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Item 1. Business

2024-04-10 compared with 2023-03-16 · 414 added, 219 removed, 518 unchanged (55% of the section changed)

We are an early commercial-stage life sciences instrumentation and research

services company engaged in the development of scientific assets and novel intellectual property across multiple “omics” fields.

We leverage our expertise with True Single Molecule Sequencing (tSMS) technology enabling researchers and clinicians to contribute major

advancements to scientific research and development by accelerating one’s understanding of the molecular mechanisms of disease and

fundamental biological processes.

We believe our proprietary sequencing technology platform has critical advantages over existing NGS

(Next Generation Sequencing) technologies, particularly for emerging applications in the research and development of biomarker discovery,

We are an early commercial-stage life sciences instrumentation and

research services company engaged in the development of scientific assets and novel intellectual property across multiple “omics”

We leverage our expertise with True Single Molecule Sequencing (tSMS) technology enabling researchers and clinicians to contribute

major advancements to scientific research and development by accelerating one’s understanding of the molecular mechanisms of disease

and fundamental biological processes.

We believe our proprietary sequencing technology platform has critical advantages over existing

NGS (Next Generation Sequencing) technologies, particularly for emerging applications in the research and development of biomarker discovery,

epigenetics, nucleotide chemistry, forensics, and cell-free nucleic acid analysis.

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The inherent limitations of current technologies are summarized below:

Biased results :

Short-read NGS technology typically requires a large number of DNA molecules during the sequencing process.

To generate enough DNA molecules, an amplification step is required during sample preparation.

This amplification process can introduce errors known as amplification bias.

The effect of this bias is that resulting copies are not uniformly representative of the original template DNA, causing skewed data representation in the final results.

This amplification process can introduce

errors known as amplification bias.

The effect of this bias is that resulting copies are not uniformly representative of the original

template DNA, causing skewed data representation in the final results.

Lower sensitivity :

In cases where the original template DNA contains regions of relatively high G-C content or relatively high A-T content, the amplification process tends to under-represent these regions.

In cases where the

original template DNA contains regions of relatively high G-C content or relatively high A-T content, the amplification process

tends to under-represent these regions.

As a result, these regions, which may contain entire genes, can be completely missed.

The non-linear nature of the amplification thus limits its ability to detect subtle changes in the genetic signature.

non-linear nature of the amplification thus limits its ability to detect subtle changes in the genetic signature.

Inefficient library preparation :

Many of our competitors use systems requiring multi-step sample preparation protocols to prepare sample libraries before sequencing.

This library preparation technique is inefficient, capturing only a fraction of the informative input material.

The process selectively captures the molecules that are present in large quantities while losing lower frequency molecules, thus not producing a true representation of the input material.

our competitors use systems requiring multi-step sample preparation protocols to prepare sample libraries before sequencing.

library preparation technique is inefficient, capturing only a fraction of the informative input material.

The process selectively

captures the molecules that are present in large quantities while losing lower frequency molecules, thus not producing a true

representation of the input material.

The library preparation protocol limits the minimal amount of input sample.

The library preparation steps also add significant burden on the sample preparation.

preparation steps also add significant burden on the sample preparation.

Inadequate throughput :

Applications such as transcriptome profiling, gene expression and biomarker discovery require accurate quantification of data.

The long-read single molecule technologies fall short due to the smaller number of strand throughput required to substantiate the presence or absence of a biomarker in a specific sample.

The short-read amplification technology is limited due to a skewed data representation caused by the non-linear amplification bias present in the workflow.

Applications such

as transcriptome profiling, gene expression and biomarker discovery require accurate quantification of data.

The long-read single

molecule technologies fall short due to the smaller number of strand throughput required to substantiate the presence or absence of

a biomarker in a specific sample.

The short-read amplification technology is limited due to a skewed data representation caused by

the non-linear amplification bias present in the workflow.

Our Technology Solution

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following five major steps.

Sample preparation :

preparation :

A double helix strand is cut into fragments of 100–200 nucleotides in length.

In the case of cfDNA and cfRNA material, this step is not necessary as cell-free strands are generally short and fit the profile of the input material.

The strand fragments are then denatured to a single strand, and a poly-A universal priming sequence is added to one end of each strand as shown in the following figure.

In the case of cfDNA and

cfRNA material, this step is not necessary as cell-free strands are generally short and fit the profile of the input material.

fragments are then denatured to a single strand, and a poly-A universal priming sequence is added to one end of each strand as shown

in the following figure.

Sample loading :

The strands are hybridized in a flow cell with billions of universal Oligo T capture sites mobilized on the flow cell surface.

The tSMS method typically utilizes a dT50 primer to initiate sequencing from a 3’ poly-A tail, although other capture primers may be used to increase the specificity of sample hybridization.

The strands are

hybridized in a flow cell with billions of universal Oligo T capture sites mobilized on the flow cell surface.

The tSMS method

typically utilizes a dT50 primer to initiate sequencing from a 3’ poly-A tail, although other capture primers may be used to

increase the specificity of sample hybridization.

Template registration :

Once hybridized, a “Fill & Lock” step fills up the rest of the open bases from the poly-A tail followed by the addition of fluorescently labelled nucleotides to the start of the strand.

A laser illuminates the flow cell and the camera records the location of each captured sample strand.

Once hybridized,

a “Fill & Lock” step fills up the rest of the open bases from the poly-A tail followed by the addition of

fluorescently labelled nucleotides to the start of the strand.

A laser illuminates the flow cell and the camera records the location

of each captured sample strand.

The flow cell is moved in sequential steps to allow the camera to cover its entire active area.

The dye molecules are then cleaved and washed away.

dye molecules are then cleaved and washed away.

tSMS sequencing-by-synthesis :

DNA polymerase enzyme and the first of the four types of novel fluorescently labelled nucleotides are added.

If the nucleotide is complementary to the next base in the template strand, the polymerase will add it to the primer strand.

The nucleotides are designed to inhibit the polymerase from incorporating more than one base at a time on the same strand.

Excess polymerase and unincorporated nucleotides are then washed away.

This step ensures that only the incorporated nucleotides are available for fluorescence imaging.

The narrow bandwidth laser illuminates the flow cell surface to excite the fluorescently labelled nucleotides.

The camera records the locations where fluorescently labelled nucleotides were added.

The fluorescent dye molecules are then cleaved from the labelled nucleotides and washed away.

This step ensures that these molecules are fluoresced only for that particular nucleotide addition cycle.

DNA polymerase enzyme and the

first of the four types of novel fluorescently labelled nucleotides are added.

If the nucleotide is complementary to the next base

in the template strand, the polymerase will add it to the primer strand.

The nucleotides are designed to inhibit the polymerase from

incorporating more than one base at a time on the same strand.

Excess polymerase and

unincorporated nucleotides are then washed away.

This step ensures that only the incorporated nucleotides are available for

fluorescence imaging.

The narrow bandwidth laser

illuminates the flow cell surface to excite the fluorescently labelled nucleotides.

The camera records the locations where

fluorescently labelled nucleotides were added.

The fluorescent dye molecules

are then cleaved from the labelled nucleotides and washed away.

This step ensures that these molecules are fluoresced only for that

particular nucleotide addition cycle.

The process is repeated with each of the four types of labelled nucleotides

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In sequencing, this is known as the “read length.”

Data processing :

The image analysis computer analyzes the series of images from each cycle and determines the sequence of bases in the template strand.

The sequence is “read” by correlating the position of a fluorescent molecule in its vertical track with the knowledge of which base was added at that cycle.

The sequence data is packaged in standard sequencing data formats for further bioinformatics analysis.

The image analysis computer analyzes the series of images from each cycle and determines the sequence of bases in

the template strand.

The sequence is “read” by correlating the position of a fluorescent molecule in its vertical track with

the knowledge of which base was added at that cycle.

The sequence data is packaged in standard sequencing data formats for further bioinformatics

Our True Single Molecule Sequencer (tSMS)

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and DNA consisting of major components:

Sequencing Kit :

The flow cells and reagents are the major components of a sequencing kit that the instrument needs at the start of every new run.

The custom flow cell features 25 discrete flow channels, and each channel of the flow cell has millions of capture probes deposited on the cover glass.

The flow cells and reagents are the major components of a sequencing kit that the instrument needs at the start

of every new run.

The custom flow cell features 25 discrete flow channels, and each channel of the flow cell has millions of capture

probes deposited on the cover glass.

The sequencing samples are loaded into the flow cell channels using the sample loader.

The sequencing run can sequence up to two flow cells in a single run.

The reagent kit for the sequencing run consists of custom pre-packaged bottles that store proprietary tSMS chemistry reagents and wash buffers for the system.

All of the flow cells and reagent kits are barcoded, so the sequencer can scan and store the barcodes as a part of the experiment setup procedure.

The sequencing

run can sequence up to two flow cells in a single run.

The reagent kit for the sequencing run consists of custom pre-packaged bottles

that store proprietary tSMS chemistry reagents and wash buffers for the system.

All of the flow cells and reagent kits are barcoded,

so the sequencer can scan and store the barcodes as a part of the experiment setup procedure.

Sample Loader :

The sample loader facilitates loading the billions of tailed single strands onto the glass surface of the standard 25 channel flow cell.

A temperature-controlled chamber improves the hybridization efficiency and houses a mechanism to hold a standard flow cell used in the system.

The proprietary sample loading block design helps to keep the transfer volume to near zero microliter, while the system offers precision control of loading the sample in 25 discrete channels without any cross-contamination.

The input material volume for the sample loader can be as little as 20 microliters.

The sample loader

facilitates loading the billions of tailed single strands onto the glass surface of the standard 25 channel flow cell.

temperature-controlled chamber improves the hybridization efficiency and houses a mechanism to hold a standard flow cell used in the

The proprietary sample loading block design helps to keep the transfer volume to near zero microliter, while the system

offers precision control of loading the sample in 25 discrete channels without any cross-contamination.

The input material volume

for the sample loader can be as little as 20 microliters.

tSMS Sequencer :

The sequencer accepts up to two flow cells for a sequencing run, allowing sequencing of up to 50 individual samples in a single run.

The benchtop sequencer is a fully-automated device that combines a Total Internal Reflection Fluorescence (TIRF) microscopy technique with a high-precision, temperature-controlled microfluidics system.

The microfluidics system houses the reagent kit required to perform tSMS chemistry, and uses high-precision pumps and valves to formulate the chemistry just-in-time for delivery to the flow cell chamber during each chemistry cycle.

The two-flow cell design maximizes the machine utilization by performing the chemistry cycle on one flow cell while the other flow cell is going through the imaging cycle, and vice-a versa.

The flow cells are mounted on a high-speed, high-accuracy multi-axis stage that moves the flow cell along the channel with nanometer grade precision.

The high-power optics system consists of a narrow bandwidth laser to provide the excitation signal, while the high-fidelity imaging system uses a highly sensitive camera for capturing the single molecule signal emitted by the fluorophores.

All of these subsystem operations are integrated and controlled by an on-board computer in a completely automated fashion over the course of the run.

A simple touch screen based graphical user interface walks the user through an intuitive run setup.

A typical run on the sequencer captures three to six million images containing information about billions of individual single molecules in the strands.

The sequencer accepts up

to two flow cells for a sequencing run, allowing sequencing of up to 50 individual samples in a single run.

The benchtop sequencer

is a fully-automated device that combines a Total Internal Reflection Fluorescence (TIRF) microscopy technique with a

high-precision, temperature-controlled microfluidics system.

The microfluidics system houses the reagent kit required to perform

tSMS chemistry, and uses high-precision pumps and valves to formulate the chemistry just-in-time for delivery to the flow cell

chamber during each chemistry cycle.

The two-flow cell design maximizes the machine utilization by performing the chemistry cycle on

one flow cell while the other flow cell is going through the imaging cycle, and vice-a versa.

The flow cells are mounted on a

high-speed, high-accuracy multi-axis stage that moves the flow cell along the channel with nanometer grade precision.

The high-power

optics system consists of a narrow bandwidth laser to provide the excitation signal, while the high-fidelity imaging system uses a

highly sensitive camera for capturing the single molecule signal emitted by the fluorophores.

All of these subsystem operations are

integrated and controlled by an on-board computer in a completely automated fashion over the course of the run.

A simple touch

screen based graphical user interface walks the user through an intuitive run setup.

A typical run on the sequencer captures three

to six million images containing information about billions of individual single molecules in the strands.

Image Analysis Engine :

The image analysis engine processes the images captured by the sequencer camera, aligns them with the template image at individual position, and creates the sequence data file to be used for further bioinformatics analysis.

It features a high-power CPU array with large storage capacity hard drives specifically designed for intensive image analysis and storage purposes.

The image analysis engine runs parallel to the camera, processing the images as soon as the camera starts imaging the flow cell.

The image analysis engine software monitors the instrument status and automatically uploads the sequence data at the end of the run at a user-configurable network location.

analysis engine processes the images captured by the sequencer camera, aligns them with the template image at individual position,

and creates the sequence data file to be used for further bioinformatics analysis.

It features a high-power CPU array with large

storage capacity hard drives specifically designed for intensive image analysis and storage purposes.

The image analysis engine runs

parallel to the camera, processing the images as soon as the camera starts imaging the flow cell.

The image analysis engine software

monitors the instrument status and automatically uploads the sequence data at the end of the run at a user-configurable network

The instrument has a web-based interface for remote monitoring that

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of emerging markets for sequencing-based technologies that represent significant potential opportunities for us, such as but not limited

Life sciences research and development:

NGS technologies are accelerating the discovery and development of more effective new drugs.

The complex nature of biological pathways, disease mechanisms and multiple drug targets requires an accurate, unbiased, and sensitive molecular counting platform.

Single molecule sequencing, with its unparalleled quantitative accuracy in large-scale expression profiling could enable high-throughput screening of promising drug leads.

During clinical trials, our technology could potentially be used for companion diagnostics to generate individual genetic profiles that can provide valuable information on likely response to therapy, toxicology or risk of adverse events.

The tSMS platform may also enable more precise selection of patient pools and individualization of therapy.

sciences research and development:

NGS technologies are accelerating the discovery and development of more effective

The complex nature of biological pathways, disease mechanisms and multiple drug targets requires an accurate, unbiased, and

sensitive molecular counting platform.

Single molecule sequencing, with its unparalleled quantitative accuracy in large-scale expression

profiling could enable high-throughput screening of promising drug leads.

During clinical trials, our technology could potentially be

used for companion diagnostics to generate individual genetic profiles that can provide valuable information on likely response to therapy,

toxicology or risk of adverse events.

The tSMS platform may also enable more precise selection of patient pools and individualization

● Liquid biopsy:

Liquid biopsy is emerging as a simple and non-invasive alternative to the traditional tissue biopsy approach for disease screening and monitoring.

A simple draw of blood contains millions of tiny fragments of cell-free DNA/RNA material with lengths on the order of 100–200bp, which carry informative signatures of cancer and other life-threatening diseases even in a very early stage of the disease progression.

With its quantitative accuracy, simple sample preparation methodology, and its ability to accurately sequence fragmented short molecules, our single molecule sequencing offers an excellent solution for liquid biopsy.

Infectious disease:

biopsy is emerging as a simple and non-invasive alternative to the traditional tissue biopsy approach for disease screening and

A simple draw of blood contains millions of tiny fragments of cell-free DNA/RNA material with lengths on the order of

100–200bp, which carry informative signatures of cancer and other life-threatening diseases even in a very early stage of the

disease progression.

With its quantitative accuracy, simple sample preparation methodology, and its ability to accurately sequence

fragmented short molecules, our single molecule sequencing offers an excellent solution for liquid biopsy.

Infectious diseases are disorders caused by bacteria, viruses and fungi.

These organisms contain DNA and RNA that act as infectious agents to transmit disease from person to person, by insect or animal, or through food and environmental means.

The detection and sequencing of the DNA and RNA from pathogens provides medically actionable information for diagnosis, treatment and monitoring of infections.

These organisms contain DNA and RNA that act

as infectious agents to transmit disease from person to person, by insect or animal, or through food and environmental means.

The detection

and sequencing of the DNA and RNA from pathogens provides medically actionable information for diagnosis, treatment and monitoring of

Accurate sequence information could also help to predict drug resistance.

Clinical diagnostics:

Our amplification and ligation free sequencing method allows us to identify subtle changes in the RNA transcript levels that are undetectable with other methods presumably due to bias and loss of low-level transcripts inherent to the other technologies.

The power of our tSMS technology can help to address the large unmet need for biomarker discovery to diagnose diseases such as cardiovascular diseases and cancer at very early stages.

The potential of our technology for bio-marker discovery is illustrated in Figure 4 below, where tSMS RNA-seq was utilized to identify RNA-based gene expression changes associated with ADHD [McCaffrey TA, St Laurent G 3 rd , Shtokalo D, et al.

Our amplification and ligation free sequencing method allows us to identify subtle changes in the RNA transcript

levels that are undetectable with other methods presumably due to bias and loss of low-level transcripts inherent to the other technologies.

The power of our tSMS technology can help to address the large unmet need for biomarker discovery to diagnose diseases such as cardiovascular

diseases and cancer at very early stages.

The potential of our technology for bio-marker discovery is illustrated in Figure 4 below,

where tSMS RNA-seq was utilized to identify RNA-based gene expression changes associated with ADHD [McCaffrey TA, St Laurent G 3 rd ,

Shtokalo D, et al.

Biomarker Discovery in Attention Deficit Hyperactivity Disorder:

RNA Sequencing of Whole Blood in Discordant Twin and Case-controlled Cohorts.

RNA Sequencing of Whole Blood in Discordant Twin

and Case-controlled Cohorts.

BMC Med Genomics .

Further studies offer the opportunity for validating future diagnostics applications.

Further studies offer the opportunity for validating future diagnostics

applications.

Biomarker Discovery in ADHD using tSMS

Microbiome analysis:

Microbial communities in and on the body show uniform bacterial diversity in healthy individuals.

Drugs and diet can disrupt the microbial diversity, and thereby can affect disease progression and treatment efficacy.

Our technology can accurately quantify the gene signature for all bacteria present and capture a real-time snapshot of the microbiome.

This data can be used by physicians for disease treatment by applying methods to encourage growth of beneficial microbes and eliminate harmful microbes.

communities in and on the body show uniform bacterial diversity in healthy individuals.

Drugs and diet can disrupt the microbial

diversity, and thereby can affect disease progression and treatment efficacy.

Our technology can accurately quantify the gene

signature for all bacteria present and capture a real-time snapshot of the microbiome.

This data can be used by physicians for

disease treatment by applying methods to encourage growth of beneficial microbes and eliminate harmful microbes.

These examples of emerging markets for sequencing-based technologies

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customers in developing new instruments optimized for specific assay and chemistry performance in order to support a wide array of applications.

Figure 6 below summarizes three priority areas of research and development for current and potential collaborations.

Three Priority Areas of Research and

Our target customers are consumers of NGS products and services engaged

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Provide the scientific community with a combination of research services and instrumentation to serve markets that we believe are inadequately addressed by existing technologies.

Assist in the development of new classes of RNA-based diagnostics tests.

Collaborate with researchers to enhance pharmacogenomics and biomarker discovery.

Support drug developers seeking a better understanding of the side effects of their new drugs.

Continue to innovate and develop new aspects of our products and technology, applications and instrumentation through scientific collaborations, including grants.

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research efforts.

The majority of our current customers are early adopters of genomics technology including tSMS.

A significant portion

of the funding for these developing technologies has historically come from research grants provided by government agencies and non-profit

research centers.

We often collaborate with customers to drive innovation in the field of genomic sciences through grant funded research

Our key collaborators and our current activities are highlighted below:

Our current customers are early adopters of genomics technology including tSMS.

A significant portion of the funding

for these developing technologies has historically come from research grants provided by government agencies and non-profit research centers.

We often collaborate with customers to drive innovation in the field of genomic sciences through grant funded research activities.

key collaborators and our current activities are highlighted below:

Department of Justice’s Federal Bureau of Investigation

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investigative context and have probative value.

The Bernstein Laboratory

We have worked closely with the lab of Bradley Bernstein, M.D., Ph.D.,

Chair of Cancer Biology at the Dana Farber Cancer Institute and Harvard Medical School to address fundamental questions in chromatin biology

and epigenetic regulation.

Bernstein is also the founder and Director of the Broad Institute Epigenomics Program.

from the Broad Institute have used antibody-based detection coupled with tSMS to begin decoding a dual-marking system in modified histones

that signals for a gene to be activated or repressed.

Early results, published in Science , suggest differentiated cells exhibit

different patterns of “bivalent” markings than embryonic cells.

Our collaboration encompasses technology development, single-cell

RNA and DNA analysis, and the creation of novel intellectual property.

In addition to completing NIH grant funded research activities,

we have provided Dr.

Bernstein with tSMS systems and onsite support.

In 2021, we published a single-cell RNA focused technology development

manuscript in the Peer-reviewed journal, Cell Report.

The Ting Laboratory

We have been a long-time research collaborator with David Ting, M.D.,

Assistant Professor, Medicine at Harvard Medical School and a leading member at the Dana Farber/Harvard Cancer Center in using tSMS to

better understand cancer.

His research is focused on the role of non-coding RNA transcription in cancer as it relates to tumorigenesis

and as novel biomarkers.

In this research area, the Ting Laboratory was first to discover aberrant overexpression of pericentromeric RNA

repeats by RNA-seq using tSMS, which were found to play a significant role in pancreatic cancer and other epithelial cancers [Bersani,

PNAS , December 2015].

This discovery resulted in new intellectual property related to pancreatic cancer biomarkers and the subsequent

founding of Rome Therapeutics, an early-stage company focused on unlocking the repeatome to discover powerful new classes of medicines

for cancer and autoimmune diseases.

We have provided Dr.

Ting with tSMS systems and onsite support, research services, and access to sample

preparation methodologies.

The Jackson Laboratory for Genomic Medicine

Led by Chia-Lin Wei, Ph.D.

with The Jackson Laboratory (“JAX”)

and supported by a recent four-year, $2.3 million grant from the National Institute of General Medical Sciences, we are assisting in the

development of new methods for chromatin interaction analysis in single nuclei, with single-molecule resolution.

JAX has stated that preliminary

results indicate that, once fully developed, the methods under development have the potential to exceed previous methodologies and to

revolutionize the field of three-dimensional (“3D”) genome biology.

Our research grant efforts, including instrument prototype

and sequencing kit development, are continuing and will focus on generating genome-wide, single-molecule chromatin interaction maps in

a variety of biological systems and uncovering the structural detail of multiplex chromatin loci that are currently unresolvable given

standard NGS.

We developed a prototype system in the second half of 2021 and utilized this system for sample testing and data generation

Weizmann Institute of Science

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Weizmann Institute with access to prototype sequencing systems, sequencing kits, and sample preparation methodologies.

True Bearing Diagnostics, Inc.

We have participated in a research collaboration with Timothy McCaffrey,

of The George Washington University’s Center of Genomic Medicine and True Bearing Diagnostics, Inc, performing tSMS on whole-blood

RNA to identify transcripts associated with coronary artery disease (“CAD”).

In comparison to other platforms that include

NGS technologies, only our tSMS platform could consistently identify the novel mRNA signature in CAD patients.

We believe this collaboration

will provide the blueprint for a diagnostic test that could significantly reduce the more than one million U.S.

catheterizations that

are performed annually at a cost of approximately $20 billion per year.

A scientific manuscript detailing biomarker discovery efforts

for CAD was published in a 2021 peer reviewed journal.

We have provided True Bearing Diagnostics with research services and access to

sample preparation methodologies.

Potential future work includes the development of a CAD-focused clinical system for regulatory clearance.

Tetracore, Inc.

focuses on antibody-based and nucleic acid-based detection

reagents and technologies, and contracts with the U.S.

Government for the development of real-time PCR diagnostic tests for biological

warfare threat agents, novel nucleic acid extraction procedures, and specialized nucleic acid products.

We have provided Tetracore with

tSMS systems and onsite support.

We are actively preparing applications for submission to the NIH, DARPA and other funding agencies regarding

the use of our technology in the development and production of detection tools.

These potential products, including non-NGS applications,

are for clinical, animal health, and domestic preparedness testing.

Future Products

We expect to partner or collaborate with biotech and pharma companies

to develop a clinical-grade tSMS sequencer for use with one or more diagnostic tests.

We intend for our partners to commercialize diagnostic

tests for applications for which the tSMS platform offers accurate diagnostic capability, such as non-invasive prenatal testing for early

pregnancy and high-body-mass-index-mothers, liquid biopsy for oncology applications, microbiome analysis, and transcriptome-based diagnostics

for cardiovascular disease, infectious disease and others.

We will look to increase industry visibility and expand our reach globally

for both sequencing services and instrument sales through strategic customer relationships and partnerships with larger organizations

that can increase global support, supply and distribution.

Through those partnerships, we plan to identify new, high-value, cutting-edge

applications that are uniquely enabled by our amplification-free, direct DNA and RNA sequencing technology.

The accuracy, sensitivity and simplicity of the tSMS platform allows

the technology to be applied for developing assays and instruments used for quality control of manufactured therapeutic products, including

gene therapy and vaccine technologies.

We plan to explore commercial-stage partnerships with therapeutics companies interested in accessing

our tSMS platform.

to develop a clinical-grade diagnostic tests.

We intend for our partners to commercialize these diagnostic or forensic tests for applications

liquid biopsy for oncology applications, microbiome analysis, and transcriptome-based diagnostics for cardiovascular disease, infectious

disease and others.

We will look to increase industry visibility and expand our reach globally for both sequencing services and instrument

sales through strategic customer relationships and partnerships with larger organizations that can increase global support, supply and

distribution.

Through those partnerships, we plan to also identify new, high-value, cutting-edge applications that are uniquely enabled

by our tSMS platform.

As our partners or collaborators expand their product lines to address

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and can take from one to three years, or longer.

We have not sought FDA approval of our sequencers because to-date

we have marketed them for research purposes and not for clinical diagnostics.

We have not sought FDA approval of our sequencers because to-date we

have marketed them for research purposes and not for clinical diagnostics.

Through our partners or collaborators, we will likely need

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Defining our value proposition in terms of commercial value and solution to customer needs, as related to platform flexibility, speed to solution, and comprehensive quality of the genetic information provided.

new literature that highlights our technology, instruments and capabilities.

This includes brochures, white papers, application notes,

case studies, and solution’s value proposition marketing material.

● Implementing

new customer facing programs including trade show participation, posters and presentations to showcase the solutions for commercial needs,

and attending scientific conferences that publish the research data from the tSMS platform.

visibility in segment verticals with segment organization participation and by creating integrated training and education programs as

a part of instrument sales and the training process.

research collaborations with key opinion leaders to address critical, high potential needs and publish the findings in the peer-reviewed

scientific journals.

Creating new literature that highlights our technology, instruments and capabilities.

This includes brochures, white papers, application notes, case studies, and solution’s value proposition marketing material.

Implementing new customer facing programs including trade show participation, posters and presentations to showcase the solutions for commercial needs, and attending scientific conferences that publish the research data from the tSMS platform.

Expanding visibility in segment verticals with segment organization participation and by creating integrated training and education programs as a part of instrument sales and the training process.

Furthering research collaborations with key opinion leaders to address critical, high potential needs and publish the findings in the peer-reviewed scientific journals.

We believe this approach maximizes value to our customers and shareholders

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and we believe several are prepared to provide these services once production demand exceeds internal capacity.

Our current manufacturing staff is comprised of a team of

engineers and technicians each having more than 10 years of experience with the tSMS product line.

manufacturing team has deep experience with the tSMS platform and has the ability to adapt to future needs on both the hardware and

sequencing kits.

In addition, this group has experience in FDA product clearance and working in an FDA regulated environment.

team has been involved in manufacturing commercially available tSMS instruments since its original design and subsequent production

Our current manufacturing staff is comprised of a team of engineers

and technicians each having more than 10 years of experience with the tSMS product line.

The manufacturing team has deep experience

with the tSMS platform and has the ability to adapt to future needs on both the hardware and sequencing kits.

In addition, this group

has experience in FDA product clearance and working in an FDA regulated environment.

The team has been involved in manufacturing commercially

available tSMS instruments since its original design and subsequent production in 2008.

We are planning to establish a controlled manufacturing process and

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Some of our research and development accomplishments include:

of a second generation tSMS sequencer in benchtop form-factor;

sample preparation, flow cell and reagent tSMS processes;

machine-learning methods-based image analysis algorithms;

● Co-authored

multiple publications in scientific journals;

multiple National Institutes of Health grant awards for technology development.

Production of a second generation tSMS sequencer in benchtop form-factor;

Optimized sample preparation, flow cell and reagent tSMS processes;

Innovated machine-learning methods-based image analysis algorithms;

Co-authored multiple publications in scientific journals;

Received multiple National Institutes of Health grant awards for technology development.

We plan to continue our investment in research and development to enhance

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All of the patents under this sublicense have since expired.

We have two pending patent applications, one filed in 2021 and the

other filed in 2022.

We received a Notice of Allowance regarding our previous patent application 15/754.222.

In October 2022, the USPTO

notified us that the related patent term adjustment was 779 days.

Our issued and pending patents cover various aspects of our sequencing

technology, and we expect to continue to file new patent applications to protect the improvements to our technologies.

We have one pending patent applications filed in 2021.

a Notice of Allowance regarding our previous patent application 15/754.222.

In October 2022, the USPTO notified us that the related patent

term adjustment was 779 days.

Our issued and pending patents cover various aspects of our sequencing technology, and we expect to continue

to file new patent applications to protect the improvements to our technologies.

We have registered our corporate name (SeqLL) and design logo, as well

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infringing the proprietary rights of third parties, and acquiring licenses for technology or products.

As of December 31, 2022, we had seven employees.

None of our employees

are represented by a collective bargaining agreement, and we have never experienced any work stoppage.

We believe we have good relations

with our employees.

As of December

31, 2023, we had seven employees.

None of our employees are represented by a collective bargaining agreement, and we have never experienced

any work stoppage.

We believe we have good relations with our employees.

Properties and Facilities

On February 2, 2022, we entered into a new lease agreement for approximately

On February 2, 2022, we entered into a lease agreement for approximately

15,538 square feet of corporate office and laboratory space in Billerica, Massachusetts.

5 unchanged sentences

We are currently not a party to any material legal proceedings.

Proposed Merger with Lyneer Investments LLC

We have entered into an Agreement and Plan of Reorganization dated

May 29, 2023, as amended, pursuant to which our wholly-owned subsidiary, SeqLL Merger LLC (“SeqLL Merger Sub”),

will merge (the “Merger”) with and into Lyneer Investments LLC (“Lyneer”), with Lyneer continuing as our wholly-owned subsidiary.

In connection with the consummation of the Merger, we will sell our existing assets, other than cash and cash equivalents, which will

be distributed to our pre-Merger stockholders in connection with the Merger, to a newly-formed company owned by our current

employees and management, for nominal consideration, and our continuing business operations will be those of Lyneer.

Lyneer, through its operating subsidiaries, primarily Lyneer Staffing

Solutions, is a national strategic staffing firm servicing the commercial, professional, finance, direct placement, and managed service

provider verticals.

The firm was formed under the principles of honesty and integrity, and with the view of becoming the preferred outside

employer of choice.

Since its formation in 1995, Lyneer has grown from a regional operation to a national staffing firm with offices and

geographic reach across the United States.

Lyneer’s management believes, based on their knowledge of the

industry, that Lyneer is one of the prominent and leading staffing firms in the ever-evolving staffing industry.

Lyneer, headquartered

in Lawrenceville, New Jersey, has over 100 total locations and approximately 300 internal employees.

Its management also believes

that Lyneer is an industry leader in permanent, temporary and temp-to-perm placement services in a wide variety of areas, including,

but not limited to, accounting & finance, administrative & clerical, hospitality, IT, legal, light industrial and medical

Its deep expertise and extensive experience have helped world class companies revolutionize their operations, resulting in greater

efficiency and streamlined processes.

Its comprehensive suite of solutions covers all aspects of workforce management, from recruitment

and hiring to time and attendance tracking, scheduling, performance management, and predictive analytics.

Lyneer takes a personalized

approach to each client, working closely with them to understand their unique needs and develop a tailored roadmap for success.

Lyneer offers a comprehensive range of recruiting services, including temporary and permanent staffing, within the light industrial, administrative,

and financial sectors.

Its services are designed to meet each client’s needs, including payroll services and vendor management services/managed

service provider solutions.

Its extensive network of offices and onsite operations provide local support for its clients, while its national

presence gives Lyneer the resources to tackle even the most complex staffing needs.

With a focus on integrity, transparency and customer

service and a commitment to results, we believe Lyneer has earned a reputation as one of the premier workforce solutions partners in the

United States.

Business Model and Acquisition Strategy

Atlantic Acquisition Corp.

(“Atlantic”) was formed in Delaware

on October 6, 2022 as a special purpose vehicle to acquire control of a public company such as our company.

The management team of

Atlantic, which will become the management of our company upon consummation of the Merger, has over 150 combined years of specific

corporate management and investment banking experience.

Atlantic’s business strategy for our company is based upon Lyneer

being a high-growth U.S.-based outsourced services and workforce solutions company with management who have a more than 25-year operating

Based on their knowledge of the industry, Atlantic’s management believes that through their mergers and acquisitions strategy,

they can build our company into a global staffing organization that redefines the way companies grow professional teams.

Its mission is

to leverage new technologies and business partnerships to create streamlined hiring processes that resolve the challenges of modern day

employment economics.

Accordingly, Atlantic’s management is actively engaged in discussions and negotiations with multiple acquisition

targets that complement Atlantic’s core business strategy.

In addition, following the Merger, our strategic direction will be enhanced

by a program that will extend Lyneer’s breadth of services to its broad national reach in a number of complementary areas.

has identified and is focusing on a number of high-demand fields, in particular, the medical, legal and financial services fields.

Atlantic is in the process of investigating a number of opportunities for acquisitions by us of staffing companies that operate in these

identified sectors.

Atlantic’s corporate acquisition strategy is premised on the

seamless consolidation and integration of technology and back-office infrastructure, coupled with performance improvements and value

Its core thesis is designed to allow us to assist our client companies in the transformation of stagnation into growth to achieve

sustainable results through their most important asset:

Atlantic’s goal is to create for us a business designed to deliver

to our clients targeted industry talent at speed and scale while also growing the pool of in-demand talent for this same constituency.

Lyneer’s recruiters will provide specific and data-driven guidance, development, training, and access to jobs.

Atlantic believes

this approach is particularly applicable in several growth sectors, including legal and financial services, technology, and healthcare.

The current climate of industry fragmentation and overall economic uncertainty create a moment that Atlantic believes is ripe for strategic

consolidation.

After the closing of the Merger, Atlantic intends to cause us to aggressively engage in this “M&A” strategy

and to take advantage of the synergies and opportunities created by this congruence of events.

By advantageously augmenting Lyneer’s

existing significant capabilities through acquisition, Atlantic believes we will be able to create material margin improvement.

Atlantic currently has a robust pipeline of potential acquisition targets

for our company and is in negotiations and discussions with outsourced services and workforce solutions acquisition targets in key service

Management of Atlantic believes that multiple targets in the $100,000,000 revenue range are readily available for acquisition

by us within a short period of time.

However, Atlantic does not currently have any binding agreements, arrangements or understandings

concerning any potential acquisition.

By implementing Atlantic’s detailed acquisition strategy, Atlantic’s

management believes we will be able to rapidly accelerate the growth of our company, thus increasing and maximizing shareholder value.

Atlantic’s management plans to pursue “cornerstone acquisitions” focusing on targets with robust profits, diverse client

bases, large national/large regional coverage in contract/permanent staffing, executive search, recruitment process, and outsourcing.

In order to meet such management’s “cornerstone acquisition” criterion, a company should have over $50,000,000 in revenue

and EBITDA margins of no less than 10%.

In addition, Atlantic’s management plans to pursue “tuck-in” acquisitions with

a focus on acquiring high-margin niche staffing companies that can benefit from the synergies of a larger organization with increased

Under its “tuck-in” program, Atlantic’s management intends to acquire smaller profitable companies in business

segments consistent with its larger anchor organizations.

Post-Merger, Atlantic’s management plans to integrate companies

and maximize synergies and economics to improve our sales and lower operating costs, while, at the same time, continuing to focus and

expand on its acquisition strategy of high-margin profitable outsourced services and workforce solution providers.

On May 29, 2023, we, SeqLL Merger Sub, Atlantic, Atlantic Merger

LLC, a Delaware limited liability company and a majority-owned subsidiary of Atlantic (“Atlantic Merger Sub”), Lyneer,

IDC Technologies, Inc., a California corporation (“IDC”), and Lyneer Management Holdings LLC, a Delaware limited liability

company (“Lyneer Management”), entered into an Agreement and Plan of Reorganization (as amended, the “Merger Agreement”),

pursuant to which (i) Atlantic Merger Sub will be merged with and into Lyneer, with Lyneer continuing as the surviving entity and

as an approximately 44%-owned subsidiary of Atlantic, an approximately 50%-owned subsidiary of IDC, and an approximately 6%-owned subsidiary

of Lyneer Management (the “Lyneer Merger”), and (ii) SeqLL Merger Sub will subsequently be merged with and into Lyneer,

with Lyneer continuing as the surviving entity and as our wholly-owned subsidiary (the “SeqLL Merger”).

Lyneer, IDC and

Atlantic are collectively referred to herein as the “Sellers.”

We currently expect the Merger to be consummated in the second quarter

of 2024, subject to the satisfaction of certain closing conditions, including our consummation of a public offering of our equity securities

in which we receive gross proceeds of $20 million (the “Public Offering”), of which there can be no assurance.

At the effective

time of the Merger, in consideration of 100% of the membership interests of Lyneer, we will (i) pay to IDC and Lyneer Management

an aggregate of $16,250,000 in cash (the “Cash Consideration”), (ii) issue to (a) IDC and Lyneer Management an aggregate

of 5,500,000 shares of our common stock and (b) to Atlantic 300,000 shares of our common stock, in each case assuming a public offering

price of $10.00 per Unit in this Public Offering (the “Stock Consideration”), and (iii) issue to IDC a convertible promissory

note (the “Merger Note,” and collectively with the Cash Consideration and the Stock Consideration, the “Merger Consideration”)

in the principal amount of $18,750,000 that will mature on July 31, 2024.

The Merger Note will not bear interest and will not be

convertible prior to an event of default under the Merger Note.

If an event of default should occur under the Merger Note, the Merger

Note will bear interest at the rate of 7% per annum commencing upon the date of such event of default and will be convertible into shares

of our common stock at a price per share that equals then-current market prices, but not less than 80% of the price per share at

which our common stock is sold in the Public Offering.

If the Merger Note is converted into shares of our common stock, IDC will have

demand and incidental registration rights with respect to such shares.

We believe we will have to sell additional equity or debt securities

prior to the maturity date of the Merger Note to pay or refinance the Merger Note when due.

The Merger Agreement contains customary representations and warranties

from the parties, and each party has agreed to customary covenants applicable to such party, including, among others, covenants relating

to (i) the conduct of their respective businesses in the ordinary course prior to the effective time of the Merger and (ii) the

requirement of each party to maintain and preserve intact their respective business organizations, assets, properties and material business

Pursuant to the Merger Agreement as originally executed, we were also required, prior to the closing of the Merger, to declare

a cash dividend payable to our stockholders of record as of the close of business on September 26, 2023, in an amount equal our cash and

cash equivalents as of the closing date of the Merger, less any amounts withheld for taxes and certain other obligations as of such date.

Concurrently with the declaration of such cash dividend, we were also required to declare a stock dividend issuable to such stockholders

of an aggregate of number of shares of our common stock that, when added to such value of the outstanding shares of common stock

on September 26, 2023, in each case valued at the price per share at which our common stock is sold in the Public Offering, will equal

However, on November 3, 2023, the parties to the Merger Agreement amended the Merger Agreement to delete the requirement

for the declaration of such dividends in consideration of our agreement to make a settlement offer within 90 days of the closing of the

Merger to our stockholders of record as of the close of business on September 26, 2023 to settle any claims for failing to pay such dividends

by issuing to such stockholders the amount of cash and the number of shares of our common stock that such stockholders would have received

had such dividends been declared and made.

In connection with the execution and delivery of the Merger Agreement,

we entered into the Asset Purchase Agreement with SeqLL Omics.

SeqLL Omics was recently formed by Daniel Jones, our current Chairman of

the Board and Chief Executive Officer, and certain other employees of our company, for the purpose of carrying on our pre-Merger business

after the Merger.

Subject to the terms and conditions of the Asset Purchase Agreement, SeqLL Omics has agreed to purchase from us, and

we have agreed to sell to SeqLL Omics, for a purchase price of $1,000, all of our rights and interest in our assets and properties as

they exist immediately prior to consummation of the Merger, excluding cash and cash equivalents.

In negotiating the Merger Agreement with

Atlantic, it was a requirement of Atlantic that at the closing of the Merger, we will have disposed of our pre-Merger business operations,

including all or substantially all of our assets, and will have transferred or satisfied all of our pre-Merger liabilities, other

than those pre-Merger liabilities that we have expressly agreed to retain pursuant to the Merger Agreement.

Summary of Risk Factors Related to Lyneer

Lyneer’s business is subject to numerous risks and uncertainties

that could affect our business and our company following consummation of the Merger.

The significant risks include, but are not limited

to, the following:

● Lyneer’s history of losses may harm our ability to

obtain additional financing;

● Lyneer’s ability to restructure its existing debt obligations

and to eliminate existing joint and several liability with its current parent company, IDC;

● following the consummation of the Merger, a default by Lyneer

on its existing credit facilities could result in foreclosure on IDC’s controlling ownership interest in our company and foreclosure

on our ownership of the equity securities of Lyneer;

● Lyneer’s ability to retain its largest clients;

● Lyneer’s ability to integrate the combined operations

of our previously-acquired companies;

● our ability to make future acquisitions following the Merger,

and effectively integrate any future combined operations;

● general economic conditions in the United States;

● our ability to achieve and maintain profitability following

● our ability to sustain or grow our customer base for Lyneer’s

current services and provide superior customer service;

● our liquidity and working capital requirements following

the Merger, including our cash requirements over the next 12 months;

● our ability to relist our securities on the Nasdaq Capital

Market following the Merger and to satisfy and maintain the ongoing listing requirements for the Nasdaq Capital Market;

● compliance with the U.S.

regulations applicable to our

● our ability to implement Atlantic’s roll-up strategy

and future plans of operations;

● expectations regarding the size of Lyneer’s market;

● our expectations following the Merger regarding the future

market demand for our services;

● compliance with applicable laws and regulatory changes;

● our ability to identify, attract and retain qualified personnel

and the loss of key personnel;

● the limitation of liability and indemnification of our officers

and directors following the Merger;

● economic conditions affecting the staffing industry in which

Lyneer operates;

● maintaining Lyneer’s intellectual property rights and

any potential litigation involving intellectual property rights;

● our ability following the Merger to anticipate and adapt

to a developing market(s) and to technological changes;

● following the Merger, acceptance by customers of any new

● a competitive environment characterized by numerous, well-established and

well-capitalized competitors;

● the ability to develop and upgrade our technology and information

systems and keep up with rapidly evolving industry standards;

● any interruption in the supply of services;

● discontinuance of support for our information systems from

third party vendors;

● significant fluctuations in Lyneer’s quarterly operating

● following the Merger, the extent, liquidity, volatility and

duration of any public trading market for our securities;

● the resale of our securities following the Merger could adversely

affect the market price of our common stock and our ability to raise additional equity capital;

● we may become subject to “penny stock” rules,

which could damage our reputation and the ability of investors to sell their shares;

● following the Merger, insiders, including significant stockholders,

will continue to have substantial control over our company.

Unless the Merger Agreement has been terminated, Investors should consider

the risks and uncertainties relating to the Merger and Lyneer summarized above, as well as the more detailed discussion of such risks

and uncertainties included in our in our registration statement on Form S-1 (Registration No.

333-272908) filed with the SEC, a copy of

which is publicly available through the SEC’s website at http://www.sec.gov .

Additional risks relating to Lyneer not

presently known to us or that we currently deem immaterial may also affect us following consummation of the Merger.

If, following the

Merger, any of these risks occur, our business, financial condition, or results of operations could be materially and adversely affected.

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