To the extent our broad commercial release phase is unsuccessful, our financial results will be adversely impacted. Even if we are able to execute on our commercialization plan, our success depends on broad scientific and market acceptance of the Proteograph Product Suite, which we may fail to achieve.
To the extent our broad commercialization plan is unsuccessful, our financial results will be adversely impacted. Even if we are able to execute on our commercialization plan, our success depends on broad scientific and market acceptance of the Proteograph Product Suite, which we may fail to achieve.
Due to the competition for qualified personnel in the San Francisco Bay Area and San Diego, we expect to continue to utilize foreign nationals to fill part of our recruiting needs.
Due to the competition for qualified personnel in the San Francisco Bay Area, we expect to continue to utilize foreign nationals to fill part of our recruiting needs.
A weak or declining economy, rising inflation, rising interest rates, or bank failures could strain our customers’ budgets or cause delays in their payments to us.
A weak or declining economy, rising inflation, rising interest rates, government shutdowns or bank failures could strain our customers’ budgets or cause delays in their payments to us.
This impact could have a material, adverse impact on our liquidity, capital resources, operations and business and those of the third parties on which we rely, such as the manufacturer of our SP100 automation instrument, Hamilton Company, and could worsen over time.
This impact could have a material, adverse impact on our liquidity, capital resources, operations and business and those of the third parties on which we rely, such as the manufacturer of our SP100 and SP200 automation instruments, Hamilton Company, and could worsen over time.
Any failure to compete effectively could materially and adversely affect our business, financial condition and operating results. We may need to raise additional capital to fund commercialization plans for the Proteograph Product Suite, including manufacturing, sales and marketing activities, expand our investments in research, and develop and commercialize new products and applications.
Any failure to compete effectively could materially and adversely affect our business, financial condition and operating results. 49 Table of Contents We may need to raise additional capital to fund commercialization plans for the Proteograph Product Suite, including manufacturing, sales and marketing activities, expand our investments in research, and develop and commercialize new products and applications.
Additionally, a new privacy law, the California Privacy Rights Act (CPRA), went into effect on January 1, 2023. The CPRA modifies the California Consumer Privacy Act (CCPA) significantly, potentially resulting in further uncertainty and requiring us to incur additional costs and expenses in an effort to comply.
Additionally, the California Privacy Rights Act (CPRA), which went into effect on January 1, 2023, modifies the California Consumer Privacy Act (CCPA) significantly, potentially resulting in further uncertainty and requiring us to incur additional costs and expenses in an effort to comply.
In addition, we cannot assure you that our competitors do not have or will not develop products or technologies that currently or in the future will enable them to produce competitive products with greater capabilities or at lower costs than ours or that are able to run comparable experiments at a lower total experiment cost.
In addition, we cannot assure you that our competitors do not have or will not develop products or technologies, including through the use of AI , that currently or in the future will enable them to produce competitive products with greater capabilities or at lower costs than ours or that are able to run comparable experiments at a lower total experiment cost.
Our ability to achieve and maintain scientific and commercial market acceptance of the Proteograph Product Suite will depend on a number of factors. We expect that the Proteograph will be subject to the market forces and adoption curves common to other new technologies. The market for proteomics and genomics technologies and products is in its early stages of development.
Our ability to achieve and maintain scientific and commercial market acceptance of the Proteograph Product Suite will depend on a number of factors. We believe that the Proteograph is subject to the market forces and adoption curves common to other new technologies. The market for novel proteomics technologies and products is in its early stages of development.
Foreign Corrupt Practices Act (FCPA), and other U.S. federal laws and regulations, including with respect to not doing business with sanctioned parties, as prohibited by the office of Foreign Asset Control; • export requirements and import or trade restrictions, including, without limitation, with respect to biological samples, and trade retaliation laws; • restrictions on both inbound and outbound cross-border investment, including enhanced oversight by the Committee on Foreign Investment in the United States (CFIUS) and substantial restrictions on investment from China; • laws and business practices favoring local companies; • risks associated with transactions or payments denominated in foreign currency, longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; 52 Table of Contents • changes in social, economic, political and climate conditions or in laws, regulations and policies governing foreign trade, manufacturing, research and development, investment, and climate control both domestically as well as in the other countries and jurisdictions in which we operate and into which we may sell our products, including as a result of the separation of the United Kingdom from the European Union (Brexit); • potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements, and other trade barriers; • difficulties and costs of staffing and managing foreign operations; and • difficulties protecting, maintaining, enforcing or procuring intellectual property rights.
Foreign Corrupt Practices Act (FCPA), and other U.S. federal laws and regulations, including with respect to not doing business with sanctioned parties, as prohibited by the office of Foreign Asset Control; • export requirements and import or trade restrictions, including, without limitation, with respect to biological samples, and trade retaliation laws; • restrictions on both inbound and outbound cross-border investment, including enhanced oversight by the Committee on Foreign Investment in the United States (CFIUS) and substantial restrictions on investment from China; • laws and business practices favoring local companies; • risks associated with transactions or payments denominated in foreign currency, longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; • changes in social, economic, political and climate conditions or in laws, regulations and policies governing foreign trade, manufacturing, research and development, investment, and climate control both domestically as well as in the other countries and jurisdictions in which we operate and into which we may sell our products; • potentially adverse consequences associated with tariffs, changes in trade restrictions or relationships, potential retaliatory tariffs and actions from other countries, customs charges, bureaucratic requirements, and other trade barriers; • difficulties and costs of staffing and managing foreign operations; and • difficulties protecting, maintaining, enforcing or procuring intellectual property rights.
We cannot predict the outcome of these judicial challenges or how Congress or the FDA will regulate LDTs in the future, or how that regulatory system will impact our business.
We cannot predict the outcome of these judicial challenges or how Congress or the FDA will regulate products in our industry in the future, or how that regulatory system will impact our business.
While this regulatory classification is exempt from certain FDA requirements, such as the need to submit a premarket notification commonly known as a 510(k), and some of the requirements of the FDA’s Quality System Regulations (QSRs), we would be subject to ongoing FDA “general controls,” which include compliance with FDA regulations for labeling, inspections by the FDA, complaint evaluation, corrections and removals reporting, promotional restrictions, reporting adverse events or malfunctions for our products, and general prohibitions against misbranding and adulteration.
While this regulatory classification is exempt from certain FDA requirements, such as the need to submit a premarket notification commonly known as a 510(k), and applicable requirements under FDA’s QMSR, we would be subject to ongoing FDA “general controls,” which include compliance with FDA regulations for labeling, inspections by the FDA, complaint evaluation, corrections and removals reporting, promotional restrictions, reporting adverse events or malfunctions for our products, and general prohibitions against misbranding and adulteration.
The multi-class structure of our common stock will have the effect of concentrating voting control with certain stockholders and it may depress the trading price of our Class A common stock.
The multi-class structure of our common stock had the effect of concentrating voting control with certain stockholders and it may depress the trading price of our Class A common stock.
We currently compete with life sciences technology and the diagnostic companies that are supplying components, products and services that serve customers engaged in proteomics analysis. These companies include Agilent Technologies, Bio-Techne, Bruker, Danaher, DiaSorin, and Thermo Fisher Scientific.
We face significant competition in the life sciences technology market. We currently compete with life sciences technology and the diagnostic companies that are supplying components, products and services that serve customers engaged in proteomics analysis. These companies include Agilent Technologies, Bio-Techne, Bruker, Danaher, DiaSorin, Illumina and Thermo Fisher Scientific.
We have and will continue to spend significant amounts of effort continuing to develop our software to meet our customers’ and potential customers’ evolving needs. There is no assurance that the development or deployment of our software will be compelling to our customers or function correctly.
We have and will continue to spend significant amounts of effort continuing to develop our software to meet our customers’ and potential customers’ evolving needs, including as a result of AI. There is no assurance that the development or deployment of our software will be compelling to our customers or function correctly.
As technologies change in the future for life sciences research tools, generally, and in proteomics and genomics technologies, specifically, we will be expected to upgrade or adapt the Proteograph solution to keep up with the latest technology.
As technologies change in the future for life sciences research tools, generally, and in proteomics and genomics technologies, specifically, including as a result of AI, we will be expected to upgrade or adapt the Proteograph solution to keep up with the latest technology.
Our instruments are manufactured at our third-party manufacturer’s facilities in Nevada, and our consumables are manufactured at various locations in the United States and internationally. 85 Table of Contents Our facilities in Redwood City and those of our third-party manufacturers are vulnerable to natural disasters, public health crises, including the impact of health epidemics such as the COVID-19 pandemic, climate change and catastrophic events.
Our instruments are manufactured at our third-party manufacturer’s facilities in Nevada, and our consumables are manufactured at various locations in the United States and internationally. 80 Table of Contents Our facilities in Redwood City and those of our third-party manufacturers are vulnerable to natural disasters, public health crises, including the impact of health epidemics, climate change and catastrophic events.
Additionally, there is ongoing uncertainty regarding the new U.S. presidential administration’s economic and other policies and priorities, such as potential changes in trade restrictions or relationships, tariffs and exchange controls, and potential retaliatory tariffs by other countries.
Additionally, there is ongoing uncertainty regarding the current administration’s economic and other policies and priorities, such as potential changes in trade restrictions or relationships, tariffs and exchange controls, and potential retaliatory tariffs by other countries.
If our distributors fail to effectively market and sell our products in full compliance with applicable laws and regulations, our results of operations and business may suffer. The life sciences technology market is highly competitive. If we fail to compete effectively, our business and results of operations will suffer. We face significant competition in the life sciences technology market.
If our distributors fail to effectively market and sell our products in full compliance with applicable laws and regulations, our results of operations and business may suffer. 48 Table of Contents The life sciences technology market is highly competitive. If we fail to compete effectively, our business and results of operations will suffer.
The area in which we compete involves rapid innovation and some of our customers have in the past, and more may in the future, elect to create their own assays rather than rely on a third-party supplier such as ourselves.
We also face competition from researchers developing their own products. The area in which we compete involves rapid innovation and some of our customers have in the past, and more may in the future, elect to create their own assays rather than rely on a third-party supplier such as ourselves.
There is no assurance that we or our third-party manufacturer will be able to continue to manufacture our SP100 automation instrument so that it consistently achieves the product specifications and produces results with acceptable quality. Our NPs and other consumables have a limited shelf life, after which their performance is not ensured.
There is no assurance that we or our third-party manufacturer will be able to continue to manufacture our SP100 and SP200 automation instruments so that they consistently achieve the product specifications and produce results with acceptable quality. Our NPs and other consumables have a limited shelf life, after which their performance is not ensured.
Budget cuts, layoffs at federal agencies, hiring freezes, return-to-office policies, and other measures taken by the new presidential administration, including measures by the Department of Government Efficiency, can have a material impact on our industry, including the business of our customers and our operations.
Budget cuts to research and federal agencies, layoffs at federal agencies, hiring freezes, return-to-office policies, the current government shutdown, lapse in government appropriations and other measures taken by the current administration, including measures by the Department of Government Efficiency, can have a material impact on our industry, including the business of our customers and our operations.
We are in the early stages of commercialization, and we may not be able to commercialize the Proteograph Product Suite as planned.
We are in the commercialization stage, and we may not be able to commercialize the Proteograph Product Suite as planned.
We are in the early stages of our commercialization plan and our revenues have been concentrated in a relatively small number of customers, including a related party, PrognomiQ. For the years ended December 31, 2024 and 2023, PrognomiQ accounted for 17% and 28% of our revenue, respectively.
We are executing on our commercialization plan and our revenues have been concentrated in a relatively small number of customers, including a related party, PrognomiQ. For the years ended December 31, 2025 and 2024, PrognomiQ accounted for 5% and 17% of our revenue, respectively.
Some of our current competitors are large publicly-traded companies, or are divisions of large publicly-traded companies, and may enjoy a number of competitive advantages over us, including: • greater name and brand recognition; • greater financial and human resources; • broader product lines; • larger sales forces and more established distributor networks; • substantial intellectual property portfolios; • larger and more established customer bases and relationships; and • better established, larger scale and lower cost manufacturing capabilities. 54 Table of Contents We also face competition from researchers developing their own products.
Some of our current competitors are large publicly-traded companies, or are divisions of large publicly-traded companies, and may enjoy a number of competitive advantages over us, including: • greater name and brand recognition; • greater financial and human resources; • broader product lines; • larger sales forces and more established distributor networks; • substantial intellectual property portfolios; • larger and more established customer bases and relationships; and • better established, larger scale and lower cost manufacturing capabilities.
We are also aware of an issued patent and pending patent application in Europe owned by a third party directed to a method of identifying biomarkers in biofluids using nanoparticles, which is projected to expire in 2037 without taking into account any possible patent term extensions.
We are also aware of pending patent applications in Europe and the United States owned by a third party directed to methods of identifying biomarkers in biofluids using nanoparticles, which is projected to expire in 2037 without taking into account any possible patent term extensions.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOur cybersecurity risk management program includes a cybersecurity incident response plan. 90 Table of Contents We design and assess our program based on recommendations from trusted sources, such as the National Institute of Standards and Technology and the Center for Internet Security, as well as information security standards issued by the International Organization for Standardization, including ISO 27001.
Biggest changeOur cybersecurity risk management program includes a cybersecurity incident response plan. 85 Table of Contents We design and assess our program based on recommendations from trusted sources, such as the National Institute of Standards and Technology and the Center for Internet Security, as well as information security standards issued by the International Organization for Standardization, including ISO 27001.
In addition, our VP of Information Technology updates the Audit Committee, as necessary, regarding any material cybersecurity incidents, as well as any incidents with lesser potential impact. 91 Table of Contents We have established an internal cross-functional Steering Committee and a leadership committee with the objective of overseeing the cyber security program, incidents, risks and initiatives.
In addition, our VP of Information Technology updates the Audit Committee, as necessary, regarding any material cybersecurity incidents, as well as any incidents with lesser potential impact. 86 Table of Contents We have established an internal cross-functional Steering Committee and a leadership committee with the objective of overseeing the cyber security program, incidents, risks and initiatives.
In 2024, our cybersecurity systems and processes achieved ISO 27001 certification. We use these cybersecurity frameworks and information security standards as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business.
In 2025, our cybersecurity systems and processes achieved ISO 27001 certification. We use these cybersecurity frameworks and information security standards as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business.

Item 2. Properties

Properties — owned and leased real estate

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Removed
In addition, we lease approximately 3,500 square feet of office space in San Diego, California under a lease that runs through July 2025.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeMine S afety Disclosures Not applicable. 92 Table of Contents PART II.
Biggest changeMine S afety Disclosures Not applicable. 87 Table of Contents PART II.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees. Dividend Policy We have not declared or paid any cash dividends on our capital stock since our inception.
Biggest changeHolders of Common Stock As of February 23, 2026, there were 27 holders of record of our Class A common stock. The actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.
Issuer Purchases of Equity Securities The following table represents a month-to-month summary of information with respect to purchases of common stock made during the three months ended December 31, 2024: Period Total Number of Shares Purchased (1) Average Price Paid per Share (2) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (3) Approximate Dollar Value (in thousands) of Shares that May Yet Be Purchased Under the Plans or Programs (3) October 1 - October 31 730,493 $ 1.95 730,493 $ 13,249 November 1 - November 30 — $ — — $ 13,249 December 1 - December 31 — $ — — $ 13,249 Total 730,493 $ 1.95 730,493 (1) All shares of common stock were retired upon repurchase.
Issuer Purchases of Equity Securities The following table represents a month-to-month summary of information with respect to purchases of common stock made during the three months ended December 31, 2025: Period Total Number of Shares Purchased (1) Average Price Paid per Share (2) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (3) Approximate Dollar Value (in thousands) of Shares that May Yet Be Purchased Under the Plans or Programs (3) October 1 - October 31 — $ — — $ 3,145 November 1 - November 30 — $ — — $ 3,145 December 1 - December 31 31,923 $ 1.79 31,923 $ 3,088 Total 31,923 $ 1.79 31,923 (1) All shares of common stock were retired upon repurchase.
We intend to retain future earnings, if any, to finance the operation and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future.
Dividend Policy We have not declared or paid any cash dividends on our capital stock since our inception. We intend to retain future earnings, if any, to finance the operation and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future.
Removed
Our Class B common stock is not listed or traded on any stock exchange. Holders of Common Stock As of February 26, 2025, there were 21 holders of record of our Class A common stock and 11 holders of record of our Class B common stock.
Added
On February 25, 2026, the Company's Board of Directors authorized an additional repurchase up to $25.0 million of its issued and outstanding Class A common stock. Item 6. [Res erved] 88 Table of Contents
Removed
Item 6. [Res erved] 93 Table of Contents

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeWe maintain a full valuation allowance on our domestic deferred tax assets as we have concluded that it is more likely than not that the deferred assets will not be realized. 96 Table of Contents Results of Operations Comparisons of the Years Ended December 31, 2024 and 2023 The following table summarizes our results of operations for the periods presented: Year ended December 31, Change 2024 2023 Amount % (dollars in thousands) Revenue: Product $ 8,695 $ 8,506 $ 189 2 % Service 2,960 2,016 944 47 % Related party 2,292 4,660 (2,368 ) (51 )% Grant and other 223 1,479 (1,256 ) (85 )% Total revenue 14,170 16,661 (2,491 ) (15 )% Cost of revenue: Product 4,402 5,398 (996 ) (18 )% Service 1,465 685 780 114 % Related party 712 1,430 (718 ) (50 )% Grant and other 536 642 (106 ) (17 )% Total cost of revenue 7,115 8,155 (1,040 ) (13 )% Gross profit 7,055 8,506 (1,451 ) (17 )% Operating expenses: Research and development 50,585 53,019 (2,434 ) (5 )% Selling, general and administrative 56,571 58,950 (2,379 ) (4 )% Total operating expenses 107,156 111,969 (4,813 ) (4 )% Loss from operations (100,101 ) (103,463 ) 3,362 (3 )% Other income (expense): Interest income 16,666 17,764 (1,098 ) (6 )% Loss on equity method investment (2,649 ) — (2,649 ) 100 % Other expense (417 ) (578 ) 161 (28 )% Total other income 13,600 17,186 (3,586 ) (21 )% Loss before provision for income taxes (86,501 ) (86,277 ) (224 ) 0 % Provision for income taxes 98 — 98 100 % Net loss $ (86,599 ) $ (86,277 ) $ (322 ) 0 % Revenue Year ended December 31, Change 2024 2023 Amount % (dollars in thousands) Revenue $ 14,170 $ 16,661 $ (2,491 ) (15 )% Revenue in fiscal year 2024 decreased by $2.5 million, or 15% as compared to the prior year.
Biggest changeWe maintain a full valuation allowance on our domestic deferred tax assets as we have concluded that it is more likely than not that the deferred assets will not be realized. 91 Table of Contents Results of Operations The following table summarizes our results of operations for the periods presented: Year ended December 31, Change 2025 2024 Amount % (dollars in thousands) Revenue: Product $ 11,207 $ 8,695 $ 2,512 29 % Service 4,151 2,960 1,191 40 % Related party 761 2,292 (1,531 ) (67 )% Other 459 223 236 106 % Total revenue 16,578 14,170 2,408 17 % Cost of revenue: Product 5,336 4,402 934 21 % Service 1,531 1,465 66 5 % Related party 224 712 (488 ) (69 )% Other 1,022 536 486 91 % Total cost of revenue 8,113 7,115 998 14 % Gross profit 8,465 7,055 1,410 20 % Operating expenses: Research and development 43,874 50,585 (6,711 ) (13 )% Selling, general and administrative 42,583 56,571 (13,988 ) (25 )% Total operating expenses 86,457 107,156 (20,699 ) (19 )% Loss from operations (77,992 ) (100,101 ) 22,109 (22 )% Other income (expense): Interest income 11,522 16,666 (5,144 ) (31 )% Loss on equity method investment (5,919 ) (2,649 ) (3,270 ) 123 % Other expense (1,010 ) (417 ) (593 ) 142 % Total other income 4,593 13,600 (9,007 ) (66 )% Loss before provision for income taxes (73,399 ) (86,501 ) 13,102 (15 )% Provision for income taxes 201 98 103 105 % Net loss $ (73,600 ) $ (86,599 ) $ 12,999 (15 )% Revenue Year ended December 31, Change 2025 2024 Amount % (dollars in thousands) Revenue $ 16,578 $ 14,170 $ 2,408 17 % Revenue in fiscal year 2025 increased by $2.4 million, or 17% as compared to the prior year.
Investing Activities In 2024, cash provided by investing activities was $65.9 million, which was attributable to the proceeds from maturities of available-for-sale securities of $342.0 million and proceeds from disposal of property and equipment of $0.3 million.
In 2024, cash provided by investing activities was $65.9 million, which was attributable to the proceeds from maturities of available-for-sale securities of $342.0 million and proceeds from disposal of property and equipment of $0.3 million.
Our future capital requirements will depend on many factors including our revenue growth rate, investments in continued commercialization efforts, acquisitions of complementary or enhancing technologies or businesses, including intellectual property rights, the timing and extent of additional capital expenditures to invest in existing and new facilities, the expansion of sales and marketing and international activities and the extent and magnitude of our ongoing research and development programs.
Our future capital requirements will depend on many factors including our revenue growth rate, investments in continued commercialization efforts, acquisitions of complementary or enhancing technologies or businesses, including intellectual property rights, the timing and extent of additional capital expenditures to invest in existing and new facilities and equipment, the expansion of sales and marketing and international activities and the extent and magnitude of our ongoing research and development programs.
Financing Activities In 2024, cash used in financing activities was $11.5 million, which was primarily attributable to the repurchases of Class A common stock under our share repurchase program of $11.8 million. This partially was offset by the proceeds of $0.3 million from the issuance of Class A common stock in connection with our employee stock purchase plan.
This partially was offset by the proceeds of $0.4 million from the issuance of Class A common stock in connection with the employee stock purchase plan. In 2024, cash used in financing activities was $11.5 million, which was primarily attributable to the repurchases of Class A common stock under our share repurchase program of $11.8 million.
Stock-Based Compensation Stock-based compensation expense relates to stock options with service-based vesting conditions, stock options with market-based vesting conditions, stock purchase rights under our employee stock purchase plan (ESPP), restricted common stock awards (RSAs) and restricted stock units (RSUs). All awards are measured at fair value on grant date and forfeitures are recognized as they occur.
Stock-Based Compensation Stock-based compensation expense relates to stock options with service-based vesting conditions, stock options with market-based vesting conditions, stock purchase rights under our employee stock purchase plan (ESPP), and restricted stock units (RSUs). All awards are measured at fair value on grant date and forfeitures are recognized as they occur.
We maintain a letter of credit issued to the lessor in the amount of $0.5 million as of each of December 31, 2024 and 2023, which is secured by restricted cash and is presented as noncurrent at each date based on the term of the underlying lease.
We maintain a letter of credit issued to the lessor in the amount of $0.5 million as of each of December 31, 2025 and 2024, which is secured by restricted cash and is presented as noncurrent at each date based on the term of the underlying lease.
Our expenses may increase in connection with our ongoing activities, as we: • broadly commercialize the Proteograph Product Suite; • attract, hire and retain qualified personnel; • continue to build our sales, marketing, service, support and distribution infrastructure as part of our commercialization efforts; • build-out and expand our in-house NP manufacturing capabilities; • continue to engage in research and development of other products and enhancements to the Proteograph Product Suite; • implement operational, financial and management information systems; • obtain, maintain, expand, and protect our intellectual property portfolio; and • build the infrastructure to operate and scale as a public company. 95 Table of Contents Components of Results of Operations Revenue Our product revenue consists of an instrument with embedded software essential to the instrument’s functionality and consumables.
Our expenses may increase in connection with our ongoing activities, as we: • broadly market and sell the Proteograph Product Suite; • attract, hire and retain qualified personnel; • continue to build our sales, marketing, service, support and distribution infrastructure as part of our commercialization efforts; • build-out and expand our in-house NP manufacturing capabilities; • continue to engage in research and development of other products and enhancements to the Proteograph Product Suite; • implement operational, financial and management information systems; • obtain, maintain, expand, and protect our intellectual property portfolio; and • build the infrastructure to operate and scale as a public company. 90 Table of Contents Components of Results of Operations Revenue Our product revenue consists of an instrument with embedded software essential to the instrument’s functionality and consumables.
If the product or service has no history of sales or if the sales volume is not sufficient, we rely upon prices set by management, adjusted for applicable discounts. 101 Table of Contents A portion of our revenue relates to lease arrangements.
If the product or service has no history of sales or if the sales volume is not sufficient, we rely upon prices set by management, adjusted for applicable discounts. A portion of our revenue relates to lease arrangements.
We intend to focus our commercial efforts in the United States and expect to grow our international presence. Cost of Revenue We utilize third-party manufacturers for production of our SP100 instrument and we manufacture our NPs and assemble our assay kits internally.
We intend to focus our commercial efforts in the United States and expect to grow our international presence. Cost of Revenue We utilize third-party manufacturers for production of our instruments and we manufacture our NPs and assemble our assay kits internally.
Cost of revenue consists primarily of costs of the components of the Proteograph Product Suite, including the SP100 instrument and consumables, cost of services related to the generation and analysis of proteomic data on behalf of our customers, and distribution-related expenses such as logistics and shipping costs.
Cost of revenue consists primarily of costs of the components of the Proteograph Product Suite, including the instruments and consumables, costs of services related to the generation and analysis of proteomic data on behalf of our customers, and distribution-related expenses such as logistics and shipping costs.
Payments associated with these agreements are not included in this discussion of contractual obligations. 98 Table of Contents Our operating lease obligations reflect our lease obligations for our office and laboratory space in Redwood City, California and office space in San Diego, California.
Payments associated with these agreements are not included in this discussion of contractual obligations. 93 Table of Contents Our operating lease obligations reflect our lease obligations for our office and laboratory space in Redwood City, California.
Our service revenue primarily consists of revenue received from the generation and analysis of proteomic data on behalf of customers. Our related party revenue is comprised of both product sales and services performed for related parties. Our grant and other revenue consists of research-related grants, lease arrangements, and shipping revenue. Our revenue is primarily generated domestically.
Our service revenue primarily consists of revenue received from the generation and analysis of proteomic data on behalf of the customer. Our related party revenue is comprised of both product sales and services performed for related parties. Other revenue consists of shipping revenue and lease arrangements. Our revenue is primarily generated domestically.
Product revenue consists of sales of an instrument with embedded software essential to the instrument’s functionality and consumables. Service revenue primarily consists of revenue received from the generation and analysis of proteomic data on behalf of our customers.
Revenue Recognition Our revenue is generated primarily from sales of products and services. Product revenue consists of sales of an instrument with embedded software essential to the instrument’s functionality and consumables. Service revenue primarily consists of revenue received from the generation and analysis of proteomic data on behalf of our customers.
In determining whether a transaction should be classified as a sales-type or operating lease, the Company considered the following criteria at lease commencement: (1) whether title of the instrument transfers automatically or for a nominal fee by the end of the lease term, (2) whether the present value of the minimum lease payments equals or exceeds substantially all of the fair value of the leased instrument, (3) whether the lease term is for the major part of the remaining economic life of the leased instrument, (4) whether the lease grants the lessee an option to purchase the leased instrument that the lessee is reasonably certain to exercise, and (5) whether the underlying instrument is of such a specialized nature that it is expected to have no alternative use to the Company at the end of the lease term.
If a standalone price is not available for a component, it is estimated using the best information available. 96 Table of Contents In determining whether a transaction should be classified as a sales-type or operating lease, the Company considered the following criteria at lease commencement: (1) whether title of the instrument transfers automatically or for a nominal fee by the end of the lease term, (2) whether the present value of the minimum lease payments equals or exceeds substantially all of the fair value of the leased instrument, (3) whether the lease term is for the major part of the remaining economic life of the leased instrument, (4) whether the lease grants the lessee an option to purchase the leased instrument that the lessee is reasonably certain to exercise, and (5) whether the underlying instrument is of such a specialized nature that it is expected to have no alternative use to the Company at the end of the lease term.
We expect to continue to incur significant losses and do not expect positive cash flows from operations for the foreseeable future.
We anticipate that we will continue to incur net losses and do not expect positive cash flows from operations for the foreseeable future.
The change in our net operating assets and liabilities was primarily due to an increase in inventory levels of $1.9 million for anticipated revenue growth and a $1.3 million increase in prepaid expenses and other current assets, which was partially offset by a decrease in accounts receivable of $0.3 million.
The change in our net operating assets and liabilities was primarily due to an increase in inventory levels of $2.7 million, a decrease in accrued liabilities and other liabilities of $1.4 million, and an increase of $0.1 million in prepaid expenses and other assets, which was partially offset by an increase in accounts payable of $3.4 million, a decrease in accounts receivable of $0.5 million, and an increase in deferred revenue of $0.2 million.
Our commercial strategy is focused on growing adoption by the research community of the Proteograph, expanding the installed base, increasing utilization to generate revenue from the purchase of Proteograph consumables and growing our service offering through the STAC.
Our commercial strategy is focused on growing adoption of the Proteograph by researchers in academic and commercial settings, expanding the installed base, increasing utilization to generate revenue from the purchase of Proteograph consumables and growing our service offering through the Seer Technology Access Center (STAC).
The change in our net operating assets and liabilities was primarily due to an increase in inventory levels of $2.7 million, a decrease in accrued liabilities and other liabilities of $1.4 million, and an increase of $0.1 million in prepaid expenses and other assets, which was partially offset by an increase in accounts payable of $3.4 million, a decrease in accounts receivable of $0.5 million, and an increase in deferred revenue of $0.2 million. 99 Table of Contents In 2023, cash used in operating activities was $59.1 million, attributable to a net loss of $86.3 million, partially offset by a net change in our net operating assets and liabilities of $2.7 million and non-cash charges of $29.9 million.
The change in our net operating assets and liabilities was primarily due to an increase in inventory levels of $2.9 million, a decrease of $1.6 million in prepaid expenses and other assets, which was partially offset by an increase in accounts payable of $1.1 million. 94 Table of Contents In 2024, cash used in operating activities was $46.1 million, attributable to a net loss of $86.6 million and a net change in our net operating assets and liabilities of $0.1 million, partially offset by non-cash charges of $40.6 million.
The decrease was primarily due to a $5.1 million decrease in stock-based compensation and a $2.3 million decrease in employee compensation costs. The decrease was offset by a $4.2 million increase in professional services and a $0.9 million increase in facility expenses.
The decrease was primarily due to a $9.2 million decrease in stock-based compensation, a $2.0 million decrease in professional services, a $0.9 million decrease in allocated costs, a $0.8 million decrease in business expenses, a $0.3 million decrease in facility expenses, a $0.3 million decrease in travel expenses, and a $0.2 million decrease in employee compensation costs.
Cash Flows The following table summarizes our cash flows for the periods indicated: Year ended December 31, 2024 2023 (in thousands) Net cash used in operating activities $ (46,109 ) $ (59,065 ) Net cash provided by investing activities 65,858 37,904 Net cash (used in) provided by financing activities (11,495 ) 452 Net increase (decrease) in cash, cash equivalents and restricted cash $ 8,254 $ (20,709 ) Operating Activities In 2024, cash used in operating activities was $46.1 million, attributable to a net loss of $86.6 million and a net change in our net operating assets and liabilities of $0.1 million, partially offset by non-cash charges of $40.6 million.
Cash Flows The following table summarizes our cash flows for the periods indicated: Year ended December 31, 2025 2024 (in thousands) Net cash used in operating activities $ (44,448 ) $ (46,109 ) Net cash provided by investing activities 61,548 65,858 Net cash used in financing activities (10,568 ) (11,495 ) Net increase in cash, cash equivalents and restricted cash $ 6,532 $ 8,254 Operating Activities In 2025, cash used in operating activities was $44.4 million, attributable to a net loss of $73.6 million and a net change in our net operating assets and liabilities of $0.6 million, partially offset by non-cash charges of $29.7 million.
Selling, General and Administrative Year ended December 31, Change 2024 2023 Amount % (dollars in thousands) Selling, general and administrative $ 56,571 $ 58,950 $ (2,379 ) (4 )% Selling, general and administrative expenses in fiscal year 2024 decreased by $2.4 million, or 4% as compared to the prior year.
Selling, General and Administrative Year ended December 31, Change 2025 2024 Amount % (dollars in thousands) Selling, general and administrative $ 42,583 $ 56,571 $ (13,988 ) (25 )% Selling, general and administrative expenses in fiscal year 2025 decreased by $14.0 million, or 25% as compared to the prior year.
The standalone selling price is based on the price we would separately sell that promised good or service to a customer. If a standalone price is not available for a component, it is estimated using the best information available.
The standalone selling price is based on the price we would separately sell that promised good or service to a customer.
For all service-based stock options granted, we calculate the expected term using the simplified method for “plain vanilla” stock option awards. For the expected volatility, we use a blended rate based on the historical volatility of the stock price of our Class A common stock and average volatility of our comparable publicly traded peer companies.
For all service-based stock options granted, we calculate the expected term using the simplified method for “plain vanilla” stock option awards. For the expected volatility, we use the historical volatility of the stock price of our Class A common stock. The risk-free interest rate is based on the yield available on U.S.
The Company also has certain contractual obligations for third-party technology used as part of its normal operations. The contractual obligations represent future cash commitments and liabilities under agreements with third parties and exclude orders for goods and services entered into in the normal course of business that are not enforceable or subject to change.
The contractual obligations represent future cash commitments and liabilities under agreements with third parties and exclude orders for goods and services entered into in the normal course of business that are not enforceable or subject to change. These outstanding commitments amounted to $0.4 million as of December 31, 2025.
Total Other Income Year ended December 31, Change 2024 2023 Amount % (dollars in thousands) Total other income $ 13,600 $ 17,186 $ (3,586 ) (21 )% Total other income in fiscal year 2024 decreased by $3.6 million, or 21% as compared to the prior year.
Total Other Income Year ended December 31, Change 2025 2024 Amount % (dollars in thousands) Total other income $ 4,593 $ 13,600 $ (9,007 ) (66 )% Total other income in fiscal year 2025 decreased by $9.0 million, or 66% as compared to the prior year.
We expect a highly efficient sales model because our workflow integrates with most existing proteomics laboratories’ workflows and also complements large-scale genomics research. We are focused on removing barriers to access to the Proteograph, including through the STAC service offering.
We expect a highly efficient sales model because our workflow integrates with most existing proteomics laboratories’ workflows and it also complements large-scale genomics research.
The expected dividend yield is assumed to be zero as we have never paid dividends and have no current plans to pay dividends on our common stock.
Treasury zero-coupon issues in effect at the time of grant for periods corresponding with the expected term of the options. The expected dividend yield is assumed to be zero as we have never paid dividends and have no current plans to pay dividends on our common stock.
We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates. 95 Table of Contents While our significant accounting policies are described in the notes to our consolidated financial statements, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results.
The decrease was primarily due to the loss in the equity method investment and lower rates of interest earned on cash invested in money market funds, U.S. Treasury securities, commercial paper, and corporate debt securities. Liquidity and Capital Resources Since the date of our incorporation, we have incurred significant operating losses and negative cash flows from operations.
The decrease was primarily due to the loss in the equity method investment and lower rates of interest earned on cash invested in money market funds, U.S. Treasury securities, U.S. Non-Treasury securities, commercial paper, and corporate debt securities and loss on asset disposals.
We obtain some of the reagents and components used in the Proteograph workflow from third-party suppliers. While some of these reagents and components are currently sourced from a single supplier, these products are readily available from numerous suppliers.
While some of these reagents and components are currently sourced from a single supplier, these products are readily available from numerous suppliers. While we currently perform some filling and packaging of the Proteograph assay and the related consumables, we may eventually have our filling and packaging outsourced to a third party.
These outstanding commitments amounted to $4.5 million as of December 31, 2024. We take a long-term view in growing and scaling our business and regularly review opportunities that meet our long-term growth objectives.
We take a long-term view in growing and scaling our business and regularly review opportunities that meet our long-term growth objectives.
Cost of Revenue Year ended December 31, Change 2024 2023 Amount % (dollars in thousands) Cost of revenue $ 7,115 $ 8,155 $ (1,040 ) (13 )% 97 Table of Contents Cost of revenue in fiscal year 2024 decreased by $1.0 million, or 13% as compared to the prior year.
The increase was due to higher product sales and service revenue. Cost of Revenue Year ended December 31, Change 2025 2024 Amount % (dollars in thousands) Cost of revenue $ 8,113 $ 7,115 $ 998 14 % Cost of revenue in fiscal year 2025 increased by $1.0 million, or 14% as compared to the prior year.
In addition, we will continue to build the necessary infrastructure for these activities in the United States, European Union, the United Kingdom, and other countries and regions, including Asia-Pacific, as we execute on our commercialization strategy for the Proteograph. 94 Table of Contents We leverage well-established unit operations to formulate and manufacture our NPs at our facilities in Redwood City, California.
We have built, and will continue to build our sales, marketing, support and product distribution capabilities. In addition, we will continue to build the necessary infrastructure for these activities in the United States, European Union, the United Kingdom, and other countries and regions, including Asia-Pacific, as we execute on our commercialization strategy for the Proteograph.
Non-cash charges primarily consisted of stock-based compensation of $34.4 million, $5.6 million of depreciation and amortization, $0.8 million of provision for inventory excess and obsolescence, $0.4 million of loss on disposal of property and equipment, and $0.2 million of non-cash operating lease expense, offset by $11.5 million of net accretion of premiums on available-for-sale securities.
Non-cash charges primarily consisted of $15.4 million of stock-based compensation, $6.1 million of depreciation and amortization, $5.9 million of loss on equity method investment, $1.1 million of net amortization of premium on available-for-sale securities, and $1.0 million of loss on disposal of property and equipment.
Starting in January 2025, we renewed the agreement under an extended term through December 2027. Following this extended term, the agreement will automatically renew annually for a maximum of two one-year renewal periods. Hamilton has represented to us that it maintains ISO 9001 and ISO 13485 certifications.
We have entered into a non-exclusive agreement with Hamilton that covers the manufacturing of the automation instrument and its continued supply on a purchase order basis. Starting in January 2025, we renewed the agreement under an extended term through December 2027. Following this extended term, the agreement will automatically renew annually for a maximum of two one-year renewal periods.
Assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and we use significantly different assumptions or estimates, our equity-based compensation could be materially different.
We will continue to use judgment in evaluating the expected volatility, expected terms, and interest rates utilized for our stock-based compensation calculations on a prospective basis. Assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted involve inherent uncertainties and the application of significant judgment.
Our ability to generate product and service revenue sufficient to achieve profitability, if ever, will depend on the successful commercialization of the Proteograph Product Suite and related products and services. We are commercializing the Proteograph Product Suite as an integrated solution comprised of consumables, our SP100 automation instrument and software.
Our ability to generate product and service revenue sufficient to achieve profitability, if ever, will depend on the successful commercialization of the Proteograph Product Suite and related products and services. In May 2025, we advanced our commercial offering with the launch of the new Proteograph Product Suite, featuring the Proteograph ONE assay and SP200 automation instrument.
The decrease was primarily due to lower headcount which resulted in a decrease in employee compensation costs of $2.3 million and a decrease of $1.2 million in stock-based compensation. The decrease was offset by a $1.1 million increase in laboratory expenses.
The decrease was primarily due to a $2.5 million decrease in stock-based compensation, a $2.2 million decrease in allocated costs, a $1.6 million decrease in laboratory expenses, and a $0.5 million decrease in professional services.
We procure certain components of our consumables from third-party manufacturers, which includes the commonly-available raw materials needed for manufacturing our proprietary engineered NPs. We are currently manufacturing using our production-scale and pilot lines and continue to build out our manufacturing capabilities to support broad commercial availability of our products.
We are currently manufacturing using our production-scale lines and continue to build out our manufacturing capabilities to support broad commercial availability of our products. We obtain some of the reagents and components used in the Proteograph workflow from third-party suppliers.
In 2023, cash provided by investing activities was $37.9 million, which related to the proceeds from maturities of available-for-sale securities of $445.3 million and proceeds from sale of available-for-sale securities of $3.0 million. This was offset by the purchases of available-for-sale securities of $403.1 million and purchases of property and equipment, primarily for laboratory equipment, of $7.3 million.
Investing Activities In 2025, cash provided by investing activities was $61.5 million, which was attributable to the proceeds from maturities of available-for-sale securities of $237.8 million and proceeds from disposal of property and equipment of $0.6 million.
While we currently perform some filling and packaging of the Proteograph assay and the related consumables, we may eventually have our filling and packaging outsourced to a third party. We conduct vendor and component qualification for components provided by third-party suppliers and quality control tests on our NPs.
We conduct vendor and component qualification for components provided by third-party suppliers and quality control tests on our NPs. We designed the automation instrument and have outsourced its manufacturing to Hamilton Company, a leading manufacturer of automated liquid handling workstations.
In 2023, cash provided by financing activities was $0.5 million, which was primarily attributable to proceeds of $0.4 million from the issuance of Class A common stock in connection with our employee stock purchase plan and net proceeds of $0.1 million from the exercise of stock options.
This partially was offset by the proceeds of $0.3 million from the issuance of Class A common stock in connection with our employee stock purchase plan.
Cash received from customers in advance of product shipment or providing services is recorded as a contract liability. Our contracts with our customer generally do not include rights of return. At times, we may enter into arrangements with payment terms which exceed one year from the transfer of control of the product or service.
Cash received from customers in advance of product shipment or providing services is recorded as a contract liability. Our contracts with our customer generally do not include rights of return. We have elected the practical expedient to account for shipping and handling activities that occur after the customer has obtained control as a fulfillment activity.
Research and Development Year ended December 31, Change 2024 2023 Amount % (dollars in thousands) Research and development $ 50,585 $ 53,019 $ (2,434 ) (5 )% Research and development expenses in fiscal year 2024 decreased by $2.4 million, or 5% as compared to the prior year.
The increase was primarily due to higher volume from consumables sales. 92 Table of Contents Research and Development Year ended December 31, Change 2025 2024 Amount % (dollars in thousands) Research and development $ 43,874 $ 50,585 $ (6,711 ) (13 )% Research and development expenses in fiscal year 2025 decreased by $6.7 million, or 13% as compared to the prior year.
Our operations have been funded primarily through the sale and issuance of equity securities since inception. We anticipate that we will continue to incur net losses and do not expect positive cash flows from operations for the foreseeable future.
Liquidity and Capital Resources Since the date of our incorporation, we have incurred significant operating losses and negative cash flows from operations. Our operations have been funded primarily through the sale and issuance of equity securities since inception.
During the years ended December 31, 2024 and 2023, we incurred a net loss of $86.6 million and $86.3 million and used $46.1 million and $59.1 million of cash in operations, respectively. As of December 31, 2024, we had an accumulated deficit of $392.4 million and cash, cash equivalents, and investments of $299.5 million.
Hamilton has represented to us that it maintains ISO 9001 and ISO 13485 certifications. During the years ended December 31, 2025 and 2024, we incurred a net loss of $73.6 million and $86.6 million and used $44.4 million and $46.1 million of cash in operations, respectively.
We are broadly commercializing the Proteograph Product Suite through a direct sales channel in the United States, and through both direct and distributor sales channels in regions outside the United States. Since we are in the early stages of commercialization, we have built, and will continue to build our sales, marketing, support and product distribution capabilities.
We are focused on removing barriers to access to the Proteograph, including through the STAC service offering. 89 Table of Contents We sell the Proteograph Product Suite through a direct sales channel in the United States, and through both direct and distributor sales channels in regions outside the United States.
Removed
We designed the SP100 automation instrument and have outsourced its manufacturing to Hamilton Company, a leading manufacturer of automated liquid handling workstations. We have entered into a non-exclusive agreement with Hamilton that covers the manufacturing of the SP100 automation instrument and its continued supply on a purchase order basis.
Added
With the new Proteograph workflow, we believe we have achieved a transformative milestone by significantly improving the performance and scalability of deep, unbiased proteomic analysis.
Removed
The decrease was primarily due to lower related party product sales and no grant revenue being recognized during the period. The decrease was partially offset by an increase in service revenue.
Added
These advancements push the boundaries of the original capabilities of the Proteograph Product Suite launched in 2021, further addressing limitations in deep, unbiased proteomic workflows, including prohibitive costs of large-scale studies, time-consuming manual workflows, and performance variability introduced by manual handling.
Removed
The decrease was primarily due to lower product revenue from fewer instrument sales, which has a higher cost of revenue.
Added
We market and sell the Proteograph Product Suite as an integrated solution comprised of consumables, our automation instrument and software.
Removed
We lease approximately 3,500 square feet of office space in San Diego, California under a lease that runs through July 2025. We have certain purchase commitments related to our inventory management with certain manufacturing suppliers wherein we are required to purchase the amounts forecasted in a blanket purchase order within a certain time period.
Added
We leverage well-established unit operations to formulate and manufacture our NPs at our facilities in Redwood City, California. We procure certain components of our consumables from third-party manufacturers, which includes the commonly-available raw materials needed for manufacturing our proprietary engineered NPs.
Removed
While our significant accounting policies are described in the notes to our consolidated financial statements, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results. 100 Table of Contents Revenue Recognition Our revenue is generated primarily from sales of products and services.
Added
As of December 31, 2025, we had an accumulated deficit of $466.0 million and cash, cash equivalents, and investments of $240.6 million. We expect to continue to incur significant losses and do not expect positive cash flows from operations for the foreseeable future.
Removed
In such cases, we assess whether the arrangement contains a significant financing component. If a significant financing component exists, the transaction price is adjusted for the financing portion of the arrangement, which is recorded as interest income over the payment term using the effective interest method.
Added
From time to time, we have certain purchase commitments related to our inventory management, cloud-based information systems, property and equipment maintenance and support services, and various other products and services over periods that extend beyond one year.
Removed
We do not assess whether a significant financing component exists when, at contract inception, the period between the transfer of control to a customer and final payment is one year or less. We have elected the practical expedient to account for shipping and handling activities that occur after the customer has obtained control as a fulfillment activity.
Added
This was offset by the purchases of available-for-sale securities of $173.2 million, purchase of investment in equity security of $1.9 million, and purchases of property and equipment of $1.8 million, which was primarily for laboratory equipment.
Removed
The comparable companies were chosen based on their similar size, life cycle stage, or area of specialty. The risk-free interest rate is based on the yield available on U.S. Treasury zero-coupon issues in effect at the time of grant for periods corresponding with the expected term of the options.
Added
Financing Activities In 2025, cash used in financing activities was $10.6 million, which was primarily attributable to the repurchases of Class A common stock under our share repurchase program of $10.2 million and the taxes withholding payments related to net settlement of restricted stock units of $0.8 million.
Removed
We value RSAs based on the difference between the fair value of the underlying stock at the measurement date and the purchase price.
Added
As a result, if factors or expected outcomes change and we use significantly different assumptions or estimates, our stock-based compensation could be materially different. Recent Accounting Pronouncements See Note 2. Summary of Significant Accounting Policies of the Notes to Consolidated Financial Statements in Item 8.
Removed
We value RSUs based on the fair value of the underlying stock at the measurement date. 102 Table of Contents We will continue to use judgment in evaluating the expected volatility, expected terms, and interest rates utilized for our stock-based compensation calculations on a prospective basis.
Added
Financial Statements and Supplementary Data for additional information regarding recent accounting pronouncements, including the respective expected dates of adoption and estimated effects, if any, on our consolidated financial statements. 97 Table of Contents
Removed
Recent Accounting Pronouncements See Note 2 to our consolidated financial statements included elsewhere in this Annual Report for more information about recent accounting pronouncements, the timing of their adoption, and our assessment, to the extent we have made one yet, of their potential impact on our financial condition of results of operations.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk Interest Rate Risk We have exposure to interest rate risk that relates to our cash and cash equivalents and investments held in money market funds, U.S. Treasury securities, commercial paper, corporate debt securities and government agency debt. The goals of our investment policy are liquidity and capital preservation.
Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk Interest Rate Risk We have exposure to interest rate risk that relates to our cash and cash equivalents and investments held in money market funds, U.S. Treasury securities, U.S. Non-Treasury securities, commercial paper, and corporate debt securities. The goals of our investment policy are liquidity and capital preservation.

Other SEER 10-K year-over-year comparisons