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Item 1. Business

2024-03-08 compared with 2023-03-15 · 162 added, 211 removed, 418 unchanged (47% of the section changed)

Analysis for Life

We are leading a revolution in measurement devices for chemical and biochemical analysis with our simple handheld and desktop devices, addressing critical-to-life applications.

We are reimagining where Mass Spec technology can be used if it is sufficiently small in size, low in cost, and simple to operate.

Analysis at the Speed of Life

We are making revolutionizing chemical and biochemical analysis simple, smart and speedy with our purpose-built handheld and desktop devices that empower people to take swift action in life-altering applications.

Company Overview

We have developed an innovative suite of purpose-built handheld and desktop mass spectrometry, or Mass Spec, devices for the point-of-need.

Leveraging our proprietary platform technology, we make the extraordinary analytical power of Mass Spec available in devices that are significantly smaller and more accessible than conventional laboratory instruments.

Our Mass Spec devices are used at the point-of-need to interrogate unknown and invisible materials and provide quick, actionable answers to directly address some of the most critical problems in life sciences research, bioprocessing, quality assurance/quality control, forensics and adjacent markets.

We have developed an innovative suite of purpose-built handheld and desktop devices for the point-of-need chemical and biochemical analysis.

Leveraging our proprietary mass spectrometry, or Mass Spec, microfluidics, and analytics and machine learning technologies, we make devices that are significantly smaller and more accessible than conventional laboratory instruments.

Our devices are used at the point-of-need to interrogate unknown and invisible materials and provide quick, actionable answers to directly address some of the most critical problems in life sciences research, bioprocessing, pharma/biopharma, forensics and adjacent markets.

The term “products” or “devices” used in this “Business” section each refer to the MX908, Rebel, ZipChip Interface, Maverick, and Maven and related sampling devices.

We create simplified measurement devices that our customers can use as accurate tools where-and-when their work needs to be done, rather than overly complex and centralized analytical instrumentation.

We believe the insights and answers our devices provide will accelerate workflows, reduce costs, and offer transformational opportunities for our end users.

Since the launch of our first device, we have sold more than 2,300 handheld and desktop devices to over 550 customers in over 45 countries, including all 20 of the top 20 pharmaceutical companies by revenue, as well as numerous domestic and foreign government agencies and leading academic institutions.

Our current products are available for both battery powered handheld and desktop applications, including our flagship devices -- MX908 and Rebel.

We believe the insights and answers our devices provide accelerate workflows, reduce costs, and offer transformational opportunities for our end users.

Since the launch of our first device, we have sold more than 2,800 handheld and desktop devices to over 700 customers in 56 countries, including all 20 of the top 20 pharmaceutical companies by revenue, as well as numerous domestic and foreign government agencies and leading academic institutions.

Our current products are available for both battery-powered handheld and desktop applications.

Front-line workers rely upon our handheld devices to combat the opioid crisis and detect counterfeit pharmaceuticals and illicit materials in the air or on surfaces at levels 1,000 times below their lethal dose.

Our desktop devices are accelerating development and production of biotherapeutics by identifying and quantifying extracellular species in bioprocessing critical to cell health and productivity.

They sit either alongside or connected to bioreactors and fermenters producing drug candidates, functional proteins, cell and gene therapies, and synthetic biology-derived products.

They sit alongside or are directly connected to bioreactors and fermenters producing drug candidates, functional proteins, cell and gene therapies, and synthetic biology derived products.

We believe the insights and answers our devices provide accelerate workflows, reduce costs, and offer transformational opportunities for our end users.

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While Mass Spec is an extremely powerful analytical tool, conventional Mass Spec instruments are very large, expensive, and highly complex, which has profoundly bottlenecked market opportunities and relegated them to the equivalent of mainframe computers in central facilities.

We are seeking to reimagine where Mass Spec technology can be used if it is sufficiently small in size, low in cost, and simple to operate.

We are reimagining where Mass Spec technology can be used if it is sufficiently small in size, low in cost, and simple to operate.

Our proprietary Mass Spec platform relies on extreme miniaturization of the core of Mass Spec -- the ion trap and its vacuum system.

Using semiconductor microfabrication techniques, we design and produce components that are more than a thousand fold smaller in volume when compared with most laboratory Mass Spec instruments and costs only dollars to manufacture.

Using semiconductor microfabrication techniques, we design and produce components that are more than a thousand-fold smaller in volume when compared with most laboratory Mass Spec instruments and costs only

dollars to manufacture.

The vacuum system alone in a typical laboratory instrument weighs hundreds of pounds and requires several hundred watts of power, 24 hours per day, 365 days per year.

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The size of a business card, our microfluidic capillary-electrophoresis, or CE, chip has demonstrated world-class performance and speed in separating everything from small molecules such as metabolites and drugs, to biopharmaceutical proteins, antibodies, and oligonucleotides.

With our acquisition of TRACE Analytics GmbH (“Trace”) in August 2022, we obtained microfluidic aseptic sampling technology that enables on-line automated monitoring and control in bioprocess applications.

With our acquisition of Trace Analytics GmbH, renamed 908 Devices GmbH, in August 2022, we obtained microfluidic aseptic sampling technology that enables on-line automated monitoring and control in bioprocess applications.

This validated technology provides cell-free and sterile bioreactor sampling with no volume or prep required.

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Lastly, it is imperative that a point-of-need solution is operable by the widest possible user base.

We have an industry-leading software automation and machine learning team comprised of nine members, each with advanced scientific degrees, who have collective experience working on 30 commercial product launches and have won numerous research and innovation awards.

We have an industry-leading software automation and machine learning team comprised of eleven members, each with advanced scientific degrees, who have collective experience working on 30 commercial product launches and have won numerous research and innovation awards.

They have applied advanced software automation and machine learning techniques to both control the hardware in our devices and interpret the incredibly rich and complex data streaming off of them.

It is common for expert data interpretation from a laboratory Mass Spec instrument to take hours or days -- we can provide answers immediately to maximize value to the customer in critical-to-life applications where minutes matter.

Our team can provide answers immediately to maximize value to the customer in critical-to-life applications where minutes matter.

Our team applied its deep expertise in data analytics, machine learning and optical spectroscopy to develop a proprietary modeling approach that automatically processes Raman spectra from a wide variety of mammalian cell culture media types and cell lines.

This proprietary modeling approach powers our Maverick desktop device.

Introduced in 2023, Maverick offers bioprocess scientists easy-to-integrate in-line analysis and control without the need for substantial expert configuration or setup.

We fundamentally believe that the technology platform we have built and the investments we are making will allow people to answer chemical and biochemical questions in times and places that were previously inconceivable.

Given the market opportunity, we expect to face substantial competition from large established manufacturers of Mass Spec laboratory-based instruments and from new entrants;

Given the market opportunity, we expect to face substantial competition from large established manufacturers of laboratory-based instruments and from new entrants;

however, our proprietary advances have enabled us to manufacture the first truly handheld Mass Spec devices and compact desktops and we believe we are well-positioned to face future competition.

As we democratize the extraordinary power of Mass Spec, we believe our technology platform can expand in future opportunities far beyond the conventional central laboratory market for Mass Spec and associated front-end separations.

We believe our technology platform can expand in future opportunities far beyond the conventional central laboratory market for Mass Spec and associated front-end separations.

We estimate our total addressable market, or TAM, for our devices was $5.7 billion in 2022 and is growing to an estimated $27 billion by 2027.

The TAM for our handhelds was estimated to be $1.3 billion in 2022 with expansion to over $3.9 billion with software application extensions for GxP cleaning validation, and other related quality control assays.

Our desktop devices supporting bioprocess development represented an estimated TAM of $0.8 billion in 2022 expanding significantly to approximately $15 billion with execution of our roadmap and the rapid growth of cell therapy.

We see additional opportunity to address the estimated $3.6 billion in 2022 across the research chromatography market space growing to more than $8.1 billion with further market growth and roadmap expansion into complex metabolomics and proteomics.

We see additional opportunity to service the estimated TAM of $3.6 billion in 2022 across the research chromatography market space growing to more than $8.1 billion with further market growth and roadmap expansion into complex metabolomics and proteomics by 2027.

Our estimates of our TAM are based on potential customer research and development spending, addressable aspects of potential customers’ end product development process, and potential platform usage.

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We have developed a proprietary Mass Spec platform and approach that allow us to move the capabilities of conventional Mass Spec beyond the central laboratory.

Our proprietary High-Pressure Mass Spec, or HPMS, technology enables us to produce significantly smaller, purpose-built Mass Spec devices that are much more ideal for use in point-of-need settings, in contrast to conventional mainframe Mass Spec solutions.

Our proprietary High-Pressure Mass Spec, or HPMS, technology enables us to produce significantly smaller, purpose-built Mass Spec devices that are better suited for use in point-of-need settings, in contrast to conventional mainframe Mass Spec solutions.

The combination of HPMS, our proprietary microfluidic sampling and separation technology, and our data analytics, and machine-learning technology provides the foundations of an adaptable platform that can serve a growing number of new and adjacent applications and markets.

● Point-of-need technologies disrupting Mass Spec and creating new product categories .

Leveraging our Mass Spec platform, we have developed a portfolio of desktop and handheld devices that are reinventing the Mass Spec industry by accessing a variety of point-of-need market segments that were historically considered

impossible for conventional Mass Spec manufacturers.

Our products are small, purpose-built devices that avoid the typical size and complexity issues related to conventional Mass Spec while also offering real-time, actionable answers to new classes of users.

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Army and the U.S.

Marine Corps and other international, federal and state agencies.

Air Force and other international, federal and state agencies.

These customers have validated our platform through the collective purchase of more than 2,800 devices, with more than 14,000 users trained on our devices.

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Our Growth Strategy

We are pursuing the democratization of the gold-standard molecular analysis laboratory technique:

Just as mainframe computers transitioned to desktops, tablets, and mobile devices, we are leading a transformation of the Mass Spec market.

We are making chemical and biochemical analysis simple, smart and speedy by incorporating our microscale Mass Spec, microfluidics, and analytics and machine learning technology platform into handheld and desktop devices that provide users with robust answers at the point of need.

Our growth strategy includes the following key elements:

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We believe a relentless focus on these fundamentals drives consumption of consumables.

We further believe broadscale democratization of Mass Spec is enabled by our progress on these same fundamentals.

● Drive enterprise adoption in our seeded accounts.

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● Grow the installed base through expansion of commercial channels .

Since the commercial launch of our first handheld, the installed base of our handheld and desktop devices has grown to more than 2,300 devices over 45 countries.

Since the commercial launch of our first handheld, the installed base of our handheld and desktop devices has grown to more than 2,800 devices in 56 countries.

With our handheld and desktop device installations now taking root in the United States, we will focus on expanding our commercial channels to better serve the forensics, life sciences research, bioprocessing, quality assurance/quality control, and synthetic biology markets.

We look to expand both our direct channel in the United States and our international reach.

We anticipate growing our network of international distributors focused in regions with a concentrated and rapidly expanding life sciences presence, specifically, Europe, China, Japan, India, and South Korea.

We look to have local application and support specialists and sales managers supporting our distribution partners.

● Deepen our footprint into the rapidly growing bioprocessing market.

We designed our first desktop device to accelerate development and enhance production by identifying and quantifying extracellular species critical to cell health and productivity.

They sit alongside bioreactors and fermenters producing drug candidates, functional proteins, cell and gene therapies, and synthetic biology derived products.

We anticipate growing our network of international channel partners focused in regions with a concentrated and rapidly expanding life sciences presence, specifically, Europe, China, Japan, India, and South Korea.

We look to have local application and support specialists and sales managers supporting our channel partners.

● Deepen our footprint in the bioprocessing market.

Our desktop devices are designed to accelerate development and enhance production by identifying and quantifying extracellular species critical to cell health and productivity.

They sit alongside or are directly connected to bioreactors and fermenters producing drug candidates, functional proteins, cell and gene therapies, and synthetic biology derived products.

We look to expand our product line with additional panels, for example focused extracellular panels, and intracellular analysis, such as cellular flux, and pathway analysis.

Consistent with our thesis of driving simplicity and convenience of measurement, we will progress from an at-line measurement tool to an on-line integrated device with comprehensive bioprocess analytics and control.

Our novel aseptic sampling technology, obtained through our acquisition of TRACE Analytics GmbH, provides a measurable step forward in our goal to move from at-line to on-line devices.

We believe our technology platform can serve as the cornerstone of an integrated “bioprocess brain” by monitoring and managing the comprehensive extracellular environment.

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We will continue to leverage our integrated sample preparation and microfluidic separations platform to expand our pipeline of new, customer-driven point-of-need applications that can be addressed by both our handheld and desktop devices.

As our customers continue to prove out new applications in areas such as diagnostics and proteomics, we will look to incorporate select assays investigated by these customers into our handheld and desktop devices where those form factors can accelerate usage.

As our customers continue to prove out new applications in areas such as diagnostics, metabolomics, and proteomics, we will look to incorporate select assays investigated by these customers into our handheld and desktop devices where those form factors can accelerate usage.

We have already incorporated a number of customer-driven assays into both MX908 and Rebel and will continue to do so as we believe this will provide us with an expanding list of new point-of-need applications and market opportunities within forensics, life sciences research, bioprocessing, quality assurance/quality control and synthetic biology.

In addition, we continue to make advancements in our core technologies to drive the evolution of our product portfolio beyond current applications and needs to enter new markets.

Our Industry Background

Conventional Mass Spec -- The Mainframe Computer of the Analytical Laboratory

Mass Spec is the gold-standard analytical technique for molecular analysis.

This technology is highly regarded for its ability to provide an extraordinarily detailed analysis of a wide variety of molecular samples -- from small molecule chemicals to large complex proteins.

Mass Spec instruments identify the components of samples via highly detailed mass-to-charge (m/z) measurements, and in some cases, can quantify those components.

Together with its associated front-end separation technologies, Mass Spec can resolve and analyze the most complex of samples with high fidelity.

However, while Mass Spec is an extremely powerful analytical technique, the capabilities of conventional Mass Spec instruments are largely relegated to centralized laboratory settings due to their size, complexity, and high price.

When compared in context to the computer industry, conventional Mass Spec instruments represent the mainframe computer of the analytical laboratory.

The Democratization of Mass Spec—Handhelds and Desktops

Given the inherent limitations of conventional mainframe Mass Spec instruments, we believe there is a compelling opportunity for handheld and compact desktop Mass Spec devices.

Analogous to the democratization of computer

technologies, as price, access, and complexity are reduced, user space expands, utilization increases, and new applications emerge.

While our expectation is that centralized laboratory Mass Spec instruments will continue to exist in laboratory settings -- just as mainframes still exist today as supercomputers servicing the most challenging computational problems -- we believe that the democratization of Mass Spec will open up new markets and applications.

We also see many parallels with how next generation gene sequencing, or NGS, was democratized and has expanded the market for NGS through desktop devices.

In addition, we continue to

make advancements in our core technologies to drive the evolution of our product portfolio beyond current applications and needs to enter new markets.

Our Technology

Our Technology Platform

We have developed a technology platform designed to bring Mass Spec out of the confines of central laboratories and to the point-of-need.

Our technology platform democratizes the Mass Spec market with high-fidelity handheld and desktop devices.

We believe this democratization gives rise to:

We have developed a core technology platform designed to bring Mass Spec out of the confines of central laboratories and to the point-of-need with high-fidelity handheld and desktop devices.

We believe that providing simple, smart, and speedy devices that provide robust answers when and where people need them gives rise to:

● an expanded and more diverse set of users;

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These results are possible as our handheld and desktop devices are designed for extreme convenience and speed, requiring minimal training and maintenance.

Our platform uses proprietary microscale Mass Spec and microfluidic technologies to prepare, separate, and characterize species at the molecular level, with integrated machine learning and analytics to automatically provide answers regarding identity, purity, and quantity.

Our platform is centered around using proprietary microscale Mass Spec and microfluidic technologies to prepare, separate, and characterize species at the molecular level, with integrated machine learning and analytics to automatically provide answers regarding identity, purity, and quantity.

The core elements of our technology platform include:

● Our High-Pressure Mass Spec, or HPMS, approach enables Mass Spec at the point-of-need;

● microfluidics enable convenient sample preparations and fast separations;

● analytics and machine learning technology provide actionable answers versus raw data.

● Our High-Pressure Mass Spec, or HPMS, approach, which enables Mass Spec at the point-of-need;

● microfluidics enable convenient sample preparations, fast separations, and aseptic sampling;

● analytics and machine learning technology, which provides actionable answers versus raw data.

HPMS Approach Enables Mass Spec at the Point-of-Need

Mass Spec is the gold-standard analytical technique for molecular analysis.

This technology is highly regarded for its ability to provide an extraordinarily detailed analysis of a wide variety of molecular samples -- from small molecule chemicals to large complex proteins.

Mass Spec instruments identify the components of samples via highly detailed mass-to-charge (m/z) measurements, and in some cases, can quantify those components.

Together with its associated front-end separation technologies, Mass Spec can resolve and analyze the most complex of samples with high fidelity.

Given the inherent limitations of conventional mainframe Mass Spec instruments, we believe there is a compelling opportunity for handheld and compact desktop Mass Spec devices.

A key component of our technology is our proprietary microscale ion trap, which we estimate is 1,000 times smaller than those in conventional laboratory Mass Spec instruments.

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This allows for highly complex separations with high resolution to be completed in minutes.

In 2022, we strengthened our core microfluidic technology with the acquisition of Trace, which enables us to provide on-line aseptic sampling technology used in bioprocess monitoring and control.

In 2022, we strengthened our core microfluidic technology with the acquisition of Trace Analytics GmbH, which enables us to provide on-line aseptic sampling technology used in bioprocess monitoring and control.

Aseptic sampling allows for highly precise, on-line monitoring without any loss of bioreactor volume.

A reusable or single-use probe that incorporates a diffusion membrane is inserted in the bioreactor, preserving precious media and product in cell culture and fermentation processes.

Complementing our mass spec analysis, Trace also brings to us an enzyme-based electrochemical biosensor technology that generates an electrical signal proportional to concentration of targeted analytes enabling real-time monitoring and control of additional analytes, some of which are difficult to measure with mass spec (e.g.

glucose and lactate).

Complementing our mass spec analysis, Trace Analytics GmbH also brings to us an enzyme-based electrochemical biosensor technology that generates an electrical signal proportional to concentration of targeted analytes enabling real-time monitoring and control of additional analytes, some of which are difficult to measure with mass spec (e.g., glucose and lactate).

Aseptic sampling enables on-line automated monitoring and control of bioprocesses.

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Achieving that aim requires very sophisticated autonomous and adaptive control systems and the machine learning engine to interpret the data and produce a clear, accurate result.

Our devices are designed to provide fast, statistically rigorous answers by providing autonomous control systems and applying rigorous machine learning methods.

Control/optimization:

Conventional Mass Spec configuration and tuning is highly complex.

An example of such a configuration panel is shown on the right below.

Our devices need to manage themselves autonomously for maximum value to the customer.

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This ability to automatically control the system reduces or eliminates the user’s responsibility and opportunity for error in set up, optimization, and troubleshooting.

product’s “settings” screen shown below on the left looks very simple, but the embedded analytics and machine learning system controls and optimizes more than a hundred parameters continuously in real-time.

MX908 Settings/Configuration

Laboratory Mass Spec Settings/Configuration

Our product’s screen shown above right looks very simple, but the embedded analytics and machine learning system controls and optimizes more than a hundred parameters continuously in real-time.

Machine learning/embedded analytics:

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Several examples of these elements are highlighted below in the “Our Products” section.

Our devices are designed to provide fast, statistically-rigorous answers by providing

autonomous control systems and applying rigorous machine learning methods.

We were founded on a vision to deliver high quality Mass Spec to a broad set of users at the point-of-need.

We offer handheld and desktop devices, each of which are capable of providing quick, high-fidelity and actionable results.

These aspects are important to our customers, who previously have had to choose between a slow and thorough analysis by Mass Spec in a laboratory or a point-of-need result that may have been more timely, but provided only a partial

measurement picture prone to false-positives.

For instance, forensics customers who do not have access to laboratory-based Mass Spec instruments have at best had access to the field techniques of Ion-mobility spectrometry and Raman/FTIR spectroscopy, each with its own severe limitation of specificity (ability to distinguish one chemical from another) and sensitivity (ability to detect minute amounts), respectively.

For instance, forensics customers who do not have access to laboratory-based Mass Spec instruments have at best had access to the field techniques of Ion-mobility spectrometry and Raman/FTIR spectroscopy, each with its own limitation of specificity (ability to distinguish one chemical from another) and sensitivity (ability to detect minute amounts), respectively.

Our bioprocess customers have likewise only had access to a cropped measurement picture by largely relying on simple enzymatic and electrochemical sensors that can measure just a few simple gases and other analytes with poor accuracy.

Our devices are changing this paradigm and providing laboratory-like results at the point-of-need.

The 908 Devices suite of devices includes (from left to right):

MX908, ZipChip, Rebel, Maven and Maverick.

Launched in June 2017, MX908 is a handheld, battery-powered, Mass Spec device designed for rapid analysis of solid, liquid, vapor and aerosol materials of unknown identity.

It is an agile, multi-purpose device utilized by a wide spectrum of user segments for a variety of forensic field applications such as chemical, explosive, priority drug and HazMat operations, detecting materials at the trace level.

We have sold approximately 2,000 MX908s into every U.S.

state, in over 45 countries and across five continents.

We have sold 2,422 MX908s into every U.S.

state, in 56 countries and across five continents.

More than 10,000 operators, including in numerous domestic and foreign government agencies, have been trained to use the MX908.

When a civilian or military first responder, customs agent, or front-line worker is presented with residue on a package, a powder in the ER, pills at a border crossing, an apparent overdosing individual, or a mass casualty event, immediate actionable information is needed.

When a civilian or military first responder, customs agent, or front-line worker is presented with residue on a package, a powder in the emergency room, pills at a border crossing, an apparent overdosing individual, or a mass casualty event, immediate actionable information is needed.

opioid crisis in particular is driving demand for broadly capable point-of-need measurement devices that can detect a multitude of hazards at trace quantities.

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Compared to a leading transportable Mass Spec product, the MX908 is up to 15x faster, up to 10x smaller and up to 2x cheaper.

The MX908 is able to start up in less than a minute, completing analysis of gas and vapor materials in less than ten seconds, and solids and liquids in less than a minute.

The MX908 is able to start up in less than a minute, completing analysis of gas and vapor materials in less than ten seconds, and solids, liquids, and aerosols in less than a minute.

The MX908 was designed to operate in harsh outdoor environments such as pervasive rain and dust, and scorching to freezing temperatures in a nimble 4.3 kg (approximately 10 lb) handheld form factor.

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These mission modes provide a categorization of functionality, allow the device to guide operators through proper procedures with visual cues, and present results in a manner most relevant for that operational intent.

The mission modes also allow the

software to optimize the hardware operation of the MX908 to maximize sensitivity and specificity for a given class of chemicals, much as a laboratory chemist would do by changing the settings on their conventional Mass Spec.

The mission modes also allow the software to optimize the hardware operation of the MX908 to maximize sensitivity and specificity for a given class of chemicals, much as a laboratory chemist would do by changing the settings on their conventional Mass Spec.

The MX908’s machine-learning software, enabled by our proprietary technology platform, serves as a critical element of the device.

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Since introducing the MX908, we have continued to expand the device’s capability through mission add-ons such as offering an Aerosol Module accessory to detect and identify aerosolized chemical hazards, adding targets to allow responders to identify additional priority drug substances, and providing a Bluetooth capability that enables seamless data transfer and accelerates support in the field.

We recently added pesticide identification capability, which we developed in conjunction with the U.S.

Forest Service, an agency of the U.S.

Department of Agriculture.

Field agency personnel can now easily and safely identify toxic chemicals used in illegal marijuana growing operations on federal lands and quickly begin site remediation, instead of waiting weeks for lab results.

We recently added the MX908 Beacon accessory, which is a remote area monitoring system secured in a rugged case that can detect and identify aerosolized and vapor threats.

The MX908 Beacon accessory leverages the MX908 and Aerosol Module combined with a cloud-based solution to enable remote identification of toxic chemical hazards.

All these added capabilities are aimed to address gaps in responders’ workflows, increase engagement, and drive utilization.

We are currently working to expand the MX908’s mission add-ons to support the detection of adulterated and counterfeit pharmaceuticals and have a roadmap of applications in quality control and quality assurance, including GxP cleaning validation.

Services and Consumables

Our MX908 comes with a standard warranty for up to one year from purchase.

Our customers also can purchase extended warranty service plans, which include hardware repair and replacement coverage, technical support, and software updates.

We designed the MX908 to be intuitive and easy-to-use, while ensuring that the MX908 is operating as it is intended is critical to our customers.

The annual and extended warranty service plans provide the customer the ability to contact us to assist in validating their results given the severity and context of the situations in which our devices operate.

Our technical support, also known as our Reachback program, allows any participating MX908 user to email, text, or call a 908 Devices Scientific Support Team member to receive support 24 hours per day, 365 days per year to ensure the MX908 is working as intended.

The Scientific Support Team is staffed by M.Sc.

chemists and forensic scientists expert in the operation of the MX908 and other field analytical technologies.

Our extended warranty service plans are sold with multiyear commitments, which allows us to deepen our relationship with

customers and provides us with an upfront payment, a predictable recurring revenue stream, and an opportunity to offer additional future services.

For simplicity and convenience, we also sell single-use swab samplers for the analysis of liquid and solid materials.

These swab samplers are most heavily used today by customers who are evaluating drug substances.

However, we designed the MX908 so that it does not require swab samplers or any other consumables for a number of other applications.

Our customers value the low-logistics tail of our MX908.

We have a roadmap to continue to expand the MX908’s mission add-ons to support the detection of adulterated and counterfeit pharmaceuticals and to develop applications in quality control and quality assurance, including GxP cleaning validation.

The Rebel is a small desktop analyzer providing real-time information on the extracellular environment in bioprocesses.

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Our focus has been on increasing U.S.

placements, but we also have a meaningful international opportunity and have recently sold Rebels in China, Japan, South Korea and Europe.

placements, but we also have a meaningful international opportunity and have sold Rebels in China, Japan, South Korea and Europe.

Cells have been harnessed to serve as microscopic factories producing myriad molecular species large and small.

The markets for cellular-derived products include therapeutics, including cell therapy and personalized medicine, new and sustainable foods and beverages, and industrial materials.

Many of these products, such as protein-based

therapeutics, can only be economically produced by cells in a bioreactor.

Many of these products, such as protein-based therapeutics, can only be economically produced by cells in a bioreactor.

Making these products in an efficient and reproducible way remains a challenge to our customers in bioprocessing.

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This adds substantial delays and cost and typically takes three to six weeks to produce lab reports equivalent to those produced by the Rebel in only 15 minutes.

The following graphics illustrate the complexity and processing time of a traditional HPLC Mass Spec analysis compared to the Rebel process.

Rebel is currently configured to report concentrations of 33 critical extracellular metabolites in cell culture media, such as amino acids, vitamins, and biogenic amines, which are known to substantially affect the growth profile and properties of the resulting biological entities and their expressed materials.

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The Rebel software is compliant for operation in GxP environments.

Consumables and Services

Rebel’s operation requires a consumable kit that includes:

● one microfluidic preparation and separation chip;

● diluent electrolyte for samples, including internal standards;

● background electrolyte for separation;

● performance qualification and calibration standards.

Currently, customers of Rebel who are actively utilizing the device are consuming on average approximately half of a 200-sample kit per month.

With continuous operation, the Rebel is capable of consuming approximately one 200-sample kit a day.

We also offer an annual certification kit and service plan.

The certification kit is shipped to the customer, who loads the provided samples, and executes a certification protocol.

The system is remotely qualified and certified based on the data acquired meeting factory specifications.

Annual and extended warranty and service plans are available for the Rebel.

The Maverick, launched in September 2023 to complement our Mass Spec technology, is an optical in-line analyzer that provides real-time monitoring and control of multiple bioprocess parameters, including glucose, lactate and total biomass, in mammalian cell cultures.

The device also provides rich process fingerprint data to support large-scale efforts in predictive bioprocess modeling.

The Maverick utilizes Raman spectroscopy, a largely non-invasive and non-destructive technology that provides rich, chemical data.

The use of Raman spectroscopy for characterizing critical process parameters, or CPPs, and critical quality attributes, or CQAs, in bioprocessing has grown considerably during the last 10 years.

Unlike conventional spectroscopic methods that utilize a multivariate empirical calibration approach requiring expert configuration, Maverick requires no complex modeling and can be set up in minutes.

We have developed a proprietary approach that we refer to as the de novo model, which means “from the beginning.” Maverick’s purpose-built de novo model automatically processes Raman spectra from a wide variety of cell culture media types and cell lines, thereby delivering actionable process parameters or direct process control actions.

We also provide open access to the raw spectral data enabling spectroscopic experts to extend the device’s capabilities for more advanced predictive control of CPPs and CQAs.

The Maverick hub can monitor up to six bioreactor models simultaneously, with independent analog/digital control of feed systems for each.

Remote, real-time web access to bioreactor status and settings is also supported through the Maverick hub.

As a spectroscopic-based device, Maverick is extensible to other analytes and parameters.

Maverick enables biopharmaceutical process development scientists and manufacturers to enhance understanding of their process and implement dynamic control strategies more quickly and easily, which can accelerate workflows and improve process efficiency.

Maven and Trace C2

The Maven, launched in January 2023, is our first on-line device for bioprocess monitoring and control.

The Maven, launched in January 2023, to complement our Mass Spec technology, is our first on-line device for bioprocess monitoring and control.

Connecting directly to a single bioreactor, Maven provides real-time continuous monitoring and control of glucose and lactate in cell culture and fermentation processes.

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This is especially beneficial in cell therapy applications where tight control of cell culture conditions is vital.

In addition to providing real-time measurements, Maven comes with integrated PID and on/off controllers that enable out-of-the-box feeding automation.

The Maven is GMP compliant, takes up a small footprint, and in keeping with our focus on simplicity, is easy to use.

In addition to providing real-time measurements, Maven comes with integrated proportional-integral-derivative, or PID, and on/off controllers that enable out-of-the-box feeding automation.

The Maven is Good Manufacturing Practices, or GMP, compliant, takes up a small footprint, and in keeping with our focus on simplicity, is easy to use.

Maven can be used in concert with our at-line Rebel device, which quantitates over 30 analytes, to improve and optimize cell culture feeding strategies.

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The device includes a dedicated on-board peristaltic pump and an integrated PID controller that can be used for feeding substrates without any additional auxiliary equipment.

The Trace C2 and related sampling products were developed by Trace, which we acquired in August of 2022.

Consumables and services

Consumable sets of buffers, probes and biosensors are required for the Maven, Trace C2 and related sampling devices.

Annual and extended warranty and service plans are available for these devices.

The Trace C2 and related sampling products were developed by Trace Analytics GmbH, which we acquired in August of 2022.

Our ZipChip solution is a plug-and-play, high-resolution separation platform that optimizes Mass Spec sample analysis.

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With ZipChip, researchers can switch applications in minutes, instead of hours typical with an alternative such as liquid chromatography.

Leveraging our data analytics capabilities, we have also incorporated an automated software solution called DARWIN to expedite the analysis of the ZipChip and Mass Spec data for proteins and biotherapeutics.

DARWIN eliminates most of the manual choices, selections, and decisions encumbering typical analysis software and directly and rapidly reports identified species, modifications and relative abundances.

Since launch of the ZipChip platform in March 2016, we have sold 234 ZipChip Interfaces and have established 28 multi-unit accounts in leading, global pharmaceutical organizations and academic institutions.

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Consumables and Services

Handheld Device

Our MX908 comes with a standard warranty for up to one year from purchase.

Our customers also can purchase extended warranty service plans, which include hardware repair and replacement coverage, technical support, and software updates.

We designed the MX908 to be intuitive and easy-to-use, as it is critical to our customers to know that the MX908 is operating as intended.

The Scientific Support Team is staffed by M.Sc.

chemists and forensic scientists expert in the operation of the MX908 and other field analytical technologies.

Our extended warranty service plans are sold with multiyear commitments, which allows us to deepen our relationship with customers and provides us with an upfront payment, a predictable recurring revenue stream, and an opportunity to offer additional future services.

For simplicity and convenience, we also sell single-use swab samplers for the analysis of liquid and solid materials.

These swab samplers are most heavily used today by customers who are evaluating drug substances.

However, we designed the MX908 so that it does not require swab samplers or any other consumables for a number of other applications.

Our customers value the low-logistics tail of our MX908.

Desktop Devices

Annual and extended warranty and service plans are available for the Rebel, Maven, Maverick, ZipChip Interface, and Trace C2 devices.

Rebel’s operation requires a consumable kit that includes a microfluidic and separation chip, electrolytes, and performance qualification and calibration standards.

Currently, customers of Rebel who are actively utilizing the device are consuming on average approximately half of a 200-sample kit per month.

With continuous operation, the Rebel is capable of consuming approximately one 200-sample kit a day.

We also offer an annual certification kit for the Rebel.

The certification kit is shipped to the customer, who loads the provided samples, and executes a certification protocol.

The system is remotely qualified and certified based on the data acquired meeting factory specifications.

Calibration kits are required for the Maverick.

We offer a variety of kits for the ZipChip Interface that include microfluidic ZipChips and different reagents optimized for a wide scope of applications.

These kits include intact antibody, charge variance, metabolomics, peptide and oligonucleotides.

Annual and extended warranty and service plans are available for the ZipChip interface.

Consumable sets of buffers, probes and biosensors are required for the Maven, Trace C2 and related sampling devices.

Market Opportunities

We have developed ultracompact, high-fidelity Mass Spec devices to interrogate the unknown and invisible and provide actionable results in critical-to-life point-of-need applications.

Our first products are purpose-built handheld and

desktop Mass Spec devices that currently address a range of applications and markets.

We have developed ultracompact, high-fidelity Mass Spec devices to interrogate the unknown and invisible and provide actionable results in life-altering point-of-need applications.

Our first products are purpose-built handheld and desktop Mass Spec devices that currently address a range of applications and markets.

We estimate our TAM for our devices was $5.7 billion in 2022, and is growing to an estimated $27 billion by 2027.

Our desktop devices supporting bioprocess development represented a total addressable market of $0.8 billion in 2022 expanding significantly to approximately $15 billion with execution of our roadmap and the rapid growth of cell therapy.

We see additional future opportunity to address an estimated $3.6 billion in 2022 across the laboratory chromatography market space growing to more than $8.1 billion with further market growth and roadmap expansion into metabolomics and complex proteomics.

Our desktop devices supporting bioprocess development represented a TAM of $0.8 billion in 2022 expanding significantly to approximately $15 billion with execution of our roadmap and the rapid growth of cell therapy by 2027.

We see additional future opportunity to service an estimated TAM of $3.6 billion in 2022 across the laboratory chromatography market space growing to more than $8.1 billion with further market growth and roadmap expansion into metabolomics and complex proteomics by 2027.

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Testing for controlled substances is one of the major drivers for the use of Mass Spec in the field forensics setting.

According to the latest available data from the Bureau of Justice, U.S.

criminal forensic laboratories handled approximately 4 million requests, roughly 1.2 million of which were controlled substances-related.

We believe that this increase in requests will be even more acute for the point-of-need setting.

In the field forensics setting, high accuracy and fidelity can be just as important at the point-of-need as it is in the laboratory.

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The toxicity of fentanyl and its analogs is 100 to 10,000 times the potency of morphine, creating an opioid crisis of unprecedented scale and breadth.

Fentanyl is considered to be the deadliest drug threat facing the United States today according to the Drug Enforcement Administration (DEA).

In November 2022, the DEA issued a public safety alert warning of a sharp increase in the lethality of fentanyl-laced fake prescription pills.

The alert noted that DEA testing found six out of 10 pills contained a potentially lethal dose, an increase from the DEA’s September 2021 alert that four out of 10 pills were found to contain a potentially lethal dose.

In addition, the DEA announced in December 2022 that it had seized over 50.6 million fentanyl-laced fake prescription pills in 2022, more than double the amount of fentanyl-laced fake prescription pills it had seized in 2021.

Fentanyl is considered to be the deadliest drug threat facing the United States today, according to the U.S.

Drug Enforcement Administration, or DEA.

The DEA also seized more than 77 million fentanyl-laced fake prescription pills in 2023, up from 50.6 million such pills in 2021.

DEA laboratory testing also showed that seven out of ten pills tested contained a potentially deadly dose of fentanyl, an increase from four out of ten pills in 2021 and six out of ten pills in 2022.

In addition, in March 2023, the DEA issued its third public safety alert in just three years warning the American public of a sharp increase in pills containing fentanyl mixed with xylazine, a powerful sedative that the U.S.

Food and Drug Administration approved for veterinary use.

The alert noted that xylazine and fentanyl drug mixtures place users at a higher risk of suffering a fatal drug poisoning.

The potency and diversity of these emerging classes pose a major challenge for point-of-need measurements.

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An outsize portion of this opportunity is driven by testing in autologous cell therapies and is commensurate with the total expected cell batches produced.

Future Market Opportunities

The fastest and most convenient way to explore new applications incorporating our platform technology is through interfacing with a conventional general-purpose laboratory Mass Spec instrument.

Our laboratory interface connects our proprietary microfluidic chips, called ZipChips, to conventional Mass Spec Instruments, in a simple and customer friendly manner to form a discovery platform.

Our research customers incorporate our ZipChip Interface into their projects due to its preparation convenience and separation speed.

These customers prove-out new assays spanning a

range of markets from diagnostics to consumer health and beauty, to agrochemical, oil and gas, and defense.

They measure such things as novel therapeutics, quality and process attributes, and explore metabolomics and complex proteomics.

We estimate our ZipChip platform was able to address $3.6 billion in 2022 across the research chromatography market space growing to more than $8.1 billion with further market growth roadmap expansion into metabolomics and complex proteomics.

The resulting pipeline and market multiplier for subsequent point-of-need products has not been considered and may be significant.

We sell our products worldwide through an experienced direct sales force as well as through domestic and international channel distribution partners.

Our customers are primarily in the pharmaceutical and biotech market, the government market and to a lesser extent, academic markets.

We are always looking for new opportunities to engage directly with our customers.

To that end, we held user meetings in 2021 and 2022, which covered the full breadth of our product platforms and their applications.

These events brought more than 175 attendees together, both virtually and in person, to hear our customers share their success using our handheld and desktop devices to provide rapid and robust actionable information at the point of need.

These customer talks spanned the breadth of our customer base:

from pharma – with Amgen, Boehringer Ingelheim, Merck, AstraZeneca and Sartorius – to top research institutions – with MIT, Johns Hopkins University and Dana Farber Cancer Institute – to government agencies – with the USDA, Maine Drug Enforcement Agency, Ohio Bureau of Criminal Investigation and the Fresno, California Police Department.

It was inspiring to hear the impact our technology is having across a range of topics, from bioprocess monitoring to identification of counterfeit pharmaceuticals to high-throughput drug discovery.

And, perhaps even most importantly, these user meetings give our customers the opportunity to engage in discussion together – not only to share their experiences but also to increase awareness and educate each other on the value of our technology across these different application areas.

We sell our products worldwide through an experienced direct sales force as well as through domestic and international channel partners.

Our customers are primarily in the pharmaceutical and biotech market, the government market and to a lesser extent, the academic market.

Primary users of our handheld device include law enforcement, military and civilian first responders, and customs and border protection personnel.

Primary users of our desktop devices include process development scientists, process engineers, and research scientists.

Manufacturing and Supply

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Inventory is held in our Boston facilities in a 700 square foot controlled-access cage.

As a result of the Trace acquisition, we also have in-house manufacturing facilities in Braunschweig, Germany.

The MX908, Rebel and ZipChip Interface are manufactured, tested and shipped from our Boston facility.

As a result of the acquisition of Trace Analytics GmbH, we also have in-house manufacturing facilities in Braunschweig, Germany.

The MX908, Rebel, Maverick and ZipChip Interface are manufactured, tested and shipped from our Boston facility.

The Maven and related sampling devices are manufactured, tested and shipped from our Braunschweig facility.

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The assembly of technology-sensitive components such as our proprietary vacuum pumps and ion trap/ionization module is completed in-house.

Currently, our Boston manufacturing facility is capable of supporting the production of approximately 2,000 MX908, Rebel and ZipChip Interface units combined per year.

Currently, our Boston manufacturing facility is capable of supporting the production of approximately 2,000 MX908, Rebel, Maverick and ZipChip Interface units combined per year.

When our annual sales exceed 2,000 units, we expect that we would need to either expand our in-house production operations, or transfer some or all aspects of assembly to contract manufacturers, to accommodate larger run-rates.

We believe there are numerous domestic and international contract manufacturers that could be qualified to produce the MX908, Rebel and/or ZipChip Interface when third party demand for our products outpace our current manufacturing capacity.

The autosampler subassembly of the Rebel is supplied by a single supplier, Spark Holland B.V.

Volume manufacturing of the ZipChip Interface had been previously outsourced to Columbia Tech, an ISO 9001 wholly-owned subsidiary of Coghlin Companies, Inc., through September 30, 2021.

Our Boston facility can and has manufactured ZipChip Interfaces, and upon review of our and Columbia Tech’s manufacturing processes, we transitioned manufacturing of the ZipChip Interface back to our Boston facility beginning in the fourth quarter of 2021.

The final testing and shipment of ZipChip Interfaces has been and will continue to be completed from our Boston facility.

Additionally, we maintain resources to handle all warranty and service of our devices.

We believe there are numerous domestic and international contract manufacturers that could be qualified to produce the MX908, Rebel, Maverick and/or ZipChip Interface when third party demand for our products outpace our current manufacturing capacity.

The autosampler subassembly of the Rebel and ZipChip are supplied by a single supplier.

The Raman spectrometer, and optical probe and fiber assemblies, for Maverick are supplied by a single supplier.

The Maven device subassembly is supplied by a single supplier under a contract manufacturing arrangement.

We are continuously evaluating and updating our supply chain to ensure our ability to respond to customer demand for our products.

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We plan to continue the diversification of our supply chain as we scale.

We use our annual demand planning to assess initial device needs for each year, and we update and reassess those estimates as needed, including with respect to the levels of inventory that we believe will be required to support anticipated customer demand.

We use our annual demand planning to assess initial device needs for

each year, and we update and reassess those estimates as needed, including with respect to the levels of inventory that we believe will be required to support anticipated customer demand.

The MX908 incorporates a number of non-proprietary consumables that are commercial-off-the-shelf available and sourced from a number of reputable suppliers.

Sampling swabs that are used for the analysis of liquid and solid materials in the MX908 are currently single-sourced from DSA Detection.

Sampling swabs that are used for the analysis of liquid and solid materials in the MX908 are currently single-sourced.

While we believe that alternatives are available, it would take time to identify and validate replacement swab samples, which could compromise our ability to supply these to our MX908 customers on a timely basis.

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Our microfluidic chips are produced and assembled in our Boston cleanroom facilities.

The substrate is supplied by Micronit Microtechnologies B.V.

The substrate is supplied by a single supplier.

While we believe that alternative suppliers would be available, it would take time to identify and qualify alternate suppliers and transfer design requirements to them, which could negatively affect our ability to supply these chips to our Rebel and ZipChip customers on a timely basis.

Sales and Marketing

We distribute our devices and consumables via direct field sales and support organizations located in North America and through a combination of our own sales force and more than 40 third party distributors in domestic and international markets which include Australia, Canada, China, Czech Republic, Germany, Japan, Singapore, Turkey, and the United Kingdom.

In North America, we use distribution partners to provide our products to end customers where a contract vehicle is required.

We distribute our devices and consumables via direct field sales and support organizations located in North America and through a combination of our own sales force and more than 42 third party channel partners in domestic and international markets which include Australia, Canada, China, Czech Republic, Germany, Japan, Saudi Arabia, Singapore, Turkey, and the United Kingdom, or UK.

In North America, we use channel partners to provide our products to end customers where a contract vehicle is required.

Since the commercial launch of our first handheld, the installed base of our devices has grown to more than 2,800 devices across more than 56 countries.

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As of December 31, 2023, we had 70 people employed in sales, sales support and marketing.

This staff is primarily located in the United States and we have recently hired internationally, using a professional employment organization, to support our sales and applications efforts.

We intend to significantly expand our sales, support, and marketing efforts in regions with a concentrated life sciences presence, including large pharmaceutical and biopharma companies.

For example, we plan to establish a direct sales footprint in Europe, and to develop a distribution and support network in China.

This staff is primarily located in the United States, but we have also hired internationally at our facility in Braunschweig, Germany, and in other countries using a professional employment organization, to support our sales and applications efforts.

We intend to expand our sales, support, and marketing efforts in regions with a concentrated life sciences presence, including large pharmaceutical and biopharma companies.

For example, in 2023, we established a direct sales footprint in Europe for our desktop products, and have developed a sales, training and support network in China.

Additionally, we believe that there is significant opportunity in other Asia-Pacific countries such as India and South Korea as well as other areas such as Australia and South America.

We plan to expand into these regions via initial penetration with distributors and then subsequent support with direct sales and support personnel.

We plan to continue to expand into these regions via initial penetration with channel partners and then subsequent support with direct sales and support personnel.

Our business model is focused on driving the adoption of our products and maximizing use across our customers’ value chains.

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As a result of these factors, and the budget cycles of our customers, our sales cycle can often be six to twelve months, or longer.

Our Rebel devices are relatively new to the life science marketplace and require a capital investment by our customers.

Our Rebel and Maverick devices are relatively new to the life science marketplace and require a capital investment by our customers.

The sales process typically involves numerous interactions and demonstrations with multiple people within an organization.

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We also release updates and additions to our library of spectral images enabling identification of additional chemicals.

Our MX908 and ZipChip Interface devices are covered under a return-to-factory warranty model for repairs.

Our Maven, Maverick, MX908 and ZipChip Interface devices are covered under a return-to-factory warranty model for repairs.

Depending on availability, loaner units are made available to minimize downtime with our customers.

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

Research and development expense totaled $17.5 million in the year ended December 31, 2022.

We expect our research and development expense to increase for the foreseeable future as we enhance our existing products, develop new products for our current markets and introduce new products in new markets.

We expect our research and development expense to be maintained at this level as we balance resources to enhance our existing products, develop new products for our current markets and introduce new products in new markets.

We consider the holistic nature of our internal product development teams critical to our products’ success.

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The majority of our research and development operations are conducted in our Boston facility.

We also conduct additional research and development operations out of a second facility in Chapel Hill (approximately 2,000 square feet), North Carolina to support assay development for Rebel and ZipChip.

Our R&D and marketing teams also receive input from two Scientific Advisory Boards (SAB) implemented in 2021, one SAB board with deep expertise in bioprocess development, and cell and gene therapy processes and production, and the other SAB board made up of thought leaders in proteomics who will be invaluable to the continued advancement of our platform mass spec and microfluidic technology and its application to contemporary problems in proteomics-oriented life science research.

We have a range of competitors extending from small, privately held companies with single-point solutions to large, publicly-held corporations, including those with a portfolio of Mass Spec products, such as Agilent, Bruker, Danaher, Inficon, Teledyne, PerkinElmer, Shimadzu, Thermo Fisher Scientific, and Waters Corp.

We also conduct additional research and development operations out of our facility in Morrisville, North Carolina to support assay development for Rebel, Maverick and ZipChip, and out of our facility in Braunschweig, Germany to support assay development of our Maven and related products and aseptic sampling development.

Our R&D and marketing teams also receive input from two Scientific Advisory Boards, each an SAB, one SAB with deep expertise in bioprocess development, and cell and gene therapy processes and production, and the other SAB board made up of thought leaders in proteomics who will be invaluable to the continued advancement of our platform mass spec and microfluidic technology and its application to contemporary problems in proteomics-oriented life science research.

We have a range of competitors extending from small, privately held companies with single-point solutions to large, publicly-held corporations, including those with a portfolio of Mass Spec products, such as Agilent, Bruker, Danaher, Inficon, Teledyne, Endress & Hauser, PerkinElmer, Shimadzu, Thermo Fisher Scientific, and Waters Corp.

Many of these companies have greater resources and market presence than we do.

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We provide our products to customers pursuant to terms and conditions that impose restrictions on use and disclosure.

We also seek to avoid disclosure of our intellectual property using contractual obligations, by requiring employees, consultants and contractors with access to our proprietary information to execute nondisclosure, non-competition and assignment of intellectual property agreements.

assignment of intellectual property agreements.

In addition, we generally control access to our proprietary and confidential information through the use of internal and external controls.

Our foundational technology in the area of miniature Mass Spec originated as an effort at Oak Ridge National Laboratories led by our Scientific Founder J.

Michael Ramsey, now a Professor of Chemistry at the University of North Carolina.

Michael Ramsey, Professor Emeritus of Chemistry at the University of North Carolina.

As of December 31, 2023, our owned patent assets included approximately 19 U.S.

patents, no pending U.S.

patent applications, 41 foreign patents and five pending foreign patent applications in various foreign jurisdictions, including Australia, Austria, Canada, China, France, Germany, the European Union, Hong Kong, Israel, Japan, South Korea, Singapore, Switzerland and Taiwan.

patent applications, 45 foreign patents and four pending foreign patent applications in various foreign jurisdictions, including Australia, Austria, Canada, China, France, Germany, the European Union, or EU, Hong Kong, Israel, Japan, South Korea, Singapore, Switzerland and Taiwan.

The subject matter covered by our owned patent assets includes core aspects of compact Mass Spec technology, a design for a handheld Mass Spec device, a design for a modular Mass Spec chamber, patents for multiple ionization modes and adaptive pressure operation within survey period, the determination of preferred ionization mode, adaptive resolution control, adaptive operation to reduce power consumption, and the detection of positive and negative ions.

As of December 31, 2023, our in-licensed patent assets included approximately 29 U.S.

patents, two pending U.S.

patent applications, 18 foreign patents, and three pending foreign patent applications.

patents, one pending U.S.

patent application, 22 foreign patents, and two pending foreign patent applications.

The subject matter covered by our in-licensed patent assets includes a microfabricated ionization source and a microfabricated ionizer chip, microscale Mass Spec systems, devices and related methods, a miniature charged particle trap with an elongated trapping region for Mass Spec, high pressure Mass Spec signal enhancement by means of convective transport, electrospray ionization interface to high pressure Mass Spec, a method of sample injection for chemical separations in microfluidic devices, integrated sample processing for electrospray ionization devices, and microchips with integrated multiple electrospray ionization emitters and related methods, systems and devices.

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The currently issued in-licensed patents are expected to expire from 2023 to 2039.

We do not expect any of the in-licensed patents that are set to expire in 2022 to have a material effect on our business as those patents relate to a prior design for the ion trap and we have since in-licensed new patents covering the current design.

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

As of December 31, 2022, we owned eight registered trademarks in the United States, nine registered foreign trademarks, and two U.S.

pending trademark applications.

Our registered trademarks and pending trademark applications include trademarks for 908 Devices, Rebel, MX908, ZipChip, MAVEN, and our logo.

As of December 31, 2023, we owned six registered trademarks in the United States, 17 registered foreign trademarks, three U.S.

pending trademark applications, and two pending foreign trademark applications.

Our registered trademarks and pending trademark applications include trademarks for 908 Devices, Rebel, MX908, ZipChip, Maven, Maverick, and our logo.

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

In June 2012, we entered into two license agreements, which were subsequently amended in August 2013 with UT-Battelle, LLC, or UTB, which manages and operates the Oak Ridge National Laboratory under its prime contract with the U.S.

Department of Energy, pursuant to which UTB granted us an exclusive, sublicensable, worldwide license under certain patent rights owned by UTB related to Mass Spec technology to develop, manufacture, use and commercialize products, services and methods that are covered by such patent rights, or the Licensed Products, in the defined fields of use within forensics, life sciences, industrial process monitoring and food and environmental testing and safety.

The patents are related to the design and operation of microscale ion traps and ion sources with flexible operating pressures, and were the first patents that enabled us to reduce the size of our Mass Spec platform.

We refer to these two licenses as the UTB Agreements.

We paid UTB an upfront payment of $5,000 in connection with executing the UTB Agreements and made a payment of $15,000 in January 2013.

In addition, we issued an aggregate of 73,750 shares of our common stock to UTB, which had an aggregate fair value at the time of issuance of approximately $25,200.

Additionally, we must pay UTB a low-single digit percentage royalty on our net sales of Licensed Products that are covered by a valid claim of the licensed patents, subject to an annual minimum royalty payment owed to UTB of $70,000.

We are also obligated to pay UTB a percentage of certain royalty income received from any sublicensees ranging from the lower- to mid-double-digit percentages.

To date, we have not issued any sublicenses under the UTB Agreements.

The are no future milestone payments to be made by the Company under the UTB Agreements.

We are obligated to use commercially reasonable efforts to develop, manufacture and commercialize the Licensed Products.

The UTB Agreements will continue until the expiration of the last to expire patent or last to be abandoned patent application that is licensed to us, unless terminated earlier in accordance with the terms of the UTB Agreements, which we currently expect will be in 2025.

We may terminate the UTB Agreements by providing advance written notice of 60 days as specified in the UTB Agreements.

UTB may terminate the UTB Agreements if we violate or fail to perform any terms of the UTB Agreements and we fail to cure such violation or failure within 90 days of notice thereof from UTB.

Additionally, if we challenge the validity or enforceability of any of the licensed patents, the UTB Agreements will automatically terminate.

University of North Carolina, Chapel Hill

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We may assume the risk of making these determinations on our own, or we may decide to request formal governmental jurisdictional rulings.

Although our current products and services are not subject to ITAR licensing requirements, such licensing requirements could apply to our future products and services.

Prior to 2023, none of our products were subject to ITAR registration or other related requirements.

With the commencement of the initial production phase of our Aerosol and Vapor Chemical Agent Detector, or AVCAD, program to support safety missions for the U.S.

military and Coast Guard, we determined that certain spectral databases, algorithms, libraries and alarm set point levels built into our AVCAD software were subject to ITAR, and we registered as a manufacturer with the Directorate of Defense Trade Controls, or DDTC, of the Department of State.

Under generally applicable U.S.

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Our products are currently marketed as research use only, or RUO.

Products such as ours that are marketed for RUO are not intended for use in a clinical investigation or for clinical diagnostic use outside an investigation and must be labeled “For Research Use Only.

including the requirements for clearance or approval and compliance with manufacturing requirements known as the Quality System Regulation.

Products such as ours that are marketed for RUO are not intended for use in a clinical investigation or for clinical diagnostic use outside an investigation and must be labeled “For

Research Use Only.

Not for use in diagnostic procedures.” Products that are intended for RUO and are properly labeled as RUO are exempt from compliance with the FDA’s requirements applicable to medical devices more generally, including the requirements for clearance or approval and compliance with manufacturing requirements known as the Quality System Regulation.

A product labeled RUO but intended to be used diagnostically may be viewed by the FDA as adulterated and misbranded under the Federal Food, Drug, and Cosmetics Act and subject to FDA enforcement activities.

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Our telephone number is (857) 254-1500.

On December 22, 2020, we completed our initial public offering, or IPO, pursuant to which we issued and sold 7,475,000 shares of common stock, inclusive of 975,000 shares pursuant to the full exercise of the underwriters’ option to purchase additional shares.

We received net proceeds of $136.6 million after deducting underwriting discounts and commissions and other offering costs.

On November 15, 2021, we completed an underwritten public offering, pursuant to which we issued and sold 3,150,000 shares of common stock at a public offering price of $32.00 per share.

We received net proceeds of $94.4 million after deducting underwriting discounts and commissions and other offering costs.

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.

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For so long as we are an emerging growth company, we will not be required to (i) engage an independent registered public accounting firm to report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act, (ii) submit certain executive compensation matters to stockholder advisory votes, or (iii) disclose certain executive compensation related items.

We may continue to be an “emerging growth company” until December 31, 2025, though we may cease to be an “emerging growth company” earlier under certain circumstances, including if (i) we have more than $1.07 billion in annual revenue in any fiscal year, (ii) we become a “large accelerated filer” as a result of the market value of our common stock that is held by non-affiliates exceeding $700 million as of any June 30, or (iii) we issue more than $1.0 billion of non-convertible debt over a three-year period.

We may continue to be an “emerging growth company” until December 31, 2025, though we may cease to be an “emerging growth company” earlier under certain circumstances, including if (i) we have more than $1.235 billion in annual gross revenue in any fiscal year, (ii) we become a “large accelerated filer” as a result of the market value of our common stock that is held by non-affiliates being greater than or equal to $700 million as of any June 30, or (iii) we issue more than $1.0 billion of non-convertible debt over a three-year period.

Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period, provided in Section 13(a) of the Exchange Act, for complying with new or revised accounting standards.

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We have elected to use this extended transition period for complying with new or revised accounting standards until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.

As a result, our financial statements and the reported results of operations contained therein may not be directly comparable to those of other public companies.

result, our financial statements and the reported results of operations contained therein may not be directly comparable to those of other public companies.

We are also a “smaller reporting company,” as defined in Regulation S-K.

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

What changed 10-K

Item 1. Business