What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-03-02 compared with 2025-03-17 · 334 added, 273 removed, 250 unchanged (71% of the section changed)

We are a life sciences company that develops and commercializes next-generation, ultra-sensitive digital immunoassay platforms that advance life sciences research and diagnostics.

Our platforms are based on our proprietary digital “ Simoa ” detection technology and enable customers to reliably detect protein biomarkers at ultra-low concentrations in blood, serum and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies.

The ability of our Simoa platforms to detect proteins in the femtomolar range enables the development of novel therapies and diagnostics and has the potential to identify early-stage disease markers before symptoms appear to facilitate a paradigm shift in healthcare from an emphasis on later-stage treatment to a focus on earlier detection, monitoring, prognosis, and, ultimately, prevention.

Our Simoa platforms have achieved significant commercial adoption with an installed base of over 1,000 instruments, and scientific validation with citations in more than 3,200 scientific publications in areas of high unmet medical need and research interest such as neurology, oncology and immunology, and inflammation.

We are a life sciences company transforming healthcare innovation by accelerating biomarker breakthroughs from discovery to diagnostics using our ultra-sensitive translational research and spatial biology instruments, consumables, and services.

We continue to invest in pushing a paradigm shift in healthcare from an emphasis on later-stage treatment to a focus on earlier detection, monitoring, prognosis, and, ultimately, prevention.

Our combined platforms have achieved significant commercial adoption with an installed base of over 2,500 instruments and scientific validation with citations in more than 6,200 scientific publications in areas of high unmet medical need and research interest such as neurology, oncology, immunology, and inflammation.

Our proprietary digital “Simoa” detection technology enables customers to reliably detect protein biomarkers at ultra-low concentrations in blood, serum and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies.

Multi-plexing biomarker analysis in tissue samples with our “Spatial Biology” platforms enables scientists to understand the localized interactions occurring on the cellular level.

We believe our combination of technologies will enable scientists to help drive diagnostic innovation in the evolving healthcare landscape with data across the tissue to fluid continuum.

Currently, the ability of our Simoa platforms to detect proteins in the femtomolar range is enabling the development of novel therapies and diagnostics and has the potential to identify early-stage disease markers before symptoms appear.

We sell our proprietary instruments and related consumables worldwide to research laboratories, contract research organizations ("CROs"), academic institutions, and bio-pharmaceutical companies.

In addition, we provide assay development and sample testing services, including four Laboratory Developed Tests (“LDT”), using our proprietary technology through our Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified Accelerator Laboratory (the “Accelerator Laboratory”) located in Billerica, Massachusetts.

In addition, we provide contract research services and clinical laboratory testing services, including four Laboratory Developed Tests ("LDTs"), using our proprietary technology and platforms through our Accelerator Laboratory, which is certified under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA"), located in Bedford, Massachusetts (the "Accelerator Laboratory").

Recent Developments

Acquisition of Emission, Inc.

On January 8, 2025, we acquired all of the issued and outstanding shares of capital stock of Emission, Inc.

(“Emission”) for an upfront payment of $10.0 million, with an additional $10.0 million payable upon completion of certain technical milestones.

Additionally, the shareholders of Emission (collectively, the “Emission Shareholders”) may receive up to an additional $50.0 million in earnout payments through December 31, 2029, contingent upon the achievement of certain performance milestones.

Emission is based in Georgetown, Texas and manufactures large-scale, highly-uniform dye-encapsulating magnetic beads designed for low and mid-plex assays and a mid-plex platform that reads its proprietary beads.

In connection with the closing, the parties entered into a call option agreement (the “Option Agreement”), pursuant to which the Emission Shareholders have the right to repurchase all of the outstanding capital stock of Emission for $10.0 million after five years if Emission’s revenues do not exceed $5.0 million in any one year during such five-year period.

If the Emission Shareholders exercise the right to repurchase Emission under the Option Agreement and consummate the repurchase, we will retain a perpetual, fully-paid, irrevocable license to all Emission intellectual property required to continue to manufacture and commercialize our products.

The acquisition of Emission allows us to secure the supply of highly controlled beads for use in our next generation Simoa ONE instrument that we expect to launch by the end of 2025.

It also allows us to develop a new multi-plex segment targeting third-party OEM customers for these beads, which we have branded as Nova Beads.

Agreement to Acquire Akoya Biosciences, Inc.

On January 9, 2025, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) to acquire Akoya Biosciences, Inc.

(“Akoya”), a life sciences technology company delivering spatial biology solutions through the power of spatial phenotyping.

Spatial phenotyping refers to a rapidly evolving technology that enables academic and biopharma scientists to detect and map the distribution of cell types and biomarkers across whole tissue samples at single-cell resolution, enabling advancements in their understanding of disease progression and patient response to therapy.

Recent Board of Directors and Management Transitions

In the second half of 2025, four new directors joined our board of directors and four previous members of our board of directors departed, including Dr.

David Walt, our founding scientist.

Additionally, in January 2026 Dr.

Masoud Toloue left the company, and Everett Cunningham became our Chief Executive Officer and joined our board of directors.

The selection process for these new board members and our CEO reflects a deliberate enhancement of technology, commercial, spatial, and diagnostics expertise across our leadership and board of directors.

Acquisition of Akoya Biosciences, Inc.

On July 8, 2025, we acquired Akoya Biosciences, Inc.

("Akoya"), a life sciences technology company based in Marlborough, Massachusetts delivering spatial biology solutions through the power of spatial phenotyping.

Spatial phenotyping refers to a rapidly evolving technology that enables scientists to detect and map the distribution of cell types and biomarkers across whole tissue samples at single-cell resolution, enabling advancements in their understanding of disease progression and patient response to therapy.

Akoya commercializes proprietary instrument platforms, reagents, software, and services that offer end-to-end solutions to perform tissue analysis and spatial phenotyping from discovery through translational and clinical research and diagnostics.

Pursuant to the Merger Agreement, a newly formed, wholly owned subsidiary of Quanterix will merge with and into Akoya, with Akoya continuing as the surviving corporation and becoming a wholly owned subsidiary of Quanterix (the “Merger”).

Upon completion of the Merger, each issued and outstanding share of common stock of Akoya will be converted into 0.318 of a share of our common stock.

The closing of the Merger is subject to a number of conditions,

Table of Cont ents

(i) approval of the issuance of shares of our common stock in the Merger by our stockholders;

(ii) approval of the Merger by Akoya stockholders;

(iii) the effectiveness of the registration statement on Form S-4 filed with the SEC in connection with the Merger;

(iv) the absence of any order issued or entered, or any law enacted or promulgated having the effect of restraining, enjoining, making illegal or otherwise prohibiting the consummation of the Merger;

(v) our submission to Nasdaq of a notification of shares of our common stock to be issued in connection with the Merger;

(vi) performance by each party of its respective obligations under the Merger Agreement;

and (vii) the absence of a material adverse effect with respect to each of Akoya and us.

Subject to fulfillment or waiver of the closing conditions, we expect that the Merger will close in the second quarter of 2025.

We and Akoya have also agreed to use our respective reasonable best efforts to cooperate in good faith to enter into one or more agreements pursuant to which we would provide Akoya with bridge financing.

Any such financing would be in the form of subordinated convertible note(s) in an aggregate principal amount not to exceed $30.0 million, subject to Akoya having obtained any required consents and satisfied any other conditions under Akoya’s existing credit facility.

As of the date of filing of this annual report, we are negotiating the potential terms of such financing.

Acquisition of Emission, Inc.

On January 8, 2025, we acquired Emission, Inc.

("Emission"), a life sciences manufacturing company based in Georgetown, Texas.

Emission produces large-scale, highly-uniform dye-encapsulating magnetic beads designed for low and mid-plex assays and a mid-plex platform that reads its proprietary beads.

The transaction secured the use of Emission’s highly controlled beads in our next generation platforms and expansion into a new multi-plex segment targeting third-party original equipment manufacturer customers.

For further information about the Akoya and Emission acquisitions, refer to Note 3 - Acquisitions in the Notes to Consolidated Financial Statements for the year ended December 31, 2025 included in the section titled, "Part II, Item 8.

Financial Statements and Supplemental Data" of this Annual Report on Form 10-K.

FDA 510(k) Submission for a Multi-Analyte Algorithmic Blood Test for Alzheimer’s Disease Detection

On January 31, 2026, we submitted a 510(k) premarket notification to the U.S.

Food and Drug Administration ("FDA") for our multi-analyte algorithmic blood test for Alzheimer’s disease ("AD").

This submission represents a significant milestone in the Company’s mission to provide superior, non-invasive, high-performance diagnostic tools to aid in the evaluation of patients with cognitive symptoms for possible Alzheimer’s disease.

Our multi-analyte test previously received Breakthrough Device Designation from the FDA, a program intended to accelerate the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.

Our test, if cleared by the FDA, is intended to aid in identifying whether patients with cognitive symptoms are likely to have amyloid brain plaques—a hallmark of Alzheimer’s disease —providing diagnostic clarity through a non-invasive blood test.

LucentAD Complete Medicare Pricing

In November 2025, the Centers for Medicare & Medicaid Services ("CMS") approved a reimbursement rate of $897 for our LucentAD Complete multiplex test.

This milestone provides a nationally recognized reference price, an important step for coverage decisions with payers, enables broader access.

and supports efforts to bring this multiplex diagnostic solution to hospitals and laboratories across the country.

In addition, based on available data, we believe LucentAD Complete has the potential to obtain a Local Coverage Determination, which would support more consistent reimbursement of claims.

Cooperation Agreement with Kent Lake Partners

As previously disclosed, on August 4, 2025, we entered into a Cooperation Agreement (the "Cooperation Agreement") with Kent Lake PR LLC, the general partner of Kent Lake Partners LP (together, "Kent Lake"), pursuant to which we agreed to retain an executive search firm to identify a potential candidate to be appointed to our board of directors (the "Board").

We also agreed to cooperate with Kent Lake to select an individual from the executive search firm’s list of six candidates and to appoint such person as a Class I director by December 1, 2025.

On November 20, 2025, the Board appointed two new directors, including one new Class I director.

Also pursuant to the Cooperation Agreement, we sought and obtained stockholder approval at our 2025 annual meeting of stockholders of an amendment to our Amended and Restated Certificate of Incorporation that declassified the Board, and we amended our bylaws to adopt a majority voting standard for uncontested director elections, with a plurality voting standard for contested director elections.

In the Cooperation Agreement, Kent Lake agreed to abide by certain voting commitments, customary standstill obligations and mutual non-disparagement, and no litigation provisions until the date that is thirty days prior to the nomination deadline under the bylaws for the nomination of director candidates for election to the Board at the 2027 annual meeting of stockholders, unless the Cooperation Agreement is earlier terminated in accordance with its terms.

Industry Background

6 unchanged sentences

If the target is present in the sample, it attaches to the plate via the antibody.

Then, a second molecule, often an enzyme-linked antibody, is added, binding to the target.

Then, a second

molecule, often an enzyme-linked antibody, is added, binding to the target.

The enzyme produces a detectable signal (like fluorescence or a color change) when a specific substrate is added, indicating the presence and quantity of the target molecule in the sample.

1 unchanged sentence

Efforts to increase the sensitivity of conventional ELISA have had limited success due to procedural complexity and length.

Our Simoa Technology

Immunohistochemistry ("IHC") is the traditional technique used for detecting and localizing antibody protein markers in tissue samples.

This microscopy application allows clinicians and scientists to visualize target antigens within tissue slides helping to understand their location and distribution to help diagnose cancer or tumor types.

The application generates fluorescent signals through the use of antibodies linked to a fluorophore or secondary antibody carrying a detectable enzyme or dye.

Our Spatial Biology platforms have advanced this concept to a highly multiplexed capability enabling a 2D/3D functional view of tissue and biomarkers.

Detecting multiple biomarkers with this technology now enables significantly more detail to be extracted from the same tissue sample for better precision and understanding in the tissue microenvironment.

Spatial proteomics and fluid-based biomarker analysis both continue to evolve and expand their use case from core research markets to clinical applications.

Quanterix believes that the combination of insights gained from the use of our instrumentation will drive innovation and application expansion supporting clinical decision making into the future.

Our Technologies

Simoa Technology

Our Simoa bead-based and planar array technologies are based on traditional ELISA technology but significantly advance conventional ELISA technology and are capable of substantially greater protein detection sensitivity.

5 unchanged sentences

In Simoa bead-based digital technology measurements, however, the detected signal relies on a binary signal/no signal readout, enabling single molecule detection, and analytical sensitivity in the femtomolar range compared with nanomolar and picomolar levels of detection in conventional ELISA.

Simoa Planar Array Technology

Simoa planar array immunoassays utilize the basic principles of conventional microplate-based sandwich ELISA.

However, unlike ELISA, which runs the enzyme-substrate reaction on all molecules coating the entire bottom surface in one well, Simoa planar array reactions are run on spatially segregated micro-spots within the bottom of microtiter plate wells that concentrate the signal to a surface area 1,000 times smaller than a traditional ELISA.

The small spot size and spatial segregation of each spot enables multiplexing up to 12 different assays within a single sample well.

Table of Cont ents

Our commercial strategy is based on three core growth vectors:

(i) G row menu;

(ii) E xpand into adjacencies;

and (iii) T ranslate into diagnostics.

Our plans to achieve this GET strategy include:

• Growing through rapid internal menu expansion.

In August 2022, we initiated an assay redevelopment program with the objective of improving our ability to manufacture and deliver high-quality assays at scale.

This program was substantially completed in the fourth quarter of 2023, and in 2024, we launched 20 new assays that were developed using improved protocols, manufacturing efficiencies and reagent improvements to provide more consistent results and improved lot-to-lot consistency.

Following the assay redevelopment program, assay development time has been reduced from more than 18 months to less than six months.

• Continuing to grow our leadership position in the measurement of neuro-based biomarkers .

We intend to leverage the growing importance of neurological biomarkers to advance the development of therapeutics and diagnostics for neurodegenerative conditions, including Alzheimer’s disease.

The importance of neurological biomarkers, such as neurofilament light chain ( “ NfL ” ), p-Tau 181, p-Tau 217 and glial fibrillary acidic protein ( “ GFAP ” ), has increased significantly in recent years, and our ultra-sensitive Simoa platforms have allowed research of neurological disorders, previously limited primarily to cerebrospinal fluid ( “ CSF ” ), to expand significantly.

• Growing menu through strategic acquisitions.

We intend to strategically acquire businesses and technologies to grow our operations and strengthen our market position, as evidenced by our recent acquisition of Emission and our proposed acquisition of Akoya.

We expect that acquisitions may continue to be an important part of our strategy to increase scale, and we intend to strategically pursue acquisitions to expand product menu, add technologies, and/or provide access to complementary or strategic growth areas.

• Expanding further into indications beyond neurology .

Although we intend to continue to extend our leadership position in measuring neuro-based biomarkers, the ability of our Simoa technology to detect and quantify low abundance proteins with exquisite sensitivity is a distinct advantage in detecting disease earlier in other indications, in particular oncology and immunology.

There are over 950 scientific publications that reference Simoa technologies in non-neurology indications.

We have announced our intent to launch Simoa ONE, a new instrument, by the end of 2025.

Simoa ONE is expected to enable up to a 10-fold increase in sensitivity over current Simoa platforms and to allow a substantial increase in plexing and specificity.

The Simoa ONE is also expected to have a simple and efficient workflow.

We expect these attributes to be particularly attractive to researchers and clinicians in oncology and immunology.

In addition, many cancers begin in tissue before they move and migrate to blood.

With the proposed acquisition of Akoya, we believe we will be able to combine Akoya’s biomarker detection capability in tissue with our ultra-sensitive biomarker detection in blood to drive development of faster, better testing tools for monitoring and detection in oncology and immunology.

• Expanding our presence in diagnostics .

Our ultra-sensitive Simoa platforms have enabled the development of a new category of less-invasive diagnostic tests and tools based on blood, serum, saliva and other fluids that could replace current invasive, expensive, and inconvenient diagnostic methods, including spinal tap, diagnostic imaging and biopsy.

We currently offer four neurological LDTs through our Accelerator Laboratory.

• Helping to build the global infrastructure for Alzheimer’s disease testing and diagnosis .

There are over 55 million people living with Alzheimer’s disease, a number that is expected to double by 2050.

We believe our ultrasensitive technology can enable earlier detection.

We are helping to build the global infrastructure for Alzheimer’s testing in two ways.

First, we are enabling partners by providing Simoa technology to a number of the top prescribing hospital networks and reference labs globally.

We entered into 12 of these partnerships in 2024 and intend to continue to grow this network in 2025.

Second, through our Lucent Diagnostics brand, we are offering best-in-class diagnostic testing through our LucentAD Complete test, which was launched in November 2024.

Table of Cont ents

Our Products and Services

We currently offer the following three Simoa instruments, which we believe are among the most sensitive multiplex protein detection platforms commercially available today:

We commercially launched our HD-X instrument in the second half of 2019.

The HD-X is an upgraded version of the Simoa HD-1 (our first Simoa instrument, which was launched in January 2014) that was designed to deliver significant productivity and operational efficiency improvements, as well as greater user flexibility.

Our HD-X is our flagship instrument that empowers biomarker research and accelerates drug development.

It is a fully automated immunoassay platform with multiplexing and custom assay capability designed to deliver significant productivity and operational efficiency improvements, as well as greater user flexibility.

The HD-X is based on our bead-based technology, and assays run on the HD-X are fully automated.

By the end of 2024, approximately 84% of the HD installed base were HD-X instruments.

We commercially launched our SR-X instrument in December 2017 as a compact benchtop instrument with a lower price point, more flexible assay preparation, and a wider range of applications.

Our SR-X instrument is a compact benchtop instrument with a lower price point, more flexible assay preparation, and a wider range of applications.

The SR-X utilizes the same Simoa bead-based technology and assay kits as the HD-X.

1 unchanged sentence

The offline sample prep provides additional flexibility to enable researchers to apply Simoa detection in an expanded range of applications.

We commercially launched the SP-X instrument in April 2019.

The SP-X uses the Simoa planar array technology developed initially by Aushon Biosystems (Aushon), which we acquired in 2018, for multiplex chemiluminescent immunoassay measurement, which we refined by leveraging our proprietary sophisticated Simoa image analysis and data analysis algorithms to provide sensitivity similar to that found in our Simoa bead-based platform.

Simoa Planar Array Technology

Simoa planar array immunoassays utilize the basic principles of conventional microplate-based sandwich ELISA.

The small spot size and spatial segregation of each spot enables multiplexing up to 12 different assays within a single sample well.

Our SP-X uses Simoa planar array technology for multiplex chemiluminescent immunoassay measurement with sensitivity similar to that found in our Simoa bead-based platforms.

Simoa Assays and Consumables

2 unchanged sentences

The current menu of assay kits for the planar array instrument includes approximately 45 biomarkers ranging from 1-10 analytes per assay in the areas of immunology, and oncology research.

In addition to the assays we have developed, the Simoa platforms allow ease and flexibility in assay design, enabling our customers to develop their own proprietary in-house assays, called homebrew assays, using our homebrew assay kits.

In addition to the assays we have developed, the Simoa platforms allow ease and flexibility in assay design, enabling our customers to develop their own proprietary in-house assays, which we refer to as "homebrew" assays, using our homebrew assay kits.

These kits include all components required for customers to run tests using their own antibodies.

Our consumables portfolio for our bead-based platform also includes our proprietary Simoa disks that are unique to our bead-based platform, as well as cuvettes and disposable tips.

Table of Cont ents

In January 2025, we acquired Emission, a manufacturer of large-scale, highly-uniform dye-encapsulating magnetic beads designed for low and mid-plex assays.

These proprietary beads are engineered for consistency, scalability, and reliability.

This acquisition allows us to secure the supply of these highly controlled beads for use in our next generation Simoa ONE instrument.

It also allows us to develop a new multi-plex segment targeting third-party OEM customers for these beads, which we have branded as Nova Beads.

NfL Antibodies and NfL ELISA Kits

In August 2019, we acquired UmanDiagnostics AB ( “ Uman ” ), a company located in Umeå, Sweden, that commercializes proprietary NfL antibodies and NfL ELISA kits.

Uman’s NfL antibodies are used by researchers and biopharmaceutical and diagnostics companies to detect NfL to advance the development of therapeutics and diagnostics for certain neurodegenerative conditions.

Since we commercially launched the first assay that could reliably measure NfL in blood using Uman’s antibodies and our Simoa technology in 2017, NfL has seen dramatic growth as a neurological biomarker.

Through Uman, we sell proprietary NfL capture and detection antibodies, as well as two NfL ELISA kits for CSF, one of which is CE-certified in Europe, and one RUO NfL ELISA kit for serum.

Through our CLIA-certified Accelerator Laboratory, we provide customers a contract research option.

Spatial Technology

Our Spatial Biology solutions measure protein expression and cellular phenotypes within intact tissue while preserving spatial context and tissue architecture.

By enabling the simultaneous detection of multiple biomarkers at single-cell resolution across whole tissue sections, our platforms provide quantitative insights into cellular composition, organization, and interactions within complex biological systems.

Conventional genomic and proteomic techniques, including next-generation sequencing ("NGS"), single-cell analysis, flow cytometry, and mass spectrometry, generate valuable molecular data but generally require tissue dissociation or destruction.

As a result, these methods do not preserve spatial relationships between cells or localized biomarker expression within the native tissue environment.

Traditional histological and non-destructive tissue analysis methods preserve tissue structure but are typically limited to measuring a small number of biomarkers per sample and often rely on qualitative interpretation by trained pathologists.

Our Spatial Biology platforms are designed to address these limitations by enabling end-to-end spatial phenotyping, allowing researchers to quantitatively analyze large numbers of protein biomarkers and cell types across intact tissue sections at single-cell resolution.

The resulting data generate high-dimensional, spatially resolved maps that characterize tissue architecture, cellular heterogeneity, and biomarker co-localization, supporting the study of tissue dynamics and cell–cell interactions.

Our Spatial Biology technology platform integrates proprietary imaging hardware, scalable multiplexing enabled by barcoded antibody chemistry and classic Opal™ chemistry, and curated biomarker panels designed for standardized implementation.

Together, these components support reproducible, whole-slide imaging and the generation of structured, computationally analyzable datasets.

We believe our platform capabilities support applications across the research continuum, from exploratory and discovery-stage research through translational and clinical research settings.

These capabilities are intended to enable customers to advance the understanding of human biology, disease mechanisms, and therapeutic response, and to support the progression of spatial biology insights into downstream research and clinical workflows.

Spatial Biology Instruments

PhenoCycler & PhenoImager Fusion

Our PhenoCycler and PhenoImager Fusion instrument modules operate in a coordinated manner and provide the customer with a complete system for performing high-quality, high-plex tissue biomarker measurements.

Our PhenoCycler employs a barcoded antibody-based chemistry designed to enable highly multiplexed protein detection through cyclic signal readout rather than sequential antibody staining.

In this workflow, all antibodies in a panel are applied to the tissue simultaneously in a single staining step.

Each antibody is conjugated to a unique oligonucleotide barcode that serves as a molecular identifier for its target protein.

Following antibody binding, signal detection is achieved through iterative cycles of oligonucleotide hybridization and dehybridization.

In each cycle, a defined set of fluorescently labeled reporter oligonucleotides—each complementary (antisense) to a subset of the antibody barcodes—are introduced together with a nuclear counterstain.

Each cycle enables detection of multiple protein targets through reporter hybridization, while the nuclear stain provides consistent spatial reference across cycles.

After reporter hybridization, the tissue is imaged using the PhenoImager Fusion to capture spatially resolved signal from the bound reporters.

The reporter oligonucleotides are then removed through controlled dehybridization, enabling subsequent cycles of reporter hybridization and imaging on the same tissue section.

This process allows repeated signal acquisition without repeated antibody staining or tissue stripping.

This cyclic hybridization, imaging, and dehybridization approach enables multiplexed detection of protein biomarkers while preserving tissue integrity and spatial context.

The cycling steps are automated through the PhenoCycler fluidics system and are designed to operate in conjunction with the PhenoImager Fusion imaging platform, which performs whole-slide imaging following each reporter hybridization cycle.

PhenoImager HT

Our PhenoImager HT is a whole-slide imaging platform designed to support multiplexed tissue imaging using single-round staining and imaging workflows.

The system enables one-shot detection of multiple protein biomarkers within a single imaging acquisition, typically supporting low- to mid-plex immunofluorescence and brightfield assays while preserving tissue morphology and spatial context.

PhenoImager HT is designed to image formalin-fixed paraffin-embedded ("FFPE") and fresh frozen tissue sections and tissue microarrays.

The platform supports both fluorescence and chromogenic detection methods and is compatible with established IHC and immunofluorescence workflows commonly used in translational research and clinical laboratory environments.

Unlike cyclic imaging approaches, PhenoImager HT performs multiplexed imaging in a single imaging step, enabling streamlined workflows and reduced assay complexity.

This one-shot imaging approach is intended to support applications where moderate levels of multiplexing are sufficient and where workflow simplicity, reproducibility, and compatibility with existing laboratory practices are important considerations.

Image data generated by PhenoImager HT are processed into our proprietary QPTIFF file format, as well as additional standard image formats, to support downstream analysis using our software solutions and third-party image analysis platforms.

The system is commonly used in translational research, biomarker validation, and LDT workflows, and has historically supported applications bridging discovery research and clinical investigation.

Spatial Biology Assays

Our Spatial Biology assays are based primarily on proprietary barcoding chemistry designed to support multiplexed protein detection in spatial biology applications.

This chemistry utilizes barcoded antibodies in combination with cyclic signal detection workflows, enabling multiplexed analysis of protein expression while preserving tissue architecture and spatial context.

These assays are designed for use across our Spatial Biology platforms, including PhenoCycler, PhenoImager Fusion, and PhenoImager HT, depending on the assay format and level of multiplexing required.

We offer a portfolio of ready-to-use, preconfigured antibody panels under our PhenoCode brand.

For the PhenoCycler platform, these include curated discovery panels designed for high-plex spatial phenotyping applications, such as the PhenoCode IO60 panel, Mouse IO panel, Human Neuro panel, and Mouse Neuro panel.

These panels are designed to support standardized implementation of multiplexed spatial assays and are intended to reduce assay development complexity for customers.

For our PhenoImager platforms, we offer PhenoCode Signature Panels, which are designed for single-round, low- to mid-plex imaging workflows.

These panels are intended to support translational research, biomarker validation, and clinical research workflows where streamlined assay execution and reproducibility are important considerations.

In addition to ready-to-use panels, we sell a broad range of reagents on an à la carte basis, including barcoded antibodies, reporters, buffers, and ancillary reagents.

These offerings allow customers to design and optimize custom panels and workflows tailored to specific research objectives and experimental requirements.

This modular reagent approach is intended to support flexibility across discovery, translational, and applied research use cases.

We also support Opal ‘classic’ chemistry, an immunofluorescence method based on unconjugated primary antibodies, secondary antibodies conjugated to polymer HRP, and a suite of TSA-conjugated fluorophores.

Opal chemistry protocols for multiplexed measurements can be automated on industry-standard autostainers.

The signal amplification provides enhanced sensitivity.

Opal chemistry is compatible with standalone PhenoImager Fusion and PhenoImager HT systems.

This chemistry is commonly used in established immunohistochemistry and immunofluorescence workflows and provides continuity for customers with existing assay investments.

Through our CLIA-certified Accelerator Laboratory, we provide research customers contract research services and we provide medical providers clinical laboratory testing services.

The Accelerator Laboratory supports multiple projects and services, including:

• Sample Testing.

Utilizing commercially available Simoa kits, we have run large studies for customers with thousands of specimens and small experiments with just a few samples.

We have extensive experience testing many different sample types where biomarkers may be present at very low levels.

• Homebrew Assay Development.

Utilizing proprietary or commercially available reagents in combination with our homebrew assay kits, we can rapidly develop a prototype assay exhibiting improved sensitivity compared to traditional ELISA.

The Accelerator Laboratory can also be used to screen reagents to identify the optimal assay format or expand prototype efforts for further assay optimization to ultimately deliver the highest level of performance.

• Custom Assay Development.

After identifying the optimal assay and conditions, the Accelerator Laboratory can be used to generate qualified bulk reagents or custom assay kits, providing customer access to kits for assays not yet commercially available on the Simoa platform.

• LDT Testing .

We currently offer the following four LDTs through our Accelerator Laboratory:

• Research and Clinical Trial Testing:

Utilizing either our commercially available reagent kits, or customer specific custom assays, our Accelerator Laboratory provides customers access to our Simoa and Spatial Biology platforms by running studies ranging from thousands of specimens to small de novo experiments with just a few samples.

Partnering with clients to address critical needs on sample volume, custom assay development, and unique study designs, we support a broad range of programs from large scale clinical trial data generation to research focused cohorts supporting discovery, validation, and clinical testing of predictive biomarkers in translational research and enabling patient stratification and selection in clinical studies.

• Lucent Diagnostics:

In July 2023, we launched Lucent Diagnostics, a suite of clinical laboratory testing services for neurology healthcare providers, initially focused on Alzheimer’s disease.

To support a streamlined provider workflow, Lucent Diagnostics includes a web portal where healthcare providers can order sample collection materials, order a test, track the status of a test, and retrieve the test report.

The process for testing involves a healthcare provider drawing a blood sample from an individual and shipping the sample to our Accelerator Laboratory to analyze the sample and communicate the result back to the provider.

Healthcare providers can currently order the following tests through Lucent Diagnostics:

LucentAD p-Tau 181:

1 unchanged sentence

Simoa NfL LDT:

an LDT to quantitatively measure NfL in serum as an aid in the evaluation of individuals for possible neurodegenerative conditions or other causes of neuronal or central nervous system damage.

an LDT to quantitatively measure neurofilament light chain ("NfL") in serum as an aid in the evaluation of individuals for possible neurodegenerative conditions or other causes of neuronal or central nervous system damage.

LucentAD p-Tau 217:

1 unchanged sentence

LucentAD Complete:

a multi-marker (p-Tau 217, amyloid β 42 ( “ Aβ42 ” ), amyloid β 40 ( “ Aβ40 ” ), NfL, and GFAP) algorithmic LDT for high accuracy plasma detection of amyloid pathology to aid in diagnostic evaluation of patients with cognitive issues who may have Alzheimer’s disease.

By using a proprietary algorithm to score five AD-related biomarkers, LucentAD Complete provides significantly better amyloid classification compared to single-marker tests alone and has lowered the intermediate zone of a single-marker test from 30% to 10%, while maintaining high sensitivity, specificity and accuracy.

Table of Cont ents

• Lucent Diagnostics.

In July 2023, we launched Lucent Diagnostics, a neurology healthcare provider-facing portal, with testing services initially focused on Alzheimer’s disease.

Healthcare providers can currently order the following tests through Lucent Diagnostics:

LucentAD p-Tau 181, LucentAD p-Tau 217 and LucentAD Complete .

a multi-marker (p-Tau 217, amyloid β 42 ("Aβ42"), amyloid β 40 ("Aβ40"), NfL, and glial fibrillary acidic protein ("GFAP")) algorithmic LDT for high accuracy plasma detection of amyloid pathology to aid in diagnostic evaluation of patients with cognitive issues who may have Alzheimer’s disease.

By using a proprietary algorithm to score five Alzheimer's disease-related biomarkers, LucentAD Complete provides significantly better amyloid classification compared to single-marker tests alone and has lowered the intermediate zone of a single-marker test from approximately 30% to 10%, while maintaining high sensitivity, specificity, and accuracy.

Extended Warranty and Service Contracts

We also generate revenues through extended-warranty and service contracts for our installed base of instruments.

Research and Development

We continue to seek to improve our platform and technology to enable more sensitive detection and measurement of biological molecules.

This evaluation includes examining new assay formats and instrumentation improvements and upgrades to increase the performance of our Simoa assays and instruments.

We intend to expand our assay menu to extend the scope of applications for our platform to biomarkers of significant interest to the scientific community.

Using breakthrough technology licensed from the laboratory of our co-founder, David Walt, we are developing Simoa ONE, a new instrument that we expect to launch by the end of 2025.

Simoa ONE is expected to enable up to a 10-fold increase in sensitivity over current Simoa platforms.

The instrument is based on optically encoded barcodes and proprietary beads developed by Emission to allow a substantial increase in plexing and specificity of Simoa measurements.

Simoa ONE is based on simple instrumentation and assay workflow to efficiently deliver high throughput, quantitative results.

Our commercial strategy is based on three core growth vectors:

(i) Grow menu;

(ii) Expand into adjacencies;

and (iii) Translate into diagnostics.

Our plans to achieve this GET strategy include:

• Growing through rapid internal menu expansion .

In 2024 and 2025, we launched 20 and 11 new Simoa assays, respectively that were developed using improved protocols, manufacturing efficiencies, and reagent improvements to provide more consistent results and improved lot-to-lot consistency.

In 2025, we also launched two Spatial Biology panels.

We expect that the expansion of our assay menu to increase average consumable pull-through as additional assays become available for use on our existing installed base.

• Continuing to grow our leadership position in the measurement of neuro-based biomarkers .

We intend to leverage the growing importance of neurological biomarkers to advance the development of therapeutics and diagnostics for neurodegenerative conditions, including Alzheimer’s disease.

The importance of neurological biomarkers, such as NfL, p-Tau 181, p-Tau 217 and GFAP, has increased significantly in recent years, and our ultra-sensitive Simoa platforms have allowed research of neurological disorders, previously limited primarily to cerebrospinal fluid ("CSF"), to expand significantly.

• Expanding further into indications beyond neurology .

The ability of our Simoa technology to detect and quantify low abundance proteins with exquisite sensitivity is a distinct advantage in detecting disease earlier in other indications, in particular oncology and immunology.

There are over 1020 scientific publications that reference Simoa technologies in non-neurology indications.

We expect to expand our Simoa product offerings into adjacencies through internal research and development investment.

The acquisition of Akoya establishes us in the spatial biology market with applications across research and clinical trial settings.

The acquisition diversifies our revenues by disease type, shifting from over 90% neurology to a diversified mix of approximately 60% neurology and 40% oncology.

Furthermore, we believe researchers will be able to combine the capabilities of our multiplexed biomarker detection in tissue with our ultra-sensitive biomarker detection in blood to achieve new discoveries about disease onset and progression in oncology and immunology.

• Expanding our presence in diagnostics .

Our ultra-sensitive Simoa platforms have enabled the development of a new category of less-invasive diagnostic tests that could replace current invasive, expensive, and inconvenient diagnostic methods, including spinal tap and diagnostic imaging.

We currently offer four neurological LDTs through our Accelerator Laboratory.

• Helping to build the global infrastructure for Alzheimer’s disease testing and diagnosis .

There are over 55 million people living with Alzheimer’s disease, a number that is expected to double by 2050.

We believe our ultrasensitive technology can enable earlier detection.

We are helping to build the global infrastructure for Alzheimer’s testing in two ways.

First, we are enabling partners by providing Simoa technology to a number of the top prescribing hospital networks and reference labs globally.

We entered into 13 of these partnerships in 2025 bringing the total number of partners at the end of 2025 to 25 and intend to continue to grow this network in 2026.

Second, through Lucent Diagnostics, we are offering best-in-class diagnostic testing through our LucentAD Complete test, which was launched in November 2024.

Our Key Focus Areas

We have focused the application of our Simoa technology on areas of high growth and high unmet need and where existing platforms have significant shortcomings that our technology addresses, including neurology, oncology and immunology, as well as inflammation .

We have focused the application of our technologies on areas of high growth and high unmet need and where existing platforms have significant shortcomings that our technology addresses, including neurology, oncology, and immunology.

The ability of Simoa technology to detect neurological biomarkers in blood at ultra-low levels, combined with our multiplexing capability, has significantly advanced neurology research, drug development, and diagnostics test development.

1 unchanged sentence

The challenge with developing blood-based tests for the brain is that the blood-brain barrier, which is formed by endothelial cells lining the cerebral microvasculature, is very tight and severely restricts the movement of proteins and other substances between these endothelial cells and into blood circulation.

Accordingly, diagnosis of brain disease and injury has traditionally required either brain imaging or a spinal tap to collect CSF.

Accordingly, diagnosis of brain disease and injury has traditionally required either brain imaging or a spinal tap to collect

The sensitivity of Simoa technology has enabled researchers to discover that extremely small amounts of critical neural biomarkers diffuse through the blood brain barrier and are released into the blood during injury and in connection with many neurodegenerative brain diseases.

3 unchanged sentences

This capability has materially contributed to rapid research progress, notably in the Alzheimer’s disease landscape.

Our Spatial Biology platforms enable high-plex, single-cell protein analysis directly within intact brain tissue, making them highly relevant to neurology research and neurodegenerative disease markets.

Neurological disorders such as Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, and amyotrophic lateral sclerosis ("ALS") are driven by complex cellular interactions—including neurons, glia, immune cells, and vascular components—that cannot be fully understood through bulk or dissociated assays.

Our Spatial Biology technologies allow researchers to localize and quantify dozens of protein biomarkers simultaneously while preserving anatomical context, supporting the identification of disease-associated cell states, pathogenic microenvironments, and therapeutic targets.

This capability is increasingly important as pharmaceutical and academic groups prioritize biomarker-driven drug development, patient stratification, and translational research in neurology, positioning spatial biology as a foundational tool in a large, growing, and underserved research and clinical development market.

Developments on the Alzheimer’s Disease Landscape

The FDA approval of Leqembi and Kisunla as disease-modifying treatments for Alzheimer’s disease has underscored an urgent need for non-invasive widely available blood tests to facilitate diagnosis in the early stages of the

Table of Cont ents

disease to identify patients for treatment when therapeutic intervention is most likely to provide clinical benefit.

Currently established biomarker- based approaches to diagnostic workup for Alzheimer’s include positron emission tomography ( “ PET ” ) imaging and CSF biomarkers for amyloid and phosphorylated tau, both of which are invasive, expensive, and may not be widely available.

A Rand Corporation study on the readiness of the U.S.

health care system infrastructure for an Alzheimer’s treatment highlighted a dire situation of unpreparedness and where key bottlenecks lie.

The model assumed annual mild cognitive impairment screening for adults leading to 7.5 million referrals to a diagnostic phase in a secondary specialist setting, which is well beyond the country’s capacity.

Of these referrals, 6.7 million were assumed to require CSF biomarker or amyloid PET testing for biomarker- based diagnosis of Alzheimer’s disease at an estimated cost of $20.1 billion.

Of the amyloid positive subjects, 80% (2.4 million) were assumed to fit the criteria for therapeutic intervention.

Assessing the effectiveness of an anti-amyloid Alzheimer’s therapy by testing for amyloid plaque reduction over the course of treatment would potentially involve serial testing of each subject with CSF analysis or PET imaging at a significant cost with currently available detection modalities.

According to the Alzheimer’s Association, there are over 7 million individuals living with Alzheimer’s disease and other dementias in the United States, and that figure is expected to double by 2060.

The FDA's approval of Leqembi and Kisunla as disease-modifying treatments for Alzheimer’s disease has underscored an urgent need for non-invasive, widely available blood tests to facilitate diagnosis in the early stages of the disease to identify patients for treatment when therapeutic intervention is most likely to provide clinical benefit.

Established biomarker-based approaches to diagnostic workup for Alzheimer’s include positron emission tomography ("PET") imaging and CSF biomarkers for amyloid and phosphorylated tau, both of which are invasive, expensive, and may not be widely available.

Recently two blood tests for assessing the risk of brain amyloid pathology associated with Alzheimer’s disease in individuals with early signs of cognitive impairment were cleared by the FDA.

This is an important milestone demonstrating support by regulatory authorities for the use of high quality blood tests as part of Alzheimer’s diagnostic workflows.

Assessing the effectiveness of an anti-amyloid Alzheimer’s therapy by testing for amyloid plaque reduction over the course of treatment with serial testing represents another potential opportunity for blood biomarker tests.

The availability of a simple blood test for amyloid positivity has the potential to alleviate bottleneck and cost burdens and facilitate the accessibility of Alzheimer’s therapeutic intervention for patients.

We believe our Simoa technology is well-suited to meet this critical need.

High Accuracy Simoa p-Tau 217 Test

The Alzheimer’s field has converged to a consensus on the most desirable single blood-based biomarker at present:

plasma p-Tau 217.

This biomarker has been shown to out-perform all the other plasma biomarker candidates for Alzheimer’s diagnostics and disease progression monitoring.

The biomarker also has the distinction of being low abundance in blood and difficult to measure by conventional means.

We provide multiple assays for robustly measuring p-Tau 217 in plasma and helping to establish the clinical evidence through a body of peer reviewed publications demonstrating the superiority of this biomarker relative to other biomarkers.

While p-Tau 217 has demonstrated superiority over other plasma neural biomarkers, the strength of the data across a number of other biomarker candidates (p-Tau 181, amyloid β 42/40 ratio, GFAP, NfL) is such that all these biomarkers were included in the recently published “ Revised criteria for diagnosis and staging of Alzheimer’s disease:

Alzheimer’s Association Workgroup.

” However, only p-Tau 217 was recommended as being sufficiently accurate as a single biomarker to enable a diagnostic use case.

We have launched the LucentAD p-Tau217 LDT for clinical use.

This test was robustly validated across two independent cohorts (873 samples), and the diagnostic accuracy of the test was shown to meet or exceed the recommendation of the Alzheimer’s Association Workgroup (≥90% accuracy, sensitivity and specificity ≥90%).

Thus, the LucentAD p-Tau 217 test meets or exceeds the diagnostic performance criteria for a plasma-based test for Alzheimer’s disease.

We believe our Simoa technology is well-suited to meet these critical needs.

Simoa Multi-Marker Algorithmic Test

7 unchanged sentences

Validation data for the clinical performance of the test for amyloid detection was presented at the Clinical Trials on Alzheimer’s Disease annual meeting late 2024.

The data across over 1,000 patients showed that the test delivered best-in-class performance for amyloid detection accuracy as well as reduced uncertainty in borderline cases.

The data across more than 1,000 patients showed that the test delivered best-in-class performance for amyloid detection accuracy as well as reduced uncertainty in borderline cases.

We launched this multi-marker algorithmic test as an LDT in November 2024 under the brand name LucentAD Complete.

The test has also received Breakthrough Device designation by the FDA, and clinical trials to support a regulatory filing are in progress.

Additionally, in November 2025 CMS approved a reimbursement rate of $897 for this test.

A version of this multi-analyte algorithmic blood test received Breakthrough Device designation by the FDA, and we submitted a 510(k) premarket notification to the FDA earlier this year.

Other Neurological Conditions

1 unchanged sentence

Evidence of the potential clinical utility of NfL as a biomarker in multiple sclerosis has progressed rapidly, and Simoa’s role in that progression has been foundational.

Table of Cont ents

April 2022, the FDA granted our Simoa NfL serum test Breakthrough Device designation as a prognostic aid in assessing the risk of disease activity in patients diagnosed with relapsing-remitting multiple sclerosis ( “ RRMS ” ).

In April 2022, the FDA granted our Simoa NfL serum test Breakthrough Device designation as a prognostic aid in assessing the risk of disease activity in patients diagnosed with relapsing-remitting multiple sclerosis ("RRMS").

The test has shown promise to be used in conjunction with clinical, imaging and laboratory findings as an aid in identifying RRMS patients who are at lower or higher risk for relapse within four years.

1 unchanged sentence

Current methods of TBI diagnosis involve CT scans that fail to diagnose approximately 90% of mild TBI.

Simoa technology has demonstrated the sensitivity to identify relevant neurological biomarkers, such as NfL, tau, GFAP and UCH-L1, to more adequately aid in diagnosis of TBIs and overall brain health.

Simoa technology has demonstrated the sensitivity to identify relevant neurological biomarkers, such as NfL, tau, GFAP, and ubiquitin C-terminal hydrolase L1 ("UCH-L1"), to more adequately aid in diagnosis of TBIs and overall brain health.

Researchers in neurology have used Simoa technology to study biomarkers in the blood of athletes after concussion in many high-impact sports.

Simoa can measure critical neural biomarkers in blood that correlate repeated head trauma from both concussions and subconcussive events with poor patient outcomes, including the potential development of Chronic Traumatic Encephalopathy, which currently can only be diagnosed after death via a brain autopsy.

Simoa can measure critical neural biomarkers in blood that correlate to repeated head trauma from both concussions and subconcussive events with poor patient outcomes, including the potential development of Chronic Traumatic Encephalopathy, which currently can only be diagnosed after death via a brain autopsy.

Additional assays for blood-based biomarkers with potential utility in Alzheimer’s research and diagnostics have either been launched or are in development.

1 unchanged sentence

Oncology and Immunology

Our ultra-sensitive Simoa technology has the potential to detect increased levels of oncology biomarkers during the very early stages in disease development.

Biomarkers can be useful tools for diagnostics, prognostics and predictive cancer detection.

However, many traditional assay technologies can only detect these biomarkers after the disease has progressed and the patient has become symptomatic.

Simoa’s highly sensitive detection capability has the potential to enable earlier detection, better monitoring and treatment and improved prognoses for patients.

Additionally, Simoa technology has shown early promise as a liquid biopsy alternative to more invasive diagnostic procedures.

Our Spatial Biology platforms are highly relevant to oncology research due to their ability to resolve the tumor microenvironment at single-cell resolution while preserving tissue architecture.

Cancer progression, immune evasion, and therapeutic response are driven by spatially organized interactions among tumor cells, immune infiltrates, stromal cells, and vasculature—features that are not captured by bulk or non-spatial assays.

Our technologies enable simultaneous measurement of dozens of protein biomarkers within intact tumor tissue, supporting biomarker discovery, mechanism-of-action studies, and identification of predictive and pharmacodynamic markers for immuno-oncology and targeted therapies.

As oncology drug development increasingly relies on biomarker-guided patient selection and translational insights linking tissue biology to clinical outcomes, spatial biology has become a critical enabling technology, underpinning demand from pharmaceutical companies, translational research centers, and clinical research laboratories in one of the largest and fastest-growing life sciences markets.

Cancer immunotherapy is a promising new area that is significantly affecting cancer remission rates.

1 unchanged sentence

There exists a significant need to develop biomarker tools to monitor these drugs and their effects.

Circulating (serum and plasma) protein biomarkers have the potential to be used in the field of health-oncology to stratify patients, predict response, predict recurrence, reveal mechanism of action and monitor for adverse effects.

Circulating protein biomarkers (serum and plasma) have the potential to be used in the field of health-oncology to stratify patients, predict response, predict recurrence, reveal mechanism of action and monitor for adverse effects.

One technical challenge facing the health-oncology drug development process has been the availability of immunoassays with sufficient sensitivity to measure immunomodulatory biomarkers directly in serum and plasma.

1 unchanged sentence

In particular key immune regulatory cells (T-regs, dendritic cells, macrophages) secrete very low amounts of the protein Interferon gamma (“IFN-gamma”) and these levels cannot be reliably measured in serum and plasma using conventional, immunoassay technology, however they can be tracked with our Simoa IFN-gamma assay.

Additionally, we have developed an ultra-sensitive assay for IL-6, which is one of the cytokines commonly measured for monitoring cytokine release syndrome as an adverse effect in immunotherapies.

Additionally, we have developed an ultra-sensitive assay for ubiquitin C-terminal hydrolase L1 ("IL-6"), which is one of the cytokines commonly measured for monitoring cytokine release syndrome as an adverse effect in immunotherapies.

Several studies have shown that our ultrasensitive assays can be valuable tools for monitoring health-oncology drugs and protocols.

We believe that our Simoa ONE instrument, which is expected to be launched by the end of 2025, with its increased sensitivity, increased plexing ability and simple and efficient workflow will be well suited for oncology and immunology indications.

Inflammation underlies the response of the body to injury in a variety of diseases.

3 unchanged sentences

We believe the sensitivity of Simoa technology can provide a clearer picture of the underlying state of the immune response and disease progression.

Our Simoa technology also has the potential to be used by companies developing anti-inflammatory drugs to quantify the effect a drug has on a particular inflammatory cytokine and to monitor therapeutic efficacy.

We believe that a better understanding of the inflammatory response will be critical to future opportunities for wellness screening and disease

Table of Cont ents

response monitoring.

Anti-inflammatory drugs are expensive and can have serious side effects, such as increased risk of infection.

By monitoring biomarkers indicative of response, clinicians may be able to adjust dose to reduce side effects or increase efficacy.

Combining the ultra-sensitive capabilities of our Simoa technology with our Spatial Biology platform is highly relevant to inflammation research because inflammatory diseases are driven by localized, cell-to-cell signaling events that vary by tissue compartment and disease stage.

Conditions such as autoimmune disorders, fibrosis, cardiovascular disease, and inflammatory bowel disease involve complex interactions among immune cells, parenchymal cells, and stromal elements that cannot be adequately characterized using bulk or non-spatial methods.

Our Spatial technologies enable high-plex, single-cell protein analysis within intact tissue, allowing researchers to map inflammatory pathways, immune cell activation states, and spatial biomarkers associated with disease progression and therapeutic response.

Research and Development

We continue to seek to improve our technologies to enable more sensitive detection and measurement of biological molecules.

This effort includes examining new assay formats to increase their performance.

We intend to expand our assay menu to extend the scope of applications for our platforms to biomarkers of significant interest to the scientific community.

Further, we are developing new instrumentation to update our current Simoa platforms, with a design that aims to ultimately have higher sensitivity and multiplexing.

For example, in late 2025, we launched an early access program to our next generation instrument "Simoa ONE" to give key evaluators hands-on experience with the technology.

We continue to gather feedback on this instrument to innovate its design and determine which features are most important.

Sales and Marketing

We distribute our Simoa instruments and consumables via direct field sales and support organizations located in North America and Europe and through a combination of our own sales force and third-party distributors in additional countries, including Australia, Brazil, China, Czech Republic, India, Hong Kong, Israel, Japan, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and UAE.

In addition, we sell Uman’s NfL antibodies and NfL ELISA kits directly and in conjunction with a distributor worldwide.

We distribute our instruments and consumables via direct field sales and support organizations located in North America and Europe and through a combination of our own sales force and third-party distributors in additional countries, including Australia, Brazil, China, Czech Republic, Cypress, India, Hong Kong, Israel, Japan, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and UAE.

In addition, we sell NfL antibodies and NfL ELISA kits produced by our Swedish subsidiary, UmanDiagnostics AB ("Uman"), directly and in conjunction with a distributor worldwide.

As of December 31, 2025, we had 151 employees in sales, sales support, and marketing, including technical field application scientists and field service personnel.

This staff is primarily located in North America and Europe.

We expect we will expand our sales, support, and marketing efforts in the future by expanding our direct footprint in Europe as well as developing a comprehensive distribution and support network in China and other Asia-Pacific region countries where significant new opportunities exist.

We expect we will expand our sales, sales support, and marketing efforts in North America as it relates to the commercialization of our LucentAD Complete test.

Additionally, we expect to continue to develop a comprehensive distribution and support network in China and other APAC region countries where significant new opportunities exist.

Manufacturing and Supply

We outsource the manufacturing of our Simoa bead-based instruments to third-party manufacturers, and we manufacture our planar array instrument and all assay kits in our own facilities.

The HD-X instrument is supplied by STRATEC, based in Birkenfeld, Germany, and is manufactured and shipped from its Birkenfeld and Beringen, Switzerland facilities.

The SR-X is supplied by Paramit, based in Morgan Hill, California, and is shipped to our global customers by Paramit.

See the section titled “ — Key Agreements ” for a description of our agreements with STRATEC and Paramit.

We outsource the manufacturing of our Simoa bead-based instruments and Spatial Biology instruments to third-party manufacturers, and we manufacture our planar array instrument and all assay kits in our own facilities.

Our HD-X instrument is supplied by STRATEC, based in Birkenfeld, Germany, and is manufactured and shipped from its Birkenfeld and Beringen, Switzerland facilities.

Our SR-X instrument is supplied by Paramit, based in Morgan Hill, California, and is shipped to our global customers by Paramit.

Our Spatial Biology instruments are manufactured by Columbia Tech, based in Westborough, Massachusetts.

See the section titled " Key Agreements" for a description of our agreements with these manufacturers.

Installation of, and training on, our instruments is provided by our employees where we conduct direct sales, and by distributors where sales are conducted through distributors.

We believe this manufacturing strategy is efficient and conserves capital.

However, in the event it becomes necessary to utilize a different contract manufacturer for the HD-X or the SR-X, we could experience additional costs, delays and difficulties in doing so, and our business could be harmed.

The SP-X instruments are manufactured, tested, shipped and supported by us from our Billerica, Massachusetts facility.

However, in the event it becomes necessary to utilize a different contract manufacturer for the HD-X, SR-X, or Spatial Biology instruments, we could experience additional costs, delays and difficulties in doing so, and our business could be harmed.

Our SP-X instrument is manufactured, tested, shipped and supported by us from our Billerica, Massachusetts facility.

All internal components are sourced domestically except one significant component that is sourced in Germany.

1 unchanged sentence

Although we believe that alternatives would be available, it would take time to identify and validate replacement components, which could negatively affect our ability to supply SP-X instruments on a timely basis.

We assemble our assay kits for our bead-based platform in our Billerica, Massachusetts facility.

We assemble our assay kits for our Simoa bead-based platforms and Spatial Biology platforms in our Billerica, Massachusetts facility.

Our bead-based assays include all components required to run an enzyme-based immunoassay, such as beads, capture and detector reagents, enzyme reagents and enzyme substrate.

These reagents are sourced from a limited number of suppliers, including certain single-source suppliers.

Reagents for our assays are sourced from a limited number of suppliers, including certain single-source suppliers.

Although we believe that alternatives would be available, it would take time to identify and validate replacement reagents for our assay kits, which could negatively affect our ability to supply assay kits on a timely basis.

As part of our assay redevelopment program, we have increased the shelf life of our bead-based assays to 18 months and believe we are able to mitigate this supplier risk through inventory control.

Simoa disks for our bead-based platform are supplied through a single source supplier pursuant to a long-term supply agreement with STRATEC Consumables GmbH, a subsidiary of STRATEC.

Simoa disks for our bead-based platforms are supplied through a single source supplier pursuant to a long-term supply agreement with STRATEC Consumables GmbH, a subsidiary of STRATEC.

We believe that this agreement provides for a sufficient notification period to allow for supply continuity and the identification and tech transfer to a new supplier in the event either party wishes to terminate the relationship.

Our cuvettes for our bead-based platform are single sourced through STRATEC, and the disposable tips used in our bead-based platform are commercially available.

Table of Cont ents

Our cuvettes for our bead-based platforms are single sourced through STRATEC, and the disposable tips used in our bead-based platforms are commercially available.

We assemble our 96-well sample plate kits for our planar array platform in our Billerica, Massachusetts facility.

3 unchanged sentences

Because our planar array assays have a shelf life of 12 months, we believe we are able to mitigate this risk through inventory control.

Through our wholly owned subsidiary, Emission, based in Georgetown, Texas, we manufacture these proprietary, next generation monodisperse microspheres (i.e.

beads) entirely in-house from readily available materials, which consist of monomers, stabilizers, and surfactants.

In the event current suppliers of raw materials are unable to fill orders, we believe there are many alternative suppliers as all the materials are widely commercially available.

NfL antibodies and NfL ELISA Kits

1 unchanged sentence

Functional testing and verification of concentration are performed at Uman before the material is approved for use in production activities.

The antibodies can be aliquoted and sold as single reagents or used for the production of Uman’s NfL ELISA kits.

The contract manufacturer of antibodies is audited regularly, and we have entered into a written supply agreement with the contract manufacturer.

The current shelf-life of the antibodies is 18 months.

The antibodies currently have a shelf life of 18 months and can be aliquoted and sold as single reagents or used for the production of Uman’s NfL ELISA kits.

All components in Uman’s NfL ELISA kits are manufactured in-house at Uman from starting materials sourced from suppliers that have been evaluated and approved.

3 unchanged sentences

After testing and batch record review, the material is released to market.

The current shelf-life of the kits is 18 months (NF-light ELISA (CSF)) or 13 months (NF-light Serum ELISA).

The current shelf-life of the kits is 18 months (NfL ELISA (CSF)) or 13 months (NfL Serum ELISA).

Key Agreements

Development Agreement and Supply Agreement with STRATEC

In August 2011, we entered into a Strategic Development Services and Equity Participation Agreement with STRATEC, pursuant to which STRATEC undertook the development of the Simoa HD instrument.

In September 2011, we also entered into a Supply and Manufacturing Agreement with STRATEC (the “STRATEC Supply Agreement”), pursuant to which STRATEC agreed to supply HD instruments to us, and we agreed to procure those instruments exclusively from STRATEC, subject to STRATEC’s ability to supply the instruments.

In August 2011, as amended in November 2016 and July 2025, we entered into a Strategic Development Services and Equity Participation Agreement with STRATEC, pursuant to which STRATEC undertook the development of the Simoa HD instrument.

In September 2011, as amended in October 2013, we also entered into a Supply and Manufacturing Agreement with STRATEC (the "STRATEC Supply Agreement"), pursuant to which STRATEC agreed to supply HD instruments to us, and we agreed to procure those instruments exclusively from STRATEC, subject to STRATEC’s ability

to supply the instruments.

We are responsible for obtaining any regulatory approval necessary to sell the instruments.

3 unchanged sentences

On termination by us for STRATEC’s insolvency or uncured material breach or termination by STRATEC for convenience, we are granted a nonexclusive royalty free license of STRATEC intellectual property to manufacture the instruments.

In certain of these circumstances, we could be obligated to issue warrants to purchase our common stock.

Paramit Manufacturing Services Agreement

2 unchanged sentences

Paramit has no obligation to maintain inventory in excess of any open purchase orders or materials in excess of the amount Paramit reasonably determines will be consumed within 90 days or within the lead time of manufacturing our instrument, whichever is greater.

We have an obligation to purchase any material or instruments deemed in excess

Table of Cont ents

pursuant to the Paramit Agreement.

We have an obligation to purchase any material or instruments deemed in excess pursuant to the Paramit Agreement.

The price is determined according to a mutually agreed-upon pricing formula.

The parties agreed to review the pricing methodology yearly or upon a material change in cost.

The Paramit Agreement had an initial three-year term with automatic one year extensions.

It is terminable by either party for convenience with written notice to the other party given at least nine months prior to the end of the then-current term.

The Paramit Agreement is terminable by either party for convenience with written notice to the other party given at least nine months prior to the end of the then-current annual term.

The agreement may also be terminated by us with three months’ notice to Paramit upon the occurrence of (i) a failure of Paramit to obtain any necessary governmental licenses, registrations or approvals required to manufacture our instrument or (ii) an assignment by Paramit of its rights or obligations under the agreement without our consent.

The Paramit Agreement is terminable by Paramit with 30 days’ notice to us in the event of a material breach after written notice and a 60-day opportunity to cure the breach.

We compete with both established and development-stage life science companies that design, manufacture and market instruments for proteomics discovery and clinical research applications.

For example, companies such as Bio-Techne, MesoScale Discovery, Gyros, SEER, MilliporeSigma, Bio-Rad Laboratories, Thermo Fisher Scientific, Alamar, C2N Diagnostics, and others, have products for protein measurements in biofluids that compete in certain segments of the market in which we sell our products.

Our Accelerator Laboratory competes with other research laboratories such as LabCorp, Covance, Q2 Solutions, Rules Based Medicine, Monogram Biosciences, Frontage, PPD Laboratories, and others, some of which are customers of ours.

In addition, as we or our partners expand the applications for our products to include diagnostics, we expect to compete with companies such as Siemens, Abbott, Roche, Fujirebio, DiaSorin, Ortho Clinical Diagnostics and Thermo Fisher Scientific.

Furthermore, our technology and products are showing promise for non-invasive early disease detection, and in the future, we could experience competition from companies that develop and market imaging and other molecular detection technologies.

In addition, a number of other companies and academic groups are in the process of developing novel technologies for life science research and diagnostics.

Many of the companies with which we compete or will compete have substantially greater resources than we have.

The life science instrumentation and lab services industries are highly competitive and expected to grow more competitive with the increasing knowledge gained from ongoing research and development.

we believe the principal competitive factors for us include:

• sensitivity;

• cost of instruments and consumables;

• reputation among customers and key opinion leaders;

• innovation in product offerings;

• accuracy and reproducibility of results;

• customer support infrastructure.

We believe that we are well positioned with respect to these competitive factors and expect to enhance our position through ongoing global expansion, innovative new product introductions and ongoing collaborations, and partnerships with key opinion leaders.

Columbia Tech Manufacturing Agreement

In July 2019, Akoya entered into a Manufacturing Agreement ("the CT Agreement") with Columbia Tech to manufacture its Spatial Biology instruments on an as-ordered basis.

We are responsible for obtaining any regulatory approval necessary to sell the instruments.

The instrument price is established by Columbia Tech and is subject to certain adjustments.

The CT Agreement is terminable by either party for convenience upon 90 days' notice to the other party.

The CT Agreement may also be terminated by either party with 30 days' notice of an uncured material breach, or by us if Columbia Tech fails to deliver ordered products within 45 days of the delivery date.

Intellectual Property

Our success depends in part on our ability to obtain and maintain intellectual property protection for our products and technology.

We use a variety of intellectual property protection strategies, including patents, trademarks, trade secrets, and other methods of protecting proprietary information.

Our patent strategy is multilayered, providing coverage of aspects of the core technology as well as specific uses and applications.

The first layer is based on protecting the fundamental methods for detecting single molecules independent of the specific analyte to be detected.

The second layer covers embodiments of the core technology directed to the detection of specific analytes.

The third layer protects novel instrumentation, consumables, and manufacturing processes used in applying the invention to certain commercial products or future product opportunities.

The fourth layer is concerned with

Table of Cont ents

specific uses of the core technology (e.g., biomarkers and diagnostics).

We rely primarily on a combination of patent, copyright, trademark, and trade secret laws, as well as contractual provisions with employees and third parties, to establish and protect our intellectual property rights.

Our patent strategy is to pursue broad protection for key technologies, supplemented by additional patent filings covering conceptual methods, specific aspects of current and proposed products, and forward-looking applications and technological developments, and licensing of certain patent families from third parties.

We also engage in strategic analysis of our owned and licensed patent assets and pursue additional patent claims from our existing portfolio that may provide us with market and other competitive advantages.

We do not rely heavily on trade secret protection but do maintain a certain amount of in-house know-how that is not disclosed publicly.

We provide products to customers, commercial, and academic collaborators pursuant to agreements with non-disclosure terms and other conditions that impose restrictions on use and disclosure.

We further make use of contractual obligations that require our employees, consultants, and contractors with access to our proprietary information to execute non-disclosure, non-competition and assignment of intellectual property agreements to preserve our intellectual property

We generally control access to our proprietary and confidential information through the use of internal and external controls that are subject to periodic review.

Our Simoa patent strategy protects but is not limited to:

fundamental methods for detecting single molecules independent of the specific analyte to be detected, embodiments of the core technology directed to the detection of specific analytes, novel instrumentation, consumables, and manufacturing processes used in applying the invention to certain commercial products or future product opportunities and specific uses of the core technology (e.g., biomarkers and diagnostics).

Our Spatial Biology patent strategy protects but is not limited to:

spatial / tissue multiplexing technologies and spatial / tissue signal amplification technologies for both protein and nucleic acids;

selective labeling, RNA sequence identification and error correction visualizing tissues and compartments within cells, image, and signal processing technologies including spectral unmixing, dynamic optical correction, machine classifiers, multiple-image registration, systems and methods for whole-slide imaging, automated adjustment of imaging systems, extraction of pure spectra from sample images, focus determination in imaging systems as well as specific biomarkers or combinations thereof for use in discovery and diagnostics.

Our patent strategy is both offensive and defensive in nature, seeking to protect not only technology we currently practice but also alternative, related embodiments.

As of December 31, 2024, we owned or exclusively licensed more than 100 issued patents and patent applications worldwide.

As of December 31, 2025, our active patent portfolio (owned or exclusively licensed) included approximately 154 issued patents worldwide with an additional 102 applications pending.

Our owned or exclusively licensed patents and patent applications, if issued, are expected to expire between 2026 and 2043, 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.

Our core Simoa bead-based technology, directed to general methods and devices for single molecule detection, originated at Tufts, in the laboratory of Professor David Walt, who is the founder of Quanterix and a current member of our Board.

Our core Simoa technology, directed to general methods and devices for single molecule detection, originated at Tufts University ("Tufts"), in the laboratory of Professor David Walt, who is one of the founders of Quanterix.

Professor Walt and his students pioneered the single molecule array technology, including technologies that enabled the detection of single enzyme labels in arrays of microwells, thereby facilitating ultra-sensitive detection.

We have exclusively licensed from Tufts the relevant patent rights related to these technologies (see the section titled “— License Agreement with Tufts University ” below).

We have exclusively licensed from Tufts the relevant patent rights related to these technologies (see the section titled "Material Licenses").

Our core Spatial Biology labeling technology PhenoCycler (formerly CODEX) originated in the laboratory of Professor Garry P.

Nolan at Stanford, who is a former member of Akoya's board of directors.

Patent families covering this technology are exclusively licensed from Stanford University (see the section titled "Material Licenses").

Our key Spatial Biology imaging technology PhenoImager (formerly Phenoptics) originated at Cambridge Research and Instrumentation Inc, ("Cambridge Research"), a company that was later acquired by Caliper Life Sciences, Inc.

("Caliper Life Sciences").

Caliper Life Sciences was subsequently acquired by Perkin Elmer, Inc., subsequently known as Revvity ("PKI").

We purchased key patent assets covering this technology from PKI, Cambridge Research, and Caliper Life Sciences, and also licensed certain supplemental patents from PKI, Cambridge Research, and VisEn Medical Inc.

("VisEn Medical").

Some of the supplemental patents are exclusively licensed and others are non-exclusively licensed (see the section titled "Material Licenses").

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.

4 unchanged sentences

For further discussion of the risks relating to our intellectual property, see the section titled "Risk Factors — Risks Related to our Intellectual Property."

License Agreement with Tufts University

Material Licenses

Tufts University

In June 2007, as amended in April 2013, August 2017, and September 2020, we entered into a license agreement with Tufts, pursuant to which we obtained an exclusive, worldwide license to all patent rights to the Simoa bead-based technology owned by Tufts, as well as a non-exclusive license to related know-how.

8 unchanged sentences

Upon termination of the agreement, all rights revert to Tufts.

Stanford University

In November 2015, Akoya entered into an exclusive (equity) agreement with Stanford University ("Stanford"), pursuant to which Stanford granted Akoya an exclusive, sublicensable (subject to certain requirements), worldwide license under certain patent rights owned by Stanford relating to oligonucleotide-based biological sample labeling to make, use and sell products and services that are covered by such patent rights (the “Stanford Licensed Products”) in all fields of use.

The patents are related to oligonucleotide-based labeling technology, and we refer to this technology as the CODEX 1 technology.

In November 2016, the agreement was amended to include an exclusive, sublicensable (subject to certain requirements), worldwide license granted to Akoya by Stanford under additional patent rights owned by Stanford relating to oligonucleotide-based biological sample labeling to make, use, and sell products and services that are covered by such patent rights, in all fields of use (such products and services are also included in the Stanford Licensed Products).

We refer to the technology disclosed in the additional patents as the CODEX 2 technology.

Akoya is obligated to use commercially reasonable efforts to develop, manufacture, sell and develop markets for Stanford Licensed Products, including with respect to accomplishing specific goals with specific deadlines set forth in the agreement.

Akoya made one-time upfront payments upon the execution of the agreement and amendments.

We are required to pay Stanford annual license maintenance fees in the mid-five figures.

We further agreed to make certain milestone payments based on specified patent issuance and sales milestone events.

We are also obligated to pay Stanford a low single-digit percentage royalty on net sales of Stanford Licensed Products and a portion of any of its sublicensing income.

Subject to Stanford’s approval, we control the prosecution and maintenance of the licensed patents and, if we develop Stanford Licensed Products, we have the first right to institute a suit, or defend any declaratory judgment action, related to third-party infringement of the licensed patents.

The agreement will continue until the expiration, revocation, invalidation or abandonment of the last patent or patent application that is licensed to us, unless terminated earlier in accordance with its terms.

The last licensed patent is set to expire in 2036.

We may terminate the agreement at any time by providing advance written notice of at least 30 days.

Stanford may terminate the agreement if we violate or fail to perform any material terms thereof or for our failure to achieve certain milestones or use commercially reasonable efforts to develop and commercialize the Stanford Licensed Products and fail to cure such violation or failure within 30 days of written notice from Stanford.

PKI/Revvity, Cambridge Research, and VisEn Medical

In September 2018, in connection with the acquisition of the Quantitative Pathology Solutions ("QPS") technology from PKI, Akoya entered into a license and royalty agreement with PKI, Cambridge Research, and VisEn Medical, (collectively, the "Licensor"), pursuant to which the Licensor granted Akoya an exclusive, nontransferable, sublicensable (subject to certain conditions), worldwide license within certain fields of use under certain patent rights and know-how owned by the Licensor to make, use, and sell products within such fields of use, as well as a similar, non-exclusive license under certain other patent rights.

The licensed patents relate to methods and systems for analyzing biological samples, and in particular, slide-mounted tissue samples.

We are obligated to pay the Licensor royalties ranging from low to mid single-digit percentages on net sales of products covered by either license on a decreasing schedule that ends upon the expiration of the last valid claim of the licensed patents, at which point the agreement shall terminate and our rights and licenses thereunder shall survive on a fully-paid up, royalty-free basis.

The last licensed patent is set to expire in 2036.

Neither we nor the Licensor has the right to terminate the agreement prior to such expiration.

The Licensor has the first right to control the prosecution, maintenance and defense of the licensed patents.

We have the first right to enforce any exclusively licensed patent with respect to third-party infringement occurring solely within its licensed field of use, and Licensor has the first right to enforce the license patents with respect to any other third-party infringement.

If any exclusively licensed patent is believed to be infringed by the development, manufacture, use, offer for sale, sale or importation of a product by the third-party solely inside field of use worldwide, the Licensor has the first right to institute, prosecute and control any action or proceeding with respect to such infringement of such patent.

University of Washington

In June 2018, Akoya entered into an exclusive patent license agreement with the University of Washington (the "University"), pursuant to which the University granted Akoya an exclusive, sublicensable (subject to certain conditions), worldwide license in certain fields of use under certain patent rights owned by the University relating to technology for molecular profiling of cells and tissue specimens, to make, use and sell products that are covered by such patent rights, or the Washington Licensed Products.

The licensed patents are related to the detection of biomolecules, particularly proteins and nucleic acids, in biological samples.

We are obligated to pay the University a low single-digit percentage running royalty on net sales of Washington Licensed Products, subject to certain minimum annual royalty payments and potential reductions based on a royalty-stacking allowance for certain third -party rights that are required to be obtained to make, use, sell or import Washington Licensed Products.

We are also obligated to make cumulative one-time payments to the University upon the achievement of certain commercial milestones, as well as sharing a portion of any of its non-royalty sublicensing income.

We are obligated to use commercially reasonable efforts to commercialize the inventions covered by the licensed patent rights and to make and sell Washington Licensed Products as soon as practicable and maximize sales thereof, including with respect to accomplishing specific goals with specific deadlines set forth in the agreement.

The University must conduct the prosecution of the licensed patents per our instructions and at our expense, subject to certain exceptions.

We have the first right to defend and enforce the licensed patents at its expense.

The agreement will expire when all licensed patent rights have terminated, unless terminated earlier in accordance with the terms thereof.

The last licensed patent is set to expire in 2032.

We may terminate the agreement at any time by providing advance written notice of at least 60 days.

The University may terminate the agreement if we violate or fail to perform any material term thereof and fail to cure such violation or failure within 60 days of written notice from the University.

In addition, the University may terminate the exclusive license agreement upon 10 days’ prior written notice upon certain insolvency-related events involving us or should we challenge the validity of the licensed patents.

We compete with both established and development-stage life science companies that design, manufacture, and market instruments for proteomics discovery and clinical research applications.

Companies such as Bio-Techne, MesoScale Discovery, SEER, Bio-Rad Laboratories, Alamar, Spear Bio, and others, have products for protein measurements in biofluids that compete in certain segments of the market in which we sell our products.

In the spatial biology market, there

are companies, both established and early-stage, that have indicated that they are designing, manufacturing, and marketing products for, among other things, tissue analysis, single-cell analysis and spatial analysis.

These companies include 10x Genomics, Vizgen, Bio-Techne, Bruker, Miltenyi Biotec, and Standard BioTools, each of which has products that compete to varying degrees with some but not all of our product solutions, as well as a number of other emerging and established companies.

Our Accelerator Laboratory competes with other research laboratories such as LabCorp, Covance, Q2 Solutions, Rules Based Medicine, Monogram Biosciences, Frontage, Thermo Fisher Scientific, and others, some of which are customers of ours.

In addition, as we or our partners expand the applications for our products to include diagnostics, we expect to compete with companies such as Roche, Fujirebio, Danaher, and C2N Diagnostics.

Many of the companies with which we compete or will compete have substantially greater resources than we have.

However, we believe we are differentiated from our competitors for several reasons, including our position as a leader in a large and growing market, proprietary technologies, rigorous product development processes, scalable infrastructure, and positive customer experience.

We believe our customers view our products and company favorably because of these differentiators.

The life science instrumentation and lab services industries in which we operate are highly competitive and expected to grow more competitive with the increasing knowledge gained from ongoing research and development.

we believe the principal competitive factors for us include:

• sensitivity;

• cost of instruments and consumables;

• reputation among customers and key opinion leaders;

• innovation in product offerings;

• accuracy and reproducibility of results;

• customer support infrastructure.

For further discussion of the risks we face relating to competition, see the section titled “Risk Factors — Risks Related to our Business and Industry — Our market is highly competitive, and if we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenue, or achieve and sustain profitability.”

Government Regulation

The majority of our products are currently intended for RUO applications, although our customers may use our products to develop their own products that are subject to regulation by the FDA or CMS.

The majority of our products are currently intended for research use only ("RUO") applications, although our customers may use our products to develop their own products that are subject to regulation by the FDA or CMS.

Although in vitro diagnostic products intended for RUO are not currently required to obtain premarket clearance or approval by the FDA, products labeled as RUO are subject to the FDA’s premarket review requirements if they are determined to be intended for use for clinical rather than non-clinical research purposes.

1 unchanged sentence

Not for Diagnostic Procedures.”

Table of Cont ents

The FDA has issued Final Guidance for Industry and Food and Drug Administration Staff on "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only" (the "RUO/IUO Guidance").

1 unchanged sentence

The RUO/IUO Guidance explains that the FDA will review the totality of the circumstances when evaluating whether equipment and testing components are properly labeled as RUO.

Merely including a labeling statement that a product is intended for research use only will not necessarily exempt the device from the FDA’s premarket notification and clearance process (510(k)), premarket approval, or other requirements, if the circumstances surrounding the distribution of the product indicate that the manufacturer intends its product to be used for clinical diagnostic use.

Merely including

a labeling statement that a product is intended for research use only will not necessarily exempt the device from the FDA’s premarket notification and clearance process (510(k)), premarket approval, or other requirements, if the circumstances surrounding the distribution of the product indicate that the manufacturer intends its product to be used for clinical diagnostic use.

These circumstances may include written or verbal marketing claims or links to articles regarding a product’s performance in clinical applications, a manufacturer’s provision of technical support for clinical validation or clinical applications, or solicitation of business from clinical laboratories, all of which could be considered evidence of intended uses that conflict with RUO labeling.

We believe that our labeling and promotion of our products, including the custom assay RUO products developed by the Accelerator Laboratory, is consistent with the RUO/IUO Guidance because we have not promoted our products for clinical use in humans.

IVD tests that are commercially distributed and intended for clinical diagnostic use are regulated by the FDA as medical devices, however, the FDA has traditionally not regulated most laboratory tests referred to as LDTs (as discussed further below).

The FDA defines a medical device in part as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article which is intended for the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in man.

In vitro diagnostics ("IVD") tests that are commercially distributed and intended for clinical diagnostic use are regulated by the FDA as medical devices, however, the FDA has historically not regulated most laboratory tests referred to as LDTs (as discussed further below).

We currently offer four LDTs through our CLIA-certified laboratory:

5 unchanged sentences

We own and operate a CLIA-certified laboratory.

The CLIA are federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States (with the exception of research testing that does not report patient specific results).

CLIA, along with federal regulations promulgated under CLIA, apply to all clinical laboratory testing performed on humans in the United States (with the exception of research testing that does not report patient specific results).

A clinical laboratory is defined by CLIA as any facility that performs examinations of specimens obtained from humans for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of health of, human beings.

CLIA requires such laboratories to be certified by the federal government and mandates compliance with various operational, personnel, facilities administration, quality and proficiency testing requirements intended to ensure that testing services are accurate, reliable and timely.

CLIA requires such laboratories to be certified by the federal government (or a CMS-approved accreditation organization) and mandates compliance with various operational, personnel, facilities administration, quality and proficiency testing requirements intended to ensure that testing services are accurate, reliable and timely.

CLIA certification also is a prerequisite to be eligible to bill state and federal health care programs, as well as many private insurers, for laboratory testing services.

3 unchanged sentences

The biennial survey is conducted by CMS, a CMS agent (typically a state agency), or a CMS-approved accreditation organization.

High complexity, CLIA-certified laboratories, such as our, frequently develop testing procedures to provide diagnostic results to customers.

High complexity, CLIA-certified laboratories, such as ours, frequently develop testing procedures to provide diagnostic results to customers.

These tests have been offered by high-complexity laboratories for the last few decades as LDTs, the validation and performance of which are subject to CMS oversight through its enforcement of CLIA.

The FDA also has claimed that it has regulatory authority over LDTs under the agency’s medical device authorities, but historically has not exercised enforcement with respect to most LDTs when they meet FDA’s definition of an LDT.

FDA defines an LDT as an in vitro diagnostic that is intended for clinical use and is designed, manufactured, and used within a single high-complexity, CLIA- certified laboratory.

In October 2023, FDA issued a proposed rule regarding LDTs that would establish that in vitro diagnostic products are devices under the Federal Food, Drug, and Cosmetic Act, including when the

Table of Cont ents

manufacturer is a laboratory.

FDA finalized this rule in April 2024.

Under the Final Rule, FDA will provide greater oversight of LDTs by phasing out its general enforcement discretion approach for most LDTs, and phase in medical device regulation, for most LDTs over a period of four years.

FDA intends to continue to exercise general enforcement discretion from all requirements under the FDCA for five categories of LDTs:

(1) 1976-Type LDTs;

(2) human leucocyte antigen (HLA) tests used for organ, stem cell, and tissue transplantation;

(3) tests manufactured and used within the Department of Defense (DoD) or the Veterans Health Administration (VHA);

(4) forensic (law enforcement) tests;

and (5) public health surveillance tests.

LDTs that do not fall into any of these five categories are subject to a phase-out of FDA’s previous enforcement discretion approach and a phase-in of medical device regulation over a period of four years and in five stages.

However, FDA intends to exercise continued enforcement discretion from certain aspects of medical device regulation for certain types of LDTs.

For example, FDA intends to exercise regulatory discretion to not require premarket review or most quality system requirements for “currently marketed” LDTs, which include LDTs that were offered as of May 6, 2024, which is the date the FDA’s rule was finalized.

Similarly, FDA intends to exercise regulatory discretion to not require premarket review or most quality system requirements for certain tests offered within integrated health systems.

In addition, FDA will exercise regulatory enforcement discretion to not require premarket review for tests first offered after May 6, 2024, but which have been subject to review and approval by the New York State Department of Health’s Clinical Laboratory Evaluation Program (NYS CLEP).

Finally, FDA intends to exercise regulatory enforcement discretion and generally not enforce premarket review requirements for certain modifications made to 510(k)-cleared and De Novo- authorized tests by CLIA-certified, high-complexity laboratories, even if that 510(k) clearance or De Novo authorization is held by a different manufacturer.

Certain groups have challenged the legality of FDA’s Final Rule regarding LDTs, asserting (among other things) that the rule exceeds FDA’s statutory authority to regulate medical devices.

That lawsuit is pending, with a decision from the District Court expected sometime in 2025.

It is also possible that the federal government will modify, delay, or revoke the Final Rule.

If the Final Rule is not modified, delayed, revoked, or invalidated when the requirements of the rule go into effect, the rule will result in an increased regulatory burden, including additional costs and delays in introducing new LDTs, and could result in tests being removed from the market.

The FDA also has claimed that it has regulatory authority over LDTs under the agency’s medical device authorities, but historically did not enforce those requirements with respect to most LDTs.

However, in April 2024, the FDA ended its policy of enforcement discretion for LDTs and finalized a rule that would subject nearly all LDTs—including the LDTs that we offer—to regulation as devices under the Federal Food, Drug, and Cosmetic Act ("FDCA").

In response to FDA's final rule, several organizations filed legal challenges, asserting that the FDA rule violated the Administrative Procedure Act because LDTs do not qualify as “devices” under the FDCA.

On March 31, 2025, a federal district court agreed with the challengers, holding that LDTs are laboratory services and do not meet the definition of a “device” in the FDCA.

Therefore, the district court held that FDA’s rule was invalid and FDA could not regulate LDTs as devices.

4:24-cv-00479-SDJ (E.D.

The FDA did not appeal that district court decision and subsequently withdrew the LDT rule.

Notwithstanding this district court decision, and FDA’s decision to not appeal, it is possible that in the future the FDA could again attempt to assert that LDTs are medical devices and must comply with the requirements of the FDCA.

It is also possible that the FDA could attempt to assert that some LDTs do qualify as an “LDT.” Historically, FDA defined an

LDT as a test that is intended for clinical use and is designed, manufactured, and used within a single high-complexity, CLIA-certified laboratory.

If a diagnostic test commercialized by a clinical laboratory does not meet all elements of this definition, it is possible that the FDA could assert that the test is not an LDT and is subject to its jurisdiction as a medical device.

If a laboratory is out of compliance with state laws or regulations governing licensed laboratories or with CLIA, it may be subject to enforcement actions that may include suspension, limitation, or revocation of the license or CLIA certificate, assessment of financial penalties or fines, or imprisonment.

6 unchanged sentences

and may be easier or more difficult to satisfy and are subject to change.

For example, in the E.U.

new regulations recently entered into force that introduce greater regulation of medical devices and IVDs.

For example, in the European Union ("E.U.") new regulations recently entered into force that introduce greater regulation of medical devices and IVDs.

The IVD regulation is significantly different from the IVD Directive that it replaces in that it ensures that the new requirements apply uniformly and on the same schedule across the member states, includes a risk-based classification system and increases the requirements for conformity assessment.

6 unchanged sentences

When all requirements are met, a notified body will be contacted, and the certification initiated.

Table of Cont ents

The NF-light Serum ELISA is currently sold only as a RUO product (not intended for diagnostic use).

9 unchanged sentences

Rules under HIPAA and HITECH include specific security standards and breach notification requirements.

Department of Health and Human Services (through the Office for Civil Rights) has direct civil enforcement authority against Covered Entities and Business Associates with regard to both the Security and Privacy Rules.

Department of Health and Human Services (through the Office for Civil Rights) has direct civil enforcement

authority against Covered Entities and Business Associates with regard to both the Security and Privacy Rules.

Department of Justice has criminal enforcement authority against Covered Entities, Business Associates, and certain other entities and individuals.

7 unchanged sentences

In the E.U., stringent data protection and privacy rules which substantially impact the use of patient data across the healthcare industry became effective in May 2018.

The GDPR applies uniformly across the E.U.

The General Data Protection Regulation ("GDPR") applies uniformly across the E.U.

and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance.

8 unchanged sentences

For example, the U.S.

Occupational Safety and Health Administration (“OSHA”), has established extensive requirements relating specifically to workplace safety for healthcare employers in the

Table of Cont ents

Occupational Safety and Health Administration (“OSHA”), has established extensive requirements relating specifically to workplace safety for healthcare employers in the U.S.

This includes requirements to develop and implement multi-faceted programs to protect workers from exposure to blood-borne pathogens, including preventing or minimizing any exposure through needle stick injuries.

4 unchanged sentences

Department of Transportation, the U.S.

Public Health Service, the United States Postal Service and the International Air Transport Association.

Public Health Service, the U.S.

Postal Service, and the International Air Transport Association.

We generally use third-party vendors to dispose of regulated medical waste, hazardous waste, and radioactive materials that we may use during our research and services.

2 unchanged sentences

Of our 450 full-time employees, 382 were located in the United States and 68 were located in 14 foreign countries.

None of our employees is represented by a labor union or subject to a collective bargaining agreement.

None of our employees are represented by a labor union or subject to a collective bargaining agreement.

Our culture emphasizes the impact our work has on the detection of neurological and other critical disorders.

7 unchanged sentences

employees), healthcare and insurance benefits, paid time off, family leave, employee assistance programs, and behavioral health services.

Additionally, all our employees are eligible for annual equity-based grants with vesting conditions designed to award our employees’ performance and encourage retention.

Additionally, some of our employees are eligible for annual equity-based grants with vesting conditions designed to award our employees’ performance and encourage retention.

Company Culture

We are committed to an inclusive culture which is grounded on our values of integrity, respect, and equality.

In support of our inclusive culture, we sponsor an internal group of culture champions who are focused on diversity, equity, and inclusion.

These champions are comprised of employees and executives whose mission is to provide respectful workplace training and awareness to strengthen employee understanding and knowledge of key topics focused on diversity and inclusion.

In support of our inclusive culture, we sponsor an internal group of culture champions comprised of employees and executives whose mission is to provide respectful workplace training and awareness to strengthen employee understanding and knowledge of these values.

As of December 31, 2025, approximately 45% of our employees were women and approximately 33% of our employees were people of color.

1 unchanged sentence

Our employee handbook and Corporate Code of Conduct and Ethics set forth policies that reflect our values and provide guidance for registering complaints in the event of any violation of our policies.

An “open door” policy is maintained at all levels of the organization, and any form of retaliation against an employee is strictly prohibited.

An “open door” policy is maintained at all levels of the organization, and any form of retaliation against an employee for making a good faith complaint is strictly prohibited.

Employee Engagement and Wellness

2 unchanged sentences

We provide our employees with a wide range of policies and practices to ensure an environment of physical and psychological safety and well-being.

Table of Cont ents

Corporate Information

We were incorporated under the laws of the State of Delaware in April 2007 under the name “Digital Genomics, Inc.” In August 2007, we changed our name to “Quanterix Corporation.” Our principal executive offices are located at 900 Middlesex Turnpike, Billerica, Massachusetts 01821, and our telephone number is (617) 301-9400.

We were incorporated under the laws of the State of Delaware in April 2007 under the name "Digital Genomics, Inc.".

In August 2007, we changed our name to "Quanterix Corporation".

Our principal executive offices are located at 900 Middlesex Turnpike, Billerica, Massachusetts 01821, and our telephone number is (617) 301-9400.

Information Available on the Internet

6 unchanged sentences

Our electronically filed reports and other information that we file with the SEC can be viewed on the SEC’s website at www.sec.gov .

Table of Cont ents

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

What changed 10-K

Item 1. Business