UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒ ANNUAL REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31 , 2023
☐ TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ____________ to
____________
Commission File Number 333-254886
SeqLL
Inc .
(Exact name of registrant as specified in its charter)
Delaware 46-5319744
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification Number)
3 Federal Street , Billerica , Massachusetts 01821
(Address of Principal Executive Offices) (Zip Code)
(781) 460-6016
(Registrant’s Telephone Number, Including
Area Code)
Securities registered pursuant to Sectio n
12(b) of the Act: None
Securities
registered pursuant to Section 12(g) of the Act:
Title of each class
Common Stock, par value $.00001 per share
Warrants to purchase Common Stock
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports) and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”,
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:
Large accelerated filer ☐ Accelerated filer ☐
Smaller reporting company ☒ Non-accelerated filer ☒
Emerging growth company ☒
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. Yes ☐ No ☒
If securities
are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included
in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).
☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The aggregate market value of the registrant’s common stock held
by non-affiliates of the registrant was approximately $ 3,769,559 based on the closing price on the Nasdaq Capital Market as of June
30, 2023, the last business day of the registrant’s most recently completed second fiscal quarter.
There were 380,648 shares of the registrant’s common stock, $0.00001
par value, outstanding as of March 31, 2024.
SEQLL INC.
TABLE OF CONTENTS
PART I
Item 1
Business
1
Item 1A
Risk Factors
22
Item 1B
Unresolved Staff Comments
42
Item 1C
Cybersecurity
42
Item 2
Properties
42
Item 3
Legal Proceedings
42
Item 4
Mine Safety Disclosures
42
PART II
Item 5
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
43
Item 6
[Reserved]
43
Item 7
Management’s Discussion and Analysis of Financial Condition and Results of Operations
43
Item 7A
Quantitative and Qualitative Disclosures About Market Risk
50
Item 8
Financial Statements and Supplementary Data
50
Item 9
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
50
Item 9A
Controls and Procedures
50
Item 9B
Other Information
51
Item 9C
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
51
PART III
Item 10
Directors, Executive Officers and Corporate Governance
52
Item 11
Executive Compensation
58
Item 12
Security Ownership of Certain Beneficial Owners and Management and Related Stockholders Matters
63
Item 13
Certain Relationships and Related Transactions, and Director Independence
65
Item 14
Principal Accounting Fees and Services
66
PART IV
Item 15
Exhibits and Financial Statement Schedules
67
Item 16
Form 10–K Summary
67
SIGNATURES
68
EXHIBIT INDEX
LIST XBRL DOCUMENTS
As used in this Annual Report on Form 10-K, the terms “we”,
“us”, “our” and the “Company” mean SeqLL Inc. and its wholly owned subsidiary SeqLL, LLC, taken as
a whole (unless the context indicates a different meaning).
i
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual
Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements
are contained principally in the sections titled “Business,” “Risk Factors” and “Management’s Discussion
and Analysis of Financial Condition and Results of Operations,” but are also contained elsewhere in this report. In some cases,
you can identify forward-looking statements by the words “may,” “might,” “will,” “could,”
“would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,”
“believe,” “estimate,” “predict,” “project,” “potential,” “continue”
and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the
future, although not all forward-looking statements contain these words. These statements relate to future events or our future financial
performance or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels
of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. These
forward-looking statements include, but are not limited to, statements about:
● our ability to consummate our proposed merger with Lyneer Investments
LLC;
● the proposed terms of the proposed merger with Lyneer Investments LLC,
including the number of shares of our common stock to be issued in such proposed merger and the financing we will have to consummate in
connection therewith;
● the proposed business of Lyneer Investments LLC that will constitute
the business of our company following such proposed merger;
● the success, cost and timing of our current product development activities,
including statements regarding the timing of initiation and completion of our research and development programs;
● developments regarding next generation sequencing technologies;
● our
expectations regarding the market size and growth potential for our business;
● the
implementation of our strategic plans, including strategy for our business and related financing;
● our
ability to maintain and establish future collaborations and strategic relationships;
● the
rate and degree of market acceptance of our products;
● our
ability to generate sustained revenue or achieve profitability;
● the
potential for our identified research priorities to advance our technology;
● the
pricing and expected gross margin for our products;
● our
commercialization, marketing and manufacturing capability and strategy;
● our
research and development plans including, among other things, statements relating to future uses, quality or performance of, or benefits
of using, products or technologies;
● updates
or improvements of our products;
● intentions
regarding seeking regulatory approval for our products;
● our
competitive position;
● our
estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for, or ability to obtain, additional financing
as necessary; and
● our
ability to maintain our intellectual property position for our technology.
You should read this report, including the section
titled “Risk Factors,” and the documents that we reference elsewhere in this report and have filed as exhibits to this report
completely and with the understanding that our actual results may differ materially from what we expect as expressed or implied by our
forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In
light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation
or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.
These forward-looking statements represent our
estimates and assumptions only as of the date of this report regardless of the time of delivery of this report. Except as required by
law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future
events or otherwise after the date of this report. All subsequent forward-looking statements attributable to us or any person acting on
our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.
ii
SUMMARY
RISK FACTORS
Our business is subject to varying degrees of risk
and uncertainty. Investors should consider the risks and uncertainties summarized below, as well as the risks and uncertainties discussed
in Part I, Item 1A, “Risk Factors” of this Annual Report on Form 10-K. Additional risks not presently known to us or that
we currently deem immaterial may also affect us. If any of these risks occur, our business, financial condition, or results of operations
could be materially and adversely affected.
Our business is subject to the following principal
risks and uncertainties:
● As
we have incurred recurring losses and negative cash flows since our inception, there is no assurance that we will be able to continue
as a going concern absent additional financing.
● We
are an early, commercial-stage company with a limited operating history.
● If
our tSMS sequencing instruments or sequencing services fail to achieve and sustain sufficient market acceptance, we will not generate
expected revenue and our business may not succeed.
● Our
research and development efforts may not result in the benefits we anticipate, and our failure to successfully market, sell and commercialize
our current and future sequencing instruments and services products could have a material adverse effect on our business, financial condition
and results of operations.
● If
we are unable to successfully develop and timely manufacture our sequencing instruments and reagents, our business may be adversely affected.
● We
must successfully manage new product introductions and transitions related to the tSMS technology, we may incur significant costs during
these transitions, and they may not result in the benefits we anticipate.
● We
rely on other companies for certain components and materials and intend to outsource sub-assembly manufacturing in the future. We may
not be able to successfully assemble or manufacture reagents and instruments or scale the manufacturing process necessary to build and
test multiple products on a full commercial basis, which could materially harm our business.
● We
may be unable to consistently manufacture our instruments and reagents to the necessary specifications or in quantities necessary to
meet demand at an acceptable cost.
● Increased
market adoption of our products by customers may depend on the availability of sample preparation and informatics tools, some of which
may be developed by third parties.
● Single
molecule sequencers are highly complex, have recurring support requirements and could have unknown defects or errors, which may give
rise to claims against us or divert application of our resources from other purposes.
● If
we lose members of our senior management team or other key personnel or are unable to successfully retain, recruit and train qualified
scientists, engineers and other personnel, our ability to maintain and develop our products could be harmed and we may be unable to achieve
our goals.
● A
significant portion of our potential sales depends on customers’ spending budgets that may be subject to significant and unexpected
variation which could have a negative effect on the demand for our products.
● We
are, and may become, subject to governmental regulations that may impose burdens on our operations, and the markets for our products
may be narrowed.
● Our
sales cycle is unpredictable and lengthy, which makes it difficult to forecast revenue and may increase the magnitude of quarterly or
annual fluctuations in our operating results.
For a more detailed discussion of these risks and
uncertainties, you should consider, you are urged to carefully review, the risk and uncertainties described under Part I, Item 1A, “Risk
Factors” of this Annual Report on Form 10-K.
As discussed further under the caption Part I, Item 1 , “Business”
of this Annual Report on Form 10-K, we have entered into an agreement for the merger of our company with Lyneer Investments LLC. If such
merger is consummated, the business of Lyneer Investments LLC will become our principal business and our current business operations will
be sold for nominal consideration to a newly-formed company owned by our current employees and management. The business of Lyneer
Investments LLC is subject to varying degrees of risk and uncertainty. If our agreement for the merger of our company with Lyneer Investments
LLC has not been terminated, Investors should consider the risks and uncertainties of Lyneer Investments LLC that are summarized in our
registration statement on Form S-1 (Registration No. 333-272908) filed with the Securities and Exchange Commission (the “SEC”),
a copy of which is publicly available through the SEC’s website at http://www.sec.gov .
iii
GLOSSARY OF CERTAIN SCIENTIFIC TERMS
The medical and scientific terms used in this
report have the following meanings:
“Bioinformatics” means a subdiscipline
of biology and computer science concerned with the acquisition, storage, analysis, and dissemination of biological data, most often DNA
and amino acid sequences.
“cDNA” means complementary DNA created
from RNA through the use of reverse transcriptase.
“DNA” means deoxyribonucleic acid,
a self-replicating material present in nearly all living organisms as the carrier of genetic information.
“Double helix” is a structure formed
by a pair of parallel helices intertwined around a common axis. DNA is a double helix.
“DRS” means Direct RNA Sequencing,
a method for sequencing RNA molecules without conversion to complementary DNA (“cDNA”) or amplification via PCR.
“Epigenetic” is the changes in gene
expression that do not involve changes in the DNA sequence.
“FDA” means the U.S. Food and Drug
Administration.
“Flow cell” means an optical cell
used for detection and measurement of biological samples.
“Gene” is a portion of a DNA that
serves as the basic unit of heredity.
“Gene expression” is a process by
which information from a gene is used for the synthesis of a functional product.
“Genome” is an organism’s complete
set of DNA.
“Genomics” refers to the study of
all an organism’s genetic material and their interactions to influence the organism. Large-scale studies are required to understand
how changes in an organism’s genes influence the organism.
“Helix” is an extended spiral chain
of molecules.
“LDT” means Laboratory Developed Tests.
“Ligation” is a process of joining
two DNA strands by chemical linkage.
“Microfluidics” is the science of
manipulating and controlling fluids, usually in very small ranges.
“Next Generation Sequencing” means
a high-throughput sequencing to sequence DNA and RNA molecules much more quickly and cheaply than the previously used techniques.
“NGS” means Next Generation Sequencing.
iv
“Nucleic Acid” means a complex organic
substance present in living cells, such as DNA or RNA.
“Nucleotide bases” or “Nucleotides”
are building blocks of nucleic acids and include adenine (“A”), cytosine (‘C”), guanine (“G”), thymine
(“T”) and uracil (“U”).
“Omics” refers to various different
biological analyses approaches whereby researchers can analyze complex biological data, often in high throughput methods, to find novel
associations between biological entities, pinpoint relevant biomarkers and build elaborate markers of disease and physiology. Examples
of various “omics” analyses include: genomics, proteomics, transcriptomics, epigenomics, and metabolomics. When two or more
of the -omics analyses approaches are combined either directly in analyses and/or in examination of -omics data sets, the approach is
referred to as “multi-omics.”
“PCR” means Polymerase Chain Reaction,
which is a technique used to generate multiple copies (thousands to millions) of DNA sequences.
“Proteomic(s)” refers to the large-scale
study of proteins. The proteome is the entire set of proteins that is produced or modified in an organism or system.
“RNA” means ribonucleic acid, a material
present in all living cells which acts as a messenger carrying instructions from the DNA for controlling the synthesis of proteins.
“RNA-Seq” means RNA Sequencing, an
NGS method that involves the conversion of RNA into cDNA for subsequent sample preparation and sequencing.
“Throughput” refers to the rate at
which an assay can be performed during a given time period.
“Transcript” is a single stranded
RNA synthesized by transcription of DNA.
“Transcriptome” refers to the sum
of all RNA molecules, inclusive of noncoding and coding RNAs, that are contained within a population of cells or a single cell.
“tSMS” means True Single Molecule
Sequencing.
v
PART I
BUSINESS
ITEM 1.
BUSINESS
Overview
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,
epigenetics, nucleotide chemistry, forensics, and cell-free nucleic acid analysis. Our mission is to empower researchers with improved
genetic tools that enable scientists and physicians to better understand the molecular mechanisms of disease and the underlying biological
systems. This knowledge is essential to the continued development of new breakthroughs in genomic medicine that address the critical concerns
involved with today’s precision medicine.
Our single molecule technology enables researchers to identify and
synthesize DNA or RNA strands, irrespective of abundance, in a biological sample and is capable of analyzing billions of molecules in
parallel, which positions us as both competitive and complementary with other NGS platforms. We believe our technology advantage is a
simplified method of quantifying DNA and RNA molecules at single molecule resolution because our platform does not require the routine
PCR amplification and library preparation and ligation steps required by most NGS systems, thereby avoiding systematic bias and consequential
additional costs. Our current sequencing platform offers advantages, such as the ability of certain samples to reveal previously unknown
molecular profiles by directly detecting single molecules with little to no manipulation of the original sample. Our tSMS platform then
generates data that is highly accurate and creates reproducible molecular profiles, often providing researchers with new insights into
the biology being researched. As supported by multiple peer-reviewed research publications, our tSMS technology platform has assisted
medical researchers in uncovering potentially significant DNA and RNA biomarkers for the early detection of diseases.
Our strategy is to integrate the tSMS platform with the development
of novel applications across multiple market segments, and to generate revenue through sales of partnership-specific systems and related
flow cells and reagents, which we refer to as “sequencing kits”, research services and research grants. We do not offer or
sell any products that are founded upon or incorporate our tSMS platform directly to healthcare professionals or consumers. To strengthen
our market position, we strive to build and control intellectual property around the instruments, sequencing kits and methods that enable
these applications to strengthen our market position. Integral to this strategy will be to work with existing customers in developing
new instruments optimized for specific assay and chemistry performance in order to support a wide array of applications. Our target customers
are consumers of NGS products and services engaged in research activities and the development of new or improved products, such as academic
and government institutions, hospitals and medical centers, pharmaceutical and biotechnology companies, and non-profit research organizations.
Under our current operating model, we expect the revenue we generate
from a specific customer to scale as our partnership or collaboration with such customer matures and the intellectual property founded
on our tSMS platform is developed and sold by such customer. Initially, our customer-specific revenue is typically dependent on the funding
of, or research grants obtained by, our partners and their ability to develop novel products. During the early stages of our partnerships
or collaborations, we generally derive revenue from research services, grants, and the sale of customized instruments and sequencing kits
as intellectual property is developed. Over the longer term, however, we expect to generate increasing revenues from our customers from
the sale of application-specific assays or tests that are developed on our platform and for which we will receive royalties, a revenue
split or other renumeration for the use of our platform or jointly-developed intellectual property.
1
Background on Genetic Sequencing
Genetic inheritance in living systems is conveyed through a naturally
occurring information storage system known as deoxyribonucleic acid, or DNA. DNA stores information in linear chains of chemical bases
known as adenine (“A”), cytosine (“C”), guanine (“G”) and thymine (“T”). Inside living
cells, these chains usually exist in pairs bound together in a double helix by complementary base pairs. A “genome” is an
organism’s complete set of DNA, which for humans consists of approximately three billion DNA base pairs. Ribonucleic acid, or RNA,
is a molecule used by organisms to convey genetic information. A “transcriptome” is an organism’s complete set of RNA
molecules at an active cellular state and includes both protein coding and noncoding RNA transcripts.
Genetic sequencing is the process of determining the order of nucleotide
bases (A, C, G, or T) in a sample. This consists of three phases: sample preparation, physical sequencing and analysis. Generally, the
first step of sample preparation is either to shear the target genome into multiple small fragments or, depending on the amount of sample
DNA or RNA available, amplify the target region using a variety of molecular methods. In the physical sequencing phase, the individual
bases in each fragment are identified in order, creating individual sequence reads. The number of individual bases identified contiguously
is defined as “ read length .” The sequencing throughput is generally defined as the product of the number of individual
sequence reads and the average read length of the sequence reads. In the analysis phase, bioinformatics software is used to align overlapping
reads, which allows the original genome to be assembled into contiguous sequence.
Studying genomes and transcriptomes helps scientists understand the
inheritance of biological characteristics, developmental biology and normal and disease states of cells and organisms. Genetic variation
accounts for many of the differences between individuals, such as eye color and blood group, and also affects a person’s susceptibility
to certain diseases such as cancer, heart disease or diabetes. Genetic variation can also determine a person’s response to drug
therapies.
A trend in healthcare is towards ‘personalized medicine’
to enable more accurate diagnosis and treatment through better understanding of each individual patient’s disease. We believe that
a greater understanding of the genome will lead to this new healthcare paradigm where diseases are understood at the molecular level,
allowing patients to be diagnosed according to genetic information, in many instances earlier and more accurately, and be treated with
drugs designed to work on specific molecular targets. The goal is to offer precision-personalized medicine that will identify disease
earlier, reduce healthcare costs, and enable more appropriate and effective treatment for better outcomes and quality of life. To date,
this has largely been done through genomic testing, which provides information about a patient’s predisposition to disease or likely
response to medication, due to each individual’s unique constellation of genes. However, DNA testing is, in most cases, a static
readout that does not change through a patient’s lifetime or disease course. It does not provide information about the patient’s
current health status. An increasing number of researchers, however, now believe the transcriptome provides dynamic information about
the current state of the body that can be used to assess health, to detect early signs of disease and to enable physicians to select the
appropriate treatment, monitor response to treatment and detect unwanted side effects.
Cell-free Nucleic Acids as Disease Biomarkers: Most
of the DNA and RNA in the body are inside the cells, but a small amount of nucleic acids is also found in biological fluids such as blood,
saliva and urine. This material is generally referred to as cell-free DNA (“cfDNA”) and cell-free RNA (“cfRNA”).
Analysis of these free-floating molecules can lead to multiple applications such as early disease detection, drug selection and treatment
monitoring. For example, large amounts of cell-free DNA material might indicate a bacterial infection or sepsis in very early stages.
Cell-free DNA is typically derived from chromatin as intact nucleosomes, or histone-bound DNA, which can be analyzed in addition to solely
assessing DNA. Another such example is cfRNA analysis for detection, diagnosis and monitoring of malignant diseases such as cancer. The
cfRNA transcripts are differentially expressed between normal and cancerous tissues. These transcripts can be used as a reliable biomarker
for cancer screening and diagnostic applications. Analysis of cfRNA can be used to measure dynamic changes in the gene expression, allow
oncologists to evaluate disease status, predict outcomes from anti-tumoral therapies and monitor the disease after treatment.
Sequencing Technologies: There are different sequencing technologies
available for sequencing genetic material, each producing the sequence data in a unique format. Some of the technologies produce millions
of sequence reads with a very short-read length, generally less than 300 nucleotide bases. These technologies are generally referred as
short-read NGS platforms. Other technologies produce several thousand sequence reads of a very long-read length, generally more than 1,000
nucleotide bases. These technologies are generally referred as long-read NGS platforms. Both, the short- as well as long-read NGS technologies
have their advantages in various settings. For de novo assembly of genomes and long RNA transcripts, the long contiguous
reads from the long-read NGS technologies are preferred. Generally, short-reads can be used to further fill in gaps in the data from longer
read technologies. For molecular counting application, a large number of independent reads from short-read NGS technologies are preferred.
RNA quantitation typically occurs after converting extracted RNA molecules into cDNA fragments using commercially available reverse transcriptase
as part of that process. This approach, within which there are a variety of methods, is loosely defined as RNA sequencing or “RNA-Seq”.
Different genes are present in varying amounts in biological samples, and the success of the technique is highly dependent on the dynamic
range of the detection technology.
2
Market Opportunity
The market for our products and services is segmented into two major
categories, DNA NGS and RNA NGS, which, according to The Insight Partners, accounted for a combined addressable market opportunity of
approximately $1.03 billion in 2019 that is projected to grow to $5.26 billion by 2025 at a CAGR of 31.3%.
DNA NGS market opportunity: According
to The Insight Partners DNA NGS Market Report 2019 , the global DNA NGS market is projected to grow from $6.82 billion in 2019 to
$22.72 billion in 2025 at a CAGR of 22.2% from 2019 to 2025. Our customers in the DNA NGS market largely consist of academic and research
institutes and forensic labs. Collectively, academic and research institutes and forensic labs, pathology labs and diagnostic centers
represent a projected 58.4% of the end-user market share in 2019. The versatility of the tSMS platform can be applied across our near-term
target segments of drug discovery, precision medicine and other novel applications. We intend to focus our commercialization efforts on
academic and research institutes and forensic labs in North America and Europe, and will eventually expand our efforts to the Asia Pacific
region. North America and Europe represented 69.9% of the global market in 2019. Our targeted end users, applications and regions for
DNA NGS offered an addressable market opportunity of $0.74 billion in 2019 that is projected to grow to $4.10 billion in 2025 at a CAGR
of 33.0%.
RNA NGS market opportunity: According
to The Insight Partners NGS-based RNA Seq. Market Report 2019 , the global RNA NGS market is projected to grow from $1.63 billion
in 2019 to $4.96 billion in 2025 at a CAGR of 20.4%. We intend to leverage our simplified workflow, which reduces bias and misrepresentation
caused by various enzymatic steps that other technologies utilize, to accelerate market penetration. The RNA NGS market can be segmented
by products and services, end users, applications and sequencing technologies. Research and academic centers, pharmaceutical and biotech
companies, pathology labs, forensic labs and diagnostic centers represented a projected 76.7% share of the end users in 2019. Our simplified
and mature RNA sequencing approach will facilitate a broad application pool across diagnostics, drug discovery, precision medicine and
biomarker discovery field. We will offer RNA sequencing platform and sequencing kits, sequencing services and data analysis products featuring
our tSMS technology to such potential customers. Furthermore, we intend to focus on commercialization of our products in North America,
Europe and Asia Pacific regions, which collectively accounted for 81.2% of the global market geographically in 2019. Our targeted end
users, applications and regions for RNS NGS offered an addressable market opportunity of $0.29 billion in 2019 that is projected to grow
to $1.16 billion in 2025 at a CAGR of 26.2%.
Limitations of Existing Technologies
There are multiple short-read and long-read NGS technologies available
in the market that partially address the need for accurate and sensitive analysis of genetic information. These technologies can further
be classified based on the resolution of the technology as single-molecule sequencing technology and amplification-based technologies.
Most single-molecule sequencing technologies do not require amplification, though many of the long-read technologies still require complex
sample manipulation prior to sequencing. This is especially true for sequencing of RNA molecules. Over the past two decades, researchers
and clinicians have used these technologies to gain a deeper understanding of nucleic acids, to study biomarkers associated with disease,
to identify molecules for new drug discovery, to create novel applications for early screening and diagnosis, and more recently to create
genome-editing techniques. While researchers are making progress on various fronts by utilizing a combination of these technologies, there
remains a wide gap between the needs of the research community and the capabilities of existing sequencing tools. This gap is hindering
the advancement of scientific research. 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.
3
●
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. 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.
●
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. The library preparation protocol limits the minimal amount of input sample. The library
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.
Our Technology Solution
Our tSMS platform offers a single molecule solution for DNA and RNA
sequencing by performing detection of nucleic acids without the need for complex sample manipulation. Researchers using our platform can
analyze many billions of single molecules in a single experiment and still generate highly accurate and reproducible data. We believe
our technology’s critical advantage over other technologies is because our platform does not require the routine library preparation
steps, such as PCR amplification and ligation, necessary for use with most NGS systems, thereby avoiding systematic amplification bias.
RNA sequencing on our platform detects transcripts regardless of abundance and with high accuracy in quantifying gene expression changes
associated with certain disease as well as detecting subtle changes in RNA transcript levels that are undetectable with other methods.
Our single molecule platform is unique because it combines a proprietary
fluorescence-based optical detection apparatus with a precision microfluidics and thermal control system to perform sequencing-by-synthesis,
as illustrated in Figure 1 below.
Figure 1. tSMS Technology Workflow
Our platform typically derives sequencing information directly from
the sample itself, not a copy of the sample. It does not require amplification at any stage of the process and offers simple, straightforward
sample preparation protocols. The technology uses a single-stranded DNA and RNA material with lengths that range from less than 20 bases
to more than 1000 bases as an input. The platform then captures the material on a glass surface and uses a patented fluorescence-based
optical detection apparatus combined with a precision microfluidics system to perform a sequencing-by-synthesis reaction on the input
sample.
4
The single molecule fluorescence signal from millions of individual
strands is captured by images using a high-sensitivity camera during multiple cycles of nucleotide incorporation. Our powerful image analysis
system processes these images to produce the sequence data as an output. The output data contains millions of individual unique sequences
with the average read length of between 35–60 nucleotide bases, with a range of 20–100 nucleotide bases. This length is sufficient
to allow unambiguous identification of the origin of each sequence.
Our system still requires isolation and preparation of DNA or RNA samples;
however, our system is adaptable to most purification and preparation kits and techniques that are currently available in the market and
no additional or special steps are required to prepare the samples for sequencing.
The single molecule resolution of the sequence data in association
with a sub-100 nucleotide base read length positions our platform as the only short-read single molecule sequencer commercially available
in the market. The amplification-based short-read technologies are already helping the scientists in the fields of research, diagnostics
and therapeutics. By giving the short-read technology the power of single molecule resolution, we believe our tSMS technology offers critical
advantages over existing technologies, including:
●
Minimal Sample Preparation . Our tSMS platform offers a simple sample preparation process. The DNA strands are cut in shorter sizes, converted into single strands, and then tagged with a universal surface capture primer. By avoiding the complex multi-step library preparation method, the sample integrity is preserved, and the bias and errors in the sequence data output exhibited by other methods are avoided. The simplicity of our sample preparation workflow and its effect on the output data variance, compared to NGS data produced by an Illumina system, is illustrated in Figure 2 below. [ van den Oever et. al. (Clinical Chemistry, April 2012) ].
Figure 2. tSMS vs Amplification-based Technologies
Workflow
5
●
Greater Sensitivity . Our tSMS platform offers a high level of sensitivity as each strand is identified and synthesized irrespective of its abundance in the sample. In the existing amplification-based technologies, low expressing transcripts are typically masked due to preferences and may be missed or have their numbers minimized in the final data analysis. The simplified sample preparation along with single molecule resolution facilitates the unbiased, proportionate representation of input sample, even of the low expressing transcripts and constructs. This allows for obtaining more accurate information earlier (for potential clinical treatments or decisions to be made sooner). Figure 3 below illustrates that the tSMS platform identified low-expression transcripts missed by the standard PCR-based methodology when using Illumina. The lowest expressed quartile of transcripts was detected with our tSMS technology at a 7.10x rate compared to a leading NGS platform [Sam LT, Lipson D, Raz T, et al. A Comparison of Single Molecule and Amplification Based Sequencing of Cancer Transcriptomes. PLoS One. 2011].
Figure 3. tSMS Improves Detection of Lowest
Expressed Genes
●
High Accuracy . Our tSMS platform provides an accurate set of data and results as well as a broader range of molecules to be evaluated. The ability to count each individual molecule, combined with simplified sample preparation and greater sample sensitivity, yields an accurate quantitative representation of sample in the final data. Our technology has been demonstrated to produce robust accurate short-reads for a variety of applications.
●
Seamless Flexibility . Our tSMS platform provides flexibility in two main aspects — throughput and applications. The tSMS platform has the ability to scale the throughput across a range of small to large projects. The programmable instrument workflow and modular design of sequencing kits provide flexibility to choose the sample coverage and read length required for the final data. The simplified sample preparation allows for analysis of any genetic material that can be attached to a glass surface.
6
Our Gene Sequencing Methodology
The patented tSMS technology is the essence of our tSMS platform. The
gene sequencing methodology takes genetic material as input and produces sequence data as an output through sequentially processing the
following five major steps.
1. Sample
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.
2.
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.
3.
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. 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.
7
4.
tSMS sequencing-by-synthesis :
a.
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.
b.
Wash : Excess polymerase and
unincorporated nucleotides are then washed away. This step ensures that only the incorporated nucleotides are available for
fluorescence imaging.
c.
Image : 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.
d.
Cleave : 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
until a desired sequence length is reached. As an example, repeating this cycle 120 times adds an average of more than 33 nucleotides
to the primer strand. In sequencing, this is known as the “read length.”
8
5. 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.
Our True Single Molecule Sequencer (tSMS)
Described above is our gene sequencing methodology using our tSMS single
molecule sequencing platform. It combines a simplified operation with powerful capabilities to directly sequence original samples of RNA
and DNA consisting of major components:
1. 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 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.
9
2.
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.
3.
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.
4.
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.
The instrument has a web-based interface for remote monitoring that
updates the key sequencing metrics and the instrument status in real time. The database system of the instrument stores the detailed logs
for both record keeping and troubleshooting purposes.
Markets for Our Technology
The initial target market for our instruments and research services
has been the life sciences research and development market where we provide solutions for a variety of applications, including biomarker
discovery and diagnostic assay developments. This market includes laboratories associated with universities, scientific research centers,
government institutions, and biotechnology and pharmaceutical companies.
Our tSMS technology platform produces data with potential diagnostic
implications, detecting biomarkers for cardiovascular diseases and various types of cancer, and offers an optimal solution for use in
sequencing applications. We anticipate using these strengths to capture a portion of the growing multi-billion dollar NGS market. We strive
to build and control intellectual property around the instruments, sequencing kits and methods that enable these applications to strengthen
our market position. The major consumers of the NGS include academic and government institutes, hospitals and medical centers, pharmaceutical
and biotechnology companies, non-profit research organizations and agrigenomics organizations.
10
Introduction of new technologies and products, while positive to the
overall development of these markets, may result in greater competition for the limited financial resources available. There are a number
of emerging markets for sequencing-based technologies that represent significant potential opportunities for us, such as but not limited
to:
● 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.
● 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: 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. 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. Biomarker Discovery in Attention Deficit Hyperactivity Disorder: RNA Sequencing of Whole Blood in Discordant Twin
and Case-controlled Cohorts. BMC Med Genomics . 2020]. Further studies offer the opportunity for validating future diagnostics
applications.
Figure 4. Biomarker Discovery in ADHD using tSMS
RNA-seq
11
●
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.
These examples of emerging markets for sequencing-based technologies
represent significant potential opportunities for us. The development of these markets is subject to variability driven by ongoing changes
in the competitive landscape, evolving regulatory requirements, government funding of research and development activities, and macroeconomic
conditions. Given the ability of the tSMS platform to sequence nucleic acid fragments as well as to detect post-translational modifications
within larger chromatin molecules, we believe our technology is uniquely positioned to produce data from molecules at both ends of the
single molecule nucleic acid spectrum. This concept, and the technology leaders for each single molecule market segment, is illustrated
in Figure 5 below, with our potential applications highlighted in blue font.
Figure 5. Illustrative Single Molecule Nucleic
Acid Landscape
Our Business Strategy
Our mission is to empower researchers with improved genetic tools that
enable scientists and physicians to better understand the molecular mechanisms of disease and the underlying biological systems. This
knowledge is essential to the continued development of new approaches and breakthroughs in genomic medicine that address critical concerns
relating to today’s precision medicine efforts.
12
Our strategy is to integrate our tSMS platform with the development
of novel applications across multiple market segments, and to generate revenue through partnership-specific systems and sequencing kit
sales, research services and research grants. We strive to build and control intellectual property around the instruments, sequencing
kits and methods that enable these applications to strengthen our market position. Integral to this strategy will be to work with existing
customers in developing new instruments optimized for specific assay and chemistry performance in order to support a wide array of applications.
Our target customers are consumers of NGS products and services engaged
in research activities and the development of new or improved products, such as academic and government institutions, hospitals and medical
centers, pharmaceutical and biotechnology companies, and non-profit research organizations.
We have generated only nominal revenues to date from our current operating
model and we do not expect our revenues to scale significantly until one or more of our customers or third-party partners or collaborators
has developed application-specific assays or tests for which our platform serves as a foundation. Over the longer term, we expect to generate
revenues from our customers, partners and collaborators through a combination of product sales, research services and research grants.
We plan to expand these revenues from recurring and prospective clients by the following key strategies:
●
Provide the scientific community with a combination of research services and instrumentation to serve markets that we believe are inadequately addressed by existing technologies.
●
Continue to innovate and develop new aspects of our products and technology, applications and instrumentation through scientific collaborations, including grants.
●
Leverage our expertise and the broad applicability of our tSMS platform to grow into new markets through strategic collaborations, partnerships, existing data sets, and customers.
●
Maintain a strong culture and network of technical resources while continuously attracting new talent to build an industry leading single molecule solutions company.
Our Customers and Collaborators
Our customer base is focused on academic research, biomarker discovery,
and molecular diagnostic product development. These customers over the years have produced scientific achievements through collaborative
research efforts. 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. Our
key collaborators and our current activities are highlighted below:
U.S. Department of Justice’s Federal Bureau of Investigation
(FBI)
In February 2023, we announced the establishment of a two-year Cooperative
Research and Development Agreement (CRADA) with the FBI. Under this CRADA, SeqLL and the FBI Laboratory Division (FBI LD) will seek to
evaluate and determine the forensic capabilities of direct RNA sequencing using our tSMS platform. The FBI LD and SeqLL will collaborate
with a goal of producing an assay for forensic body fluid identification, without compromising traditional STR or DNA sequence analysis.
This agreement is among the first times the FBI is utilizing the CRADA mechanism to further develop laboratory capabilities. CRADAs enable
the sharing of resources and expertise for collaborative research that advances the FBI mission. Body fluid identification can provide
investigative context and have probative value.
13
Weizmann Institute of Science
In partnership with the laboratory of Efrat Shema, Ph.D., we have
recently developed and applied innovative single-molecule technologies to gain a deeper understanding of chromatin regulation. We are
working to establish robust single-molecule systems for genome-wide profiling of combinatorial chromatin and DNA modifications, as well
as development of novel therapeutic and diagnostic tools. We published multiple manuscripts in 2022, including “H3-K27M-mutant
nucleosomes interact with MLLI to shape the glioma epigenetic landscape” in Cell Reports and “Multiplexed, single-molecule,
epigenetic analysis of plasma-isolated nucleosomes for cancer diagnostics” in “Nature Biotechnology. We have provided the
Weizmann Institute with access to prototype sequencing systems, sequencing kits, and sample preparation methodologies.
Future Products
We expect to partner or collaborate with biotech and pharma companies
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
the diagnosis of disease, regulation by governmental authorities in the United States will become an increasingly significant factor
in development, testing, production and marketing. Products developed for the diagnostics market, depending on their intended use, may
be regulated as in vitro diagnostics by the FDA. Each medical device to be distributed commercially in the United States will likely
require either 510(k) clearance or approval of a pre-market approval application (PMA) from the FDA prior to marketing the device for
in-vitro diagnostic use. Clinical trials related to regulatory submissions may take years to complete and represent a significant expense.
The 510(k) clearance pathway usually takes from three to 12 months, but can take longer. The PMA pathway is more costly, lengthy and uncertain,
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. Through our partners or collaborators, we will likely need
to assist in pursuing regulatory approvals from the FDA when they attempt to enter the diagnostics market, which is expensive, involves
a high degree of risk and there is no assurance that we will be able to develop a commercially viable product. Even if the products under
development are authorized and approved by the FDA, our partners or collaborators must still meet the challenges of successful marketing,
distribution and customer acceptance.
14
Marketing, Sales, Service and Support
Our business model is focused on offering our customers and collaborators
access to our tSMS technology in order to drive comprehensive and reliable solutions that enhance acceptance, customer loyalty and confidence,
revenue growth and shareholder value. We plan to focus on addressing specific markets for which there are not currently adequate solutions.
This will require education and demonstration of added value by helping customers and collaborators meet program timelines, providing
data that supports their programs, and implementing custom solutions to meet each customer’s specific objectives. We currently generate
revenue by selling to existing customers and through collaborative, research-focused efforts that create additional sales and growth opportunities.
To achieve recurring growth for our research services revenues and
drive new value creation, we are implementing the following initiatives to increase market awareness of the tSMS platform:
●
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.
●
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
by supporting the largest possible number of customers.
Manufacturing
We have the capability to manufacture the required sequencing kits
and instrumentation at our own manufacturing facility. We believe manufacturing all system components internally results in greater trade
secret protection for our proprietary formulations and mechanics, a higher degree of customer satisfaction in our research business, and
lower production costs. In the future, we may outsource some of the non-proprietary reagents and basic instrumentation sub-assemblies
for parallel inventory production ramp-ups. Relationships to various contract manufacturing organizations have already been established
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. 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
environment, and to implement standards according to the International Organization for Standardization (ISO), 5S lean manufacturing methodology,
and other lean techniques. We also plan to create work cells for efficiency and material control for both sequencing kits and instrumentation.
Implementation of quality assurance in manufacturing documentation and processes is one of our top priorities as we continue the path
toward releasing a clinical grade tSMS sequencer that is compatible with the FDA clearance process.
We believe our current facilities are adequate and we have additional
room to expand to meet our manufacturing needs for the foreseeable future.
15
Research and Development
Our research and development efforts focus on maintaining our advantage
in single molecule sequencing. These efforts leverage our team’s involvement and continuing development of the tSMS technology for
over a decade. The tSMS technology blends a number of scientific disciplines, including optics, micro-fluidics, biochemistry and molecular
biology, systems engineering, and bioinformatics. Over the years, we have continuously established strong relationships with technology
leaders and leading academic centers that augment and complement our internal research and development efforts.
Some of our research and development accomplishments include:
●
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; and
●
Received multiple National Institutes of Health grant awards for technology development.
We plan to continue our investment in research and development to enhance
the performance and expand the application base of our current products, and to introduce additional products based on our technology.
In addition, our engineering team will continue their focus on increasing instrument component and system reliability, reducing costs,
and implementing additional system flexibility and versatility through the enhancement of existing products and development of new products.
Competition
Given the market opportunity, there are a significant number of competing
companies offering gene sequencing equipment or sequencing kits. These include Illumina, Inc., Pacific Biosciences of California, Inc.,
Thermo Fisher Scientific, Inc., Singular Genomics System, Inc., Element Biosciences, Inc., Ultima Genomics, Inc., and Oxford Nanopore
Technologies, Ltd. We believe we are uniquely positioned among the competition to be the only company offering high strand throughput
with the power of single molecule resolution.
Our competitors have greater financial, technical, research and/or
other resources than we do. These companies also have larger and more established manufacturing capabilities and marketing, sales and
support functions. We expect the competition to intensify within this market. The increased competition may result in pricing pressures,
which could harm our sales, profitability or market share. In order for us to successfully compete against these companies, we will need
to demonstrate that our products deliver superior performance and value. We will also need to continually improve the breadth and depth
of current and future products and applications.
Intellectual Property
Developing and maintaining a strong intellectual property position
is an important element of our business. We maintain the intellectual property through a combination of licenses, patent protection and
trade secrets.
16
We have sought, and will continue to seek, patent protection for our
technology, for improvements to our technology, as well as for any of our other technologies for which we believe such protection will
be advantageous. In 2013, as part of the Helicos bankruptcy proceedings, we entered into the following non-exclusive license agreements:
License Agreement with Helicos Biosciences Corporation. Our
tSMS technology has been in development since 2004 at Helicos Biosciences Corporation (“Helicos”), which pioneered the first
generation tSMS technology resulting in its commercialization as the HeliScope Genetic Analysis System. In 2013, Daniel Jones, a former
scientist at Helicos and our current Chief Executive Officer, formed our company to further the development of tSMS. We then purchased
much of our physical assets from Helicos, including, among other items, sequencers, laboratory equipment, internal servers, protocols
and data analysis procedures, through Helicos’ bankruptcy proceedings that began in 2012.
In 2013, we entered into, and since such date fully paid for, a non-exclusive,
royalty-free license from Helicos, for the life of such patents, for over 60 patents, all but eight of which have since expired or
been abandoned, covering key areas of our technology, including design, methods and chemistry. As part of the Helicos bankruptcy proceedings,
Fluidigm Corporation, a U.S. public company engaged in the design, manufacture and sale of biological research equipment based on integrated
fluid circuit technology, obtained the rights to this patent portfolio. The license grants to us the right to use or sell throughout the
world products or processes based upon the intellectual property covered by the licensed patents in the field of contract gene sequencing,
and prohibits us from sublicensing the intellectual property to any third party or to make any assignment of the license. The license
may be terminated by Fluidigm in the event we sub-license or assign any of the intellectual to a third party; however, we have the right
to use the patented technology in connection with any partnership or collaboration in which we have at least a 50% ownership interest.
In addition, Fluidigm has a right to terminate the license in the event Daniel Jones, our Chief Executive Officer, fails to continue to
work full time for us or if we fail to use reasonable care in the investigation, testing or solicitation of government approvals with
respect to the intellectual property. In addition, the license will automatically terminate in the event we dissolve, cease to conduct
business, file a petition for bankruptcy, assign all of our assets to a receiver or trustee or in the event we have an involuntary bankruptcy
petition initiated against us that is not dismissed within 60 days. This license is provided to us on an “as is” basis only
and without any representations or warranties, express or implied, regarding the intellectual property and the use thereof. In addition,
Fluidigm has no obligation under the license agreement to prosecute any patent application or to maintain any rights to the intellectual
property by payment of any fees to any governmental agency. While the remaining patents comprising this patent portfolio are expected
to expire in 2025 through 2028, as this patent portfolio has been broadly licensed, we do not expect such expirations to have a material
adverse effect upon our business operations.
Sub-License Agreement with Helicos Biosciences Corporation. As
part of the Helicos bankruptcy proceeding, Arizona Science and Technology Enterprises LLC (“AzTE”) agreed that Helicos could
sub-license to us the license agreement between Helicos and AzTE with respect to 10 patents owned by AzTE for the life of such patents.
All of the patents under this sublicense have since expired.
We have one pending patent applications filed in 2021. 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 registered our corporate name (SeqLL) and design logo, as well
as the phrase “tSMS” and “DRS”. We protect trade secrets, know-how, copyrights, and trademarks, as well as continuing
technological innovation and licensing opportunities to develop and maintain our competitive position. Our success depends in part on
obtaining patent protection for our products and processes, preserving trade secrets, patents, copyrights and trademarks, operating without
infringing the proprietary rights of third parties, and acquiring licenses for technology or products.
17
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 lease agreement for approximately
15,538 square feet of corporate office and laboratory space in Billerica, Massachusetts. The lease has a term of 92 months with the rent
escalating from $14,317 to $26,453 per month over the lease term.
Legal Proceedings
From time to time, we may be involved in various disputes and litigation
matters that arise in the ordinary course of business. We are currently not a party to any material legal proceedings.
Proposed Merger with Lyneer Investments LLC
Overview
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
fields. 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. In addition,
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
record. 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. Atlantic
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.
18
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
creation. 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: people. 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
verticals. 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
penetration. 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.
The Merger
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.
19
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
relations. 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
$12 million. 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;
20
● our ability to achieve and maintain profitability following
the Merger;
● 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
business;
● 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
services;
● 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
results;
● 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; and
● 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.
21
ITEM 1A.
RISK FACTORS
Investing in our securities involves a high degree of risk. You
should carefully consider the following information about these risks, together with the other information appearing elsewhere in this
report, including our financial statements, the notes thereto and the section entitled “Management’s Discussion and Analysis
of Financial Condition and Results of Operations,” before deciding to invest in our securities. The occurrence of any of the following
risks could have a material and adverse effect on our business, reputation, financial condition, results of operations and future growth
prospects, as well as our ability to accomplish our strategic objectives. As a result, the trading price of our securities could decline,
and you could lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem
immaterial may also impair our business operations and stock price.
As we have incurred recurring losses and negative operating cash
flows since our inception, there is no assurance that we will be able to continue as a going concern absent additional financing, which
we may not be able to obtain on favorable terms or at all.
We have incurred net losses since our incorporation in 2014 and we
cannot be certain if or when we will produce sufficient revenue from our operations to support our costs. Even if profitability is achieved
in the future, we may not be able to sustain profitability on a consistent basis. We expect to continue to incur substantial losses and
negative cash flow from operations for the foreseeable future. Our future is dependent upon our ability to obtain financing and upon future
profitable operations from the sale of future sequencing products.
Our ability to obtain additional financing will be subject to a number
of factors, including market conditions, our operating performance and investor sentiment. If we are unable to raise additional capital
when required or on acceptable terms, we may have to significantly delay, scale back or discontinue our operations or obtain funds by
entering into agreements on unattractive terms, which would likely have a material adverse effect on our business, stock price and our
relationships with third parties with whom we have business relationships, at least until additional funding is obtained. If we do not
have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that would likely
result in our stockholders losing some or all of their investment in us.
We do not have any credit facilities as a source of future funds, and
there can be no assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all. We may seek additional
capital through a combination of private and public equity offerings, debt financing and strategic collaborations. If we raise additional
funds through the issuance of equity or convertible debt securities, the percentage ownership of our stockholders could be significantly
diluted, and these newly issued securities may have rights, preferences or privileges senior to those of existing stockholders. Debt financing,
if obtained, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring
additional debt, could increase our expenses and require that our assets secure such debt. Moreover, any debt we incur must be repaid
regardless of our operating results.
22
We are an early, commercial-stage company with a limited operating
history.
We were incorporated in 2014 and we have had limited sales to date.
As such, we have limited historical financial data upon which to base our projected revenue, planned operating expenses or upon which
to evaluate us and our commercial prospects. Based on our limited experience in developing and marketing our existing products and services
as well as launching new products, we may not be able to effectively:
●
drive adoption of our current and future products and services;
●
attract and retain customers for our products and services;
●
provide appropriate levels of customer training and support for our products and services;
●
implement an effective marketing strategy to promote awareness of our products and services;
●
develop, manufacture and commercialize new products or achieve an acceptable return on our manufacturing or research and development efforts and expenses;
●
anticipate and adapt to changes in our market or predict future performance;
●
accommodate customer expectations and demands with respect to our products and services;
●
grow our market share by marketing and selling our products and services to new and additional market segments;
●
maintain and develop strategic relationships with vendors and manufacturers to acquire necessary materials for the production of our existing or future products;
●
adapt or scale our manufacturing activities to meet potential demand at a reasonable cost;
●
avoid infringement and misappropriation of third-party intellectual property;
●
obtain any necessary licenses to third-party intellectual property on commercially reasonable terms;
●
obtain valid and enforceable patents that give us a competitive advantage;
●
protect our proprietary technology; and
●
attract, retain and motivate qualified personnel.
If our tSMS sequencing instruments or sequencing services fail
to achieve and sustain sufficient market acceptance, we will not generate expected revenue and our business may not succeed.
We cannot be sure that our current or future tSMS sequencers or services
will gain acceptance in the marketplace at levels sufficient to support our costs. We must successfully develop and commercialize our
technology for use in a variety of life sciences and other applications. Even if we are able to implement our technology and develop products
successfully, we and/or our sales and distribution partners may fail to achieve or sustain market acceptance of our products across the
full range of our intended life science and other applications. Our sequencing instruments require sequencing kits in order to produce
sequencing data at sufficient levels to generate expected revenue. We will have to increase our internal capabilities and to collaborate
with other partners in order to successfully expand sales of our sequencing kits in the markets we seek to reach, which we may be unable
to do at the scale required to support our business.
23
Our research and development efforts may not result in the benefits
we anticipate, and our failure to successfully market, sell and commercialize our current and future sequencing instruments and services
products could have a material adverse effect on our business, financial condition and results of operations.
We have dedicated significant resources to developing sequencing instruments
and services. We are also engaged in substantial and complex research and development efforts, such as Direct RNA Sequencing (DRS™),
single cell sequencing, biomarker discovery, and epigenetic modification detection, which, if successful, may result in the introduction
of new products in the future. Our research and development efforts are complex and require us to incur substantial expenses. We may not
be able to develop and commercialize new products, or achieve an acceptable return, if any, on our research and development efforts and
expenses. There can also be no assurance that we will be able to develop and manufacture future sequencing instruments and applications
as a result of our research and development efforts, or that we will be able to market, sell and commercialize the products that result
from our research and development efforts. We will need to expand our internal capabilities and seek new partnerships or collaborations
in order to successfully market, sell and commercialize the sequencing instruments and applications that we have developed in the markets
we seek to reach.
The pioneer of our tSMS technology, Helicos Biosciences Corporation,
was unable to successfully commercialize its tSMS product offerings and there can be no assurance that the business strategy that we have
developed and are pursuing to commercialize our tSMS offerings will be successful.
Our tSMS technology has been in development since 2004 at Helicos Biosciences
Corporation (“Helicos”), which pioneered the first generation tSMS technology resulting in its commercialization as the HeliScope
Genetic Analysis System. Helicos was unable to successfully commercialize its product offerings and filed for protection under Chapter
11 of the United States Bankruptcy Code in 2012. In 2013, Daniel Jones, a former scientist at Helicos and our current Chief Executive
Officer, formed our company to further the development of tSMS. We then purchased much of our physical assets from Helicos, including,
among other items, sequencers, laboratory equipment, internal servers, protocols and data analysis procedures, through Helicos’
bankruptcy proceedings. While we believe we have developed and are pursuing a unique business strategy for our company that is distinguishable
from the business strategy that was pursued by Helicos, there can be no assurance that our business strategy will be successful or that
we will ultimately be profitable. If our current or future tSMS sequencers or services do not gain acceptance in the marketplace, our
business and financial condition would be harmed, and you could lose all or a portion of your investment in our securities.
If we are unable to successfully develop and timely manufacture
our sequencing instruments and reagents, our business may be adversely affected.
In light of the highly complex technologies involved in our sequencing
products, including instruments and reagents, there can be no assurance that we will be able to manufacture and commercialize our new
sequencing instruments and reagents on a timely basis or provide adequate support for such products. The commercial success of our sequencers
and reagents depends on a number of factors, including performance and reliability, our anticipating and effectively addressing customer
preferences and demands, the success of our sales and marketing efforts, effective forecasting and management of instrument and sequencing
services demand, purchase commitments and inventory levels and effective management of manufacturing and supply costs. Our ability to
manufacture benchtop sequencers and reagents could be negatively impacted by changes to personnel, hiring delays, resource availability,
supply chain disruption or facilities disruption, and may be insufficient to achieve customer acceptance and growth.
The development of our sequencing instruments and reagents is complex
and costly, requiring successful systems integration and reagent quality to generate usable data for customers and collaborators. Problems
in the design or quality of our products may have a material and adverse effect on our brand, business, financial condition and operating
results. Unanticipated problems with our products could divert substantial resources, which may impair our ability to support our new
and existing products, and could substantially increase our costs. If we encounter development challenges or discover errors in our products
late in our development cycle, we may be forced to delay product shipments or the scaling of manufacturing or supply. The expenses or
losses associated with delayed or unsuccessful product development or lack of market acceptance of our new products could materially and
adversely affect our business, financial condition and results of operations.
24
We must successfully manage new product introductions and transitions
related to the tSMS technology, we may incur significant costs during these transitions, and they may not result in the benefits we anticipate.
The introduction of future products may lead to our limiting or ceasing
development of further enhancements to our existing sequencing instruments and applications, as we focus our resources on new products,
and could result in reduced marketplace acceptance and loss of sales of our existing sequencing instruments or sequencing services, which
could materially adversely affect our revenue and operating results. The introduction of new products may also have a negative impact
on our revenue in the near-term as our current and future customers may delay or cancel orders of existing sequencing instruments or sequencing
services in anticipation of new products and we may also be pressured to decrease prices for our existing products. Further, we could
experience difficulty in managing or forecasting customer reactions, purchasing decisions or transition requirements with respect to newly-launched
sequencing instruments or sequencing services. We could incur significant costs in completing the transitions, including costs of inventory
write-downs of our products, as current or future customers transition to the new products. If we do not successfully manage these product
transitions, our business, reputation and financial condition may be materially and adversely affected.
Our future capital needs are uncertain, and we may need to raise
additional funds to support those needs.
To date, we have relied primarily on private debt
and equity financing to carry on our business as well as modest revenues generated from the sales of products and services. We have limited
financial resources, negative cash flow from operations and no assurance that sufficient funding will be available to us to fund our operating
expenses and to further our product development efforts. Based on these and other factors, in our audited consolidated financial statements
for the years ended December 31, 2023 and 2022, we concluded that this circumstance raised substantial doubt about our ability to continue
as a going concern within one year from the original issuance date of such financial statements. Similarly, in its report on the consolidated
financial statements for the years ended December 31, 2023 and 2022, our independent registered public accounting firm included an emphasis
of matter paragraph stating that our recurring losses from operations and continued cash outflows from operating activities raised substantial
doubt about our ability to continue as a going concern. Our consolidated financial statements for the years ended December 31, 2023 and
2022 do not include any adjustments that may result from the outcome of this uncertainty. We anticipate that we will need to raise additional
capital to fund our operations while we implement and execute our business plan. We currently do not have any contracts or commitments
for additional financing. However, we expect to seek significant future financing, namely to:
●
expand our sales and marketing efforts to further commercialize our products and services;
●
hire additional personnel;
●
add operational, financial and management information systems;
●
expand our research and development efforts to improve our product offerings and to successfully launch new products;
●
enter into collaboration agreements, if any, or in-license other products and technologies; and
●
seek FDA approval to market our existing products or new products that would be utilized for diagnostic purposes.
25
Our future funding requirements will depend on many factors, including:
●
market acceptance of our products;
●
the cost and timing of establishing additional sales, marketing and distribution capabilities;
●
the cost of our research and development activities;
●
the success of our existing distribution and marketing arrangements and our ability to enter additional arrangements in the future; and
●
the effect of competing technological and market developments.
We cannot assure you that we will be able to obtain additional funds
on acceptable terms, or at all. Our ability to obtain additional financing will be subject to market conditions, our operating performance
and investor sentiment, among other factors. If we raise additional funds by issuing equity or equity-linked securities, our stockholders
may experience dilution. Future debt financing, if available, may involve covenants restricting our operations or our ability to incur
additional debt. Any debt or equity financing may contain terms that are not favorable to us or our stockholders. If we raise additional
funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies
or our products, or grant licenses on terms that are not favorable to us. If we do not have, or are not able to obtain, sufficient funds,
we may have to delay development or commercialization of our products. We also may have to reduce marketing, customer support or other
resources devoted to our products or cease operations. Any of these factors could have a material adverse effect on our financial condition,
operating results and business.
We rely on other companies for certain components and materials
and intend to outsource sub-assembly manufacturing in the future. We may not be able to successfully assemble or manufacture reagents
and instruments or scale the manufacturing process necessary to build and test multiple products on a full commercial basis, which could
materially harm our business.
Our products are complex and involve a large number of unique components,
many of which require precision in manufacturing that is performed in-house using third-party components. The nature of our products requires
significant use of customized components that are currently available only from a limited number of sources, and in some cases, single
sources. If we are required to purchase these components from alternative sources, it could take several months or longer to qualify
the alternative sources. If we are unable to secure a sufficient supply of these product components on a timely basis, or if these components
do not meet our expectations or specifications for quality and functionality, our operations and manufacturing will be materially and
adversely affected, we could be unable to meet customer demand and our business and results of operations may be materially and adversely
affected.
The operations of our suppliers could be disrupted by conditions unrelated
to our business or operations or that are beyond our control, including but not limited to international trade restrictions or changes
resulting from factors beyond our control. If our suppliers are unable or fail to fulfill their obligations to us for any reason, we may
not be able to manufacture our instruments or reagents and satisfy customer demand or our obligations under sales agreements in a timely
manner, and our business could be harmed as a result. Our current manufacturing process is characterized by long lead times between the
placement of orders for and delivery of our products. If we have received insufficient components to manufacture our products on a timely
basis to meet customer demand, our sales and our gross margin may be adversely affected, and our business could be materially harmed.
If we are unable to reduce our manufacturing costs and establish and maintain reliable, high-volume manufacturing suppliers as we scale
our operations, our business could be materially harmed.
26
We may be unable to consistently manufacture our instruments
and reagents to the necessary specifications or in quantities necessary to meet demand at an acceptable cost.
In order to successfully generate revenue from our products, we need
to supply our customers with products that meet their expectations relating to read length, error rates and data yield in accordance with
established specifications. There is no assurance that we will be able to manufacture our products so that they consistently achieve the
product specifications and quality that our customers expect, including any products developed for clinical uses. Problems in the design
or quality of our products may have a material adverse effect on our brand, business, financial condition, and operating results. There
is also no assurance that we will be able to increase manufacturing output and decrease costs, or that we will be successful in forecasting
customer demand or manufacturing and supply costs. Furthermore, we may not be able to increase manufacturing to meet anticipated demand
or may experience downtime in our existing or new manufacturing facilities. An inability to manufacture sequencing instruments and reagents
or provide sequencing services, that consistently meet specifications, in necessary quantities and at commercially acceptable costs, will
have a negative impact, and may have a material adverse effect, on our business, financial condition and results of operations.
Rapidly-changing technology in life sciences and diagnostics
could make our technology obsolete unless we continue to develop and commercialize new and improved products and pursue new market opportunities.
The biotechnology industry is characterized by rapid and significant
technological changes, frequent new product introductions and enhancements and evolving industry standards. Our future success will depend
on our ability to continually improve our products, to develop and introduce new products that address the evolving needs of our customers
on a timely and cost-effective basis and to pursue new market opportunities. These new market opportunities may be outside the scope of
our proven expertise or in areas where the market demand is unproven, and new products and services developed by us may not gain market
acceptance. Our inability to develop and introduce new products and to gain market acceptance of such products could harm our future operating
results. Unanticipated difficulties or delays in replacing existing products with new products or other new or improved products in sufficient
quantities to meet customer demand could diminish future demand for our products and harm our future operating results.
Increased market adoption of our products by customers may depend
on the availability of sample preparation and informatics tools, some of which may be developed by third parties.
Our commercial success may depend in part upon the development of sample
preparation and software by third parties for use with our sequencing and data analysis workflow. We cannot guarantee that third parties
will develop tools that our current and future customers will find useful with our sequencing instruments given that our sample preparation
methods are uniquely tailored to single molecule sequencing. Similarly, as our sequencing methodology does not require amplification and
bridge PCR, the downstream data analysis tools required for informatics analysis are specialized. A lack of complementary sample preparation
options and software to enable broader usability may impede the adoption of our technology and may materially and adversely impact our
business.
We operate in a highly competitive industry and if we are not
able to compete effectively, our business and operating results will likely be harmed.
Some of our current competitors, including Illumina, Inc., Pacific
Biosciences of California, Inc., Thermo Fisher Scientific Inc., and BGI Group (formerly known as the Beijing Genomic Institute) as well
as other potential competitors, have greater name recognition, more substantial intellectual property portfolios, longer operating histories,
significantly greater financial, technical, research and/or other resources, more experience in new product development, larger and more
established manufacturing capabilities and marketing, sales and support functions, and/or more established distribution channels to deliver
products to customers than we do. These competitors may be able to respond more quickly and effectively than we can to new or changing
opportunities, technologies, standards or customer requirements. In light of these advantages, even if our technology is more effective
than the products or service offerings of our competitors, current and potential customers might purchase competitive products and services
instead of our products. There are also several companies that are in the process of developing or have already developed new, potentially
competing technologies, products and/or services. Increased competition may result in pricing pressures, which could harm our sales, profitability
or market share. Our failure to further enhance our existing products and to introduce new products to compete effectively could materially
and adversely affect our business, financial condition or results of operations.
27
Single molecule sequencers are highly complex, have recurring
support requirements and could have unknown defects or errors, which may give rise to claims against us or divert application of our resources
from other purposes.
Products using our technology are highly complex and may develop or
contain undetected defects or errors. Despite testing, defects or errors may arise in our products, which could result in a failure to
maintain or increase market acceptance of our products, diversion of development resources, injury to our reputation and increased warranty,
service and maintenance costs. New products or enhancements to our existing products in particular may contain undetected errors or performance
problems that are discovered only after delivery to customers. If our products have reliability or other quality issues or require unexpected
levels of support in the future, the market acceptance and utilization of our products may not grow to levels sufficient to support our
costs and our reputation and business could be harmed. We generally ship our sequencing instruments with one year of service included
in the purchase price with an option to purchase one or more additional years of service. We also provide a warranty for our sequencing
kits, which is generally limited to replacing, or at our option, giving credit for any sequencing kit with defects in material or workmanship.
Defects or errors in our products may also discourage customers from purchasing our products. The costs incurred in correcting any defects
or errors may be substantial and could materially and adversely affect our operating margins. If our service and support costs increase,
our business and operations may be materially and adversely affected.
In addition, such defects or errors could lead to the filing of product
liability claims against us or against third parties who we may have an obligation to indemnify against such claims, which could be costly
and time-consuming to defend and result in substantial damages. Although we have product liability insurance, any product liability insurance
that we have or procure in the future may not protect our business from the financial impact of a product liability claim. Moreover, we
may not be able to obtain adequate insurance coverage on acceptable terms. Any insurance that we have or obtain will be subject to deductibles
and coverage limits. A product liability claim could have a serious adverse effect on our business, financial condition and results of
operations.
We depend on the continuing efforts of our senior management
team and other key personnel. If we lose members of our senior management team or other key personnel or are unable to successfully retain,
recruit and train qualified scientists, engineers and other personnel, our ability to maintain and develop our products could be harmed
and we may be unable to achieve our goals.
Our future success depends upon the continuing services of members
of our senior management team and scientific and engineering personnel. We compete for qualified management and scientific personnel with
other life science companies, academic institutions and research institutions, particularly those focusing on genomics. If one or more
of our senior executives or other key personnel is unable or unwilling to continue in their present positions, we may not be able to replace
them easily or at all, and other senior management may be required to divert attention from other aspects of the business. In addition,
we do not have “key person” life insurance policies covering any member of our management team or other key personnel. The
loss of any of these individuals or our inability to attract or retain qualified personnel, including scientists, engineers and others,
could prevent us from pursuing collaborations and materially and adversely affect our support of existing products, product development
and introductions, business growth prospects, results of operations and financial condition.
A significant portion of our potential sales depends on customers’
spending budgets that may be subject to significant and unexpected variation which could have a negative effect on the demand for our
products.
Our instruments represent significant capital expenditures for our
customers. Potential customers for our current or future products include academic and government institutions, genome centers, medical
research institutions, clinical laboratories, pharmaceutical, agricultural, biotechnology, diagnostic and chemical companies. Their spending
budgets can have a significant effect on the demand for our products. Spending budgets are based on a wide variety of factors, including
the allocation of available resources to make purchases, funding from government sources which is highly uncertain and subject to change,
the spending priorities among various types of research equipment and policies regarding capital expenditures during economically uncertain
periods. Any decrease in capital spending or change in spending priorities of our current and potential customers could significantly
reduce the demand for our products. Any delay or reduction in purchases by potential customers or our inability to forecast fluctuations
in demand could harm our future operating results.
28
Delivery of our reagents could be delayed or disrupted by factors
beyond our control, and we could lose customers as a result.
We rely on third-party carriers for the timely delivery of our products
both domestically and internationally. As a result, we are subject to carrier disruptions and increased costs that are beyond our control.
Any failure to deliver products to our customers in a safe and timely manner may damage our reputation and brand and could cause us to
lose customers. If our relationship with any of these third-party carriers is terminated or impaired or if any of these carriers are unable
to deliver our products, the delivery and acceptance of our products by our customers may be delayed, which could harm our business and
financial results. Specific reagents utilized in our sequencing reactions are temperature-sensitive and are required to be kept and stored
in a temperature-controlled method in order to properly ship. In addition, many of the raw materials used during the manufacturing process
of our reagents require temperature control during shipment. The failure to deliver our products in a safe, temperature-controlled, and
timely manner may harm our relationship with our customers, increase our costs and otherwise disrupt our operations.
We are, and may become, subject to governmental regulations that
may impose burdens on our operations, and the markets for our products may be narrowed.
We are subject, both directly and indirectly, to the adverse impact
of government regulation of our operations and markets. Moreover, the life sciences industry, which is expected to be one of the primary
markets for our technology, has historically been heavily regulated. There are, for example, laws in several jurisdictions restricting
research in genetic engineering, which may narrow our markets. At a minimum, biosafety regulations enforced by local government must be
followed and updated should new regulations pass the approval process. Given the evolving nature of this industry, legislative bodies
or regulatory authorities may adopt additional regulations that may adversely affect our market opportunities. Additionally, if ethical
and other concerns surrounding the use of genetic information, diagnostics or therapies become widespread, there may be less demand for
our products.
Our business is also directly affected by a wide variety of government
regulations applicable to business enterprises generally and to companies operating in the life science industry in particular. Failure
to comply with government regulations or obtain or maintain necessary permits and licenses could result in a variety of fines or other
censures or an interruption in our business operations which may have a negative impact on our ability to generate revenue and the cost
of operating our business. In addition, changes to laws and government regulations could cause a material adverse effect on our business
as we will need to adapt our business to comply with such changes.
Our products could become subject to regulation by the U.S. Food
and Drug Administration or other domestic and international regulatory agencies, which could increase our costs and impede or delay our
commercialization efforts, thereby materially and adversely affecting our business and results of operations.
Our products are not currently subject to the FDA clearance or approval
since they are not intended for use in the diagnosis or treatment of disease. However, in the future, certain of our products or related
applications, such as those that may be developed for clinical uses, could be subject to FDA regulation, or the FDA’s regulatory
jurisdiction could be expanded to include our products. Even where a product is exempted from FDA clearance or approval, the FDA may impose
restrictions as to the types of customers to which we or our partners can market and sell our products. Such regulation and restrictions
may materially and adversely affect our business, financial condition and results of operations. In the event that we fail to obtain and
maintain necessary regulatory clearances or approvals for products that we develop for clinical uses, or if clearances or approvals for
future products and indications are delayed or not issued, our commercial operations may be materially harmed. Furthermore, even if we
are granted regulatory clearances or approvals, they may include significant limitations on the indicated uses for the product, which
may limit the market for the product. We do not have experience in obtaining FDA approvals and no assurance can be given that we will
be able to obtain or to maintain such approvals. Furthermore, any approvals that we may obtain can be revoked if safety or efficacy problems
develop.
29
We believe we can produce accurate financial statements on a
timely basis, however, this could be impacted by the loss of any of our accounting staff, which would adversely affect our business and
our stock price.
Ensuring that we have adequate internal financial and accounting controls
and procedures in place to produce accurate financial statements on a timely basis is a costly and time-consuming effort that needs to
be evaluated frequently. We believe our ability to produce accurate financial statements on a timely basis could be impaired due to our
small internal accounting team. We may in the future discover other areas of our internal financial and accounting controls and procedures
that need improvement. Operating as a public company requires sufficient resources within the accounting and finance functions in order
to produce timely financial information, ensure the level of segregation of duties, and maintain adequate internal control over financial
reporting customary for a U.S. public company.
Our management is responsible for establishing and maintaining adequate
internal control over financial reporting to provide reasonable assurance regarding the reliability of our financial reporting and the
preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States
(U.S. GAAP). Our management does not expect that our internal control over financial reporting will prevent or detect all errors and all
fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control
system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide
absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any,
within our company will have been detected.
Our ability to use net operating losses to offset future taxable
income may be subject to substantial limitations.
Under Section 382 of the Internal Revenue Code, a corporation
that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change net operating losses
(“NOLs”) to offset future taxable income. Significant changes in our stock ownership could result in us being unable to utilize
a material portion of our NOLs even if we attain profitability.
Our sales cycle is unpredictable and lengthy, which makes it
difficult to forecast revenue and may increase the magnitude of quarterly or annual fluctuations in our operating results.
The sales cycle for our sequencing instruments is lengthy because our
products represent a major capital expenditure and generally require the approval of our customers’ senior management. This may
contribute to substantial fluctuations in our quarterly or annual operating results, particularly during the periods in which our sales
volume is low. Factors that may cause fluctuations in our quarterly or annual operating results include, without limitation:
●
market acceptance for our products;
●
our ability to attract new customers;
●
publications of studies by us, competitors or third parties;
●
the timing and success of new product introductions by us or our competitors or other changes in the competitive dynamics of our industry, such as consolidation;
●
the amount and timing of our costs and expenses;
●
general economic, industry and market conditions;
●
changes in our pricing policies or those of our competitors;
●
the regulatory environment;
●
expenses associated with warranty costs or unforeseen product quality issues;
●
the hiring, training and retention of key employees, including our ability to grow our sales organization;
●
litigation or other claims against us for intellectual property infringement or otherwise;
●
our ability to obtain additional financing as necessary; and
●
changes or trends in new technologies and industry standards.
Because of these fluctuations, it is likely that in some future quarters
our operating results will fall below the expectations of securities analysts or investors.
30
Our operations involve the use of hazardous materials, and we
must comply with environmental, health and safety laws, which can be expensive and may adversely affect our business, operating results
and financial condition.
Our research and development and manufacturing activities involve the
use of hazardous materials, including chemicals and biological materials. Our sequencing reagents, such as tris (2-carboxyethyl) phosphine
and acetonitrile, include hazardous materials. Accordingly, we are subject to federal, state, local and foreign laws, regulations and
permits relating to environmental, health and safety matters, including, among others, those governing the use, storage, handling, exposure
to and disposal of hazardous materials and wastes, the health and safety of our employees, and the shipment, labelling, collection, recycling,
treatment and disposal of products containing hazardous materials. Liability under environmental laws and regulations can be joint and
several and without regard to fault or negligence. For example, under certain circumstances and under certain environmental laws, we could
be held liable for costs relating to contamination at our or our predecessors’ past or present facilities and at third-party waste
disposal sites. We could also be held liable for damages arising out of human exposure to hazardous materials. There can be no assurance
that violations of environmental, health and safety laws will not occur as a result of human error, accident, equipment failure or other
causes. The failure to comply with past, present or future laws could result in the imposition of substantial fines and penalties, remediation
costs, property damage and personal injury claims, investigations, the suspension of production or product sales, the loss of permits
or a cessation of operations. Any of these events could harm our business, operating results and financial condition. We also expect that
our operations will be affected by new environmental, health and safety laws and regulations on an ongoing basis, or more stringent enforcement
of existing laws and regulations. New laws or changes to existing laws may result in additional costs and may increase penalties associated
with violations or require us to change the content of our products or how we manufacture them, which could have a material adverse effect
on our business, operating results and financial condition.
Ethical, legal, privacy and social concerns or governmental restrictions
surrounding the use of genetic information could reduce demand for our technology.
Our products may be used to provide genetic information about humans
and other living organisms. The information obtained from our products could be used in a variety of applications that may have underlying
ethical, legal, privacy and social concerns, including the genetic engineering or modification of agricultural products or testing for
genetic predisposition for certain medical conditions. Governmental authorities could, for safety, social or other purposes, call for
limits on or regulation of the use of genetic testing. Such concerns or governmental restrictions could limit the use of our products,
which could have a material adverse effect on our business, financial condition and results of operations.
Disruption of critical information technology systems or material
breaches in the security of our systems could harm our business, customer relations and financial condition.
Information technology (“IT”) helps us to operate efficiently,
interface with customers, maintain financial accuracy and efficiently and accurately produce our financial statements. IT systems are
used extensively in virtually all aspects of our business, including sales forecast, order fulfilment and billing, customer service, logistics,
and management of data from running samples on our products. Our success depends, in part, on the continued and uninterrupted performance
of our IT systems. IT systems may be vulnerable to damage from a variety of sources, including telecommunications or network failures,
power loss, natural disasters, human acts, computer viruses, computer denial-of-service attacks, unauthorized access to customer or employee
data or company trade secrets, and other attempts to harm our systems. Certain of our systems are not redundant, and our disaster recovery
planning is not sufficient for every eventuality. Despite any precautions we may take, such problems could result in, among other consequences,
disruption of our operations, which could harm our reputation and financial results.
If we do not allocate and effectively manage the resources necessary
to build and sustain the proper IT infrastructure, we could be subject to transaction errors, processing inefficiencies, loss of customers,
business disruptions or loss of or damage to intellectual property through security breach. If our data management systems do not effectively
collect, store, process and report relevant data for the operation of our business, whether due to equipment malfunction or constraints,
software deficiencies or human error, our ability to effectively plan, forecast and execute our business plan and comply with applicable
laws and regulations will be impaired, perhaps materially. Any such impairment could materially and adversely affect our reputation, financial
condition, results of operations, cash flows and the timeliness with which we report our internal and external operating results.
31
Security breaches and other disruptions could compromise our
information and expose us to liability, which would cause our business and reputation to suffer.
In the ordinary course of our business, we collect and store sensitive
data, including intellectual property, our proprietary business information and that of our customers, suppliers and business partners,
and personally identifiable information of our employees, on our networks. The secure processing, maintenance and transmission of this
information is critical to our operations. Despite our security measures, our IT infrastructure may be vulnerable to attacks by hackers,
computer viruses, malicious codes, unauthorized access attempts, and cyber- or phishing-attacks, or breached due to employee error, malfeasance,
faulty password management or other disruptions. Third parties may attempt to fraudulently induce employees or other persons into disclosing
usernames, passwords or other sensitive information, which may in turn be used to access our IT systems, commit identity theft or carry
out other unauthorized or illegal activities. Any such breach could compromise our networks and the information stored there could be
accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or
proceedings, liability under laws that protect the privacy of personal information, disruption of our operations and damage to our reputation,
which could divert our management’s attention from the operation of our business and materially and adversely affect our business,
revenues and competitive position. Moreover, we may need to increase our efforts to train our personnel to detect and defend against cyber-
or phishing-attacks, which are becoming more sophisticated and frequent, and we may need to implement additional protective measures to
reduce the risk of potential security breaches, which could cause us to incur significant additional expenses.
We are subject to certain U.S. and foreign anti-corruption, anti-money
laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations.
Among other matters, U.S. and foreign anti-corruption, anti-money laundering,
export control, sanctions, and other trade laws and regulations, which are collectively referred to as Trade Laws, prohibit companies
and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors, and other partners
from authorizing, promising, offering, providing, soliciting or receiving, directly or indirectly, corrupt or improper payments or anything
else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal fines
and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation,
reputational harm, and other consequences. We have direct or indirect interactions with officials and employees of government agencies
or government-affiliated hospitals, universities, and other organizations. We also expect our non-U.S. activities to increase in time.
We plan to engage third parties for collaborations, sales and distribution of sequencing products and we can be held liable for the corrupt
or other illegal activities of our personnel, agents, or partners, even if we do not explicitly authorize or have prior knowledge of such
activities.
Risks Related to Our Intellectual Property
Failure to secure patent or other intellectual property protection
for our products and improvements to our products may reduce our ability to maintain any technological or competitive advantage over our
current and potential competitors.
Our ability to protect and enforce our intellectual property rights
is uncertain and depends on complex legal and factual questions. Our ability to establish or maintain a technological or competitive advantage
over our competitors may be diminished because of these uncertainties. For example:
●
we or our licensors might not have been the first to make the inventions covered by each of our pending patent applications or issued patents;
●
we or our licensors might not have been the first to file patent applications for these inventions;
●
the scope of the patent protection we or our licensors obtain may not be sufficiently broad to prevent others from practicing our technologies, developing competing products, designing around our patented technologies or independently developing similar or alternative technologies;
●
our and our licensors’ patent applications or patents have been, are and may in the future be, subject to interference, opposition or similar administrative proceedings, which could result in those patent applications failing to issue as patents, those patents being held invalid, or the scope of those patents being substantially reduced;
32
●
the current assignee of our intellectual property may elect to forego paying maintenance fees, placing us at risk to lose the licensed IP, or the assignee may neglect to enforce the intellectual property we license from them;
●
we or our partners may not adequately protect our trade secrets;
●
we may not develop additional proprietary technologies that are patentable; or
●
the patents of others may limit our freedom to operate and prevent us from commercializing our technology in accordance with our plans.
The occurrence of any of these events could impair our ability to operate
without infringing upon the proprietary rights of others or prevent us from establishing or maintaining a competitive advantage over our
competitors.
The intellectual property that is important to our business is
owned by other companies or institutions and licensed to us, and changes to the rights we have licensed may adversely impact our business.
We license the intellectual property that is important to our business
from Fluidigm Corporation (“Fluidigm”) (which obtained this intellectual property portfolio from Helicos Biosciences Corporation
(“Helicos”)) pursuant to a non-exclusive licensing agreement. If we fail to comply with the terms of the license, Fluidigm
could terminate the license. If these third parties who license intellectual property to us fail to maintain the intellectual property
that we have licensed, or lose rights to that intellectual property, the rights we have licensed may be reduced or eliminated, which could
subject us to claims of intellectual property infringement. Termination of our license from Fluidigm or reduction or elimination of our
licensed rights may result in our having to negotiate new or reinstated licenses with less favorable terms or could subject us to claims
of intellectual property infringement in litigation or other administrative proceedings that could result in damage awards against us
and injunctions that could prohibit us from selling our products. In addition, our license agreement from Fluidigm is non-exclusive, and
Fluidigm may license the technology to our competitors, which may result is significant competition for us.
In addition, we have limited rights to participate in the prosecution
and enforcement of the patents and patent applications that we have licensed. As a result, we cannot be certain that these patents and
applications will be prosecuted and enforced in a manner consistent with the best interests of our business. Further, because of the rapid
pace of technological change in our industry, we may need to rely on key technologies developed or licensed by third parties, and we may
not be able to obtain licenses and technologies from these third parties at all or on reasonable terms. The occurrence of these events
may have a material adverse effect on our business, financial condition or results of operations.
A license agreement for intellectual property that is important
to our business may be terminated in the event that Daniel Jones, our Chief Executive Officer, fails to continue to work full time for
us.
As discussed above, we license certain intellectual property that is
important to our business from Fluidigm (which obtained this intellectual property portfolio from Helicos) pursuant to a non-exclusive
licensing agreement. The license agreement provides that Fluidigm has a right to terminate the license in the event Daniel Jones, our
Chief Executive Officer, fails to continue to work full time for us. If we lose our rights to such intellectual property, the rights we
have licensed may be reduced or eliminated, which could subject us to claims of intellectual property infringement, require us to cease
selling certain or all of our products, negotiate less favorable agreements or otherwise result in a loss of business. In addition, such
language could prevent us from terminating Mr. Jones from his position when it would otherwise be favorable for stockholders or our business
in general.
Our licensed intellectual property and future intellectual property
will have limited window of enforcement.
Our licensed intellectual property and future intellectual property
will have limited windows of enforcement. The patents on substantially all of our licensed IP are expected to expire between 2025 and
2028, excluding any extension or adjustment of patent terms that may be available. Following the expiration and termination of the patents
relating to our licensed technology, we may face the development of similar technology from our competitors or other market participants,
which could impede our revenue and growth.
33
We may not be able to protect intellectual property and proprietary
rights worldwide.
The majority of our intellectual property is licensed from third parties
through non-exclusive license agreements. Although our company has accumulated trade secrets and know-how to make this technology work
effectively and reliably over the last decade, other entities may attempt to commercialize this technology by gaining access to the intellectual
property. As a result, we may encounter additional competition from third parties, and may require significant amounts of time and resources
to protect our intellectual property and proprietary rights.
Filing, prosecuting and defending patents on our products and other
technologies in all countries throughout the world would be cost prohibitive, and the laws of foreign countries may not protect our rights
to the same extent as the laws of the United States. Consequently, we may not be able to prevent third parties from practicing our
inventions in all countries, or from selling or importing products made using our inventions in and into the United States or other
jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own
products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not
as strong as that in the United States. These products may compete with our products, and our patents or other intellectual property
rights may not be effective or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting
and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing
countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating
to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products
in violation of our intellectual property and proprietary rights generally. Proceedings to enforce our intellectual property and proprietary
rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business,
could put our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing,
and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other
remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property and proprietary
rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop
or license.
Intellectual property laws, and patent laws and regulations in particular,
have been subject to significant variability either through administrative or legislative changes to such laws or regulations or changes
or differences in judicial interpretation, and it is expected that such variability will continue to occur. Additionally, intellectual
property laws and regulations differ by country. Variations in the patent laws and regulations or in interpretations of patent laws and
regulations in the United States and other countries may diminish the value of our intellectual property and may change the impact
of third-party intellectual property on us. Accordingly, we cannot predict the scope of the patents that may be granted to us with certainty,
the extent to which we will be able to enforce our patents against third parties or the extent to which third parties may be able to enforce
their patents against us.
If the scope of any patent protection we obtain is not sufficiently
broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical sequencing
technology and applications would be adversely affected.
The patent position of biotechnology companies generally is highly
uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result,
the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. Our owned or in-licensed
pending and future patent applications may not result in patents being issued which protect our tSMS platform, or other technologies or
which effectively prevent others from commercializing competitive technologies and applications.
34
Our ability to stop third parties from making, using, selling, offering
to sell, or importing products that infringe our intellectual property will depend in part on our success in obtaining and enforcing patent
claims that cover our technology, inventions and improvements. With respect to both licensed and company-owned intellectual property,
we cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications
filed by us in the future, nor can we be sure that any of our existing patents or any patents that may be granted to us in the future
will be commercially useful in protecting our products and the methods used to manufacture those products. Moreover, even our issued patents
do not guarantee us the right to practice our technology in relation to the commercialization of our products. The area of patent and
other intellectual property rights in biotechnology is an evolving one with many risks and uncertainties, and third parties may have blocking
patents that could be used to prevent us from commercializing our sequencing instruments and practicing our proprietary technology. Our
issued patent and those that may be issued in the future may be challenged, invalidated, or circumvented, which could limit our ability
to stop competitors from marketing related products or limit the length of the term of patent protection that we may have for our technology.
In addition, the rights granted under any issued patents may not provide us with protection or competitive advantages against competitors
with similar technology. Furthermore, our competitors may independently develop similar technologies. For these reasons, we may have competition
for our products. Moreover, because of the extensive time required for development and testing of new sequencing instruments, it is possible
that, before any particular product can be commercialized, any related patent may expire or remain in force for only a short period following
commercialization, thereby reducing any advantage of the patent.
Moreover, the coverage claimed in a patent application can be significantly
reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications we own or license
issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third
parties from competing with us, or otherwise provide us with any competitive advantage. Any patents that we own or in-license may be challenged,
narrowed, circumvented or invalidated by third parties. Consequently, we do not know whether our tSMS platform or other technologies will
be protectable or remain protected by valid and enforceable patents. Our competitors or other third parties may be able to circumvent
our patents by developing similar or alternative technologies or products in a non-infringing manner which could materially adversely
affect our business, financial condition, results of operations and prospects.
The issuance of a patent is not conclusive as to its inventorship,
scope, validity or enforceability, and patents that we own or license may be challenged in the courts or patent offices in the United States
and abroad. We or our licensors may be subject to a third-party reissuance submission of prior art to the U.S. Patent and Trademark Office
(“USPTO”) or to foreign patent authorities or become involved in opposition, derivation, revocation, re-examination, post-grant
and inter partes review, or interference proceedings or other similar proceedings challenging our owned or licensed patent
rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable,
our owned or in-licensed patent rights, allow third parties to commercialize our tSMS platform technologies or other technologies and
compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing
third-party patent rights. Moreover, we, or one of our licensors, may have to participate in interference proceedings declared by the
USPTO to determine priority of invention or in post-grant challenge proceedings, such as oppositions in a foreign patent office, that
challenge our or our licensor’s priority of invention or other features of patentability with respect to our owned or in-licensed
patents and patent applications. Such challenges may result in loss of patent rights, loss of exclusivity, or in patent claims being narrowed,
invalidated, or held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical technology
and products, or limit the duration of the patent protection of our tSMS Platform and other technologies. Such proceedings also may result
in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable to us.
We may in the future co-own patent rights relating to future sequencing
instruments, reagents, applications, or our tSMS platform with third parties. Some of our in-licensed patent rights are, and may in the
future be, co-owned with third parties. In addition, our licensors may co-own the patent rights we in-license with other third parties
with whom we do not have a direct relationship.
35
We could in the future be subject to legal proceedings with third
parties who may claim that our products infringe or misappropriate their intellectual property rights.
Our products are based on complex, rapidly developing technologies.
We may not be aware of issued or previously filed patent applications that belong to third parties that mature into issued patents that
cover some aspect of our products or their use. In addition, because patent litigation is complex and the outcome inherently uncertain,
our belief that our products do not infringe third-party patents of which we are aware or that such third-party patents are invalid and
unenforceable may be determined to be incorrect. As a result, third parties have claimed, and may in the future claim, that we infringe
their patent rights and have filed, and may in the future file, lawsuits or engage in other proceedings against us to enforce their patent
rights. In addition, as we enter new markets, our competitors and other third parties may claim that our products infringe their intellectual
property rights as part of a business strategy to impede our successful entry into those markets. Furthermore, parties making claims against
us may be able to obtain injunctive or other relief, which effectively could block our ability to develop further, commercialize, or sell
products or services, and could result in the award of substantial damages against us. Patent litigation between competitors in our industry
is common. In defending ourselves against any of these claims, we could in the future incur, substantial costs, and the attention of our
management and technical personnel could be diverted. We may be unable to modify our products so that they do not infringe the intellectual
property rights of third parties. In some situations, the results of litigation or settlement of claims may require us to cease allegedly
infringing activities, which could prevent us from selling some or all of our products. The occurrence of these events may have a material
adverse effect on our business, financial condition or results of operations.
In addition, in the course of our business, we may from time to time
have access or be alleged to have access to confidential or proprietary information of others, which, though not patented, may be protected
as trade secrets. Others could bring claims against us asserting that we improperly used their confidential or proprietary information,
or that we misappropriated their technologies and incorporated those technologies into our products. A determination that we illegally
used the confidential or proprietary information or misappropriated technologies of others in our products could result in us paying substantial
damage awards or being prevented from selling some or all of our products, which could materially and adversely affect our business.
We have not yet registered some of our trademarks in all of our
potential markets, and failure to secure those registrations could adversely affect our business.
While we believe our trademarks are registered in the markets in which
we currently operate, some of our trademark applications may not be allowed for registration in markets in which we may seek to enter
in the future, and our registered trademarks may not be maintained or enforced. In addition, in the USPTO and in comparable agencies in
many foreign jurisdictions, third parties are given an opportunity to oppose new or pending trademark applications and to seek to cancel
registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive
such proceedings.
Risks Related to our Collaborations with Third Parties
Our future collaborations may be important to our business. If
we are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely
affected.
We have limited capabilities for technology development, sales, marketing
or distribution. Accordingly, we may enter into collaborations with academic and commercial entities to provide us with important technologies
and funding for our programs and technology, and we may receive additional technologies and funding under these and other collaborations
in the future. Any future collaborations we enter into may pose a number of risks, including the following:
●
collaborators have significant discretion in determining the efforts and resources that they will apply;
●
collaborators may not perform their obligations as expected;
●
collaborators may not pursue development and commercialization of any platform or may elect not to continue or renew development or commercialization programs or license arrangements based on changes in the collaborators’ strategic focus or available funding, or external factors, such as a strategic transaction that may divert resources or create competing priorities;
●
collaborators may provide insufficient funding for the research program;
36
●
collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our sequencing instruments and applications if the collaborators believe that the competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
●
biomarkers discovered by our collaborators in collaboration with us may be viewed by our collaborators as competitive with their own products, which may cause collaborators to cease to devote resources to the commercialization of our product;
●
disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or terminations of the research, development or commercialization of new products or platforms, might lead to additional responsibilities for us with respect to technology development, or might result in litigation or arbitration, any of which would be time-consuming and expensive;
●
collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;
●
collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;
●
if a collaborator of ours is involved in a business combination, the collaborator might deemphasize or terminate the development or commercialization of any product licensed to it by us; and
●
collaborations may be terminated by the collaborator, and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable sequencing technology.
If our potential future collaborations do not result in the successful
discovery, development and commercialization of products or if one of our collaborators terminates its agreement with us, we may not receive
any future research funding or milestone potential payments under the collaboration. If we do not receive the funding we expect under
these agreements, our development of our technology and applications could be delayed and we may need additional resources to develop
products and our technology. All of the risks relating to product development, regulatory approval and commercialization described in
this prospectus also apply to the activities of our therapeutic collaborators.
Additionally, if one of our potential future collaborators terminates
its agreement with us, we may find it more difficult to attract new collaborators and our perception in the business and financial communities
could be adversely affected.
Risks Related to Ownership of Our Common Stock and Publicly-Traded
Warrants
The market price of our common stock and publicly-traded warrants
may be highly volatile, and you could lose all or part of your investment.
The prices of our common stock or publicly-traded warrants could be
subject to wide fluctuations in response to a variety of factors, which include:
●
actual or anticipated fluctuations in our financial condition and operating results;
●
announcements of technological innovations by us or our competitors;
●
announcements by our customers, partners or suppliers relating directly or indirectly to our products, services or technologies;
●
overall conditions in our industry and market;
●
addition or loss of significant customers;
●
changes in laws or regulations applicable to our products;
●
actual or anticipated changes in our growth rate relative to our competitors;
●
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, capital commitments or achievement of significant milestones;
37
●
additions or departures of key personnel;
●
competition from existing products or new products that may emerge;
●
fluctuations in the valuation of companies perceived by investors to be comparable to us;
●
disputes or other developments related to proprietary rights, including patents, litigation matters or our ability to obtain intellectual property protection for our technologies;
●
announcement or expectation of additional financing efforts;
●
sales of our common stock or warrants by us or our stockholders;
●
stock price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
●
reports, guidance and ratings issued by securities or industry analysts; and
●
general economic and market conditions.
If any of the forgoing occurs, it would cause our stock and Warrant
prices or trading volume to decline. Stock markets in general and the market for companies in our industry in particular have experienced
price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies. These
fluctuations often have been unrelated or disproportionate to the operating performance of those companies. These broad market and industry
fluctuations, as well as general economic, political and market conditions such as recessions, interest rate changes or international
currency fluctuations, may negatively impact the market price of our common stock or Warrants. You may not realize any return on your
investment in us and may lose some or all of your investment.
We may be subject to securities litigation, which is expensive
and could divert our management’s attention.
The market price of our securities may be volatile, and in the past
companies that have experienced volatility in the, market price of their securities have been subject to securities class action
litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial
costs and divert our management’s attention from other business concerns, which could seriously harm our business.
Our directors, executive officers and principal stockholders
have substantial control over our company, which could limit your ability to influence the outcome of key transactions, including a change
of control.
On April 1, 2024, our executive officers, directors and 10% stockholders
owned 147,960 shares of our common stock, or approximately 39% of the outstanding shares of our common stock, based on the number of shares
outstanding as of such date. As a result, these stockholders will be able to exercise a significant level of control over all matters
requiring stockholder approval, including the election of directors and the approval of mergers, acquisitions or other extraordinary transactions.
They may also have interests that differ from yours and may vote in a way with which you disagree and which may be adverse to your interests.
This concentration of ownership may have the effect of delaying, preventing or deterring a change of control of our company, could deprive
our stockholders of an opportunity to receive a premium for their common stock as part of a sale of our company and might ultimately affect
the market price of our common stock.
38
Our shares have become subject to the penny stock rules, which
makes it more difficult to trade our shares.
The SEC has adopted rules that regulate broker-dealer practices in
connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00, other than
securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems, provided
that current price and volume information with respect to transactions in such securities is provided by the exchange or system. As our
common stock and warrants are no longer registered on a national stock exchange and the price of our common stock is less than $5.00,
our common stock is now deemed a penny stock under the SEC penny stock rules. The penny stock rules require a broker-dealer, before a
transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified
information. In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from
those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser
and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement; (ii) a written agreement
to transactions involving penny stocks; and (iii) a signed and dated copy of a written suitability statement. These disclosure requirements
may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore stockholders may have
difficulty selling their shares.
We are an “emerging growth company” and the reduced
disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.
We are an “emerging growth company,” as defined in the
JOBS Act. We may remain an emerging growth company until as late as December 2026 (the fiscal year-end following the fifth anniversary
of the completion of our initial public offering), though we may cease to be an emerging growth company earlier under certain circumstances,
including (1) if the market value of our common stock that is held by non-affiliates exceeds $700 million as of any June 30,
in which case we would cease to be an emerging growth company as of the following December 31, or (2) if our gross revenue exceeds
$1.235 billion in any fiscal year. Emerging growth companies may take advantage of certain exemptions from various reporting requirements
that are applicable to other public companies, including not being required to comply with the auditor attestation requirements of Section 404
of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements
and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden
parachute payments not previously approved. Investors could find our common stock less attractive because we may rely on these exemptions.
If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and
our stock price may be more volatile.
In addition, Section 102 of the JOBS Act also provides that an
emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act
of 1933, as amended, or the Securities Act, for complying with new or revised accounting standards. An emerging growth company can therefore
delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably
elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will not be subject to the same
new or revised accounting standards as other public companies that are not emerging growth companies.
We incur significant costs as a result of operating as a public
company and our management has devoted substantial time to public company compliance programs.
As a public company, we incur significant legal, accounting and other
expenses due to our compliance with regulations and disclosure obligations applicable to us, including compliance with the Sarbanes-Oxley
Act, as well as rules implemented by the SEC and Nasdaq. Stockholder activism, the current political environment and the current high
level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead
to additional compliance costs and impact, in ways we cannot currently anticipate, the manner in which we operate our business. Our management
and other personnel devote a substantial amount of time to these compliance programs and monitoring of public company reporting obligations
and as a result of the new corporate governance and executive compensation related rules, regulations and guidelines prompted by the Dodd-Frank
Act and further regulations and disclosure obligations expected in the future, we will likely need to devote additional time and costs
to comply with such compliance programs and rules. These rules and regulations will cause us to incur significant legal and financial
compliance costs and will make some activities more time-consuming and costlier.
To comply with the requirements of being a public company, we may need
to undertake various actions, including implementing new internal controls and procedures and hiring new accounting or internal audit
staff. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control over financial
reporting. However, for so long as we remain an “emerging growth company” as defined in the JOBS Act or a “smaller reporting
company”, we intend to take advantage of certain exemptions from various reporting requirements that are applicable to public companies
that are not emerging growth companies and/or smaller reporting companies, including, but not limited to, for emerging growth companies,
not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act. Once we are no longer
an “emerging growth company” and if our public float is above $75 million as of the last business day of our most recently
completed second fiscal quarter or, if before such date, we opt to no longer take advantage of the applicable exemption, we will be required
to include an opinion from our independent registered public accounting firm on the effectiveness of our internal control over financial
reporting.
39
We are continuing to develop and refine our disclosure controls and
other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file with the SEC
is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that information required
to be disclosed in reports under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is accumulated and
communicated to our principal executive and financial officers. Our current controls and any new controls that we develop may become inadequate
and weaknesses in our internal control over financial reporting may be discovered in the future. Any failure to develop or maintain effective
controls when we become subject to this requirement could negatively impact the results of periodic management evaluations and annual
independent registered public accounting firm attestation reports regarding the effectiveness of our internal control over financial reporting
that we may be required to include in our periodic reports we will file with the SEC under Section 404 of the Sarbanes-Oxley Act,
harm our operating results, cause us to fail to meet our reporting obligations or result in a restatement of our prior period financial
statements. In the event that we are not able to demonstrate compliance with the Sarbanes-Oxley Act, that our internal control over financial
reporting is perceived as inadequate or that we are unable to produce timely or accurate financial statements, investors may lose confidence
in our operating results and the price of our common stock could decline.
Because we have elected to use the extended transition period
for complying with new or revised accounting standards for an emerging growth company our financial statements may not be comparable to
companies that comply with public company effective dates.
We have elected to use the extended transition period for complying
with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. This election allows us to delay the adoption of
new or revised accounting standards that have different effective dates for public and private companies until those standards apply to
private companies. As a result of this election, our financial statements may not be comparable to companies that comply with public company
effective dates, and thus investors may have difficulty evaluating or comparing our business, performance or prospects in comparison to
other public companies, which may have a negative impact on the value and liquidity of our common stock and publicly-traded warrants.
If securities or industry analysts do not publish research, or
publish inaccurate or unfavorable research, about our business, our stock and warrant prices and trading volume could decline.
The trading market for our common stock and publicly-traded warrants
will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and
industry analysts do not currently, and may never, publish research on us. If no securities or industry analysts commence coverage of
us, the price for our common stock and publicly-traded warrants could be negatively impacted. In the event securities or industry analysts
initiate coverage, if one or more of the analysts who cover us downgrade our common stock or publish inaccurate or unfavorable research
about our business, the prices of our common stock and publicly-traded warrants could decline. In addition, if our operating results fail
to meet the forecast of analysts, the prices of our common stock and publicly-traded warrants could decline. If one or more of these analysts
cease coverage of us or fail to publish reports on us regularly, demand for our common stock and publicly-traded warrants could decrease,
which might cause the prices of our common stock and publicly-traded warrants and trading volume to decline.
Anti-takeover provisions in our charter documents and under Delaware
law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders
to replace or remove our current management and limit the market price of our common stock and Warrants.
Provisions in our certificate of incorporation and bylaws, may have
the effect of delaying or preventing a change of control or changes in our management. Our amended and restated certificate of incorporation
and bylaws include provisions that:
●
provide for a staggered board of directors;
●
authorize our board of directors to issue, without further action by the stockholders, up to 20,000,000 shares of undesignated preferred stock and up to approximately 80,000,000 shares of authorized but unissued shares of common stock;
●
require that any action to be taken by our stockholders be effected at a duly called annual or special meeting and not by written consent;
●
specify that special meetings of our stockholders can be called only by our board of directors, the Chairman of the Board, the Chief Executive Officer or the President;
●
establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors;
●
provide that our directors may be removed only for cause; and
●
provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum.
40
These provisions may frustrate or prevent any attempts by our stockholders
to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors,
which is responsible for appointing the members of our management. In addition, because we are incorporated in Delaware, we are governed
by the provisions of Section 203 of the Delaware General Corporation Law, which limits the ability of stockholders owning in excess
of 15% of our outstanding voting stock to merge or combine with us.
Our Amended and Restated Certificate of Incorporation provides
that the Court of Chancery of the State of Delaware is the exclusive forum for certain litigation that may be initiated by our stockholders.
Our amended and restated certificate of incorporation provides that
the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for the following types of actions or proceedings
under Delaware statutory law or Delaware common law, subject to certain exceptions: (1) any derivative action or proceeding brought
on our behalf; (2) any action asserting a claim of breach of a fiduciary duty or other wrongdoing by any of our directors, officers,
employees or agents to us or our stockholders; (3) any action asserting a claim against us arising pursuant to provisions of the
Delaware General Corporation Law or our amended and restated certificate of incorporation or amended and restated bylaws; or (4) any
action asserting a claim governed by the internal affairs doctrine. The choice of forum provision may limit a stockholder’s ability
to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, employees or agents, which
may discourage such lawsuits against us and our directors, officers, employees and agents. Stockholders who do bring a claim in the Court
of Chancery could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near the State
of Delaware. The Court of Chancery may also reach different judgments or results than would other courts, including courts where a stockholder
considering an action may be located or would otherwise choose to bring the action, and such judgments or results may be more favorable
to us than to our stockholders. Alternatively, if a court were to find the choice of forum provision contained in our amended and restated
certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving
such action in other jurisdictions, which could adversely affect our business and financial condition. By agreeing to the exclusive forum
provisions, investors will not be deemed to have waived our compliance obligations with any federal securities laws or the rules and regulations
thereunder.
We do not anticipate paying any cash dividends on our common
stock in the foreseeable future and, as such, capital appreciation, if any, of our common stock and publicly-traded warrants will be your
sole source of gain for the foreseeable future.
We have never declared or paid cash dividends on our common stock.
We do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend to retain all available
funds and any future earnings to fund the development and growth of our business. In addition, and any future loan arrangements we enter
into may contain, terms prohibiting or limiting the amount of dividends that may be declared or paid on our common stock. As a result,
capital appreciation, if any, of our common stock and publicly-traded warrants will be your sole source of gain for the foreseeable future.
Risks Relating to Our Proposed Merger with Lyneer
Unless the Merger Agreement has been terminated, you should consider
the risks and uncertainties relating to Lyneer summarized under Item 1. “Business” above, as well as the more detailed discussion
of such risks and uncertainties included 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.
41
ITEM 1B. UNRESOLVED STAFF COMMENTS
As a Smaller
Reporting Company as defined by Rule 12b-2 of the Exchange Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure
reporting obligations and therefore are not required to provide the information requested by this Item 1B.
ITEM 1C.
CYBERSECURITY
We acknowledge the increasing importance of cybersecurity in today’s
digital and interconnected world. Cybersecurity threats pose significant risks to the integrity of our systems and data, potentially impacting
our business operations, financial condition and reputation.
As a smaller reporting company, we currently do not have formalized
cybersecurity measures, a dedicated cybersecurity team or specific protocols in place to manage cybersecurity risks. Our approach to cybersecurity
is in the developmental stage, and we have not yet conducted comprehensive risk assessments, established an incident response plan or
engaged with external cybersecurity consultants for assessments or services.
Given our current stage of cybersecurity development, we have not experienced
any significant cybersecurity incidents to date. However, we recognize that the absence of a formalized cybersecurity framework may leave
us vulnerable to cyberattacks, data breaches and other cybersecurity incidents. Such events could potentially lead to unauthorized access
to, or disclosure of, sensitive information, disrupt our business operations, result in regulatory fines or litigation costs and negatively
impact our reputation among customers and partners.
We are in the process of evaluating our cybersecurity needs and developing
appropriate measures to enhance our cybersecurity posture. This includes considering the engagement of external cybersecurity experts
to advise on best practices, conducting vulnerability assessments and developing an incident response strategy. Our goal is to establish
a cybersecurity framework that is commensurate with our size, complexity and the nature of our operations, thereby reducing our exposure
to cybersecurity risks.
In addition, our board of directors will oversee any cybersecurity
risk management framework and a dedicated committee of our board of directors or an officer appointed by our board of directors will review
and approve any cybersecurity policies, strategies and risk management practices.
Despite our efforts to improve our cybersecurity measures, there can
be no assurance that our initiatives will fully mitigate the risks posed by cyber threats. The landscape of cybersecurity risks is constantly
evolving, and we will continue to assess and update our cybersecurity measures in response to emerging threats.
For a discussion of potential cybersecurity risks affecting us, please
refer to the “Risk Factors” section.
ITEM 2. PROPERTIES .
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. The lease has a term of 92 months with the rent
escalating from $14,317 to $26,453 per month over the lease term.
ITEM 3. LEGAL PROCEEDINGS
From time to time, we may become involved in various lawsuits and legal
proceedings that arise in the ordinary course of business. Neither we nor any of our subsidiaries currently is a party to any legal proceeding
that, individually or in the aggregate, is material to our company as a whole.
ITEM 4. MINE SAFETY DISCLOSURES .
Not applicable.
42
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER
MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Market Information for Common Stock
Prior to November 13, 2023, our common stock traded on
the Nasdaq Capital Market under the symbol SQLL. Nasdaq suspended trading in our common stock effective at the open of trading on November 13,
2023 due to our failure to comply with Nasdaq Listing Rule 5550(a)(4), which required us to have a minimum of 500,000 publicly-held shares
of common stock, exclusive of shares held by officers, directors and 10% stockholders. Since November 13, 2023, our common stock
has been listed for quotation on the OTC Pink Market under the trading symbol “SEQL.”. Trading in our common stock in the
over-the-counter market has been limited and the quotations for our common stock on the OTC Pink Market are not necessarily indicative
of actual market values. During the period from November 13, 2023 to April 1, 2024, the high and low closing bid price of our common stock
on the OTC Pink Market was $6.60 and $1.40 respectively. All quotations for the OTC Pink Market reflect inter-dealer prices, without retail
mark-up, mark-down or commission and may not necessarily represent actual transactions.
On April 1, 2024, the closing bid price for our common stock on the
OTC Pink Market as reported by the quotation service operated by the OTC Markets Group was $1.40.
Holders
As of April 1, 2024, there were approximately 17 stockholders of record,
according to the records of our transfer agent, and an unknown number of additional holders of common stock held in ‘street name’.
Dividends
We have not declared any common stock dividends to date. We have no
present intention of paying any cash dividends on our common stock in the foreseeable future, as we intend to use earnings, if any, to
generate growth. The payment by us of dividends, if any, in the future, is within the discretion of our board of directors and will depend
upon, among other things, our earnings, capital requirements and financial condition, as well as other relevant factors. There are no
material restrictions in our Certificate of Incorporation, as amended, or Bylaws that restrict us from declaring dividends.
Unregistered Sales of Equity Securities
None.
Issuer Purchases of Equity Securities
None.
ITEM 6. [Reserved]
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS.
You should read the following discussion of our financial condition
and results of operations in conjunction with our audited consolidated financial statements for the year ended December 31, 2023, and
related notes included elsewhere in this report. This discussion and analysis and other parts of this report contain forward-looking statements
based upon current beliefs, plans and expectations that involve risks, uncertainties and assumptions. Our actual results and the timing
of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors,
including those set forth under “Risk Factors” and elsewhere in this report. You should carefully read the “Risk Factors”
section of this report to gain an understanding of the important factors that could cause actual results to differ materially from our
forward-looking statements. Please also see the section entitled “Cautionary Note Regarding Forward-Looking Statements and Industry
and Market Data” in this report.
Overview
This overview and outlook provide a high-level discussion of our operating
results and significant known trends that affect our business. We believe that an understanding of these trends is important to understanding
our financial results for the periods being reported herein as well as our future financial performance. This summary is not intended
to be exhaustive, nor is it intended to be a substitute for the detailed discussion and analysis provided elsewhere in this report.
About SeqLL
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.
43
Our customers are primarily the early adopters of genomics technology
and tSMS in academic research, biomarker discovery, and molecular diagnostic product development.
Our financial results have been, and will continue to be, impacted
by several significant trends, which are described below. While these trends are important to understanding and evaluating our financial
results, this discussion should be read in conjunction with our consolidated financial statements and the notes thereto within the Consolidated
Financial Statements section of this report, and trends discussed in “Risk Factors” within the Business section of this report.
Proposed Merger Agreement
Terms used and not defined in the following discussion
have the respective meanings set forth in Note 1 to our consolidated financial statements included in Part IV to this report.
On May 29, 2023, we entered into the Merger Agreement
with Atlantic, Atlantic Merger Sub, SeqLL Merger Sub, Lyneer, and the Sellers subject to the approval of our stockholders at a special
meeting, which approval has been obtained. Pursuant to the Merger Agreement and subject to the terms and conditions set forth therein,
Atlantic Merger Sub will initially be merged into Lyneer, and SeqLL Merger Sub will then be merged into Lyneer, with Lyneer continuing
as the surviving entity and as our wholly-owned subsidiary. In connection with the consummation of the Merger, we will be renamed “Atlantic
International Corp.”
Lyneer, through its subsidiaries, specializes
in the placement of temporary and temporary-to-permanent labor across various industries within the United States. Lyneer primarily places
individuals in accounting and finance, administrative and clerical, information technology, legal, light industrial, and medical roles.
It is also a leading provider of productivity consulting and workforce management solutions. Lyneer is headquartered in Lawrenceville,
New Jersey and has more than 100 locations in the U.S.
For further description of the terms of the Merger
Agreement, please refer to Note 1 to the consolidated financial statements.
Results of operations
We incurred net losses of $5,627,591 and $4,094,833 for the year ended
December 31, 2023 and 2022, respectively. We had negative cash flow from operating activities of $5,004,558 and $3,662,568 for the year
ended December 31, 2023 and 2022, respectively, and had an accumulated deficit of $24,136,275 as of December 31, 2023.
Results of operations may be adversely affected
by various factors that could cause economic uncertainty and volatility in the financial markets, many of which are beyond our control.
Our business could be impacted by, among other things, downturns in the financial markets or in economic conditions, inflation, increases
in interest rates, and geopolitical instability, such as the military conflict in Ukraine and the Israel-Hamas war. We cannot at this
time fully predict the likelihood of one or more of the above events, their duration or magnitude or the extent to which they may negatively
impact our business.
Our financial results have been, and will continue to be, impacted
by several significant trends, which are described below. While these trends are important to understanding and evaluating our financial
results, this discussion should be read in conjunction with our consolidated financial statements and the notes thereto within the Consolidated
Financial Statements section of this report, and trends discussed in “Risk Factors” in Item 1-A of Part I of this report.
44
Results of Operations
Comparison of the Years Ended December 31, 2023 and 2022
The following table summarizes our results of operations for the years
ended December 31, 2023 and 2022:
December 31,
2023
2022
Revenue
Sales
$ -
$ 1,177
Grant revenue
-
77,482
Total revenue
-
78,659
Cost of sales
-
690
Gross profit
-
77,969
Operating expenses
Research and development
2,253,354
1,568,266
General and administrative
3,479,155
2,506,851
Total operating expenses
5,732,509
4,075,117
Operating loss
(5,732,509 )
(3,997,148 )
Other (income) and expenses
Investment income
(188,716 )
(44,879 )
Unrealized gain on marketable equity securities
-
(54,508 )
Realized loss on marketable equity securities
-
106,324
Interest expense
83,798
90,748
Net loss
(5,627,591 )
(4,094,833 )
Other comprehensive income
Unrealized gain on marketable debt securities
-
22,451
Reclassification adjustment for net gains included in net loss
(22,451 )
-
Total comprehensive loss
$ (5,650,042 )
$ (4,072,382 )
Net loss per share - basic and diluted
$ (15.03 )
$ (12.38 )
Weighted average common shares - basic and diluted
374,484
330,648
Revenues
Our revenues
during the year ended December 31, 2023, were $0 as compared to revenues of $78,659 during the year ended December 31, 2022, representing
a decrease of $78,659, or 100%. During the year ended December 31, 2022, revenue included grant revenue of $77,482 and $1,177 from product
sales. The decrease in revenue was due to the fact that we do not currently have any active grants under which we are providing services,
nor have we sold any of our products to customers. We do not expect to recognize revenues until a market for our sequencing technology
further develops.
Gross Profit
Gross profit for the year ended December 31, 2023 was $0, as compared
to gross profit of $77,969 for the year ended December 31, 2022, which represented a decrease of $77,969, or 100%, primarily due to the
fact that we do not currently have any active grants under which we are providing services, nor have we sold any of our products to customers.
45
Research and Development Expenses
Research and development expenses increased by $685,088, or 44%, from
$1,568,266 for the year ended December 31, 2022 compared to $2,253,354 for the year ended December 31, 2023. The increase in expenses
was a result of our progressive return to research and development activities in relation to applications for our tSMS technology to pre-COVID-19
levels prior to entering into the Merger agreement with Lyneer. Going forward, we expect to reduce our research and development expenses
until after the closing of the Merger with Lyneer as we continue to preserve our cash resources to effect the Merger.
General and Administrative Expenses
General and administrative expenses increased by $972,304, or 39%,
from $2,506,851 for the year ended December 31, 2022 compared to $3,479,155 for the year ended December 31, 2023. The increase was primarily
attributable to approximately $705,000 in additional legal and professional fees related to the Merger in order to facilitate SEC filings,
increased operating expenses of approximately $105,000 related to accounting, legal, insurance and audit related services, and approximately
$96,000 of additional incremental expenses incurred in connection with the Merger. General and administrative expenditures will continue
to increase until the closing of the Merger with Lyneer.
Interest and Other Income/Loss
We recognized $188,716 of investment income, of which $106,051 related
to marketable debt securities and $82,665 related to cash invested in money market accounts and cash that was held in investments that
have a maturity date of less than three months during the year ended December 31, 2023. We recognized $0 of investment income related
to marketable securities and $44,879 of income earned from money market accounts during the year ended December 31, 2022.
Interest expense incurred on the promissory notes was $68,370 and $90,748
for the years ended December 31, 2023 and 2022, respectively. During the year ended December 31, 2023, we also incurred $15,428 of
interest expense related to our finance lease.
Net Loss
Overall, the net loss increased by $1,532,758, or 37%, to $5,627,591
as compared to $4,094,833 for the year ended December 31, 2022. This increase in net loss was primarily attributable to increased expenses
associated with the Merger.
Liquidity and Capital
Resources
The accompanying consolidated financial statements
have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal
course of business. We experienced negative cash flows from operations of $5,004,558 for the year ended December 31, 2023, which included
our costs and expenses related to the transactions contemplated by the Merger Agreement. As a result of our recent common stock offerings
in August 2021 and February of 2023 and the maturity of our marketable debt securities, we had cash and cash equivalents of we had cash
and cash equivalents of $2,693,991 at December 31, 2023.
The Company estimates cash resources will be sufficient
to fund its operations into the first quarter of 2025. The Company will need additional capital to fund its planned operations for the
next 12 months, if the Merger is not completed. These conditions raise substantial doubt about the Company’s ability to continue
as a going concern.
The consolidated financial statements for the years
ended December 31, 2023 and 2022 were prepared under the assumption that the Company will continue as a going concern, which contemplates
that the Company will be able to realize assets and discharge liabilities in the normal course of business.
46
Since inception, we have funded our operations primarily through equity
and debt financings, as well as from modest sales of products and research services. As of December 31, 2023, and we had an accumulated
deficit of $24,136,275.
On February 15, 2023, we issued 50,000 shares of common stock to investors
at a price of $36.00 per share (after the Reverse Stock Split). The gross proceeds of the issuance were $1.8 million. We incurred offering
expenses of approximately $0.3 million, which were paid with proceeds from the common stock issuance.
The Company expects that it will seek to raise additional capital
through equity offerings, grant financing, and convertible debt. Additional funds may not be available when it needs them on terms that
are acceptable to them, or at all. If adequate funds are not available, it may be required to delay its operational strategies, and to
delay or reduce the scope of its research or development programs.
Cash Flows
The following table sets forth the primary sources and uses of cash
and cash equivalents for each of the periods presented.
For the Years Ended
December 31,
2023
2022
Cash proceeds provided by (used in):
Operating activities
$ (5,004,558 )
$ (3,662,568 )
Investing activities
4,057,625
1,827,965
Financing activities
1,460,399
-
Net (decrease) increase in cash and cash equivalents
$ 513,466
$ (1,834,603 )
Net cash used in operating activities
Net cash used in operating activities was approximately $5.0 million
and $3.7 million for the year ended December 31, 2023 and 2022, respectively. The increase in operating spending was a result of our progressive
return to research and development activities to levels of pre-COVID-19 pandemic, prior to the announcement of the proposed Merger. In
addition, we experienced an increase in our general and administrative spending associated with legal, accounting, and consulting fees
in connection with the proposed Merger with Lyneer.
Net cash provided by investing activities
Net cash provided by investing activities was approximately $4.1 million
for the year ended December 31, 2023 as compared to approximately $1.8 million for the year ended December 31, 2022. The cash from the
investing activities is primarily attributable to the sales and maturities of marketable securities during the years ended December 31,
2023 and 2022.
Net cash provided by financing activities
Net cash provided by financing activities was approximately $1.5 million,
and $0, for the year ended December 31, 2023 and 2022, respectively. We issued 50,000 shares of common stock to investors at a price of
$36.00 per share during the year ended December 31, 2023 (after the effect of the Reverse Stock Split). The gross proceeds of the issuance
was $1.8 million. We incurred offering costs of approximately $0.3 million, which were paid with proceeds from the common stock issuance.
No such transaction occurred during the year ended December 31, 2022.
47
Recent Accounting Pronouncements
In June 2016,
the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial
Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments. ASU 2016-13 requires measurement and recognition of
expected credit losses for financial assets. In April 2019, the FASB issued clarification to ASU 2016-13 within ASU 2019-04, Codification
Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments,
or ASU 2016-13. The guidance is effective for fiscal years beginning after December 15, 2022. We adopted this standard on January 1,
2023, which had no material impact on the our consolidated financial statements.
We do not believe that any other recently issued but not yet effective
accounting pronouncements are expected to have a material effect on our consolidated financial statements.
Critical Accounting Policies and Estimates
We prepare our financial statements and accompanying
notes in conformity with accounting principles generally accepted in the United States of America, which require management to make estimates
and assumptions about future events that affect reported amounts. Estimations are considered critical accounting estimates based on, among
other things, its impact on the portrayal of our financial condition, results of operations, or liquidity, as well as the degree of difficulty,
subjectivity, and complexity in its deployment. Critical accounting estimates address accounting matters that are inherently uncertain
due to unknown future resolution of such matters. Management routinely discusses the development, selection, and disclosure of each critical
accounting estimates.
Stock-based Compensation
Our stock-based compensation program awards include stock options and
restricted stock awards. The fair value of stock option grants is estimated as of the date of the grant using the Black-Scholes option
pricing model. The fair value of restricted stock units is based on the fair value of our common stock on the date of the grant. The fair
value of the awards is then expensed over the requisite service period, generally the vesting period, for each award as compensation expense.
Our expected stock price volatility assumption is based on the volatility
of comparable public companies. The expected term of a stock option granted to employees and directors (including non-employee directors)
is based on the average of the contractual term (generally 10 years) and the vesting period. For non-employee options, the expected term
is the contractual term. The risk-free interest rate is based on the yield of U.S. Treasury securities consistent with the life of the
option. The expected dividend yield was set to zero as wedo not pay dividends on our common stock and there was no expectation of doing
so as of the respective grant dates. We recognize forfeitures related to stock-based awards as they occur.
We have periodically granted stock options and restricted stock units
to non-employees for services pursuant to ourstock plans at the fair market value on the respective dates of grant. Should we terminate
any of our consulting agreements, the unvested options underlying the agreements would be cancelled. For awards granted to non-employees,
compensation expense is recognized over the service period.
We granted stock options to purchase an aggregate of 13,550 and 27,125
shares of common stock in the years ended December 31, 2023 and 2022, respectively.
We granted restricted stock units to purchase an aggregate of 13,825
for the year ended December 31, 2023. No such restricted stock units were granted during the year ended December 31, 2022.
48
JOBS Act
Section 107 of the JOBS Act provides that an “emerging growth
company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying
with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of new or revised accounting
standards until those standards would otherwise apply to private companies. We have irrevocably elected to avail ourselves of this exemption
from new or revised accounting standards and, therefore, we will not be subject to the same new or revised accounting standards as other
public companies that are not emerging growth companies.
For as long as we remain an emerging growth company under the recently-enacted
JOBS Act, we will, among other things:
● be
permitted to have only two years of audited financial statements and only two years of related selected financial data and management’s
discussion and analysis of financial condition and results of operations disclosure;
●
be entitled to rely on an exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act;
●
be entitled to reduced disclosure obligations about executive compensation arrangements in our periodic reports, registration statements and proxy statements; and
●
be exempt from the requirements to seek non-binding advisory votes on executive compensation or golden parachute arrangements.
We currently intend to take advantage of some or all of the reduced
regulatory and reporting requirements that will be available to us so long as we qualify as an “emerging growth company.”
Among other things, this means that our independent registered public accounting firm will not be required to provide an attestation report
on the effectiveness of our internal control over financial reporting so long as we qualify as an emerging growth company, which may increase
the risk that weaknesses or deficiencies in our internal control over financial reporting go undetected.
Likewise, so long as we qualify as an emerging growth company, we may
elect not to provide certain information, including certain financial information and certain information regarding compensation of our
executive officers, that we would otherwise have been required to provide in filings we make with the SEC, which may make it more difficult
for investors and securities analysts to evaluate our company. As a result, investor confidence in our company and the market price of
our common stock may be materially and adversely affected.
49
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
As a Smaller Reporting Company as defined by Rule 12b-2 of the Exchange
Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations and therefore are not required to
provide the information requested by this Item 7A.
ITEM 8. FINANCIAL STATEMENTS .
Our Consolidated
Financial Statements are on pages F-1 through F-21
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING
AND FINANCIAL DISCLOSURES.
None.
ITEM 9A. CONTROLS AND PROCEDURES .
Evaluation of disclosure controls and procedures
Our Chief Executive Officer (who is our principal executive officer)
and Chief Financial Officer (who is our principal financial officer), conducted an evaluation of the effectiveness of the design and operation
of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange
Act of 1934 (the “Exchange Act”) as of December 31, 2023. As of December 31, 2023, based upon the evaluation, our principal
executive officer and principal financial officer concluded that our disclosure controls and procedures were effective. Disclosure controls
and procedures designed to reasonably ensure that information required to be disclosed in our reports filed under the Exchange Act,
such as this report, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
Management’s Report on Internal Controls
Over Financial Reporting
As required by SEC rules and regulations implementing Section 404
of the Sarbanes-Oxley Act, our management is responsible for establishing and maintaining adequate internal control over financial reporting.
Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of our financial statements for external reporting purposes in accordance with GAAP. Our internal control over financial
reporting includes those policies and procedures that:
(1) pertain
to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets
of our company,
(2) provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP,
and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors, and
(3) provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could
have a material effect on the financial statements.
50
Because of its inherent limitations, internal control over financial
reporting may not prevent or detect errors or misstatements in our financial statements. Also, projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree or
compliance with the policies or procedures may deteriorate. Management assessed the effectiveness of our internal control over financial
reporting at December 31, 2023. In making these assessments, management used the criteria set forth by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO) in Internal Control — Integrated Framework (2013). Based on our assessments and
those criteria, management determined that our internal controls over financial reporting were effective as of December 31, 2023.
This Report does not include an attestation report of our independent
registered public accounting firm due to our status as an emerging growth company and a smaller reporting company.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting
that occurred during the fiscal quarter ended December 31, 2023, that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION.
None .
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT
INSPECTIONS
Not Applicable.
51
PART III
ITEM 10.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
Executive Officers and Directors
The following table provides information regarding our key employees
and directors:
Name
Age
Position(s)
Executive Officers
Daniel Jones
43
President, Chief Executive Officer and Chairman
Frances Scally
56
Chief Financial Officer and Secretary
Non-Employee Directors
Patrice M. Milos, Ph.D.
65
Director
Douglas Miscoll
63
Director
David Pfeffer
64
Director
Executive Officers
Daniel Jones is our Chief Executive Officer and Chairman
of the Board. He has been our co-founder, President, and a member of our board of directors since our inception. He has served as Chief
Executive Officer since May 2018 and was elected Chairman of the Board in March 2021. Prior to becoming our CEO, he was President
from inception to May 2018. Mr. Jones has over 15 years of biotechnology industry experience, including 12 plus years
in single molecule sequencing research. Prior to founding our company, Mr. Jones held various positions at Helicos Biosciences, a
publicly-traded biotechnology tools company. During his career at Helicos Biosciences, his responsibilities included applications development,
instrument prototyping and validation, customer support and bioinformatics analysis, as well as sales and operations. In 2008, Mr. Jones
ran the first ever direct RNA sequencing experiments while at Helicos. From December 2003 to March 2007, Mr. Jones worked
at U.S. Genomics in the Methods Development group and on development of its Trilogy 2020 Single Molecule Analyzer and Direct miRNA
assays. From December 2002 to December 2003, Mr. Jones worked at EXACT Sciences on its ColoGuard assay, a non-invasive,
now FDA-approved molecular diagnostic for colorectal cancer. Mr. Jones has authored or co-authored four publications and is named
on multiple patents or patent applications. He holds a B.S. degree from Trinity College and has studied biotechnology and bioinformatics
at Brandeis University and the University of Massachusetts.
We believe Mr. Jones’ experience in the pharmaceutical industry
as well as his extensive understanding of our business, operations and strategy qualifies him to serve on our board of directors.
Frances Scally has served as our Chief Financial Officer
and Secretary since August 2022. Ms. Scally has over 30 years’ experience in strategic accounting and financial leadership,
including serving as chief financial officer, chief accounting officer and in other senior financial executive roles at both domestic
and multi-national public and private companies. Since October 2021, Ms. Scally has been a Managing Director at DLA LLC, an Advisory
firm, in which capacity she provides accounting advisory services. Prior to joining DLA LLC, Ms. Scally was the Chief Accounting Officer
and Acting Chief Financial Officer of Aceto Holdings, L.P. from April 2019 to April 2020, as well as the Chief Accounting Officer
of Aceto Corporation from March 2007 to April 2019. Aceto Corporation is an international company engaged in the development,
marketing, sale and distribution of human health products, pharmaceutical ingredients and performance chemicals. Prior to joining Aceto,
Ms. Scally was the Director of Financial Reporting and Compliance at Veeco Instruments Inc., a manufacturer of semiconductor process equipment,
from 1998-2007. From 1989-1998, Ms. Scally was employed by Ernst & Young LLP. Ms. Scally received a bachelor’s
degree in accounting from LIU Post and is a Certified Public Accountant. She is a member of New York State Society of CPAs and American
Institute of Certified Public Accountants. Ms. Scally also is a Trustee and a member of the Finance Committee for St. Edward the Confessor
Church and School.
Ms. Scally’s services as our Chief Financial Officer are being
secured pursuant to the terms of our Master Services Agreement with DLA LLC, where Ms. Scally is an employee.
52
Non-Employee Directors
Patrice M. Milos, Ph.D. has served as a member of
our board of directors since August 2021. Since September 2020, Dr. Milos has been Vice President, Scientific Operations
of Proof Diagnostics, Inc., a company that is developing a low-cost, rapid diagnostic, point-of-care testing platform for the detection
of COVID-19. From October 2016 to September 2020, Dr. Milos was a co-founder, President and Chief Executive Officer of
Medley-Genomics Inc., a company focused on using advanced data analytics to support better diagnosis and treatment of complex diseases.
From May 2013 to January 2016, Dr. Milos was President and Chief Executive Officer of Claritas Genomics Inc., a subsidiary
of Boston Children’s Hospital that provided commercial next-generation pediatric molecular diagnostic testing. Additional experience
included executive roles at Helicos BioSciences and Pfizer, Inc. Dr. Milos is also a member of the board of directors of 54Gene Inc.,
a U.S. and Nigeria-based startup that collects African genetic code for use in health research and drug development, Slater
Technology Fund, a seed-stage venture investor in early-stage technology ventures, ProThera Biologics, a life-sciences company
developing a fundamentally new paradigm for treating severe inflammation and RI Bio, a bioscience, biotech, health and life sciences industry
network group dedicated to galvanizing collaboration among industry participants. Dr. Milos has received numerous awards and honors
within the life sciences industry and has authored or co-authored over 60 biotech or life sciences publications. She earned a B.A.
in biology and chemistry from The College of Saint Rose, a M.S. and Ph.D. in plant molecular genetics and biology from Rensselaer Polytechnic
Institute and has completed Post-Doctoral work at Harvard University and Brown University in plant and mouse molecular genetics.
We believe Dr. Milos’ management experience and her extensive
background and experience in molecular genetics and biology qualifies her to serve on our board of directors.
Douglas Miscoll has served as a member of our board of
directors since October 2015. Mr. Miscoll founded Ravello Precision Partners in 2015, which operated as a hedge fund focused
on genomic biology companies. Mr. Miscoll founded Ravello Partners LLC in 2010, which manages discretionary portfolios for families
and small institutions and is active in the biotechnology sector. From 1999 until 2009, Mr. Miscoll was a Managing Director at Newlight
Management, where he was responsible for managing all aspects of two private equity funds and a hedgefund focused on technology, media
and communications companies. He originated and directed the firm’s public market investment activities. Previously, from 1994 to
1995, he was a Managing Director of Northgate Ventures, a venture capital fund focused on early stage technology companies. Mr. Miscoll
was a founding member of the management team that created K-III Communications, a leveraged build-up in the publishing and information
services industries sponsored by Kohlberg Kravis Roberts & Co. Mr. Miscoll received an M.B.A. from Georgetown University,
a Graduate Certificate from Templeton College, Oxford University, and a B.A. from Santa Clara University.
We believe Mr. Miscoll’s executive management experience
qualifies him to serve on our board of directors.
David Pfeffer has served as a member of our board of
directors since September 2018 and is currently our Audit Committee Chairman. Mr. Pfeffer has over 30 years of experience
in diverse roles in financial services; leading companies, developing and executing strategy, building businesses up from the ground floor
and driving innovation to grow in today’s ultra-competitive and dynamic global economy. Mr. Pfeffer is currently CEO of
Brick Citi Capital, LLC, an investment services and business advisory firm founded in 2019. Previously, he was Executive Vice President
and Chief Financial Officer of Oppenheimer Funds, a global asset manager, from 2004 to 2019. He was a Management Director on the Oppenheimer
Funds, Inc. board and President of Oppenheimer Funds Harbourview Asset Management. From 2009 to 2019, Mr. Pfeffer served as an Independent
Director at ICI Mutual Insurance Co., including a role as Audit Committee Chairman. From 2000 to 2004, Mr. Pfeffer worked as Institutional
Chief Financial Officer and Director at Citigroup Asset Management. Mr. Pfeffer was at J.P. Morgan from 1984 to 2000, where
he gained significant international experience serving as Chief Financial Officer and Director of JPM Brazil for five years in São
Paulo and supported JPM’s international businesses during his 16 year tenure there. Mr. Pfeffer worked as a public accountant
at Ernst & Whinney from 1981 to 1984. Mr. Pfeffer is a Certified Public Accountant, a Chartered Global Management Accountant
and has his FINRA Series 99 Operations Professional license. He graduated Cum Laude from the University of Delaware with a B.S. in
Accounting.
We believe Mr. Pfeffer’s experience in corporate governance
and capital markets qualifies him to serve on our board of directors.
Family Relationships
There are no family relationships between or among any of our directors
or executive officers. There are no family relationships among our officers and directors and those of our subsidiaries and affiliated
companies.
Board Composition and Classified Board Structure
In accordance with the terms of our restated certificate of incorporation
and amended and restated bylaws, our Board is currently divided into three classes with staggered, three-year terms. At each annual
meeting of stockholders, the successor to each director whose term then expires will be elected to serve from the time of election and
qualification until the third annual meeting of stockholders following election or such director’s death, resignation or removal,
whichever is earliest to occur. The current class structure is as follows: Class I (consisting of Mr. Jones and Dr. Milos),
whose term currently expires at the 2025 Annual Meeting of Stockholders; Class II (consisting of Mr. Miscoll), whose term will
expire at the 2023 Annual Meeting of Stockholders; and Class III (consisting of Mr. Pfeffer), whose term will expire at the
2024 Annual Meeting of Stockholders.
53
The primary responsibilities of our board of directors are to provide
oversight, strategic guidance, counseling and direction to our management. Our board of directors meets on a regular basis. Our bylaws
provide that the authorized number of directors may be changed only by resolution of the board of directors. We have no formal policy
regarding board diversity. Our priority in selection of board members is identification of members who will further the interests of our
stockholders through his or her established record of professional accomplishment, the ability to contribute positively to the collaborative
culture among board members, knowledge of our business and understanding of the competitive landscape.
Director Independence
While our common stock is no longer listed on the Nasdaq Capital
Market, our board of directors has determined that, with respect to our corporate governance, we will continue to comply with the
Nasdaq Marketplace Rules. The Nasdaq Marketplace Rules require a majority of a listed company’s board of directors to be
comprised of independent directors within one year of listing. In addition, the Nasdaq Marketplace Rules require that, subject to
specified exceptions, each member of a listed company’s audit, compensation and nominating and corporate governance committees
be independent and that audit committee members also satisfy independence criteria set forth in Rule 10A-3 under the
Exchange Act.
Under Rule 5605(a)(2) of the Nasdaq Marketplace Rules, a
director will only qualify as an “independent director” if, in the opinion of our board of directors, that person does not
have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director.
In order to be considered independent for purposes of Rule 10A-3 of the Exchange Act, a member of an audit committee of a listed
company may not, other than in his or her capacity as a member of the audit committee, the board of directors, or any other board committee,
accept, directly or indirectly, any consulting, advisory, or other compensatory fee from the listed company or any of its subsidiaries
or otherwise be an affiliated person of the listed company or any of its subsidiaries.
Our board of directors has reviewed the composition of our board of
directors and its committees and the independence of each director. Based upon information requested from and provided by each director
concerning his or her background, employment and affiliations, including family relationships, our board of directors has determined that
each of Patrice Milos, Doug Miscoll and David Pfeffer is an “independent director” as defined under Rule 5605(a)(2) of
the Nasdaq Marketplace Rules. Our board of directors also determined that the directors who serve on our audit committee, our compensation
committee and our nominating and corporate governance committee satisfy the independence standards for such committees established by
the SEC and the Nasdaq Marketplace Rules, as applicable. In making such determinations, our board of directors considered the relationships
that each such non-employee director has with our company and all other facts and circumstances our board of directors deemed relevant
in determining independence, including the beneficial ownership of our capital stock by each non-employee director.
Board Diversity
In August 2021, the SEC approved a Nasdaq Stock Market proposal to
adopt new listing rules relating to board diversity and disclosure. As approved by the SEC, the new Nasdaq listing rules require all Nasdaq
listed companies to disclose consistent, transparent diversity statistics regarding their boards of directors. The Board Diversity Matrix
below presents the Board’s diversity statistics in the format prescribed by the Nasdaq rules.
Board Diversity Matrix (As of March 31, 2024)
Total Number of Directors
4
Female
Male
Non-Binary
Did Not
Disclose
Gender
Part I: Gender Identity
Directors
1
2
1
Part II: Demographic Background
African American or Black
Alaskan Native or Native American
Asian
Hispanic or Latin
Native Hawaiian or Pacific Islander
White
1
2
Two or More Races or Ethnicities
LGBTQ+
Did Not Disclose Demographic Background
1
Board Meetings and Committees
During the year ended December 31, 2023, our board of directors held
nine meetings (including regularly scheduled and special meetings), and no director attended fewer than 75% of the total number of meetings
of the board of directors and the committees of which he or she was a member. In addition, during the year ended December 31, 2023, our
board of directors acted by unanimous written consent on 2 occasions.
54
Although we do not have a formal policy regarding attendance by members
of our board of directors at annual meetings of stockholders, we encourage, but do not require, directors to attend.
Our board of directors has established three standing committees — audit,
compensation, and nominating and corporate governance — each of which operates under a charter approved by our board of
directors. Copies of each committee’s charter has been posted on the Investor Relations section of our website, which is located
at www.seqll.com . Each committee has the composition and responsibilities described below. Our board of directors may from time
to time establish other committees.
Audit Committee
Our audit committee consists of David Pfeffer, who is the chair of
the committee, Douglas Miscoll and Patrice Milos. Our board of directors has determined that each of the members of our audit committee
satisfies the Nasdaq Marketplace Rules and SEC independence requirements. The functions of this committee include, among other things:
●
evaluating the performance, independence and qualifications of our independent auditors and determining whether to retain our existing independent auditors or engage new independent auditors;
●
reviewing and approving the engagement of our independent auditors to perform audit services and any permissible non-audit services;
●
reviewing our annual and quarterly financial statements and reports, including the disclosures contained under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and discussing the statements and reports with our independent auditors and management;
●
reviewing with our independent auditors and management significant issues that arise regarding accounting principles and financial statement presentation and matters concerning the scope, adequacy and effectiveness of our financial controls;
●
reviewing our major financial risk exposures, including the guidelines and policies to govern the process by which risk assessment and risk management is implemented; and
●
reviewing and evaluating on an annual basis the performance of the audit committee, including compliance of the audit committee with its charter.
Our board of directors has determined that David Pfeffer qualifies
as an “audit committee financial expert” within the meaning of applicable SEC regulations and meets the financial sophistication
requirements of the Nasdaq Marketplace Rules. In making this determination, our board of directors has considered Mr. Pfeffer’s
extensive financial experience and business background. Both our independent registered public accounting firm and management periodically
meets privately with our audit committee.
The audit committee had nine meetings in 2023. The audit
committee operates under a written charter that was adopted by our board of directors and satisfies the applicable rules of the SEC
and the listing standards of the NASDAQ Stock Market. A copy of the audit committee charter is available on our website at www.seqll.
com .
Compensation Committee
Our compensation committee consists of Douglas Miscoll, who is the
chair of the committee, and David Pfeffer and Patrice Milos. Our Board has determined that each of the members of our compensation committee
satisfies the Nasdaq Marketplace Rules independence requirements. The functions of this committee include, among other things:
●
reviewing, modifying and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) our overall compensation strategy and policies;
●
reviewing and approving the compensation, the performance goals and objectives relevant to the compensation, and other terms of employment of our executive officers;
●
reviewing and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) the equity incentive plans, compensation plans and similar programs advisable for us, as well as modifying, amending or terminating existing plans and programs;
●
reviewing and approving the terms of any employment agreements, severance arrangements, change in control protections and any other compensatory arrangements for our executive officers;
●
reviewing with management and approving our disclosures under the caption “Compensation Discussion and Analysis” in our periodic reports or proxy statements to be filed with the SEC; and
●
preparing the report that the SEC requires in our annual proxy statement.
55
None of our executive officers currently serves, or in the past fiscal
year has served, as a member of the board of directors or compensation committee of another entity that had one or more of its executive
officers serving as a member of our board of directors or compensation committee. None of the members of our compensation committee has
been at any time one of our officers or employees.
Our compensation committee had one meeting in 2023. The
compensation committee operates under a written charter that was adopted by our board of directors and satisfies the applicable
rules of the SEC and the listing standards of the NASDAQ Stock Market. A copy of the compensation committee charter is available on
our website at www.seqll.com .
Nominating and Corporate Governance Committee
Our nominating and corporate governance committee consists of Douglas
Miscoll, who is the chair of the committee, and Patrice Milos and David Pfeffer. Our board of directors has determined that each of the
members of this committee satisfies the Nasdaq Marketplace Rules independence requirements. The functions of this committee include, among
other things:
●
identifying, reviewing and evaluating candidates to serve on our board of directors consistent with criteria approved by our board of directors;
●
evaluating director performance on our board of directors and applicable committees of our board of directors and determining whether continued service on our board of directors is appropriate;
●
evaluating, nominating and recommending individuals for membership on our board of directors; and
●
evaluating nominations by stockholders of candidates for election to our board of directors.
During 2023, our nominating and corporate governance committee met
one time. The nominating and corporate governance committee operates under a written charter that was adopted by our board
of directors and satisfies the applicable rules of the SEC and the listing standards of the NASDAQ Stock Market. A copy of the nominating
and corporate governance committee charter is available on our website at www.seqll.com .
Scientific Advisors
Our executive team is supported by our Scientific Advisors. The Scientific
Advisors provide scientific advice regarding our tSMS technology to our executive team. Each our Scientific Advisors was selected based
on experience with our tSMS technology and familiarity with our tSMS sequencers. The Scientific Advisors are not required to provide any
particular services to us and are not currently compensated, except for periodic awards of stock options.
Efrat Shema, Ph.D. — Principal Investigator
and Assistant Professor at the Weizmann Institute of Science. Dr. Shema completed her M.Sc. and Ph.D. at the Weizmann Institute in
2007 and 2012 in molecular cell biology, after earning her B.Sc. in life sciences at the Hebrew University in Jerusalem in 2005. She moved
to Boston in 2012 as a Fulbright Scholar, conducting post-doctoral work under Dr. Bradley Bernstein at Massachusetts General Hospital,
Harvard Medical School, and the Broad Institute of MIT and Harvard. During her Ph.D. studies at the Weizmann Institute, Dr. Shema
received a prestigious Adams Fellowship from the Israel Academy of Sciences and Humanities, as well as the Otto Schwartz Prize for Excellence
and a UNESCO-L’OREAL national award for young women in life sciences. Dr. Shema collaborates with us to study epigenetic events
that contribute to cellular differentiation, early development and cancer using innovative single-molecule technologies.
Claes Wahlestedt, M.D., Ph.D. — Director,
Center for Therapeutic Innovation, Leonard M. Miller Professor and Associate Dean for therapeutic innovation at the University of
Miami. From 2005 to 2011, he was a professor and director of neuroscience at The Scripps Research Institute. The author of over 300 papers
in scientific journals, with over 43,000 citations, Dr. Wahlestedt has a long-standing interest in genomics and epigenetics and has
pioneered various translational efforts in these fields. At Scripps in 2008, he co-founded CuRNA (now part of Opko Health), a spin-off
company based on his patent for targeting regulatory noncoding RNAs to up-regulate therapeutic proteins. In 2011, he co-founded Epigenetix
Inc., a University of Miami spin-off focusing on small molecule drugs for a variety of drug targets in cancer and neuroscience. Dr. Wahlestedt
advises us on applications development and scientific strategy.
56
Philipp Kapranov, Ph.D. — Professor and Director,
Institute of Genomics at HuaQiao University, Xiamen, China. Dr. Kapranov’s primary research interest includes systems biology
and genomics in the context of gene expression and discovery of new RNA species (both protein-coding and non-coding) and their functions,
especially in the context of human disease particularly cancer. Dr. Kapranov received his B.Sc. in microbial biotechnology, from
Kiev Institute of Food Industry, Ukraine, and his Ph.D. in genetics from Michigan State University. Previously, he was a Senior Scientist
at Affymetrix where his research first demonstrated an order of magnitude increase in transcriptional activity on human chromosomes 21
and 22 over that accounted for by previously characterized and predicted exons. Dr. Kapranov is a long-time collaborator of ours
who purchased and deployed the first HeliScope in China, which his lab uses for researching non-coding RNA and basic science.
Code of Business Conduct and Ethics
Our board of directors has adopted a written code of conduct that applies
to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting
officer or controller, or persons performing similar functions. A current copy of the code and all disclosures that are required by law
or Nasdaq Marketplace Rules concerning any amendments to, or waivers from, any provision of the code is posted on our website, which is
located at www.seqll.com .
Board Leadership Structure
Our board of directors is free to select the Chairman of the board
of directors and a Chief Executive Officer in a manner that it considers to be in the best interests of our company at the time of selection.
Currently, Daniel Jones serves as our Chief Executive Officer and Chairman of the board of directors. We currently believe that this leadership
structure is in our best interests. As Chairman of the Board, Mr. Jones’ key responsibilities include facilitating communication
between our board of directors and management, assessing management’s performance, managing board members, preparation of the agenda
for each board meeting, acting as chair of board meetings and meetings of our company’s stockholders and managing relations with
stockholders, other stakeholders and the public.
We will take steps to ensure that adequate structures and processes
are in place to permit our board of directors to function independently of management. The directors will be able to request at any time
a meeting restricted to independent directors for the purposes of discussing matters independently of management and are encouraged to
do so should they feel that such a meeting is required.
Our board of directors, as a whole and also at the committee level,
plays an active role overseeing the overall management of our risks. Our Audit Committee reviews risks related to financial and operational
items with our management and our independent registered public accounting firm. Our board of directors is in regular contact with our
Chief Executive Officer and Chief Financial Officer, who report directly to our board of directors and who supervise day-to-day risk
management.
Role of Board in Risk Oversight Process
We face a number of risks, including those described herein under the
caption “Risk Factors.” Our board of directors believes that risk management is an important part of establishing, updating
and executing on our business strategy. Our board of directors has oversight responsibility relating to risks that could affect our corporate
strategy, business objectives, compliance, operations, and the financial condition and performance. Our board of directors focuses its
oversight on the most significant risks facing us and, on our processes, to identify, prioritize, assess, manage and mitigate those risks.
Our board of directors receives regular reports from members of our senior management on areas of material risk to us, including strategic,
operational, financial, legal and regulatory risks. While our board of directors has an oversight role, management is principally tasked
with direct responsibility for management and assessment of risks and the implementation of processes and controls to mitigate their effects
on us.
57
ITEM
11. EXECUTIVE COMPENSATION .
The following table sets forth total
compensation paid to our executive officers for the years ended December 31, 2023 and 2022.
Nonqualified
Non-Equity
Deferred
Option
Incentive Plan
Compensation
All Other
Name and Principal Position
Year
Salary
Bonus
Awards (1)
Compensation
Earnings
Compensation
Total
Daniel Jones
2023
$ 260,673
$ —
$ —
—
—
—
$ 260,673
Chief Executive Officer
2022
225,000
50,000 (4)
178,179
—
—
—
453,179
John W. Kennedy (3)
2023
—
—
—
—
—
—
—
Chief Financial Officer
2022
115,000
100,000
133,634
—
—
—
248,634
Frances Scally (5)
2023
145,000
—
—
—
—
—
145,000
2022
78,250
—
—
—
—
—
78,250
(1) The amounts reported in the “Option Awards” column
reflect the aggregate fair value of stock -based compensation awarded during the year computed in accordance with the provisions of the
Financial Accounting Standard Board Accounting Standards Codification Topic 718, or ASC 718. See Note 2 to SeqLL’s consolidated
financial statements for the year ended December 31, 2022 available at www.sec.gov regarding assumptions underlying the valuation
of equity awards. These amounts reflect the accounting cost for these stock options and do not reflect the actual economic value that
may be realized by the executive officer upon the vesting of the stock options, the exercise of the stock options, or the sale of the
common stock underlying such stock options.
(2) Of this bonus, $75,000 was deferred to, and paid in, 2022. Mr.
Jones shall resign from his positions with our company upon the completion of the Merger.
(3) Mr. Kennedy resigned his position as our Chief Financial Officer
on August 9, 2022.
(4) The $50,000 bonus was paid in 2023.
(5) Ms. Scally was appointed our Chief Financial Officer on August
8, 2022. Ms. Scally is a consultant to our company and all compensation for her services is paid to DLA, LLC, a financial consulting
firm with which Ms. Scally is employed. Ms. Scally shall resign from her position with our company upon the completion of the Merger.
Equity
Compensation Plan Information
The following table provides information as of December 31, 2023,
regarding our compensation plans under which equity securities are authorized for issuance:
Plan category
Number of
Securities to
be Issued
Upon
Exercise of
Outstanding
Options,
Warrants
and Rights
(a)
Weighted-
Average
Exercise
Price of
Outstanding
Options,
Warrants
and Rights
(b)
Number of
Securities
Remaining
Available for
Future
Issuance
Under Equity
Compensation
Plans
(Excluding
Securities
Reflected in
Column (a))
(c)
2014 Equity Incentive Plan – Equity compensation plan approved by security holders
54,020
$ 72.55
19,655
Equity compensation plans not approved by security holders
--
--
—
Total
54,020
$ 72.55
19,655
SeqLL Inc. 2014 Equity Incentive Plan
Our board of directors and our stockholders originally approved our
2014 Equity Incentive Plan, or the 2014 Plan, in April 2014. Our 2014 Plan allows for the grant of equity-based awards to our and
our affiliates’ officers, employees, directors and key persons. On March 18, 2021, our board of directors and stockholders
approved an amendment and restatement of our 2014 Plan to increase the number of shares of common stock available for equity awards under
the 2014 plan to 87,500 shares. The description below is of our 2014 Plan as amended and restated, except as otherwise noted.
58
Purpose. The purpose of our 2014 Plan, as amended and
restated, is to encourage and enable our and our affiliates’ officers, employees, directors and other key persons (including consultants
and prospective employees) upon whose judgment, initiative and efforts we largely depend for the successful conduct of our business to
acquire a proprietary interest in our company.
Eligibility. Participants in our 2014 Plan may include
full or part-time officers, employees, directors and key persons (including advisors and consultants) of our company or our affiliates
who are selected to receive awards from time to time by the administrator in its sole discretion.
Administration. Our 2014 Plan is administered by our
compensation committee, or, if at any time our compensation committee is not in existence, our board of directors. In addition, to the
extent applicable law permits, our board of directors may delegate any of its authority under our 2014 Plan to another committee or one
or more officers, and our compensation committee may delegate any of its authority hereunder to a sub-committee or to one or more officers,
except that no such delegation is permitted with respect to awards made to individuals who are subject to Section 16 of the Exchange Act
unless the delegation is to another committee consisting entirely of “nonemployee directors” within the meaning of Rule 16b-3
of the Exchange Act. Subject to the provisions of our 2014 Plan, the administrator has the power to administer the plan, including
but not limited to, the power to select the eligible officers, employees, directors, and key employees to whom awards are granted; to
determine the number of shares to be covered by each award; to determine the terms and conditions of any award and to amend any outstanding
award.
Authorized Shares. As of December 31, 2023, a total of 87,500 shares of our common
stock were authorized for issuance under our 2014 Plan, and at such date, stock grants of an aggregate of 67,845shares had been made under
the 2014 Plan, and 19,655 shares authorized under the 2014 Plan remained available for award purposes. All of the authorized shares
may be issued pursuant to incentive stock options. The shares available for issuance may be authorized but unissued shares or shares reacquired
by us and held in its treasury. The share reserve under our 2014 Plan is depleted by the maximum number of shares, if any, that may be
issuable under an award as determined at the time of grant. However, awards that may only be settled in cash (determined at the time of
grant) do not deplete the share reserve.
If (1) an award lapses, expires, terminates or is cancelled without
the issuance of shares, (2) it is determined during or at the conclusion of the term of an award that all or some portion of the
shares with respect to which the award was granted will not be issuable on the basis that the conditions for such issuance will not be
satisfied, (3) shares are forfeited under an award, (4) shares are issued under any award and we subsequently reacquire them
pursuant to rights reserved upon the issuance, (5) an award or a portion thereof is settled in cash, or shares are withheld by us
in payment of the exercise price or withholding taxes of an award, then such shares will be recredited to the reserve and may again be
used for new awards. However, shares recredited to reserve pursuant to clause (4) in the preceding sentence may not be issued pursuant
to incentive stock options.
Adjustments to Shares. If, as a result of any reorganization,
recapitalization, reclassification, stock dividend, stock split, reverse stock split or other similar change in our capital stock, the
outstanding shares are increased or decreased or are exchanged for a different number or kind of shares or other securities of our company,
or additional shares or new or different shares or other securities of our company or other non-cash assets are distributed with respect
to such shares or other securities, or, if, as a result of any merger, consolidation or sale of all or substantially all of our assets,
the outstanding shares are converted into or exchanged for a different number or kind of securities of our company or any successor entity
(or a parent or subsidiary thereof), the administrator will make an appropriate or proportionate adjustment in (1) the maximum number
of shares reserved for issuance under our 2014 Plan; (2) the number and kind of shares or other securities subject to any then outstanding
awards under our 2014 Plan; and (3) the exercise price for each share subject to any then outstanding stock options. The administrator
also may adjust the number of shares subject to outstanding awards and the exercise price and the terms of outstanding awards to take
into consideration material changes in accounting practices or principles, extraordinary dividends, acquisitions or dispositions of stock
or property or any other event if it is determined by the administrator that such adjustment is appropriate to avoid distortion in the
operation of our 2014 Plan, subject to the limitations described in our 2014 Plan.
Effect of a Sale Event. Unless otherwise provided in
an award or other agreement, upon a “sale event,” if the successor or surviving corporation (or parent thereof) so agrees,
then, without the consent of any holder of an award (or other person with rights in an award), some or all outstanding awards may be assumed,
or replaced with the same type of award with similar terms and conditions, subject to adjustments described in our 2014 Plan, by the successor
or surviving corporation (or parent thereof) in the sale event. A “sale event” is generally defined for this purpose as (1) any
person becoming the beneficial owner of 50% or more of the combined voting power of our then-outstanding securities (subject to exceptions
and other limitations scribed in our 2014 Plan), (2) our stockholders approving a plan of complete liquidation or dissolution of
our company, (3) the consummation of (a) an agreement for the sale or disposition of all or substantially all of our assets
(other than to certain excluded persons), (b) a merger, consolidation or reorganization of our company with or involving any other
corporation (subject to specified exceptions), or (4) a change in the majority of our board of directors that is not approved by
a supermajority of the existing board. More detailed descriptions and additional information on limitations relating to each of these
sale events are in our 2014 Plan.
If, after a sale event in which the awards are assumed or replaced,
the award holder experiences a termination event as a result of a termination of service without cause, due to death or disability, or
as a result of a resignation for good reason, in each case within 24 months after a sale event, then the award holder’s awards
will be vested in full or deemed earned in full (assuming target performance, if applicable).
To the extent the awards are not assumed or replaced in the sale event,
then, (1) each option will become immediately and fully vested and, unless the administrator determines otherwise, will be canceled
on the sale event in exchange for a cash payment equal to the excess of the price paid in the sale event over the exercise price of the
option, and all options with an exercise price lower than the price paid in the sale event will be canceled for no consideration, (2) restricted
stock and restricted stock units (not subject to performance goals) will be vested in full and settled, along with any accompanying
dividend equivalent units, and (3) all awards subject to performance goals with outstanding performance periods will be canceled
in exchange for a cash payment equal to the amount that would have been due under the award if performance had been satisfied at the better
of target or the performance trend through the sale event.
59
Limit on Director Awards. The maximum value of awards
granted during a single fiscal year to any non-employee director, taken together with any cash fees paid during the fiscal year to the
non-employee director in respect of the director’s service as a member of our board of directors during such year (including service
as a member or chair of any committees of the board), shall not exceed $800,000 in total value for the first year of service and $400,000
for future years of service (calculating the value of any such awards based on the grant date fair value of such awards for financial
reporting purposes).
Types of Awards. Awards under our 2014 Plan may consist
of incentive stock options, non-qualified stock options, restricted stock awards, unrestricted stock awards, restricted stock units,
or any combination of those awards. Some provisions of our 2014 Plan relating to these award types are summarized below.
Stock Options. A stock option is an award entitling the
recipient to acquire shares, at such exercise price as determined by the administrator (which may not be lower than the fair market value
of the underlying shares on the date of grant) and subject to such restrictions and conditions as the administrator may determine at the
time of grant. Conditions may be based on continuing employment (or other service relationship) and/or achievement of pre-established
performance goals and objectives. Stock options granted under our 2014 Plan may be either non-qualified stock options or incentive stock
options. Incentive stock options may be granted only to our employees or employees of our subsidiaries, and must certain requirements
specified in our 2014 Plan and the Code. Stock options will become exercisable at such time or times as determined by the administrator
at or after the grant date and set forth in the stock option agreement. The administrator may at any time accelerate the exercisability
of all or any portion of any stock option.
Restricted Stock. A restricted stock award is a grant
(or sale, at such purchase price as determined by the administrator) of shares that are subject to such restrictions and conditions as
the administrator may determine at the time of grant. Conditions may be based on continuing employment (or other service relationship)
or achievement of pre-established performance goals and objectives. The terms and conditions of each such agreement shall be determined
by the administrator.
Unrestricted Stock. The administrator may grant (or sell
at par value or such higher purchase price determined by the administrator) unrestricted shares, in respect of past services, in exchange
for cancellation of a compensation right, as a bonus, or any other valid consideration, or in lieu of any cash compensation due to such
individual.
Restricted Stock Units and Dividend Equivalent Units. The
administrator may grant restricted stock units representing the right to receive a future payment of cash, the amount of which is
determined by reference to our shares, shares or a combination of cash and shares. The administrator will determine all terms and conditions
of an award of restricted stock units, including but not limited to the number granted, in what form they will be settled, whether
performance goals must be achieved for the restricted stock units to be earned, the length of any vesting or performance period and
the date of payment, and whether the grant will include dividend equivalent units. The administrator will determine all terms and
conditions of an award of dividend equivalent units, including whether payment will be made in cash or shares. However, no dividend
equivalent units may be paid with respect to restricted stock units that are not earned or that do not become vested.
Termination of Employment or Service. Except as otherwise
provided in any award agreement or an award holder’s employment offer letter, severance letter or services agreement, or as determined
by administrator at the time of the award holder’s termination of employment or service:
●
If the termination is for cause, the award holder will forfeit all outstanding awards immediately upon termination and will not be permitted to exercise any stock options following termination.
●
If the termination is due to the award holder’s death or disability (when the award holder could not have been terminated for cause), the award holder will forfeit the unvested portion of any award, and any vested stock options will remain exercisable until the earlier of the original stock option expiration date or 12 months from the date of termination.
●
If the termination was for any reason other than cause, death or disability (when the award holder could not have been terminated for cause), the award holder will forfeit the unvested portion of any award, and any vested stock options will remain exercisable until the earlier of the original stock option expiration date or three months from the date of termination.
Term of Plan and Plan Amendments. Our 2014 Plan will
continue until all shares reserved for issuance under our 2014 Plan have been issued, or, if earlier, until such time as the administrator
terminates our 2014 Plan as described below. No incentive stock options may be granted after the ten (10) year anniversary of the
date of stockholder approval of the amendment and restatement of our 2014 Plan unless the stockholders have approved an extension.
60
Our board of directors may, at any time, amend, terminate or discontinue
our 2014 Plan, except that our stockholders must approve any amendment to the extent approval is required by Section 16 of the Exchange Act,
the Code, the listing requirements of any principal securities exchange or market on which our shares are then traded or any other applicable
law. In addition, stockholders must approve any amendment to our 2014 Plan that would materially increase the number of shares reserved
(except as permitted by the adjustment provisions of our 2014 Plan) or that would diminish the protections afforded by the anti-repricing
provisions of our 2014 Plan.
Any termination of our 2014 Plan will not affect the authority of our
board of directors and the administrator to administer outstanding awards or affect the rights of award holders with respect to awards
previously granted to them.
Award Amendments, Cancellation and Disgorgement. Subject
to the anti-repricing and other requirements of our 2014 Plan, the administrator may modify, amend or cancel any award. However, except
as otherwise provided in our 2014 Plan or an award agreement, the consent of the award holder is required to any amendment that materially
diminishes the holder’s rights under the award. Our 2014 Plan includes exceptions to the consent requirement for actions necessary
to comply with applicable law or the listing requirements of securities exchanges, to preserve favorable accounting or tax treatment of
any award for our company or to the extent the administrator determines that an action does not materially and adversely affect the value
of the award or is in the best interest of the affected award holder or any other person who has an interest in the award.
The administrator has full power and authority to terminate or cause
an award holder to forfeit an award, and require an award holder to disgorge to us, any gains attributable to the award, if the award
holder engages in any action constituting, as determined by the administrator in its discretion, cause for termination, or a breach of
any award agreement or any other agreement between the award holder and us or one of our affiliates concerning noncompetition, non-solicitation,
confidentiality, trade secrets, intellectual property, non-disparagement or similar obligations. In addition, any awards granted pursuant
to our 2014 Plan, and any shares issued or cash paid pursuant to an award, will be subject to any recoupment or claw-back policy that
is adopted by us from time to time, or any recoupment or similar requirement otherwise made applicable to us by law, regulation or listing
standards.
Repricing and Backdating Prohibited. Notwithstanding
anything in our 2014 Plan to the contrary, and except for the adjustments provided for in our 2014 Plan, neither the administrator nor
any other person may (1) amend the terms of outstanding stock options to reduce the exercise or grant price of such outstanding stock
options; (2) cancel outstanding stock options in exchange for stock options with an exercise or grant price that is less than the
exercise or grant price of the original stock options; or (3) cancel outstanding stock options with an exercise or grant price above
the current fair market value of a share in exchange for cash or other securities. In addition, the administrator may not make a grant
of a stock option with a grant date that is effective prior to the date the administrator takes action to approve the award.
Incentive Plan Awards
We did not make any stock option grants to our executive officers during
the fiscal year ended December 31, 2023.
61
Outstanding Equity Awards at Fiscal Year-End
The following table sets forth outstanding equity awards to our named
executive officers as of December 31, 2023.
Option Awards
Stock Awards
Name
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
Option
Exercise
Price
Option
Expiration
Date
Number of Shares or
Units of
Stock that
have not
Vested
Market
Value of
Shares or
Units of
Stock that
have
not
Vested
Daniel Jones
4,460
—
$ 98.40
9/5/2028
—
$ —
Daniel Jones
2,396
2,604
$ 69.20
1/13/2032
—
—
Director Compensation
General. The following discussion describes the significant
elements of the expected compensation program for members of our board of directors and its committees. The compensation of our directors
is designed to attract and retain committed and qualified directors and to align their compensation with the long-term interests
of our shareholders. Directors who are also executive officers (each, an “Excluded Director”) will not be entitled to receive
any compensation for his or her service as a director, committee member or Chair of our board of directors or of any committee of our
board of directors.
Director Compensation Arrangements. Our non-employee director
compensation program is designed to attract and retain qualified individuals to serve on our board of directors. Our board of directors,
on the recommendation of our compensation committee, will be responsible for reviewing and approving any changes to the directors’
compensation arrangements. In consideration for serving on our board of directors, each director (other than Excluded Directors) will
be paid an annual retainer. All directors will be reimbursed for their reasonable out-of-pocket expenses incurred while serving as
directors.
Our board of directors has approved the following compensation program
for the non-employee members of our board of directors.
Cash Compensation. Under such program, we will pay each non-employee director
a cash fee, payable quarterly, of $4,167 per month for service on our board of directors.
Equity Awards. Each non-employee director will receive
a one-time initial stock option award for 16,216 shares of our common stock, which options shall vest in arrears in two equal
tranches on the first and second anniversaries of service on our Board. Each non-employee director shall also be eligible to receive
grants of stock options, each in an amount designated by the Compensation Committee of our board of directors, from any equity compensation
plan approved by the Compensation Committee of our Board.
In addition to such compensation, we will reimburse each non-employee director
for all pre-approved expenses within 30 days of receiving satisfactory written documentation setting out the expense actually
incurred by such director. These include reasonable transportation and lodging costs incurred for attendance at any meeting of our board
of directors.
62
The following table sets forth the director compensation we accrued
in the year ended December 31, 2023 (excluding compensation to our executive officers set forth in the summary compensation table
above).
Name
Fees
Earned or
Paid in Cash
Option
Awards
Total
($)
Douglas Miscoll
$
50,000
$
—
$
50,000
David Pfeffer
60,000
(1)
—
60,000
Patrice M. Milos, Ph.D.
50,000
—
50,000
—
—
—
Total:
$
160,000
$
$
160,000
(1)
Of the amount reported in the “Fees or Paid in Cash” column, $10,000 was deferred to and paid in 2023.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
The following table sets forth certain information regarding the beneficial
ownership of our common stock as of April 1, 2024 by:
● each
person known by us to be a beneficial owner of more than 5% of our outstanding common stock;
● each
of our directors;
● each
of our named executive officers; and
● all
directors and executive officers as a group.
The amounts and percentages of common stock beneficially owned are
reported on the basis of regulations of the SEC governing the determination of beneficial ownership of securities. Under the rules of
the SEC, a person is deemed to be a “beneficial owner” of a security if that person has or shares “voting power,”
which includes the power to vote or to direct the voting of such security, or “investment power,” which includes the power
to dispose of or to direct the disposition of such security. A person is also deemed to be a beneficial owner of any securities of which
that person has a right to acquire beneficial ownership within 60 days after April 1, 2024. Under these rules, more than one person
may be deemed a beneficial owner of the same securities and a person may be deemed a beneficial owner of securities as to which he has
no economic interest. Except as indicated by footnote, to our knowledge, the persons named in the table below have sole voting and investment
power with respect to all shares of common stock shown as beneficially owned by them. The applicable percentage ownership is based on 380,648 shares
of common stock outstanding as of April 1, 2024.
63
Unless otherwise noted below, the address of the persons listed on
the table is c/o SeqLL Inc., 3 Federal Street, Billerica, Massachusetts 01821.
Name and Address of Beneficial Owner
Number of
Shares
Percentage
Executive Officers and Directors
Daniel Jones (1)
67,081
17.3 %
Frances Scally
-
-
Dr. Patrice M. Milos (2)
2,176
*
Douglas Miscoll (3)
4,080
1.1
David Pfeffer (4)
2,155
*
All directors and executive officers as a group (5 persons)
75,492
19.2
5% Stockholders
William C. St. Laurent (5)
87,105
22.8
St. Laurent Investments, LLC (6)
38,932
10.2
Wendy St. Laurent (7)
18,607
4.9
* Represents
beneficial ownership of less than 1%.
(1) Includes
(i) 59,809 shares of common stock and (ii) 7,272 shares of common stock issuable upon the exercise of currently exercisable
stock options.
(2) Includes
(i) 250 shares of common stock and (ii) 1,926 shares of common stock issuable upon the exercise of currently exercisable
stock options.
(3) Includes
(i) 1,369 shares of common stock and (ii) 2,711 shares of common stock issuable upon the exercise of currently exercisable
stock options.
(4) Includes
(i) 500 shares of common stock and (ii) 1,655 shares of common stock issuable upon the exercise of currently exercisable
stock options.
(5) Includes
(i) 406 shares of common stock issuable upon the exercise of currently exercisable stock options and (ii) 18,607 shares
of common stock held by Mr. St. Laurent’s spouse, (iii) 38,932 shares of common stock beneficially owned by St.
Laurent Investments LLC, (iv) 14,580 shares of common stock beneficially owned by the Georges C. St. Laurent III
Descendants’ Trust and (v) 14,580 shares of common stock beneficially owned by the William C. St Laurent Descendant’s
Trust. The address of Mr. St. Laurent is 120 NE 136 Avenue, Vancouver, WA 98684.
(6) Includes
(i) 38,265 shares of common stock, and (ii) 667 shares of common stock issuable upon the exercise of currently
exercisable warrants. William C. St. Laurent is the managing member of St. Laurent Investments, LLC and, as a result, may be
deemed to have voting and investment power with respect to the shares held by St. Laurent Investments, LLC. The address of St. Laurent
Investments, LLC is 120 NE 136 Avenue, Vancouver, WA 98684.
(7) The
address of Wendy St. Laurent is 120 NE 136 Avenue, Vancouver, WA 98684.
64
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR
INDEPENDENCE.
Procedures for Approval of Related Party Transactions
A “related party transaction” is any actual or proposed
transaction, arrangement or relationship or series of similar transactions, arrangements or relationships, including those involving indebtedness
not in the ordinary course of business, to which we or our subsidiaries were or are a party, or in which we or our subsidiaries were or
are a participant, in which the amount involved exceeded or exceeds the lesser of (i) $120,000 or (ii) one percent of the average
of our total assets at year-end for the last two completed fiscal years and in which any related party had or will have a direct
or indirect material interest. A “related party” includes:
●
any person who is, or at any time during the applicable period was, one of our executive officers or one of our directors;
●
any person who beneficially owns more than 5% of our common stock;
●
any immediate family member of any of the foregoing; or
●
any entity in which any of the foregoing is a partner or principal or in a similar position or in which such person has a 10% or greater beneficial ownership interest.
In March 2021, our board of directors adopted a written related-party transactions
policy. Pursuant to this policy, the Audit Committee of our board of directors will review all material facts of all related-party transactions
and either approve or disapprove entry into the related-party transaction, subject to certain limited exceptions. In determining
whether to approve or disapprove entry into a related-party transaction, our Audit Committee shall take into account, among other
factors, the following: (i) whether the related-party transaction is on terms no less favorable to us than terms generally available
from an unaffiliated third party under the same or similar circumstances; (ii) the extent of the related party’s interest in
the transaction; and (iii) whether the transaction would impair the independence of a non-employee director.
Related Party Transactions
At December 31, 2023, the Company had the following outstanding payables
to affiliated parties for past services:
December 31,
2023
SeqLL Omics Inc.
$ 73,764
St. Laurent Realty, Inc.
7,558
Total related party payables
$ 81,322
St. Laurent Realty, Inc. assisted the Company by previously providing
corporate accounting support, this entity is affiliated with William C. St. Laurent, a former member of the Company’s board of directors.
SeqLL Omics was formed by Daniel Jones, the Chairman
of the Board and Chief Executive Officer of the Company, and certain other Company employees, for the purpose of carrying on the Company’s
pre-Merger business after the Mergers. SeqLL Omics currently performs research and development services for the Company, in order to facilitate
the Company’s pre-Merger research and development efforts. The Company incurred $73,764 in relation to the services provided by
SeqLL Omics during the year ended December 31, 2023.
From April 29, 2019 to April 29, 2020, we entered into a series of
non-convertible promissory notes (the “Promissory Notes”) with St. Laurent Investments LLC amounting to $1,375,000. The Promissory
Notes, as amended, are accruing interest at 5% per annum. In June 2022, we entered into an agreement with St. Laurent Investments LLC
to extend the maturity date of the Promissory Note to July 31, 2024.
65
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
The following table sets forth the fees billed to us for professional
services rendered by Wolf & Co. for the years ended December 31, 2023 and 2022:
Services
2023
2022
Audit fees
$ 165,500
$ 147,800
Audit-related fees
109,350
8,700
Total fees
$ 274,850
$ 156,500
(1) Audit
Fees — Audit fees consist of fees billed for the audit of our annual financial statements and the review of the interim
consolidated financial statements.
(2) Audit-Related Fees — Audit-related services consist
of fees billed for assurance and related services that are reasonably related to performance of the audit or review of our financial statements
and are not reported under “Audit Fees.”.
Pre-Approval Policies and Procedures
The Audit Committee has the authority to appoint or replace our independent
registered public accounting firm (subject, if applicable, to stockholder ratification). The Audit Committee is also responsible for the
compensation and oversight of the work of the independent registered public accounting firm (including resolution of disagreements between
management and the independent registered public accounting firm regarding financial reporting) for the purpose of preparing or issuing
an audit report or related work. The independent registered public accounting firm was engaged by, and reports directly to, the Audit
Committee.
The Audit Committee pre-approves all audit services and permitted non-audit
services (including the fees and terms thereof) to be performed for us by our independent registered public accounting firm, subject to
the de minimis exceptions for non-audit services described in Section 10A(i)(1)(B) of the Exchange Act and Rule 2-01(c)(7)(i)(C) of
Regulation S-X, provided that all such excepted services are subsequently approved prior to the completion of the audit. We have
complied with the procedures set forth above, and the Audit Committee has otherwise complied with the provisions of its charter.
66
PART IV
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES .
Incorporation
by Reference
Exhibit
Number
Description
of Exhibits
Form
Filing
Date
Exhibit
Number
2.1
Agreement and Plan of Reorganization
8-K
5/31/23
2.1
2.2
Amendment
No. 1 to Agreement and Plan of Reorganization effective as of June 22, 2023
8-K
6/23/23
2.2
2.3
Amendment
No. 2 to Agreement and Plan of Reorganization effective as of October 5, 2023
S-1/A
10/18/23
2.3
2.4
Amendment
No. 3 to Agreement and Plan of Reorganization effective as of October 17, 2023
S-1/A
10/18/23
2.4
2.5
Amendment No. 4 to Agreement and Plan of Reorganization effective as of November 3, 2023
S-1/A
11/7/23
2.5
2.6
Amendment No. 5 to Agreement and Plan of Reorganization effective as of January 16, 2024
8-K
1/18/24
2.1
3.1
Amended and Restated Certificate of Incorporation
8-K
8/31/21
3.1
3.2
Amended and Restated Bylaws
8-K
8/31/21
3.2
4.1
Description of Securities
10-K
3/23/22
4.1
4.2
Specimen common stock certificate
S-1/A
5/22/19
4.1
4.3
Warrant Agency Agreement dated as of August 31, 2021 between SeqLL Inc. and VSTOCK Transfer LLC
8-K
8/31/21
10.1
4.4
Form of Common Stock Purchase Warrant
S-1/A
8/16/21
4.6
10.1#
Amended and Restated 2014 Equity Incentive Plan
S-1
3/31/21
10.1
10.2
License Agreement dated March 15, 2013 between SeqLL, LLC and Helicos Biosciences Corporation
S-1
4/23/19
10.2
10.3
Sub-License Agreement dated March 15, 2013 between SeqLL, LLC and Helicos Biosciences Corporation
S-1
4/23/19
10.3
10.4
Asset Purchase Agreement dated as of May 29, 2023
8-K
5/31/23
10.1
10.13
Investor Rights Agreement dated as of September 30, 2018
S-1/A
5/28/21
10.13
22*
Subsidiaries of the Registrant
23*
Consent of Wolf & Company, P.C.
31.1*
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as Adopted pursuant to Section 302 of The Sarbanes-Oxley Act of 2002
31.2*
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted pursuant to Section 302 of The Sarbanes-Oxley Act of 2002
32.1*
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as Adopted pursuant to Section 906 of The Sarbanes-Oxley Act of 2002
32.2*
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted pursuant to Section 906 of The Sarbanes-Oxley Act of 2002
101.INS
Inline XBRL Instance Document.
101.SCH
Inline XBRL Taxonomy Extension
Schema Document.
101.CAL
Inline XBRL Taxonomy Extension
Calculation Linkbase Document.
101.DEF
Inline XBRL Taxonomy Extension
Definition Linkbase Document.
101.LAB
Inline XBRL Taxonomy Extension
Label Linkbase Document.
101.PRE
Inline XBRL Taxonomy Extension
Presentation Linkbase Document.
104
Cover Page Interactive
Data File (formatted as Inline XBRL and contained in Exhibit 101).
*
Filed herewith.
#
Indicates a management contract or compensatory plan.
ITEM 16. FORM 10–K SUMMARY
None.
67
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934 the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized,
on the 9th day of April, 2024.
SEQLL INC.
By:
/s/ Daniel Jones
Daniel Jones
Chief Executive Officer
Pursuant to the requirements of the Securities
Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Daniel Jones
Chief Executive Officer and Chairman
April 9, 2024
Daniel Jones
(Principal Executive Officer)
/s/ Frances Scally
Chief Financial Officer and Secretary
April 9, 2024
Frances Scally
(Principal Financial and Accounting Officer)
/s/ Douglas Miscoll
Director
April 9, 2024
Douglas Miscoll
/s/ David Pfeffer
Director
April 9, 2024
David Pfeffer
/s/ Dr. Patrice Milos
Director
April 9, 2024
Dr. Patrice Milos
68
SEQLL INC.
CONSOLIDATED FINANCIAL STATEMENTS
Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm (PCAOB ID: 392 ) F-2
Consolidated Balance Sheets F-3
Consolidated Statements of Operations and Comprehensive Loss F-4
Consolidated Statements of Changes in Stockholders’ Equity F-5
Consolidated Statements of Cash Flows F-6
Notes to Consolidated Financial Statements F-7
F- 1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Stockholders and the Board of Directors of SeqLL, Inc.:
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of SeqLL,
Inc. (the “Company”) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive
loss, stockholders’ equity and cash flows for the years then ended, and the related notes to the consolidated financial statements
(collectively, the “financial statements”). In our opinion, the financial statements present fairly, in all material respects,
the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for the years
then ended, in conformity with accounting principles generally accepted in the United States of America.
Emphasis of a Matter Regarding Going Concern
The accompanying
financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial
statements, the Company has suffered recurring losses and negative cash flows from operations and has a significant accumulated deficit.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in
regard to these matters are described in Note 1. The financial statements do not include any adjustments that might result from the outcome
of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public
accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required
to be independent with respect to the Company in accordance with U.S. federal securities laws and the applicable rules and regulations
of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB.
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free
of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit
of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control
over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material
misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures
included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included
evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation
of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Wolf & Company, P.C .
We have served as the Company’s auditor since 2018.
Boston, MA
April 9, 2024
F- 2
SeqLL Inc.
Consolidated Balance Sheets
December 31,
2023
2022
Assets
Current assets
Cash and cash equivalents
$ 2,693,991
$ 2,180,525
Marketable securities
-
4,036,014
Accounts receivable, net of allowance for doubtful accounts of $ 24,507 and $ 6,016 as of December 31, 2023 and 2022, respectively
2,723
21,214
Other receivables
-
60,000
Inventory
-
165,852
Prepaid expenses
32,933
171,859
Total current assets
2,729,647
6,635,464
Other assets
Property and equipment, net
625,360
530,108
Operating lease right-of-use asset
998,346
1,129,715
Other assets
83,008
118,954
Total assets
$ 4,436,361
$ 8,414,241
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable
$ 522,940
$ 622,436
Accrued expenses
375,191
495,462
Current portion of finance lease liability
59,659
-
Current portion of operating lease liability
198,314
110,114
Non-convertible promissory notes
1,375,000
-
Total current liabilities
2,531,104
1,228,012
Non-current liabilities
Finance lease liability, less current portion
51,481
-
Operating lease liability, less current portion
1,246,033
1,444,343
Non-convertible promissory notes - long-term
-
1,375,000
Total non-current liabilities
1,297,514
2,819,343
Total liabilities
3,828,618
4,047,355
Commitments and contingencies (Note 12)
Stockholders’ equity
Preferred stock, $ 0.00001 par value; 20,000,000 shares authorized; 0 shares issued and outstanding
-
-
Common stock, $ 0.00001 par value; 300,000,000 shares authorized; 380,648 and 330,648 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively
4
3
Additional paid-in capital
24,744,014
22,853,116
Accumulated deficit
( 24,136,275 )
( 18,508,684 )
Accumulated other comprehensive income
-
22,451
Total stockholders’ equity
607,743
4,366,886
Total liabilities and stockholders’ equity
$ 4,436,361
$ 8,414,241
See accompanying report
of independent registered public accounting firm and notes to the consolidated financial statements.
Reflects a 1-for-40 reverse stock split effective
August 30, 2023
F- 3
SeqLL Inc.
Consolidated Statements of Operations and Comprehensive
Loss
December 31,
2023
2022
Revenue
Sales
$ -
$ 1,177
Grant revenue
-
77,482
Total revenue
-
78,659
Cost of sales
-
690
Gross profit
-
77,969
Operating expenses
Research and development
2,253,354
1,568,266
General and administrative
3,479,155
2,506,851
Total operating expenses
5,732,509
4,075,117
Operating loss
( 5,732,509 )
( 3,997,148 )
Other (income) and expenses
Investment income
( 82,665 )
( 44,879 )
Unrealized gain on marketable equity securities
-
( 54,508 )
Realized loss (gain) on marketable equity securities
( 106,051
)
106,324
Interest expense, net
83,798
90,748
Net loss
( 5,627,591 )
( 4,094,833 )
Other comprehensive income
Unrealized gain on marketable debt securities
-
22,451
Reclassification adjustment for net gains included in net loss
( 22,451 )
-
Total comprehensive loss
$ ( 5,650,042 )
$ ( 4,072,382 )
Net loss per share – basic and diluted
$ ( 15.03 )
$ ( 12.38 )
Weighted average common shares – basic and diluted
374,484
330,648
See accompanying report of independent registered public accounting
firm and notes to the consolidated financial statements.
Reflects a 1-for-40 reverse stock split effective
August 30, 2023
F- 4
SeqLL Inc.
Consolidated Statements of Changes in Stockholders’ Equity
Preferred Stock
Common Stock
Additional
Paid-In
Accumulated
Other
Comprehensive
Accumulated
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Deficit
Equity
Balance as of December 31, 2021
-
$ -
330,648
$ 3
$ 22,596,216
$ -
$ ( 14,413,851 )
8,182,368
Stock-based compensation expense
-
-
-
-
256,900
-
-
256,900
Other comprehensive income
-
-
-
-
-
22,451
-
22,451
Net loss
-
-
-
-
-
-
( 4,094,833 )
( 4,094,833 )
Balance as of December 31, 2022
-
$ -
330,648
$ 3
$ 22,853,116
$ 22,451
$ ( 18,508,684 )
$ 4,366,886
Issuance of common stock, net of issuance costs of $ 300,750
-
-
50,000
1
1,499,249
-
-
1,499,250
Stock-based compensation expense
-
-
-
-
391,649
-
-
391,649
Other comprehensive loss
-
-
-
-
-
( 22,451 )
-
( 22,451 )
Net loss
-
-
-
-
-
-
( 5,627,591 )
( 5,627,591 )
Balance as of December 31, 2023
-
$ -
380,648
$ 4
$ 24,744,014
$ -
$ ( 24,136,275 )
$ 607,743
See accompanying report of independent
registered public accounting firm and notes to the consolidated financial statements.
Reflects a 1-for-40 reverse stock
split effective August 30, 2023
F- 5
SeqLL Inc.
Consolidated Statements of Cash Flows
December 31,
2023
2022
Cash Flows from Operating Activities
Net loss
$ ( 5,627,591 )
$ ( 4,094,833 )
Adjustment to reconcile net loss to net cash used in operating activities:
Depreciation
154,234
87,937
Write-off of obsolete inventory
165,852
79,011
Unrealized gain on marketable equity securities
-
( 54,508 )
Realized (gain)/loss on marketable debt and equity securities
( 106,051 )
106,324
Provision for bad debts
78,491
-
Stock-based compensation
391,649
256,900
Non-cash lease expense
21,259
111,984
Changes in operating assets and liabilities
Accounts receivable, net
-
9,500
Other receivables
-
( 25,035 )
Prepaid expenses
101,420
14,197
Inventory
-
( 20,708 )
Other assets
35,946
( 68,466 )
Accounts payable
( 99,496 )
( 248,928 )
Accrued expenses
( 120,271 )
184,057
Net cash used in operating activities
( 5,004,558 )
( 3,662,568 )
Cash Flows from Investing Activities
Purchases of lab equipment
( 61,989 )
( 40,020 )
Purchases of marketable debt securities
( 2,800,386 )
( 4,014,153 )
Proceeds from sales of marketable equity securities
-
5,882,138
Maturity of marketable debt securities
6,920,000
-
Net cash provided by investing activities
4,057,625
1,827,965
Cash Flows from Financing Activities
Proceeds from issuance of common stock, gross
1,800,000
-
Payment for issuance costs of common stock
( 300,750 )
-
Repayments of finance lease liability
( 38,851 )
-
Net cash provided by financing activities
1,460,399
-
Net increase (decrease) in cash and cash equivalents
513,466
( 1,834,603 )
Cash and cash equivalents, beginning of period
2,180,525
4,015,128
Cash and cash equivalents, end of period
$ 2,693,991
$ 2,180,525
Supplemental disclosure of cash flow information and non-cash financing transactions
Right-of-use asset acquired through operating lease
$ -
$ 1,257,495
Fixed assets acquired through finance lease
$ 187,497
$ -
Leasehold improvements financed through tenant improvement allowance
$ -
$ 312,758
See accompanying report
of independent registered public accounting firm and notes to the consolidated financial statements.
F- 6
SeqLL Inc.
Notes to Consolidated Financial Statements
Years Ended December 31, 2023 and 2022
Note 1 – Nature of Operations
and Basis of Presentation
SeqLL Inc. was incorporated as a Delaware corporation
on April 3, 2014. On April 8, 2014, SeqLL Inc. acquired a 100 % ownership interest in SeqLL, LLC (“Subsidiary”), a domestic
limited liability company formed on March 11, 2013 in the State of Massachusetts. SeqLL Inc. is a holding company of the Subsidiary (together
the “Company” or “SeqLL”) and is a life sciences company focused on the development and application of innovative
genetic analysis technologies and the monetization of these technologies and related intellectual property. The Subsidiary owns technology
to enable the analysis of large volumes of genetic material by directly sequencing single molecules of DNA or RNA. The Subsidiary’s
principal office is located in Billerica, Massachusetts.
On April 26, 2023, SeqLL Merger LLC (“SeqLL
Merger Sub”) was formed in the State of Delaware as a wholly-owned subsidiary of the Company. SeqLL Merger Sub was formed solely
for the purpose of completing the Mergers (defined below). SeqLL Merger Sub has not carried on any activities as of December 31,
2023, except for activities incidental to its formation and activities undertaken in connection with the Merger.
On August 30, 2023, the Company executed one-for-40
reverse stock split as disclosed further below.
Proposed
Merger
On May 29, 2023, the Company, SeqLL Merger LLC,
a Delaware limited liability company and a wholly-owned subsidiary of the Company (“Purchaser Sub”), Atlantic Acquisition
Corp, a Delaware corporation (“Atlantic”), Atlantic Merger LLC, a Delaware limited liability company and a majority-owned
subsidiary of Atlantic (“Atlantic Merger Sub”), Lyneer Investments, LLC, a Delaware limited liability company (“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 (the “Lyneer
Merger”), and (ii) Purchaser Sub will subsequently be merged with and into Lyneer, with Lyneer continuing as the surviving entity
and as a wholly-owned subsidiary of the Company (the “SeqLL Merger” and, together with the Lyneer Merger, the “Mergers”).
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 Mergers
and (ii) the requirement of each party to maintain and preserve intact their respective business organizations, assets, properties and
material business relations.
The obligation of each of the Company, Atlantic
and Lyneer, and their respective subsidiaries, to complete the Mergers is subject to the fulfillment (or waiver, to the extent permissible
under applicable law) of certain customary closing conditions, plus the conditions that (i) the stockholders of the Company shall have
approved the issuance of the shares of the Company’s common stock in the Mergers, (ii) the Company completes the Capital Raise
to certain amount of gross proceeds as defined in the Merger Agreement, part of which will be used to pay the Cash Consideration (as
defined in the Merger Agreement), and (iii) the Company maintains the continued listing of the Company’s common stock on the Nasdaq
Capital Market following the Mergers.
F- 7
The
Merger Agreement, as most recently amended on January 16, 2024, contains certain termination rights, including (i) by mutual consent
of the Company, Atlantic, IDC and Lyneer Management, (ii) by any of the Company, Atlantic, IDC or Lyneer Management upon a material breach
of the representations or of any covenants or agreements of certain other parties, (iii) by any of the Company, Atlantic, IDC or Lyneer
Management if the Mergers have not been consummated by March 15, 2024 (the “Termination Date”), (iv) by any of the Company,
Atlantic, IDC or Lyneer Management if any governmental authority shall have issued an order or taken any other action permanently enjoining,
restraining or otherwise prohibiting the transactions contemplated by the Merger Agreement, (v) by any of the Company, Atlantic, IDC
or Lyneer Management if the special meeting of the Company’s stockholders has been held and the approval of the issuance of the
common stock of the Company in the Mergers and the change of control of the Company that will be effected as a result of such issuance
and certain other proposals contemplated by the related proxy statement was not approved, or (vi) by Atlantic, IDC or Lyneer Management
if the Company is in breach of the rules and regulations of the Nasdaq Stock Market LLC (“Nasdaq”) or has received a notice
from Nasdaq relating to the delisting or maintenance of listing of the Company’s common stock on Nasdaq and the Company fails to
cure and maintain its listing on Nasdaq prior to the closing of the Mergers.
Prior to its amendment, under the terms of the
Merger Agreement, in connection with the consummation of the Mergers, the Company was required to declare (i) a cash dividend payable
to its stockholders of record as of April 26, 2023 (the “Record Date”) in an amount equal to the Company’s cash and
cash equivalents as of the closing date of the SeqLL Merger (exclusive of any proceeds of the Capital Raise), less any amounts withheld
for taxes and certain other obligations as of such date and (ii) a stock dividend issuable to such stockholders of an aggregate of 819,352
shares of the Company’s common stock, assuming a public offering price of $ 10.00 per share in the Capital Raise. Subsequent amendments
removed the requirement for the declaration of such dividends in consideration of the Company’s agreement to make a settlement
offer within 90 days of the closing of the Mergers to its stockholders of record as of the Record Date for such dividends 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 the Company’s
common stock that such stockholders would have received had such dividends been declared and made.
The terms of the Merger Agreement as further
disclosed and described in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can
be accessed by the public over the Internet at the SEC’s website at http:/www.sec.gov or on the Company’s website at www.seqll.com/.
Reverse Stock Split
On August 29, 2023,
the Company filed a Certificate of Amendment (the “Certificate of Amendment”) to the Company’s Third Amended and Restated
Certificate of Incorporation to (i) effect a reverse stock split of its issued common stock, par value $ 0.00001 per share (“Common
Stock”), in the ratio of one-for-40 (the “Reverse Stock Split”) to be effective at 11:59 p.m., eastern time, on August
30, 2023, and (ii) to increase the authorized capital stock of the Company to 320,000,000 shares, of which 300,000,000 shares shall be
Common Stock, and 20,000,000 shares shall be Preferred Stock (the “Capital Stock Increase”). The Common Stock began trading
on a split-adjusted basis at the market open on August 31, 2023.
The Reverse Stock Split and the Capital Stock
Increase were approved by the stockholders as part of the Special Meeting. No fractional shares were issued as a result of the Reverse
Stock Split. Instead, any fractional shares that would have resulted from the Reverse Stock Split were rounded up to the nearest whole
number. The Reverse Stock Split affected all stockholders uniformly and did not alter any stockholder’s percentage interest in
the Company’s outstanding Common Stock, except for adjustments that may have resulted from the treatment of fractional shares.
All of the Company’s historical share and
per share information related to issued and outstanding common stock and outstanding options and warrants exercisable for common stock
in these financial statements have been adjusted, on a retroactive basis, to reflect this 1-for-40 reverse stock split.
F- 8
Asset Purchase Agreement
In connection with the execution and delivery of the Merger
Agreement, the Company entered into an asset purchase agreement (“Asset Purchase Agreement”) with SeqLL Omics, Inc., a
Delaware corporation (“SeqLL Omics”) on May 29, 2023. SeqLL Omics was formed by Daniel Jones, the Chairman of the Board
and Chief Executive Officer of the Company, and certain other Company employees, for the purpose of carrying on the Company’s
pre-Merger business after the Mergers. Subject to the terms and conditions of the Asset Purchase Agreement, including the
consummation of the Mergers, SeqLL Omics has agreed to purchase from the Company, and the Company has agreed to sell to SeqLL Omics,
for a purchase price of $ 1,000 , all of the Company’s rights, title and interests in the assets and properties of the Company
as it exists immediately prior to consummation of the Mergers, excluding cash and cash equivalents, including without
limitation:
●
all inventory;
●
all leasehold interests
in real estate;
●
all contracts with customers,
vendors and suppliers and all technology license agreements;
●
all intellectual property
and general intangibles;
●
all equipment and other
tangible assets used in, or related to, its business operations; and
●
all accounts receivable.
In addition to keeping its cash and cash equivalents,
the Company will not sell or transfer, and SeqLL Omics will not acquire, certain contracts unrelated to the Company’s pre-Merger
business operations, the Company’s corporate records or its rights under the Merger Agreement.
Pursuant to the Asset Purchase Agreement, SeqLL
Omics will assume from the Company all obligations or liabilities of the Company related to its pre-Merger business operations, including
those under the contracts and leases that it will purchase, other than the following:
●
obligations to pay any
rent pursuant to the Company’s real estate lease prior to the first anniversary of the closing under the Asset Purchase Agreement;
●
all obligations of the
Company under the Merger Agreement;
●
obligations of the Company
that are not related to the Company’s current business operations and arise following the closing;
● amounts payable under the promissory note of the Company in the principal amount of $ 1,375,000 payable to St. Laurent Investments LLC, an entity affiliated with William C. St. Laurent, one of the founders and (directly and through affiliates) a principal stockholder of the Company; and
●
any obligations under the
excluded contracts.
The Company will be responsible for the payment
of transfer taxes, if any, related to the transfer of the transferred assets.
Common Stock Issuance
On February 15, 2023, the Company issued 50,000
shares of common stock to investors, after the reflection of the Reverse Stock Split, at a price of $ 36.00 per share. The gross proceeds
of the issuance was $ 1,800,000 . The Company incurred offering costs of $ 300,750 .
Delisting from the Nasdaq Stock Market
On September 8, 2023, and September 18, 2023, the Company received
letters from Nasdaq regarding our compliance with Nasdaq Listing Rule 5550(a)(4), which requires us to have a minimum of 500,000 publicly-held shares
of common stock, exclusive of shares held by officers, directors and 10 % stockholders. The letters from Nasdaq indicated that according
to its calculations, as of September 7, 2023, the Company no longer met the requirements of such Rule, and the Company was given
until September 25, 2023 to submit a plan to Nasdaq to regain compliance. On September 22, 2023, the Company advised Nasdaq
that it expected to regain compliance with Rule 5550(a)(4) upon consummation of the Merger and Nasdaq granted the Company
an extension through October 15, 2023 to demonstrate compliance with the public float rule. On October 16, 2023, the Company
submitted a late request asking that the public float exception be extended through October 31, 2023. On October 17, 2023, Nasdaq
issued a final extension to October 31, 2023 and advised the Company that no further continuances would be granted and that the Company’s
failure to meet the terms of the extension would result in the immediate delisting of our securities from Nasdaq.
F- 9
On November 9, 2023, the Company confirmed to Nasdaq that our
public float as of October 31, 2023 and November 10, 2023, was below the minimum requirement in Rule 5550(a)(4). On November 10,
2023, the Company received a letter from Nasdaq indicating that, in light of the Company’s inability to meet the terms of Nasdaq’s
amended decision of October 17, 2023, Nasdaq determined to delist the Company’s securities from Nasdaq. Nasdaq suspended trading
in the Company’s securities effective at the open of trading on November 13, 2023. As the Company is pursuing a new listing
of its securities on Nasdaq, the Company has withdrawn its request for a hearing on the delisting.
On
February 21, 2024, the Company received the remove from listing notice from Nasdaq as it relates to the Company’s common stock
and warrants.
Risks and Uncertainties
The Company is subject to a number of risks similar
to other companies in its industries, including rapid technological change, competition from larger pharmaceutical and biotechnology
companies and dependence on key personnel.
Results of operations may be adversely affected
by various factors that could cause economic uncertainty and volatility in the financial markets, many of which are beyond the Company’s
control. The Company’s business could be impacted by, among other things, downturns in the financial markets or in economic conditions,
inflation, increases in interest rates, and geopolitical instability, such as the military conflicts in Ukraine and the Israel-Hamas
war. The Company cannot at this time fully predict the likelihood of one or more of the above events, their duration or magnitude or
the extent to which they may negatively impact the Company’s business.
Basis of Presentation
The accompanying consolidated financial statements
include the accounts of SeqLL Inc. and its wholly-owned subsidiaries, SeqLL, LLC and SeqLL Merger Sub. All intercompany accounts
and transactions have been eliminated in consolidation.
Going Concern Uncertainty
The accompanying consolidated financial statements have been prepared
on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
We experienced negative cash flows from operations of $ 5,004,558 for the year ended December 31, 2023, which included our costs and expenses
related to the transactions contemplated by the Merger Agreement. As a result of our recent common stock offerings in August 2021 and
February of 2023 and the maturity of our marketable debt securities, we had cash and cash equivalents of we had cash and cash equivalents
of $ 2,693,991 at December 31, 2023.
The Company estimates cash resources will be sufficient to fund its
operations into the first quarter of 2025. The Company will need additional capital to fund its planned operations for the next 12 months,
if the Merger is not completed. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.
The consolidated financial statements for the years ended December
31, 2023 and 2022 were prepared under the assumption that the Company will continue as a going concern, which contemplates that the Company
will be able to realize assets and discharge liabilities in the normal course of business.
Since inception, we have funded our operations primarily through equity
and debt financings, as well as from modest sales of products and research services. As of December 31, 2023, and we had an accumulated
deficit of $ 24,136,275 .
The Company expects that it will seek to raise additional capital through
equity offerings, grant financing, and convertible debt. Additional funds may not be available when it needs them on terms that are acceptable
to them, or at all. If adequate funds are not available, it may be required to delay its operational strategies, and to delay or reduce
the scope of its research or development programs.
F- 10
Note 2 – Significant Accounting Policies
A summary of significant accounting policies
followed by the Company in the preparation of the accompanying consolidated financial statements are as follows:
Use of Estimates
The preparation of the financial statements in
conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), requires management
to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities
at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates include
but are not limited to stock-based compensation expense, and discount rates used to establish operating and finance lease liabilities.
Actual results could differ from those estimates and changes in estimates may occur.
Cash and Cash Equivalents
The Company considers all highly liquid securities
readily convertible to cash that mature within three months or less from the original date of purchase to be cash equivalents. Financial
instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. Cash
and cash equivalents are held by financial institutions and are federally insured up to certain limits. At times, the Company’s
cash and cash equivalents balance exceeds the federally insured limits. As of December 31, 2023, the Company has not experienced a loss
on its accounts for which it exceeds federally insured deposit limits, and does not expect a loss to occur.
Accounts Receivable
Accounts receivable are presented net of an allowance for credit losses,
which is an estimate of amounts that may not be collectible. The Company performs ongoing credit evaluations of its customers and monitors
economic conditions to identify facts and circumstances that may indicate its receivables are at risk of collection. The Company provides
reserves against accounts receivable for estimated credit losses, if any, that may result from a customer’s inability to pay based
on the composition of its accounts receivable, current economic conditions and historical credit loss activity. Amounts deemed uncollectible
are charged or written-off against the reserve. The allowance for doubtful accounts was $ 24,507 and $ 6,016 as of December 31, 2023, and
2022.
Investments in marketable securities
The Company accounts for its investments in debt
securities in accordance with Accounting Standards Codification (“ASC”) 320, Investments — Debt Securities (“ASC
320”). Debt securities (which were comprised of investments in U.S. Treasury Securities at December 31, 2022), are measured at
fair value, based on quoted market prices. As the Company has classified its investments in debt securities as available-for-sale, the
Company recognizes all unrealized gains and losses in other comprehensive income, net of tax, and recognizes all realized gains and losses
in net income/loss within the Company’s consolidated statement of operations and comprehensive loss.
F- 11
The Company accounts for its investments in equity securities in accordance
with ASC 321, Investments — Equity Securities (“ASC 321”). Equity securities, which are comprised
of investments in mutual funds shares, are measured at fair value, based on quoted market prices, with all gains and losses reported
in net income/loss within the Company’s consolidated statement of operations and comprehensive loss.
The Company may sell its debt or equity securities
in response to changes in interest rates, risk/reward characteristics, liquidity needs or other factors.
Inventory
Inventory consists of finished goods, work-in-process
and raw materials and is valued at the lower of cost or net realizable value, determined by the first-in, first-out (“FIFO”)
method. As the Company manufactures the finished goods and work-in-process materials, overhead costs are included in inventory. The Company
evaluates the carrying cost of finished goods, work-in-process and raw materials items. To the extent that such costs exceed future demand
estimates and /or exhibit historical turnover at rates less than current inventory levels, the Company reduces the carrying value of
the applicable inventories. Inventory consisted of the following:
December 31,
2023
2022
Raw materials
$ -
$ 114,175
Work in process
-
51,677
Total inventory
$ -
$ 165,852
In December of 2022, the Company performed a
detailed evaluation of its inventory and determined $ 79,011 was obsolete. As such, the Company has written off this inventory as
of December 31, 2022.
In March 2023, the Company performed a detailed
evaluation of its inventory and given the lack of sales activity in prior periods, the Company has written off its remaining inventory.
Property and Equipment
Property and equipment are recorded at cost and
depreciated over the estimated useful lives of the related assets using the straight-line method. Lab and office equipment are depreciated
over a five-year period. Leasehold improvements are depreciated over the shorter of the useful life and the term of the lease. Refer
to Leases below for the Company’s finance lease accounting policy. When assets are retired or otherwise disposed of, the
cost of these assets and related accumulated depreciation or amortization are eliminated from the balance sheet and any resulting gains
or losses are included in the consolidated statement of operations and comprehensive loss in the period of disposals.
Long-lived Assets
The Company assesses, on an annual basis, the
recoverability of the carrying amount of long-lived assets used in continuing operations. Recoverability of assets to be held and used
is measured by a comparison of the carrying amount of an asset to the future net cash flow expected to be generated by the asset. A loss
is recognized when expected future cash flow (undiscounted and without interest) are less than the carrying amount of the asset. The
impairment loss is determined as the difference by which the carrying amount of the asset exceeds its fair value. No impairments were
recognized in the years ended December 31, 2023, and 2022.
Revenue Recognition
The Company’s revenue is generated primarily
from the sale of products and research services. Product revenue primarily consists of sales of genetic sequencing equipment and sequencing
reagent kits. Research service revenue primarily consists of revenue generated from gene sequencing services and grants.
F- 12
The Company recognizes revenue in accordance
with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”).
Under ASC 606, the Company recognizes revenue when control of its products and services is transferred to its customers in an amount
that reflects the consideration the Company expects to receive from its customers in exchange for those products and services. To determine
the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, the Company performs
a five-step process. This process involves identifying the contract with a customer, determining the performance obligations in the contract,
determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing
revenue when (or as) the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations
in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available
to the customer and is separately identified in the contract. The Company only applies the five-step process to contracts when it is
probable that the entity will collect consideration it expects to be entitled to in exchange for the goods or services it transfers to
the customer.
The Company evaluates contingent payments to
estimate the amount which is not probable of a material reversal to include in the transaction price using the most likely amount method.
Future payments that are not within the control of the Company, are not considered probable of being achieved until the contingencies
are resolved.
Revenue from product sales, including customized
sequencing instruments and sequencing reagent kits and off-the-shelf consumables, is recognized generally upon delivery, which is when
control of the product is deemed to be transferred.
Revenue from gene sequencing services, using
the tSMS platform, is recognized generally as the services are provided to the customer. The components of the sequencing process, including
reagent kits and off-the-shelf consumables, sample loader and sequencer, are not distinct within the context of the gene sequencing service
contract. This is because in a gene sequencing service contract the reagent kits and other components, such as off-the-shelf consumables,
used in the sequencing process, become required inputs to achieve the specified gene sequencing analysis, and the components in the sequencing
process are sequential in nature and highly interrelated as they work together to generate sample-specific data.
As the Company’s standard payment terms
are less than one year, the Company has elected the practical expedient under ASC 606-10-32-18 to not assess whether a contract has a
significant financing component. The Company has elected to exclude sales tax from revenue. The Company generally has no obligations
for returns, refunds and other similar obligations and does not provide separate equipment warranties.
The Company recognized $ 0 in revenues from gene
sequencing services for the years ended December 31, 2023 and 2022, respectively. The Company recognized $ 0 and $ 1,177 in revenues from
product sales for the years ended December 31, 2023 and 2022, respectively.
Grant Revenue
The Company’s grant revenues are derived
from research programs by various departments of the National Institute of Health (“NIH”).
Grants awarded to SeqLL for research and development
by government entities are outside the scope of the contracts with customers and contributions guidance. This is because these granting
entities are not considered to be customers and are not receiving reciprocal value for their grant support provided to the Company. These
grants provide the Company with payments for certain types of expenditures in return for research and development activities over a contractually
defined period.
The Company recognizes NIH grant revenue as reimbursable
grant costs that are incurred up to pre-approved award limits within the budget period. The costs associated with these reimbursements
are reflected as a component of research and development expense in the accompanying consolidated statements of operations and comprehensive
loss. In the years ended December 31, 2023, and 2022, the Company recognized grant revenue of $ 0 and $ 77,482 , respectively.
F- 13
Income Taxes
The Company utilizes the liability method of
accounting for income taxes as required by ASC 740, Income Taxes . Under this method, deferred tax assets and liabilities are determined
based on differences between financial reporting and the tax basis of assets and liabilities as well as net operating loss carryforwards
and tax credits and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse.
Deferred tax assets are reduced by a valuation allowance if it is more likely than not that these assets may not be realized. Currently,
there is no provision for income taxes, as the Company has incurred operating losses to date, and a full valuation allowance has been
provided on the net deferred tax assets.
The Company determines whether it is more likely
than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained,
none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the
more-likely-than-not recognition threshold is calculated as the largest amount that is more than 50 % likely of being realized upon resolution
of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income
taxes.
The Company has no accruals for interest or penalties related to income
tax matters. Tax years subsequent to 2020 remain open to examination by federal and state tax authorities.
Stock-based Compensation
The Company’s stock-based compensation
program awards include stock options and restricted stock awards. The fair value of stock option grants is estimated as of the date of
the grant using the Black-Scholes option pricing model. The fair value of restricted stock units is based on the fair value of the Company’s
common stock on the date of the grant. The fair value of the awards is then expensed over the requisite service period, generally the
vesting period, for each award as compensation expense.
The Company’s expected stock price volatility
assumption is based on the volatility of comparable public companies. The expected term of a stock option granted to employees and directors
(including non-employee directors) is based on the average of the contractual term (generally 10 years) and the vesting period. For non-employee
options, the expected term is the contractual term. The risk-free interest rate is based on the yield of U.S. Treasury securities consistent
with the life of the option. The expected dividend yield was set to zero as the Company does not pay dividends on its common stock and
there was no expectation of doing so as of the respective grant dates. The Company recognizes forfeitures related to stock-based awards
as they occur.
The Company has periodically granted stock options
and restricted stock units to non-employees for services pursuant to the Company’s stock plans at the fair market value on the
respective dates of grant. Should the Company terminate any of its consulting agreements, the unvested options underlying the agreements
would be cancelled. For awards granted to non-employees, compensation expense is recognized over the service period.
The assumptions used in determining the fair
value of share-based awards granted during the years ended December 31, 2023 and 2022 are as follows:
December 31,
2023
2022
Risk-free interest rate
3.59 % – 4.13 %
1.64 %
Expected option life
6 – 6.1 years
6 – 6.1 years
Expected dividend yield
0 %
0 %
Expected stock price volatility
57 %
54 %
F- 14
Research and Development Expenses
The Company expenses all research and development
costs as incurred. Included in research and development costs are wages, stock-based compensation and benefits of employees and other
operational costs related to the Company’s research and development activities, including facility-related expenses and external
costs of outside contractors engaged by the Company.
Segments
The Company operates in a single business segment
that includes the design, development and commercialization of products and services based on its proprietary genetic analysis technologies.
Leases
The Company accounts for its leases in accordance
with ASU No. 2016-02, Leases (Topic 842) . The Company assesses its contracts at inception to determine whether the contract contains
a lease, including evaluation of whether the contract conveys the right to control an explicitly or implicitly identified asset for a
period of time. The Company classifies its leases as either finance or operating leases, with classification affecting the pattern of
expense recognition in the Company’s consolidated financial statements. The Company accounts for the leases of less than 12 months
as short-term leases.
The Company recognizes right-of-use assets and
lease liabilities that represent the net present value of future lease payments utilizing the discount rate implicit in the lease. If
the implicit rate is not available, the Company uses incremental borrowing rate. The Company amortizes the right-of-use assets over the
remaining terms of the specific lease.
The Company’s operating lease is included
in Operating lease right-of-use asset, and Current portion of operating lease liability and Operating lease liability, less current portion
in the consolidated balance sheets.
The Company’s finance lease is included
in Property and equipment, net, Current portion of finance lease liability and Finance lease liability, less current portion in the consolidated
balance sheets.
Net Loss per Share
Basic net loss per share is computed by dividing
the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potentially
dilutive securities if their effect is antidilutive. Diluted net loss per share is computed by dividing the net loss by the weighted
average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury
stock and if-converted methods. Dilutive common stock equivalents are comprised of options outstanding under the Company’s stock
option plan and warrants. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted
shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.
The following potential shares of common stock
were not considered in the computation of diluted net loss per share as their effect would have been antidilutive:
December 31,
2023
2022
Restricted stock units
13,825
-
Stock options
54,020
50,098
Warrants for common stock
95,777
109,705
F- 15
Recently Adopted Accounting Standards
In June 2016, the Financial Accounting Standards
Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments-Credit Losses:
Measurement of Credit Losses on Financial Instruments . ASU 2016-13 requires measurement and recognition of expected credit losses
for financial assets. In April 2019, the FASB issued clarification to ASU 2016-13 within ASU 2019-04, Codification Improvements to
Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments , or ASU
2016-13. The guidance is effective for fiscal years beginning after December 15, 2022. The Company adopted this standard on January 1,
2023, which had no material impact on the Company’s consolidated financial statements.
Recently Issued Accounting Standards
The Company does not believe that any recently
issued but not yet effective accounting pronouncements will have a material effect on the accompanying consolidated financial statements.
Note 3 – Property and Equipment, net
Property and equipment are recorded at historical
cost and consist of the following:
December 31,
2023
2022
Lab equipment
$ 739,557
$ 767,010
Leasehold improvements
357,006
312,758
Office equipment
23,193
23,193
1,119,756
1,102,961
Less: accumulated depreciation
( 494,396 )
( 572,853 )
$ 625,360
$ 530,108
During the year ended December 31, 2023, the
Company wrote off $ 232,693 of fully depreciated obsolete assets.
Depreciation expense amounted to $ 154,234 and $ 86,397 for the years
ended December 31, 2023 and 2022, respectively, of which $ 28,125 and $ 0 related to the equipment under the finance lease for the years
ended December 31, 2023 and 2022, respectively.
Note 4 – Accrued Expenses
Accrued expenses consist of the following:
December 31,
2023
2022
Accrued interest
375,191
306,821
Accrued bonuses
-
135,000
Other
-
53,641
$ 375,191
$ 495,462
Note 5 – Fair Value Measurements
The accounting guidance defines fair value, establishes
a consistent framework for measuring fair value and requires disclosure for each major asset and liability category measured at fair
value on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received
to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based
measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a
basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the
inputs used in measuring fair value as follows:
Level 1:
Observable inputs such
as quoted prices in active markets.
Level 2:
Inputs, other than the
quoted prices in active markets that are observable either directly or indirectly.
Level 3:
Unobservable inputs in
which there is little or no market data, which require the reporting entity to develop its own assumptions.
F- 16
The Company did not have any assets or liabilities
that were measured at fair value on a recurring basis as of December 31, 2023.
The following table summarizes fair value measurements by level on
December 31, 2022 of the Company’s assets measured at fair value on a recurring basis:
Fair Value Measurements Using
Fair Value
Level 1
Level 2
Level 3
U.S. government and agency obligations
$ 4,036,014
$ 4,036,014
-
-
There are no assets or liabilities measured at fair value on a non-recurring
basis during the years ended December 31, 2023 and 2022.
The carrying values of financial instruments such as accounts receivable,
net, other receivables, accounts payable, and accrued expenses approximated their fair values as of December 31, 2023 and December 31,
2022 due to their short-term maturities. The carrying value of the Company’s Non-Convertible Promissory Notes approximated its fair
value as of December 31, 2023 and December 31, 2022.
Note 6 – Stock Option Plan
The Company’s 2014 Equity Incentive Plan
(the “2014 Plan”) permits the grant of options and restricted stock units for its common stock and shares of common stock
to its employees, board members and consultants for up to 87,500 shares.
As of December 31, 2023, there were 19,655 shares available for future
issuance under the 2014 Plan. Generally, option awards are granted with an exercise price equal to the fair value of the Company’s
stock at the date of grant and vest over a period of three to four years. No option may have a term in excess of ten years from the option
grant date. Certain option and share awards provide for accelerated vesting if there is a change in control (as defined by the 2014 Plan).
The weighted average grant date fair value of options granted during the years ended December 31, 2023 and 2022 was $ 11.60 and $ 35.60 ,
respectively, per share.
The stock option activity for the year ended
December 31, 2023 is as follows:
Number
of
Options
Weighted-
Average
Exercise
Price
per Share
Weighted
Average
Remaining
Contractual
Term
(in Years)
Outstanding as of December 31, 2022
50,098
$ 75.20
7.09
Granted
13,550
$ 20.04
10.00
Cancelled/Forfeited
( 9,628 )
$ 116.68
Outstanding of December 31, 2023
54,020
$ 72.55
6.81
Exercisable at December 31, 2023
27,075
$ 50.56
2.53
F- 17
The restricted stock unit activity for the year
ended December 31, 2023 is as follows:
Number
of
Shares
Weighted-
Average
Exercise
Price
per Share
Weighted
Average
Remaining
Contractual
Term
(in Years)
Outstanding as of December 31, 2022
-
$ -
-
Granted
13,825
$ 25.60
Outstanding of December 31, 2023
13,825
$ 25.60
9.17
Exercisable at December 31, 2023
-
$ -
-
During the years ended December 31, 2023 and 2022, the Company recorded
$ 391,649 and $ 256,900 of stock-based compensation associated with granted and vested stock options and restricted
stock units, respectively. As of December 31, 2023, there was $ 682,312 of unrecognized compensation expense related to unvested stock-based
compensation awards, which will be recognized over approximately 1.16 years.
Note 7 – Related Party Transactions
At December 31, 2023 and 2022, the Company had
the following outstanding payables, which are included within the Company’s accounts payable above, to affiliated parties for past
services:
December 31,
2023
December 31,
2022
SeqLL Omics Inc.
$ 73,764
$ -
Genomic Diagnostic Technologies
-
925
St. Laurent Institute
-
232,418
St. Laurent Realty, Inc.
7,558
7,558
Total related party payables
$ 81,322
$ 240,901
The above entities are affiliated with (1) William
C. St. Laurent, a former member of the Company’s board of directors, (2) relatives of Mr. St. Laurent or (3) entities controlled
by the St. Laurent family, who are controlling shareholders of the Company. St. Laurent Realty, Inc. and Genomic Diagnostic Technologies
assisted the Company by previously providing corporate accounting support; St. Laurent Institute, a non-for-profit company, provided
bioinformatics specialist support for certain sequencing services.
SeqLL Omics was formed by Daniel Jones, the Chairman
of the Board and Chief Executive Officer of the Company, and certain other Company employees, for the purpose of carrying on the Company’s
pre-Merger business after the Mergers. SeqLL Omics currently performs research and development services for the Company, in order to
facilitate the Company’s pre-Merger research and development efforts. The Company incurred $ 73,764 in relation to the services
provided by SeqLL Omics during the year ended December 31, 2023.
Note 8 – Notes Payable
From April 29, 2019, to April 29, 2020, the Company
entered into a series of non-convertible promissory notes, as amended (the “Promissory Notes”) with a certain preferred stockholder
amounting to $ 1,375,000 . The Promissory Notes had a one-year term with interest accruing at 5 % per annum. In June 2022, the Company entered
into an agreement with St. Laurent Investments LLC to extend the maturity date of the $ 1,375,000 Promissory Note to July 31, 2024. The
Company accounted for this transaction as a modification on a prospective basis.
For the years ended December 31, 2023 and 2022,
interest expense related to the non-convertible promissory notes was $ 68,370 and $ 90,748 , respectively.
F- 18
Note 9 – Common Stock Warrants
The following table summarizes information with
regard to outstanding warrants to purchase common stock as of December 31, 2023:
Number of
Shares
Issuable
Upon
Exercise of
Outstanding
Exercise
Issuance Date
Warrants
Price
Expiration Date
1/31/2019
48
$ 124.00
1/30/2024
2/7/2019
41
$ 124.00
2/6/2024
2/21/2019
41
$ 124.00
2/20/2024
3/20/2019
84
$ 124.00
3/18/2024
4/8/2019
48
$ 124.00
4/6/2024
11/19/2020
1,333
$ 164.00
6/30/2024
11/19/2020
213
$ 164.00
6/30/2024
1/8/2021
333
$ 164.00
6/30/2024
1/11/2021
667
$ 164.00
6/30/2024
2/13/2021
333
$ 164.00
6/30/2024
3/16/2021
267
$ 164.00
6/30/2024
3/16/2021
333
$ 164.00
6/30/2024
8/31/2021
87,975
$ 170.00
8/31/2026
8/31/2021
3,825
$ 187.00
8/26/2026
9/29/2021
236
$ 187.00
8/26/2026
95,777
During the year ended December 31, 2023, warrants to purchase 12,162
and 1,763 shares of common stock with an exercise price of $ 86.40 and $ 124.00 , respectively, expired.
During the year ended December 31, 2022, warrants to purchase 130 shares
of common stock with an exercise price of $ 124.00 expired.
Note 10 – Marketable Securities
The Company did not hold any marketable securities
as of December 31, 2023.
The cost and fair value of marketable securities,
which are available-for-sale debt securities, were $ 4,013,563 and $ 4,036,014 as of December 31, 2022, respectively, resulting in
a $ 22,451 unrealized gain included in the other comprehensive income for the year ended December 31, 2022.
The Company recognized a net realized loss of
$ 51,816 on marketable equity securities for the year ended December 31, 2022.
The Company’s interest and dividend income
amounted to $ 106,051 and $ 44,879 for the years ended December 31, 2023, and 2022, respectively.
F- 19
Note 11 - Income Taxes
The Tax Cuts and Jobs Act (the “TCJA”)
resulted in significant changes to the treatment of research or experimental (“R&E”) expenditures under Section 174.
For tax years beginning after December 31, 2021, taxpayers are required to capitalize and amortize all R&E expenditures that are
paid or incurred in connection with their trade or business which represent costs in the experimental or laboratory sense. Specifically,
costs for U.S. based R&E activities must be amortized over five years and costs for foreign R&E activities must be amortized
over 15 years; both using a midyear convention. The Company has implemented this standard on January 1, 2022, noting that the impact
on the Company’s consolidated financial statements was immaterial.
The Company is subject to United States federal and Massachusetts state
income taxes at an approximate combined rate of 29 % in 2023. During the years ended December 31, 2023 and 2022, there was no provision
for income taxes as the Company incurred losses during both periods. The primary component of the Company’s deferred tax assets
are its net operating loss carryforwards. At December 31, 2023, the Company has a federal and state net, operating loss carryforward of
approximately $ 21,893,488 and $ 21,486,471 , respectively, which begin expiring in 2034.
The Company’s 2018 and after federal net
operating losses can be carried forward indefinitely.
The valuation allowance against deferred tax assets was approximately
$ 6.3 million and $ 5.5 million as of December 31, 2023, and 2022, respectively. During the years ended December 31, 2023 and 2022, the
valuation allowance increased by approximately $ 0.8 million and $ 1.2 million, respectively.
As of December 31, 2023, the Company did
not maintain any foreign subsidiaries and did not have previously deferred foreign earnings subject to the transition tax.
The income tax benefit differs from the amount
of income tax determined by applying the U.S. federal income tax rate to pretax income for the years ended December 31, 2023 and
2022 due to the following:
2023
2022
Computed “expected” tax benefit
( 21.0 )%
( 21.0 )%
Increase (decrease) in income taxes resulting from:
State taxes, net of federal benefit
( 8.0 )%
( 8.0 )%
Permanent differences
0 %
0 %
Increase in valuation reserve
29.0 %
29.0 %
0 %
0 %
Note 12 – Commitments and Contingencies
Leases
The Company’s office space lease in Woburn,
Massachusetts (the “Woburn Lease”) for the Company’s corporate headquarters was on a month-to-month basis since November
2020 and was terminated in February 2022. The rent expense for this lease was $ 0 and $ 14,239 for the years ended December 31, 2023 and
2022, respectively.
On February 2, 2022, the Company entered into
a lease agreement for approximately 15,638 square feet of its new corporate office space in Billerica, Massachusetts (the “Billerica
Lease”). The Billerica Lease has a term of 92 months from its effective date and included access to certain additional office space
until August 1, 2022. In addition, the Company is required to share in certain taxes and operating expenses of the Billerica Lease.
The Billerica Lease is classified as an operating
lease. At the inception date of the Billerica Lease, the Company recorded a right-of-use asset of $ 1,481,646 in operating lease right-of-use
asset, as well as a lease liability of $ 12,222 in current liabilities and $ 1,547,614 in long-term liabilities. The operating lease right-of
use asset is less than that of the Company’s lease liabilities as of the lease inception date. This is due to the fact that the
Company as part of the Billerica Lease was allowed certain tenant improvement allowances, which amounted to $ 78,190 at lease inception.
This lease liability represented the net present value of future lease payments for the lease utilizing a discount rate of 5.98 %, which
corresponded to the Company’s incremental borrowing rate.
In August 2022, the Company received the tenant
improvement allowance from the landlord, which totaled approximately $ 312,758 . This allowance covered the leasehold improvements to the
Billerica space and was accounted for as a reduction to the right-of-use asset. As of December 31, 2023, the remaining lease term was
5.75 years.
The Company recorded expense related to the Billerica
Lease in the amount of $ 218,563 and $ 200,350 for the years ended December 31, 2023 and 2022, respectively.
During the years ended December 31, 2023 and
2022, the Company made cash payments of $ 197,307 and $ 88,366 , for amounts included in the measurement of lease liabilities.
As of December 31, 2023, the Company has presented
$ 198,314 in current portion of operating lease liability and $ 1,246,033 in operating lease liability, less current portion.
F- 20
Finance Lease
On May 1, 2023, the Company entered into a lease
agreement for laboratory equipment (the “Equipment Lease”). The Equipment Lease has a term of 36 months from its effective
date, and an end of lease purchase option of $ 1 . The Equipment Lease was classified as a finance lease. At the inception date of the
Equipment Lease, the Company recorded a right-of-use asset of $ 187,497 in property and equipment, net, as well as a lease liability of
$ 52,881 in current liabilities and $ 97,110 in long-term liabilities. The finance lease right of use asset is more than that of the Company’s
lease liabilities at the inception of the lease due to a prepayment on the lease made by the Company of $ 37,506 . The lease liability
represented the net present value of future lease payments over the lease term utilizing a discount rate of 17.44 %, which corresponded
to the rate implicit to the lease.
As of December 31, 2023, the remaining lease
term was 1.75 years.
The Company recorded expense of $ 38,854 related
to the Equipment Lease for the year ended December 31, 2023.
The Company made cash payments of $ 54,281 for
the year ended December 31, 2023.
Interest expense related to the Equipment Lease
totaled $ 15,428 for the year ended December 31, 2023. The equipment is included in Property and equipment, net and is depreciated on
a straight-line basis over a five-year period. The Company amortizes the equipment over its useful life as the Company is reasonably
certain to exercise the $ 1 purchase option for the equipment at the end of the lease term.
Depreciation expense related to finance lease
assets totaled $ 28,125 for the year ended December 31, 2023.
As of December 31, 2023, the Company has presented
$ 59,659 in current portion of finance lease liability and $ 51,481 in finance lease liability, less current portion.
The following table reconciles the undiscounted
lease liabilities to the total lease liabilities recognized on the consolidated balance sheet as of December 31, 2023:
Operating
Lease
Finance
Lease
2024
$ 275,875
$ 72,375
2025
284,151
54,281
2026
292,676
-
2027
301,456
-
2028
310,500
-
Thereafter
238,078
-
Total undiscounted lease liabilities
$ 1,702,736
$ 126,656
Less effects of discounting
258,389
15,516
Total lease liabilities
$ 1,444,347
$ 111,140
Note 13 – Subsequent Events
As part
of the Company’s continuing efforts to reduce operating expenses and conserve cash following the execution of the Merger Agreement,
the Company further reduced its workforce by terminating the employment of three full-time employees. The Company incurred total costs
of approximately $ 44,956 associated with this workforce reduction.
F-21
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.