PROSPECTUS SUMMARY
This summary of the prospectus
highlights material information concerning our business and this offering. This summary does not contain all of the information that
you should consider before making your investment decision. You should carefully read the entire prospectus and the documents incorporated
by reference herein, including the information presented under the section entitled “Risk Factors”, before making an investment
decision. This summary contains forward-looking statements that involve risks and uncertainties. Our actual results may differ significantly
from future results contemplated in the forward-looking statements as a result of factors such as those set forth in “Risk Factors”
and “Cautionary Statement Regarding Forward-Looking Statements.”
In this prospectus, unless
the context indicates otherwise, the terms “we,” “our,” “ours” “us” or similar terminology
refer to iSpecimen, Inc.
We amended our Certificate
of Incorporation on March 30, 2021 in order to effect a 1-for-5.545 reverse stock split of all outstanding shares of our common stock.
Throughout this prospectus, each reference to a number of our issued and outstanding common stock gives effect to the reverse split, unless
otherwise indicated.
Overview
iSpecimen is technology-driven
company founded to address a critical challenge: how to connect life science researchers who need human biofluids, tissues, and living
cells (“biospecimens”) for their research, with the billions of biospecimens available (but not easily accessible) in healthcare
provider organizations worldwide. Our ground-breaking iSpecimen Marketplace platform was designed to solve this problem and transform
the biospecimen procurement process to accelerate medical discovery.
The iSpecimen Marketplace
brings new capabilities to a highly fragmented and inefficient biospecimen procurement market. Our technology consolidates the biospecimen
buying experience in a single, online marketplace that brings together healthcare providers who have biospecimens and researchers across
industry, academia, and government institutions who need them. We are seeking to transform the world of biospecimen procurement much like
the way travel websites changed the consumer buying process for flights, hotels, and rental cars.
Our iSpecimen Marketplace
platform ingests de-identified healthcare data provided by our healthcare supply partners — including nearly 14 million
patient records, 72 million clinical specimen records, 1 million banked specimen records, 570 million laboratory test results, and 890,000
medical conditions as of September 30, 2021 — to allow researchers to easily search for and select research subjects, specimens,
and associated data they need to drive their research programs. It then orchestrates and manages the biospecimen procurement workflows
of both researchers and suppliers to bring efficiencies to the entire buying process. Through the iSpecimen Marketplace, researchers gain
instant access to millions of specimens anytime, anywhere, while participating supply organizations gain an opportunity to contribute
compliantly to medical research while increasing their revenue and sustainability.
Our Mission
iSpecimen’s mission
is to accelerate life science research and development, or R&D, with a global marketplace platform that connects researchers to subjects,
specimens, and associated data. Our vision is to create an “Amazon-like” global Marketplace of patients, biospecimens, and
data for research to improve the quality of human life. We implement employee programs that foster a company culture predicated on the
core values of corporate and individual growth; results and accountability; team before self; a can-do positive attitude; and the perseverance
to succeed.
Our Market Opportunity
The overall demand for human
biospecimens and related healthcare data (“annotated biospecimens”) continues to grow dramatically. Global spending on the
procurement of annotated biospecimens is estimated by our management team to have been $3 billion to $4 billion in 2020, with a market
growth rate estimated on the order of 10% to 15% annually through 2024. These expenditures are spread across the commercial, academic,
and government sectors of the healthcare and life sciences industry, with the commercial sector (biopharmaceutical and in vitro diagnostics
companies) representing the majority of the market. Market growth is primarily driven by advances in life science technologies and shifts
in R&D spending aimed at identifying and aligning biomarkers with clinical outcomes — a key step towards the development of
more targeted disease treatments and diagnostics. Both the precision medicine market (as defined below), with a growth rate of 11% per
year from 2020 to 2026 according to a Global Market Insights report, and the regenerative medicine market (as defined below), with a growth
rate of 26% per year from 2019 to 2026 according to a 2019 Fortune Business Insights report, rely heavily upon biospecimens for research
and development programs.
Precision medicine, sometimes
known as “personalized medicine,” is an innovative approach to tailoring disease prevention and treatment that takes into
account differences in people’s genes, environments, and lifestyles. The precision medicine market consists of numerous organizations
engaged in the research, development, manufacturing, and commercialization of novel drugs, diagnostic tests, and technologies that boost
the precision medicine workflow.
Regenerative medicine therapies
include cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such
therapies or products, except for those regulated solely under section 361 of the Public Health Service Act (42 U.S.C. 264) and Title
21 of the Code of Federal Regulations Part 1271 (21 CFR Part 1271). The regenerative medicine market consists of numerous organizations
engaged in the research, development, manufacturing, and commercialization of cell and immunotherapies, genetically modified cells, therapeutic
tissue engineered products, human cell and tissue products, and combination products using any such therapies or products.
Human biospecimens can be
very difficult for researchers to acquire and for healthcare providers to distribute. We believe there are over 10 million healthcare
providers worldwide that possess collections of such human biospecimens or have access to patients and their biospecimens during clinical
care, so many specimens exist that could potentially be used in research. However, researchers have little way to know which healthcare
organizations are willing to make their specimens available for research and healthcare providers likewise have little access to the research
community. Even if these organizations could identify each other, it takes time and money to execute contracts that allow them to then
transact. Once organizations are under contract with each other, researchers must then ensure that the specimens have been collected under
appropriate compliance frameworks, using collection protocols consistent with their research needs, and accompanied by required data.
Our iSpecimen Marketplace compliantly connects each side of this highly fragmented market to reduce the costs, time, and risks for both
suppliers and customers in the biospecimen supply chain. We know of no other commercial human biospecimen marketplace that provides instant
online searchability of specimens across a network of specimen providers.
The biospecimen procurement
market is poised for disruption and has many attractive characteristics of other markets with successful online marketplaces:
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Large and growing. We estimate the biospecimen market to be $3 billion
to $4 billion in size and growing rapidly, at an estimated 10% to 15% annually;
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Highly fragmented. This market today is comprised of fragmented landscape of
millions of healthcare providers who could potentially offer biospecimens and data for research, and hundreds of thousands of life science
researchers who need access to them; and
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Inefficient. Researchers and healthcare providers today largely utilize manual
processes such as email, phone calls, and spreadsheets to find each other, request specimens, and manage the specimen procurement process.
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We believe our marketplace technology has the potential
to disrupt the $3 billion to $4 billion human biospecimen supply chain industry.
Our Customers
Our customer base is
primarily comprised of three main segments: biopharmaceutical companies, in vitro diagnostic (“IVD”) companies, and
government/academic institutions. As of September 30, 2021, we have distributed our specimens to approximately 398 unique customer
organizations, comprising of many of the large IVD and biopharma companies along with federal and state government agencies, such as
the Centers for Disease Control and Prevention.
Additionally, in 2019, we entered the new and rapidly
growing regenerative medicine segment, which according to a market research report published by Fortune Business Insights, the global
regenerative medicine market was valued at $23.8 billion in 2018 and is expected to reach $152 billion by the end of 2026 thereby exhibiting
an estimated CAGR of 26%. Moreover, according to the Alliance for Regenerative Medicine, global financing for the regenerative medicine
sector set an annual record of $19.9 billion in 2020. This “rapid growth” of the regenerative medicine market is characterized
by the double-digit annual revenue growth rate combined with record global financing levels. We continue to have and maintain site participation
agreements with several provider partners which enable us to offer through our iSpecimen Marketplace, various types of annotated hematologic
products that are used in the research and development of regenerative medicine therapies. Such products include for example, whole bone
marrow aspirate, mononuclear cell fractions, and isolated immune cell products that have been collected from both healthy and diagnosed
(diseased) human donors. Some of the aforementioned products are offered in both fresh and cryopreserved formats depending on the customer’s
preference. Since entering the regenerative medicine market in late 2019, we have acquired 27 customers. The regenerative medicine market
represents 1.7% of our total revenue in 2019, 2.1% in 2020, and approximately 5.4% in the nine months ended September 30, 2021.
Our Supply Partners
Critical to the success of the iSpecimen Marketplace
is the network of healthcare providers who make their patients, samples, and data available to researchers. This supply network was built
over a nine-year period and as of September 30, 2021, our supply network consisted of more than 197 unique healthcare organizations and
biospecimen providers, including healthcare systems, community hospitals, clinics, private practice groups, commercial laboratories, blood
centers, commercial biobanks, and cadaveric donation centers. Our suppliers are located in 13 countries across the Americas, Europe, and
Asia.
Each supplier organization may give us access to
one or more of the following environments within their organization where specimens may be obtained:
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Clinical labs — This environment provides access to remnant biofluids and is typically found in hospitals, commercial
laboratories, clinics, and private practice groups;
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Pathology labs — This environment provides access to remnant tissue and remnant hematopoietic stem and immune cells
and typically exists within hospitals or commercial laboratories;
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Biorepositories — These organizations typically reside within larger healthcare systems or commercial organizations.
Generally, they collect and store specimens for unspecified future research purposes;
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Blood donor centers — These organizations typically collect large volumes of blood and derivatives for therapeutic
or research purposes. They own and operate donor centers and may manufacture a broad selection of isolated cell types (fresh or cryopreserved)
from consented donors for research use;
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Cadaveric donation centers — These organizations receive whole cadavers and provide access to cadaveric tissues,
biofluids, and stem cells, specifically for research purposes; and
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Clinical research centers — These organizations within healthcare facilities or operating as standalone entities
provide access to subjects for research programs. Patients may be approached and consented to provide specimens when they are in for healthcare
appointments (i.e. patient encounters) or may be called in to specifically participate in research projects.
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The iSpecimen Marketplace Solution
The iSpecimen Marketplace offers single-source
access to millions of human biospecimens and patients across a diverse network of specimen providers quickly and compliantly, saving researchers
time and money in their specimen procurement process while making it easier and more efficient for providers to get their specimens in
the hands of researchers who need them. Our iSpecimen Marketplace technology makes it as easy to find specimens for research as it is
to find flights on a travel website. We have adopted many of the same ease-of-use characteristics of these business-to-consumer, or B2C,
marketplaces, from simple guided searches, to the ability to refine search criteria with sliders and checkboxes, to the ability to add
chosen items to a cart in order to purchase them, to online order management. Our two-sided marketplace platform makes it easy for researchers
and healthcare providers to connect and transact, introducing efficiencies into what is otherwise a very time-consuming and manual process.
Our iSpecimen Marketplace technology is groundbreaking
in the human biospecimen procurement space. In a world where there are thousands of biospecimen providers who typically rely upon e-mail
and spreadsheets to communicate with customers to manage the bioprocurement process, our iSpecimen Marketplace offers a more efficient
user experience to life science researchers who are looking for better ways to access research subjects, specimens, and data, and to healthcare
provider organizations, who are looking to realize their missions of supporting research while augmenting their bottom line.
"The iSpecimen Marketplace instantly shows researchers the
available specimens that meet their specific inclusion and exclusion criteria."
As of September 30, 2021, we had more than 4,800
external registered users on the iSpecimen Marketplace platform, representing nearly 2,000 unique internet domains. Collectively, these
users logged into the iSpecimen Marketplace more than 103,000 times and performed more than 13,000 specimen searches yielding more than
1,400 quote requests since the launch of the marketplace in June 2017.
Planned Developments of our iSpecimen Marketplace
While the iSpecimen Marketplace currently supports
our business model of providing access to search, find, and acquire human biospecimens and associated data from “inquiry to invoice”
and positions us for future expanded business model exploration, there are a number of areas in which the iSpecimen Marketplace functionality
could be enhanced to better support our stakeholders, including our prospects and customers, iSpecimen sales and operations staff, and
our supply partners. We believe with additional investment in technology development resources, we could make significant progress in
scaling our iSpecimen Marketplace and, by the end of 2022, we expect to have capabilities such as more direct support for our prospective
collections, deeper search and workflow capabilities, and direct pricing availability in the platform.
We plan to continue technology investment to better
connect healthcare researchers with our network of suppliers to enable the acquisition of human biospecimens and data to help accelerate
research and expand the impact of our iSpecimen Marketplace platform from “inquiry to invoice” through the following key approaches:
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Enhance the customer experience. By working with our prospects and customers
to understand their needs, we strive to provide a platform that more easily enables them to specify and find human biospecimens and data
that meet the requirements of their research.
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Improve operational efficiency. By measuring the results of our operational
workflows, we endeavor to reduce the friction and manual efforts in our processes and systems.
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Increase our supplier engagement. By continuing to engage with our supply partners
to deliver solutions that make their interactions with us more fulfilling, we become more seamlessly integrated into their workflows and
daily operations.
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We continue to prioritize and release updated versions
of the iSpecimen Marketplace platform in alignment with these approaches and believe that continuing to focus on these approaches will
enable us to scale our business model more effectively.
Technology Components
The iSpecimen Marketplace technology is comprised
of four major functional areas: search; workflow; data; and administration and reporting. We continue to invest in the evolution of these
areas to improve customer and supplier engagement with the platform; provide operational efficiencies for our suppliers, our customers,
and our internal operations; and increase the liquidity of products and services obtained through the platform. Our core business objective
is to retain and grow both researcher and supplier usage of our platform to support biospecimen procurement, as well as to position our
Company to explore other adjacent business opportunities that can benefit from the use of the iSpecimen Marketplace.
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Search. The primary purpose of the iSpecimen Marketplace is to matchmake between those with access to subjects,
specimens, and data, and those with a need for them to power their research. By entering subject and sample selection requests through
the iSpecimen Marketplace, researchers can instantly search across the available medical records of large populations within iSpecimen’s
healthcare provider network to create customized patient and specimen cohorts. Researchers can specify their criteria and either refine
and review results to select specific specimens instantly, or they can request that iSpecimen find patients, specimens, and associated
data to satisfy their needs when specimens do not currently exist in our network. Using our own proprietary algorithms, we enable researchers
to explore both biospecimens that are currently available and view projections of those that are likely to become available in the future
based on historic statistical analysis of data.This allows researchers to quickly and easily determine how we can fulfill their requirements,
which is especially useful for project planning and budgeting.
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Workflow. Our workflow engine supports the unique bioprocurement workflows of our suppliers,
customers, and internal iSpecimen operations users. For our suppliers, our ability to easily integrate into their environments and automate
key parts of their bioprocurement workflow enables us to maintain a level of engagement and responsiveness necessary to successfully deliver
on specimen requests from our research customers. We make it easy for suppliers to list their specimens in our iSpecimen Marketplace by
receiving their data in the most commonly used data transmission formats for healthcare data, such as HL7 feeds (a healthcare data interchange
standard), JSON files (a standard data interchange format), and CSV files (a comma separated values file used for tabular data), and then
by harmonizing this data into standard terminology sets that allows their specimens to be searchable by our research customers. We provide
these onboarding services at no charge to our supply partners. Additionally, our iSpecimen Marketplace technology enables suppliers to
track and manage all of their specimen requests from feasibility assessment through the ordering and fulfillment process in a single web
application, thereby streamlining their bioprocurement workflow. Because the work that we do with our suppliers is often a secondary concern
to their primary mission of providing patient care, we believe that seamlessly integrating into their workflow is critical to its use
and ongoing success.
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Data. We power search
and orchestrate the procurement workflow through our ability to acquire, ingest, generate, and use big data from our healthcare provider
partners. Working with a global, centralized set of healthcare providers, we receive this data in a variety of different formats
and quality levels. We de-identify, normalize, and harmonize our supplier network’s data for usage in our iSpecimen Marketplace,
ensuring the highest level of patient privacy and compliance with HIPAA and other applicable regulations that govern the research
use of patient specimens and data. As of September 30, 2021, the iSpecimen Marketplace had ingested and harmonized data on nearly
14 million patients, 72 million clinical specimens, 1 million banked specimens, 570 million laboratory test results, and 890,000
medical conditions.
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Administrative, Compliance, and Reporting. Administration, compliance, and reporting functions
are critical components to enable users to properly evaluate and manage the bioprocurement process. Our administrative capabilities
include functions such as user management to assign users and roles and password management to ensure passwords are updated regularly,
among other capabilities. Compliance management includes manual and technology-based processes that allow iSpecimen to track and
manage unique regulatory and legal requirements across customers and suppliers (such as consent requirements versus consents granted,
required specimen and data uses versus allowable specimen and data uses, resale or distribution requirements versus resale or distribution
rights) to make sure that customer requirements and supplier requirements match before transferring specimens and data. Additionally,
we conduct regular audits of supply sites capabilities and confirm that supply sites have Institutional Review Board (“IRB”)
(or equivalent) protocols in place where required by law. Our reporting tools turn operational data into useful information by enabling
users to view operational data in tables and other visualizations. Together, they help manage and streamline administration, compliance,
and operational functions.
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Technology Development
The iSpecimen Marketplace software was developed
over nine years with more than 80 staff-years invested in research and development. It comprises an orchestration of SaaS solutions, commercial
and open source components, and custom developed software deployed in the cloud on a third-party hosting platform built and maintained
through a combination of full-time staff and outsourced partners. The team uses agile practices to develop and improve the platform. We
continue to enhance and improve the performance, functionality, and reliability of the iSpecimen Marketplace platform based on a user-informed
roadmap that is actively updated based on internal and external feedback aligned with our goals.
The iSpecimen Marketplace
relies on third parties for certain technology to support development, delivery, and operations of the platform including product management,
software development, cloud hosting, data processing, content mapping, and security services. iSpecimen uses software (including source
code) and other materials that are distributed under a “free,” “open source,” or similar licensing model, including
software distributed under the Apache License, Version 2.0, The MIT License, Mozilla Public License 2.0 (MPL-2.0), GNU General Public
License version 2, GNU Lesser General Public License version 2.1, Eclipse Public License 1.0 (EPL-1.0), Common Development and Distribution
License 1.0. In addition, iSpecimen uses software and services from commercial providers. We do not believe any of them are not generally
commercially available to us from other parties. iSpecimen does not have any technology licensing contracts signed within the last two
years upon which our business is substantially dependent. We continue to evaluate partners whose capabilities can help us deliver our
iSpecimen Marketplace solution in areas such as functionality, efficiency, and security and expect to continue to leverage and consider
additional third-party capabilities in our ongoing Marketplace development.
Our Competitive Strengths
When successfully implemented, online
marketplaces are a highly efficient supply chain that offer many advantages to both suppliers and customers, including lower costs,
reduced procurement timeframes, increased revenue (for suppliers), increased access to a large and growing supply network (for
customers), and reduced risks. While our iSpecimen Marketplace is driving these benefits now, we believe they will become even more
apparent when the iSpecimen Marketplace achieves greater scale by the end of 2022, when we expect to have capabilities such as more
direct support for our prospective collections, deeper search and workflow capabilities, and direct pricing availability in the
platform. As a result of these advantages, as of September 30, 2021, we have delivered more than 160,000 specimens in support of
more than 2,100 unique customer projects since shipping our first specimens in 2012. We have also provided our healthcare provider
partners with more than $14 million in revenue during that time.
To date, we have been unable to operate the marketplace
profitably. For the nine months ended September 30, 2021 and the year ended December 31, 2020, we reported net losses of $6,911,428 and
$4,652,084, respectively.
The Regulatory Environment
iSpecimen works with the healthcare industry and
with clinical researchers, both highly regulated environments in the United States and other countries. Government departments and agencies,
at the federal, state, and local levels have regulations related to research activities that involve human subjects as well as regulations
that govern the privacy and security of personal and healthcare data about individuals, including the collection, storage, and dissemination
of that data. To support compliance with regulations, we have both internal personnel and external resources who provide us with expertise
in various areas of compliance including a Chief Information Security Officer, Chief Privacy Officer, contracts manager, biospecimen counsel
(external), general counsel (external), IRB (external), and other employees with expertise and oversight of site compliance, lab compliance,
and operational compliance.
Our Growth Strategy
We believe we will continue to accelerate our revenue
growth by improving and expanding our iSpecimen Marketplace platform to become the most convenient, efficient, and trusted resource for
researchers to acquire, and suppliers to share research subjects, biological samples, and data for life science research. We plan to continue
to build value by pursuing strategic objectives in five key areas:
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Marketplace technology innovation. We continue to innovate our proprietary iSpecimen Marketplace
technology with search and workflow automation features that dramatically improve the buyer’s journey of searching for and compliantly
acquiring annotated biospecimens from “inquiry to invoice”, and the supplier’s journey of sharing patient and specimen
data, confirming project feasibility, and fulfilling orders;
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Increased patient data. Healthcare data is an important underlying asset of our marketplace business
model. Gaining access to increasing levels of healthcare data at our supply partner organizations will allow us to increase the efficiency
of our operations from inquiry-to-invoicing while also accelerating the overall biospecimen procurement process. Additionally, our ability
to use increasing volumes of patient data to identify and engage with patients for biospecimen research also
provides additional opportunities to move into adjacent spaces — including recurring revenue business models — such as premium
search subscriptions, patient data subscriptions, the patient recruitment for clinical trials, and software licensing;
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Supply chain expansion. In order to better support worldwide research, we continue to increase access to global patient populations, inventories of banked specimens, patient data, and prospective collection capabilities by expanding our network of high-value suppliers combined with a direct- to- patient specimen collection capability. We are agile in identifying and onboarding new global supply partners who can provide specimens and related services to meet rapidly emerging market needs such as our recent expansion into COVID-19 biomaterials for SARs-CoV-2 research, and into diagnostic, vaccine, and therapeutic development;
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High growth markets. We are focusing on servicing high growth market sectors such as COVID-19 research, precision medicine, regenerative medicine, biopharma/vaccine development, diagnostics development (e.g. oncology liquid biopsy and infectious disease), and specialized areas of life science research (e.g. cancer and autoimmune disease); and
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Organizational capacity. We continue to strengthen our organizational capacity with the right experience, training, skill sets, and resources for developing our iSpecimen Marketplace platform, expanding our marketplace of high-value suppliers and customers located in key geographies, ensuring regulatory compliance, and tracking key performance indicators while fostering a data- driven mindset.
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Additionally, we have deployed a multi-faceted go-to-market strategy
to support our customer and supplier growth initiatives. This strategy includes a focus on:
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Sales and Marketing capabilities. Our sales organization will continue
to grow and evolve to better focus on targeted market sectors and key stages of sales development to increase sales funnel conversion
rates;
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High value customers and suppliers. We will continue to grow and
retain high-value customers and suppliers by delivering excellent service and pursuing deeper relationships. For example, we are developing
preferred supplier contracts to increase purchase volume, customer retention/loyalty, and growth in the number of researchers served within
a parent account. We are also investing more resources in customer service personnel, site management personnel, and related processes;
and
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Channel partners. We will continue to collaborate with channel partners located in key non-U.S.
markets to reach more end-users of biospecimens and data, strengthen our brand visibility, increase market share, and drive iSpecimen
Marketplace utilization. These partnerships also help mitigate our risk of sales volatility in the case of an economic downturn or other
factors that negatively impact sales and market demand in the U.S.
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We have articulated our growth
plan using a strategy map balanced scorecard approach which identifies strategic objectives and connects internal processes with desired
outcomes that align with our mission and vision.
COVID-19 Impact
On January 30, 2020, the WHO
announced a global health emergency because of a new strain of coronavirus (COVID-19) originating in Wuhan, China and the risks to the
international community as the virus spread globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak
as a pandemic, based on the rapid increase in exposure globally. The pandemic had and still has both positive and negative effects on
iSpecimen’s business.
On the downside,
starting in March 2020, COVID-19 affected our supply chain’s ability to fulfill specimen requests. As healthcare providers
dealt with the COVID-19 pandemic, many temporarily shuttered their research operations, including biospecimen collection
capabilities, as they deployed resources to more critical parts of their organization or their employees stayed home to support
social distancing measures. As a result, by April 1, 2020, more than 40% of our worldwide supply was fully-disabled, (i.e. these
suppliers had halted the fulfillment of specimen requests); more than 40% was partially-disabled, (i.e. these suppliers were
fulfilling specimen requests at a slower rate than before the pandemic); and less than 15% was fully- operational. Consequently, the
overall rate at which we could fulfill specimen requests was slowed due to COVID-19 and during the three months beginning April
2020, while our purchase order value increased by more than 300% compared to same period in 2019, our revenue increased by less than
35% compared to the same period in 2019. However, over the course of the pandemic, many supply sites began to recover and became
operational by August and even more so by November 2020.
On the positive side, a new
market for COVID-19 samples emerged as a result of the pandemic and we responded to the demand and matched requests for COVID-19 specimens
to supply sites in areas of outbreak. As a result, COVID-19 specimens accounted for more than 35% of our purchase orders in 2020 and more
than 35% of our purchase orders in the nine months period ended September 30, 2021. We also employed a mobile phlebotomy service provider
to allow us to collect specimens from research subjects in their homes should this pandemic or other circumstances in the future drive
more social distancing that limits our supply sites’ ability to collect specimens.
These actions helped us to
grow revenue by 57% in the nine months ended September 30, 2021, when compared to the nine months ended September 30, 2020.
In addition, in May 2020,
we applied for and received a loan in the amount of $783,008 from the Paycheck Protection Program under the CARES Act, and in January
2021 the loan was fully forgiven.
Recent Developments
Term Loan from Bridge Bank
On
August 13, 2021, we entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Bridge Bank,
a division of Western Alliance Bank (“Bridge Bank”). Pursuant to the Loan and Security Agreement, Bridge Bank provided us
with a term loan facility in the maximum principal amount of $5,000,000, including (i) a $3,500,000 term loan advanced at the closing
and (ii) a $1,500,000 term loan available upon the Company’s request, subject to certain conditions for the 18-month period
following the Closing Date. Amounts outstanding under the Loan and Security Agreement bear interest at a per annum rate equal to the prime
rate plus 0.75%. In addition, the Company is also required to pay customary fees and expenses. At closing, the proceeds of the term loan
facility were used to repay in full the outstanding indebtedness under secured promissory notes issued by the Company from 2018 through
2020 (the “Bridge Notes”), including amounts owed to related parties (the “Related Party Bridge Notes”).
The
Loan and Security Agreement requires payments of interest only through February 2023. Beginning on March 10, 2023, the Company
is required to make monthly payments of principal and interest, based on a 30-month amortization schedule. All amounts outstanding under
the Loan and Security Agreement will become due and payable on August 10, 2025. The obligations under the Loan and Security Agreement
are secured by substantially all of the assets of the Company except for the Company’s intellectual property.
In
connection with the Loan and Security Agreement, the Company issued Bridge Bank a warrant to purchase up to 12,500 shares of the Company’s
Common Stock at an exercise price of $8.00 per share (the “Lender Warrant”).
December
2021 Private Placement
On December 1, 2021, we closed
a private placement where we issued shares and warrant shares to stockholders.
Emerging Growth Company under the JOBS Act
As a company with less than
$1.07 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” under the Jumpstart Our Business
Startups Act of 2012, or the JOBS Act. As an emerging growth company, we have elected to take advantage of reduced reporting requirements
and are relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging
growth company:
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we may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations;
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we are exempt from the requirement to obtain an attestation and report from our auditors on whether we maintained effective internal control over financial reporting under the Sarbanes-Oxley Act;
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we are permitted to provide less extensive disclosure about our executive compensation arrangements; and
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we are not required to give our stockholders non-binding advisory votes on executive compensation or golden parachute arrangements.
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We may take advantage of these
provisions until December 31, 2025 (the last day of the fiscal year following the fifth anniversary of our initial public offering) if
we continue to be an emerging growth company. We would cease to be an emerging growth company if we have more than $1.07 billion in annual
revenue, have more than $700 million in market value of our shares held by non-affiliates or issue more than $1.0 billion of non-convertible
debt over a three-year period. We may choose to take advantage of some but not all of these reduced burdens. We have elected to provide
two years of audited financial statements. Additionally, we have elected to 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
that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth
company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in Section 7(a)(2)(B) of the Securities
Act.
Corporate Information
Our principal offices are
located at 450 Bedford Street, Lexington MA 02420 and our telephone number is (781) 301-6700. Our website is www.ispecimen.com.
Our website and the information on or that can be accessed through such website are not part of this prospectus.