Filed 2026-04-01 · Period ending 2025-12-31 · 73,718 words · SEC EDGAR
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# iSpecimen Inc. (ISPC) — 10-K
**Filed:** 2026-04-01
**Period ending:** 2025-12-31
**Accession:** 0001213900-26-038607
**Source:** [SEC EDGAR](https://www.sec.gov/Archives/edgar/data/1558569/000121390026038607/)
**Origin leaf:** 0effa00ae0f46dc2676630d36f61551f429524b9c51e2dacfe182fb6cba8997c
**Words:** 73,718
---
**
UNITED
STATES**
**SECURITIES
AND EXCHANGE COMMISSION**
**Washington,
D.C. 20549**
****
**FORM10-K**
****
(Mark
One)
**ANNUAL REPORT PURSUANT TO SECTION13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**
**For
the Fiscal Year Ended December 31, 2025**
****
**TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**
For
the transition period from to
**Commission
File No. 001-40501**
****
**iSpecimenInc.**
(Exact
name of registrant as specified in its charter)
| Delaware | | 27-0480143 | |
| (State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) | |
| 8 Cabot Road, Suite 1800, Woburn, Massachusetts | | 01801 | |
| (Address of principal executive offices) | | (Zip Code) | |
**(781)
301-6700**
(Registrants
telephone number,including area code)
**N/A**
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section12(b)of the Act:
| Title of Each Class | | Trading Symbol(s) | | NameofEachExchangeonWhichRegistered | |
| Common Stock, par value $0.0001 per share | | ISPC | | The Nasdaq Stock Market LLC | |
Securities
registered pursuant to Section 12(g) of the Act: **None**
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 Section13 or 15(d)of the Securities
Exchange Act of 1934 during the preceding 12months (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 90days. Yes No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405
of Regulation S-T (232.405 of this chapter) during the preceding 12months (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 definitions of large accelerated filer, accelerated filer, smaller
reporting company, and emerging growth company in Rule12b-2 of the Exchange Act.
| Large accelerated filer | | | Accelerated filer | | |
| Non-accelerated filer | | | Smaller reporting company | | |
| | | 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 Section13(a)of the Exchange Act.
Indicate
by check mark whether the registrant has filed a report on and attestation to its managements 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.
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 registrants 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 Rule12b-2 of the Exchange Act). Yes No
The aggregate market value of the registrants outstanding common
stock held by non-affiliates as of June 30, 2025 was approximately $2,446,936, based on a per share price of $0.98, which was the last
reported sale price of the registrants common stock on such date.
As of April 1, 2026, there were 29,662,250 shares of common stock,
par value $0.0001 per share, of the registrant issued and outstanding.
**TABLE
OF CONTENTS**
****
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Page | |
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PART
I |
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Item 1. Business |
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1 | |
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Item 1A. Risk Factors |
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13 | |
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Item 1B. Unresolved Staff Comments |
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36 | |
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Item 1C. Cybersecurity |
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36 | |
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Item 2. Properties |
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37 | |
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Item 3. Legal Proceedings |
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37 | |
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Item 4. Mine Safety Disclosures |
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38 | |
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PART
II |
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Item 5. Market for Registrants
Common Equity , Related Stockholder Matters and Issuer Purchases of Equity Securities |
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39 | |
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Item 6. Reserved |
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39 | |
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Item 7. Managements Discussion
and Analysis of Financial Condition and Results of Operations |
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39 | |
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Item 7A. Quantitative and Qualitative
Disclosures About Market Risk |
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50 | |
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Item 8. Financial Statements and Supplementary
Data |
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F-1 | |
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Item 9. Changes in and Disagreements
with Accountants on Accounting and Financial Disclosure |
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51 | |
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Item 9A. Controls and Procedures |
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51 | |
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Item 9B. Other Information |
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52 | |
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Item 9C. Disclosure Regarding Foreign
Jurisdictions that Prevent Inspections |
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52 | |
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PART
III |
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Item 10. Directors, Executive Officers
and Corporate Governance |
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53 | |
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Item 11. Executive Compensation |
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57 | |
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Item 12. Security Ownership of Certain
Beneficial Owners and Management and Related Stockholder Matters |
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60 | |
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Item 13. Certain Relationships and
Related Transactions, and Director Independence |
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64 | |
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Item 14. Principal Accountant Fees
and Services |
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67 | |
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PART
IV |
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Item 15. Exhibit and Financial Statement
Schedules |
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68 | |
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Item 16. Form10-K Summary |
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71 | |
****
i
****
**SPECIAL
NOTE**
****
*As
used in this Annual Report on Form 10-K (Annual Report), unless the context otherwise requires, the terms the Company,
iSpecimen, we, us, and our refer to iSpecimen Inc., a Delaware corporation. Each
reference to a fiscal year in this Annual Report refers to the fiscal year ending in the calendar year indicated (for example, fiscal
2025 refers to the fiscal year ended December 31, 2025).*
**
**CAUTIONARY
STATEMENT**
****
This
Annual Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities
Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). These forward-looking
statements are subject to risks and uncertainties that could cause actual results to differ materially from the results projected in
any forward-looking statement. In addition to the factors specifically noted in the forward-looking statements, other important factors,
risks and uncertainties that could result in those differences include, but are not limited to, those discussed under Item 1A to Part
I Risk Factors in this Annual Report. The forward-looking statements are made as of the date of this Annual Report, and
we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those
projected in the forward-looking statements. You should consult all of the information set forth in this Annual Report and the other
information set forth from time to time in our reports filed with the Securities and Exchange Commission (the SEC) pursuant
to the Securities Act and the Exchange Act, including our reports on Forms 10-Q and 8-K.
You
can identify some of these forward-looking statements by words or phrases such as may, will, expect,
anticipate, aim, estimate, intend, plan, believe,
is/are likely to, potential, continue or other similar expressions. We have based these forward-looking
statements largely on our current expectations and projections about future events that we believe may affect our financial condition,
results of operations, business strategy and financial needs. These forward-looking statements include statements relating to:
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our ability to enter into contracts with healthcare
providers to gain access to specimens, subjects, and data on favorable terms; | |
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our ability to obtain new customers and keep existing
customers; | |
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development of our technology
to adequately keep pace to support expansion of our existing line of business or our entry into new lines of businesses; | |
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market adoption rate of our marketplace technology; | |
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our ability to continue to expand outside of the United
States in compliance with local laws and regulations; | |
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acceptance of the products and services that we market; | |
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the viability of our current intellectual property; | |
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government regulations and our ability to comply with
government regulations; | |
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our ability to retain key employees; | |
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adverse changes in general market conditions for biospecimens; | |
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our ability to generate cash flow and profitability
and continue as a going concern; | |
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our future financing plans;
and | |
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our ability to adapt to
changes in market conditions which could impair our operations and financial performance. | |
These
forward-looking statements involve numerous risks and uncertainties. Although we believe that our expectations expressed in these forward-looking
statements are reasonable, our expectations may later be found to be incorrect. Our actual results of operations or the results of other
matters that we anticipate could be materially different from our expectations. You should not place undue reliance on forward-looking
statements because they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond our control
and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include,
among other things, those listed under the section titled Risk Factors and elsewhere in this Annual Report. If one or more
of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly
from those implied or projected by the forward-looking statements. No forward- looking statement is a guarantee of future performance.
You should read this Annual Report and the documents that we reference in this Annual Report and have filed with the SEC thereto completely
and with the understanding that our actual future results may be materially different from any future results expressed or implied by
these forward-looking statements. We do not assume any obligation to update any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by law.
ii
Our
business, operating results or financial condition could be materially adversely affected by any of the following risks associated with
any one of our businesses, as well as the other risks highlighted elsewhere in this Annual Report. The trading price of our common stock
could decline due to any of these risks.
Our
business is subject to numerous risks as described in this section. Some of these risks include:
**
**Risks
Related to Our Business**
****
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We have incurred losses
since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable,
and we may never achieve or sustain profitability; | |
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There is substantial doubt
about our ability to continue as a going concern; | |
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During the year ended December
31, 2024, we identified a material weakness in our internal control over financial reporting, and we may identify material weaknesses
in the future that may cause us to fail to meet our reporting obligations or result in material misstatements of our financial statements.
If we fail to remediate this material weakness or if we otherwise fail to establish and maintain effective control over financial
reporting, our ability to accurately and timely report our financial results could be adversely affected; | |
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We may likely require additional
capital in the future and an inability to meet future capital needs could adversely impact our ability to operate; | |
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Our revenue trend is not
predictive which can lead to difficulty in accurately forecasting future results; | |
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International operation
expansion could expose us to additional risks which could harm our business, prospects, results of operation, and financial condition; | |
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We rely upon our technology
solution for the operation of our business and if our technology platform contains defects or fails to perform as expected, we may
need to suspend its availability and divert development resources, and our business and reputation may be harmed; | |
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Sustainable future revenue
growth is dependent upon the development of technology solutions that enable scale and address new markets; | |
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If our security measures
are breached, or if our services are subject to attacks that degrade or deny the ability of users to access our platforms, our platforms
and applications may be perceived as not being secure, customers and suppliers may curtail or stop using our services, and we may
incur significant legal and financial exposure; | |
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Challenges or unanticipated
costs in establishing the sales, marketing, and distribution capabilities necessary to successfully commercialize our products globally
could affect profitability; | |
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We rely upon relatively
few customers for a significant portion of revenue and do not have a recurring revenue business model. A loss of large customers
could affect our ability to operate; | |
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Customers and customer
prospects may be averse to using a self-service marketplace to procure specimens and may continue to require iSpecimen personnel
in the procurement process, impacting our scalability and profitability; | |
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We have entered into contracts
with U.S. government agencies and contractors which subjects us to federal contract and audit risk; | |
iii
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The adoption cycle of our
supply network tends to be very lengthy, which may adversely affect our ability to scale rapidly and increase revenues; | |
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Potential adverse effects
from changes in the healthcare industry, including consolidations and regulatory changes, could affect access to subjects, samples,
and data and affect our growth; | |
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We do not control the end-to-end
quality of specimens and data collected in our supply chain and quality issues can affect our reputation, revenue, and profitability; | |
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Reliance of relatively
few supply partners for significant supplies and services could affect our ability to operate and grow; | |
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Specimen collection from
human subjects, including the possible occurrence of adverse events during or after tissue collection, could provide exposure to
claims and litigation; | |
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We may lose business to
competitors which have or develop their own biorepositories and/or collection centers that can meet customers needs; | |
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We have incurred losses
from sales tax obligations owed to various jurisdictions by us because we did not collect taxes on taxable sales in prior years,
and we may never be able to recover the prior sales taxes from the customers; and | |
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We may incur additional
debt, and we are subject to the covenants and conditions contained in the Note Purchase Agreement, dated as of September 19, 2024
(the Purchase Agreement), between us and the Lender named therein (the Lender) and any other agreement
governing our debt, which may restrict our operations and ability to make investments and distributions. | |
**Risks
Related to Intellectual Property**
****
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We do not have any patents
protecting our intellectual property and if we are unable to protect the confidentiality of our trade secrets, know-how and other
proprietary and internally developed technology, our business could be adversely affected. | |
**Risks
Related to Regulatory Environment**
****
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Failure to comply with
federal and state data protection regulations could result in fines, penalties, and litigation, and have a material adverse effect
upon our business; | |
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Failure to comply with
international laws related to data protection, such as the General Data Protection Regulation (GDPR) could result in
fines, penalties, and litigation, and have a material adverse effect upon the Companys business; | |
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Failure to comply with
laws and regulations related to the protection of research subjects could result in fines, penalties, and litigation, and have a
material adverse effect upon our business; | |
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Product safety and product
liability, including bio-hazard risks, could provide exposure to claims and litigation; | |
iv
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Failure to comply with
federal and state laws around environmental, health and safety, biohazards and dangerous goods, and imports/exports could result
in fines, penalties, and litigation, and have a material adverse effect upon our business; | |
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Failure to comply with
other international laws around environmental, health and safety, biohazards and dangerous goods, imports/exports, and other regulations
could result in fines, penalties, and litigation, and have a material adverse effect upon our business; and | |
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Failure to comply with
governmental export and import regulations could result in fines, penalties, and litigation, and have a material adverse effect upon
the Companys business. | |
**Risks
Related to Our Securities**
****
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There can be no assurance
that an active and liquid trading market for our common stock will continue or that we will be able to continue to comply with Nasdaqs
continued listing standards; | |
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If we are not able to comply
with the applicable continued listing requirements or standards of The Nasdaq Stock Market LLC, our common stock could be delisted
from Nasdaq; | |
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The sale of substantial shares of our common stock
may depress our stock price; | |
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We may need additional capital, and the sale of additional
shares of common stock or other equity securities could result in additional dilution to our stockholders; | |
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We do not expect to pay dividends in the foreseeable
future. Any return on investment may be limited to the value of our common stock; | |
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Our directors, officers
and principal stockholders have significant voting power and may take actions that may not be in the best interests of our other
stockholders; | |
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Our bylaws, as amended,
designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our
stockholders, which could limit our stockholders ability to obtain a favorable judicial forum for disputes with us or our
directors, officers, or employees; and | |
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Limitations on director
and officer liability and indemnification of our officers and directors by us may discourage stockholders from bringing suit against
an officer or director. | |
v
****
**PART
I**
****
**Item
1. Business**
****
**Our Mission,
Vision, and Core Values**
****
iSpecimens
mission is to accelerate life science research, discovery and development 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.
**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.
**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.
The
platform is built upon a robust healthcare data set comprised of information about available specimens and research subjects, which then
enables the search and matchmaking process. It receives de-identified specimen and patient data from electronic medical records, laboratory
information systems, biobank inventory systems, and other healthcare data sources (either in real time via data feeds or regularly via
file extracts) and harmonizes this big data across all participating organizations into a common dataset, which now incorporates
external clinical content to further optimize and standardize the biospecimen data on iSpecimens proprietary Marketplace platform.
The data is then easily searchable by researchers using our intuitive, web-based user interface. Researchers can use their unique study
inclusion and exclusion criteria as selection filters to search the de-identified healthcare data to find matching specimens currently
available in laboratories and biobanks in our network. Researchers can then select the specific specimens they need for their studies,
add them to a cart, request quotes, place orders, and track and manage their specimen requests and associated data across projects. When
specimens are not available that meet their research criteria, researchers can, with a click of a button, request a quote for a custom
specimen collection and this custom specimen request will be distributed across our network of biospecimen providers.
Biospecimen
providers also gain efficiencies using the iSpecimen Marketplace, not only by giving providers instant access to a large researcher base,
but because the technology orchestrates the bioprocurement workflow from specimen request to fulfillment. Specimen providers gain access
to intuitive dashboards to view requests, create proposals, and track and manage their orders.
In
addition to providing the technology platform to connect researchers and healthcare providers, iSpecimen handles all marketing, sales,
contracting, and compliance functions across both sides of the marketplace.
We
market to and develop relationships with researchers and specimen providers alike to bring them together into a single platform. We contract
once with each participating customer and with each supplier organization and a single agreement then enables all users in that organization
to instantly connect and work with all other organizations in the iSpecimen network. We also audit our suppliers to confirm they have
proper Institutional Review Board (IRB) (or equivalent) protocols in place where required by law.
1
Our
iSpecimen Marketplace platform has compiled de-identified healthcare data provided by our healthcare supply partners approximately
19 million patient records, 105 million clinical specimen records, 1.4 million banked specimen records, and 1.2 million medical conditions
as of December 31, 2025 to allow researchers to easily search for and select research subjects, specimens, and associated data
they need to drive their research program. It then orchestrates and manages the biospecimen procurement workflows of both researchers
and suppliers to bring efficiency 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.
**Planned
Developments of our 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, in addition to increased patient and specimen
data integration, we expect to continue to improve the matchmaking across the platform and have capabilities such as more direct support
for our prospective collections, deeper search and workflow capabilities, increased automation, and direct pricing availability in the
platform.
As
investment allows, we plan to continue 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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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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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. | |
We
continue to prioritize and release updated versions of the iSpecimen Marketplace platform in alignment with these areas and believe that
continuing to focus on these approaches will enable us to scale our business model more effectively. As part of this continued platform
evolution, iSpecimen continues to explore adjacencies that leverage the platform including a data as a product model.
**Our Technology**
****
**Technology
Components**
****
The
legacy iSpecimen Marketplace has been operational for many years as an external-facing platform designed to facilitate search and matching
between researchers and suppliers. While it supported the Companys growth and market presence, its architecture led to increasing
operational complexity and fragmentation across commercial, data, and fulfillment processes. Recently, the Company made a strategic investment
in a new technology platform built on its SalesStack solution to modernize the legacy system.
This
new system introduces a cloud-native, next-generation architecture, providing a more secure, scalable, and efficient foundation for the
Marketplace. Key improvements include the adoption of Infrastructure-as-Code which enables automated, consistent, and more secure infrastructure
deployment. In addition, the platform establishes unified storage and workflow management, centralizing code and services to reduce silos,
improve maintainability, and lower technical debt. The new architecture also creates a future-ready foundation with streamlined deployment
capabilities, automated security controls, and seamless integration across major cloud environments, including AWS, GCP, and Azure.
Building
the Marketplace on SalesStack is an important step in unifying the Companys commercial, operational, and data capabilities within
a single, integrated system. This approach improves coordination across customer acquisition, order fulfillment, supplier engagement,
and compliance management, enabling greater operational efficiency and scalability.
The
Company has successfully transitioned its core capabilitiesincluding workflow management, data infrastructure, and administrative,
compliance, and reporting functionsfrom the legacy platform into the new system. These components now provide a more streamlined
and integrated environment for managing customer demand, supplier engagement, regulatory requirements, and operational reporting.
The
next phase of development focuses on migrating and integrating specimen and patient data into the new platform to further enable and
enhance search capabilities. Once completed, this will allow for more effective matching between researcher needs and available supply,
strengthening the overall functionality of the Marketplace.
The
Company continues to invest in advancing its technology to improve engagement across researchers and suppliers, drive operational efficiencies,
and increase liquidity within the Marketplace. The modernized platform establishes a scalable and flexible foundation that supports both current
operational needs and future innovation.
2
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Search.
The iSpecimen Marketplace enables researchers to identify and procure subjects, specimens, and associated data as part of an integrated,
end-to-end platform. | |
The
iSpecimen Marketplace enables researchers to identify and procure subjects, specimens, and associated data as part of an integrated,
end-to-end platform.
Researchers
can define subject and sample criteria within the Marketplace and access information derived from medical records across iSpecimens
healthcare provider network. This supports the creation of customized patient and specimen cohorts aligned with specific study requirements.
Users can review available options, refine their criteria, and select specimens that meet their needs, or submit requests for iSpecimen
to source specimens and data that are not immediately available.
In
addition to current availability, the platform provides visibility into expected specimen availability based on historical data trends.
These insights help researchers assess feasibility, plan studies, and make more informed budgeting decisions.
Rather
than functioning solely as a directory or referral tool, the Marketplace integrates discovery, selection, and procurement into a unified
workflow. Researchers can identify relevant specimens, initiate requests, and move efficiently toward fulfillment within a single system.
By
combining data-driven insights with streamlined workflows and intuitive user experiences, the Marketplace supports efficient collaboration
between researchers and suppliers while enabling scalable biospecimen procurement.
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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 marketplace technology enables suppliers to track and
manage all 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. | |
In
addition to supporting our suppliers workflow requirements, our workflow engine orchestrates customers bioprocurement workflows
from specimen requests through fulfillment. Customers can not only search for and select specimens, but they can track and manage their
specimen quote requests, place orders, track the progress of orders as they are fulfilled and shipped, and download packing lists, data
sheets, and other accompanying data.
Finally,
the Marketplace technology acts as the command and control center for internal iSpecimen operations users and allows them to easily federate
and manage the sourcing of specimens and data for all requested projects across a large and growing supply chain. The technology tracks
and manages requests for specimens from inquiry-to-invoice and provides a single place for internal users to manage all specimen requests,
orders, shipments, and data. Additionally, because our technology easily scales to support a growing supply network and customer base,
we have satisfied projects of all types and sizes from small specimen requests to projects with more than a thousand samples
from specific patient cohorts. As of December 31, 2025, we had delivered more than 218,000 specimens in support of more than 3,500 unique
projects since inception.
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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 networks data for usage in our iSpecimen Marketplace,
ensuring the highest level of patient privacy and compliance with HIPAA (as defined below) and all other applicable regulations that
govern the research use of patient specimens and data. As of December 31, 2025, the iSpecimen Marketplace had ingested and harmonized
data on approximately 19 million patients, 105 million clinical specimens, 1.4 million banked specimens, and 1.2 million medical
conditions. | |
3
In
addition, our platform gathers usage data that enables us to granularly understand supply and demand as well as provide value-added insights
to our business partners. For example, our biobanking partners often have access to more samples than they can economically store.
Understanding
which samples are likely to be the most useful to researchers helps guide the biobanks operational practices to optimize their
supply chain (for example, providing them with information on the medical conditions and specimen types that are in highest demand can
help guide their collection practices). Our ability to deliver relevant insights further increases the engagement with our platform and
positions us as a valuable partner. Additional inventory and capabilities data collected in the year ended December 31, 2024 as part
of our data initiatives has dramatically reduced, or entirely eliminated the need to perform a feasibility assessment, increasing conversion
rates and decreasing sales and fulfillment time leading to increased revenue.
As
we continue to ingest and generate more data, there are additional business opportunities to leverage our platform and continue to evolve
the iSpecimen Marketplace using modern approaches such as robotic process automation and artificial intelligence/machine learning techniques
to further improve the efficiency and effectiveness of the platform and enhance the value of the data. Our ability to leverage network
effects will enable us to realize increasing returns from our investments and expand into adjacent markets such as clinical trial patient
recruitment, data as a product, software-as-a-service (SaaS), and Next Generation Sequencing (an initiative launched in
late 2023). With additional data comes additional security risks we worked to mitigate through shoring up existing security processes
and protocols and the addition of a 24x7 managed risk vendor.
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Administrative, Compliance,
and Reporting. Administrative, 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 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 administrative, compliance, and reporting functions. | |
**Our
Products and Services**
****
The
iSpecimen Marketplace currently supports the supply chain management and bioprocurement process for specimens and associated data. We
derive our revenue by procuring specimens from our healthcare provider network and then distributing these annotated biospecimens to
our research client base. Revenue flows from the researchers who pay our Company to provide the specimens and we share that revenue back
with the healthcare providers who supplied them. Revenue share back to the supplying organization is generally 20% to 50%, depending
upon the sample type, collection requirements, and data provided. We are flexible and allow our suppliers to work with us using a number
of revenue share constructs, including a fixed percent revenue share arrangement (whereby we share a fixed percentage of the revenue
back with them), a fixed pricing schedule (whereby they set their pricing per specimen type), or on a project-based pricing (whereby
the supply site sets fees on a per project basis). We have derived substantially all of our revenue from annotated biospecimen procurement
and to date, have not charged our customers or suppliers fees for the use of the iSpecimen Marketplace platform, or for marketing, sales,
contracting, or compliance functions that we provide as part of the specimen procurement process.
We
generally operate in a just in time fashion, meaning we procure specimens from our suppliers and distribute specimens to
our customers after we obtain an order for specimens from a research client. Generally, we do not speculatively purchase and bank samples
in anticipation of future, unspecified needs. We believe our approach offers many advantages over a more traditional inventory-based
supplier business model where biorepositories take inventory risks, and where turnover and cash conversion cycles can be lengthy, depending
on market demand for certain specimen types.
4
Currently,
we provide access to the following types of human biospecimens from healthy and diseased-state subjects:
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Biofluids such
as whole blood, plasma, serum, urine, saliva, sputum, nasopharyngeal material, and cerebral spinal fluid; | |
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Solid tissue such
as fresh, fixed, and cryopreserved tissue; and formalin-fixed paraffin embedded blocks, slides, and curls; and | |
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Hematopoietic stem and
immune cells such as bone marrow, cord blood, whole blood, or sub-components of these tissues such as peripheral blood mononuclear
cells (including normal or mobilized leukapheresis collections) and other isolated cell types (CD34+,T cells, NK cells, B cells,
and monocytes). | |
For each
of the biospecimen types, we offer:
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Remnant specimens
specimens collected originally for clinical testing purposes but are no longer needed for clinical care of that patient. These samples
typically are sourced from clinical laboratories and pathology laboratories prior to their disposal; and | |
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Research use only specimens
specimens collected specifically for research via a direct intervention with a research subject, under a protocol that has
been reviewed and approved by an ethics committee such as an IRB and with such research subjects consent. These samples are
typically sourced at healthcare providers or commercial partners that are a part of our supply network. | |
The
cross product of all these categories (i.e. remnant or research use only and biofluids, tissues, or hematopoietic stem or immune cells)
describes the product types we use to track and manage the business. These groupings include:
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Remnant biofluids
These leftover clinical samples are procured from our clinical lab partners and are typically available days after specimen collection.
They are generally priced to the researcher per specimen, depending upon specimen type, rarity, and requested data. These specimens
contributed to approximately 23% and 11% of our revenue in 2025 and 2024, respectively. | |
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Remnant tissue
These leftover anatomic pathology samples are procured from our pathology lab partners and typically are available years after they
were first collected for clinical care. They are generally priced depending upon specimen type, rarity, and requested data. | |
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Remnant hematopoietic stem
and immune cells Remnant hematopoietic stem and immune cells includes bone marrow, cord blood, whole blood, or their viable
cellular components, that are left over from a clinical testing process. These samples may be obtained from clinical and anatomic
pathology labs. | |
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Next generation sequenced
(NGS) tissues NGS tissues include various cancer types that have been fully DNA/RNA sequenced to identify specific
biomarkers of interest. The tissues screened are tumor only FFPE specimens. Results are analyzed and paired with clinical annotation
to create a robust data package that has some utility even without the need for the specimen itself. Tissues used for the program
are a combination of remnant waiver of consent tissue blocks along with RUO fully consented blocks. | |
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Research use only biofluids
Research use only biofluids are collected directly from subjects, with their consent, and under an IRB (or equivalent) protocol.
They are generally priced to the researcher per collection, depending upon specimen type, rarity, and requested data. These specimens
contributed to approximately 56% and 49% of our revenue in 2025 and 2024, respectively. | |
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Research use only tissue
Research use only tissues are collected directly from subjects, with their consent, and under an IRB (or equivalent) protocol.
They are typically collected during a clinically required surgical procedure. We obtain these specimens from our biorepository partners,
anatomic pathology laboratories, or clinical research centers that have relationships with surgical facilities. These samples are
priced to the researcher per sample, depending upon specimen type, rarity, and requested data. These specimens contributed to approximately
18% and 39% of our revenue in 2025 and 2024, respectively. | |
5
|
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Research use only hematopoietic
stem and immune cells Research use only hematopoietic stem and immune cells includes bone marrow, cord blood, whole blood,
or their cellular components, which are collected from subjects with their consent and under an IRB (or equivalent) protocol. Some
of the aforementioned products are collected from healthy subjects or diagnosed (diseased) subjects and may be offered to researchers
in fresh or cryopreserved format. They are picked from banked inventory maintained by our supply site partners. The collection of
these samples may require subjects to undergo apheresis procedures, bone marrow extraction procedures, and/or hematopoietic stem
cell (HSC) mobilization therapies. These products are generally priced to the researcher per collection depending upon collection
type, specimen type, rarity (subject phenotype or attributes selected), required procedures, and requested data. Research use only
hematopoietic stem and immune cells were a relatively new product to us in 2019. These specimens accounted for approximately 3% and
1% of our revenue in 2025 and 2024, respectively. | |
For
each of these product types, biospecimens may already exist in laboratory archives or banked in our network of biorepositories (banked)
or may be collected in the future from our network of healthcare providers and commercial specimen providers (Remnants)
.
**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 ten-year period and as of December 31, 2025, our supply network consisted of approximately
73 unique healthcare organizations and biospecimen providers under agreement, including healthcare systems, community hospitals, clinics,
private practice groups, commercial laboratories, blood centers, commercial biobanks, clinical research sites, and cadaveric donation
centers.
Our
suppliers are located in fourteen (14) countries across the Americas, Europe, and Asia and our cost of revenue for the years ended December
31, 2025 and 2024, break out as follows geographically:
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| |
December31, | | |
|
| |
2025 | | |
2024 | | |
|
Americas | |
| 68.92 | % | |
| 66.19 | % | |
|
Europe, Middle East and Africa | |
| 31.25 | % | |
| 27.24 | % | |
|
Asia Pacific | |
| (0.17 | )%1 | |
| 6.57 | % | |
|
1 | includes supplier credits received during the year |
|
There was one supplier that accounted for 12.0% of our total cost of
revenue during the year ended December 31, 2025. There was one supplier that accounted for 11.3% of our total cost of revenue during the
year ended December 31, 2024.
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. As of December 31, 2025, approximately 12 of our healthcare supply sites provided us with access to remnant biofluids
originating in clinical labs; | |
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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. As of December 31, 2025, approximately one (1) of our healthcare supply sites provided us with access
to remnant tissue or cells originating in pathology labs; | |
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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. As of December 31, 2025, approximately 16 of our supply sites provided us with
access to specimens stored in biorepositories; | |
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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 broad selection of isolated cell types (fresh or cryopreserved) from consented donors for research
use. As of December 31, 2025, two (2) of our supply sites provided us with access to large volume blood products; | |
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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. As of December 31, 2025, one (1) of our supply sites provided us with cadaveric tissues and biofluids; and | |
6
|
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Clinical
research centers and service providers These organizations may reside within healthcare facilities such as hospitals or clinics,
or operate as standalone entities. They provide access to patients for research programs and may support study-related activities.
Patients may be approached and consented during routine healthcare encounters or may be scheduled to participate specifically in
research projects. As of December 31, 2025, approximately 41 of our healthcare supply sites operate within networks that enable direct
patient access. | |
Supply
sites may provide specimens from one or all these environments, depending on their practices and capabilities. Each supply site can select
how it will work with our Company.
In
addition to obtaining specimens and data directly from healthcare organizations, we work with several commercial biobanks and biospecimen
brokers who have their own network of healthcare provider supply partners and wish to make their samples available to our research clients
as well. While these organizations are generally considered our competitors, they are willing to work with us because we provide value
by acting as both a distribution channel for them and a supply partner to them to increase their revenues. Moreover, the inclusion of
competitors specimens in our iSpecimen Marketplace platform further strengthens our competitive position and value to our customers
by further de- fragmenting our customers buying experience.
**Our
Customers**
****
Our
customer base is primarily comprised of three main segments: biopharmaceutical companies, in vitro diagnostic companies, and government/academic
institutions. As of December 31, 2025, we had distributed our specimens to approximately 776 customers, such as the Centers for Disease
Control and Prevention. Since entering the regenerative medicine market late 2019, we have acquired 33 customers representing 0.7% of
our total revenue both in 2025 and in 2024.
From
our inception through December 31, 2025, we had distributed more than 218,000 specimens to 23 countries and our geographical revenues
distribution for the years ended December 31, 2025 and 2024 were as follows:
|
| |
December31, | | |
|
| |
2025 | | |
2024 | | |
|
Americas | |
| 94.74 | % | |
| 85.13 | % | |
|
Europe, Middle East and Africa | |
| 2.88 | % | |
| 12.71 | % | |
|
Asia Pacific | |
| 2.38 | % | |
| 2.16 | % | |
During
the year ended December 31, 2025, there was one customer that accounted for approximately 20% of our total revenue generated. During
the year ended December 31, 2024, there was one customer that accounted for approximately 29% of our total revenue generated. We continuously
engage with all customers when we receive inbound requests from them, whether they are within or outside of the Americas. Year-over-year,
our top customers have been different because their specimen needs tend to be project-based and depending upon where they are in their
research and development cycle, they may not need large numbers of specimens each year. During the year, our customer retention rates
are moderate, with 12 of our top 25 customers (48%) in the year ended December 31, 2024 also procuring specimens in the year ended December
31, 2025.
Biospecimens
have broad utility within the healthcare and life science industries, as they are collected and used throughout nearly every stage of
diagnostic and therapeutic product discovery and development. For diagnostic products, they are used consistently for preclinical discovery,
clinical validation, and post-market validation, as well as surveillance. For therapeutic products, these samples are most often used
during preclinical research involving drug target identification and validation, compound screening, lead optimization, predictive toxicology,
and pharmacokinetic studies. They are also used for biomarker companion diagnostic discovery and development, which has been shown to
reduce the costs of drug clinical trials by 30 to 60% according to Ark Research. In the case of regenerative medicine applications, hematologic
samples are used for research and development of engineered cell therapies (e.g. CAR-T, CAR-NK), stem cell therapies (e.g. hematopoietic
stem cells, mesenchymal stem cells), exosome therapies, identification of cell immunophenotypes for allogeneic therapies, and for developing
and scaling-up cell therapy manufacturing processes.
Given
recent advances in technology that now allow for the identification of molecular determinants of disease, the role of the patients
biospecimen has become even more important in all these endeavors and is essential to the development of precision medicine. This pursuit
of precision medicine by the healthcare and life science industries has further increased the already high demand for human biospecimens
and the clinical data that describe them.
7
****
**Our Competitors**
****
We
compete with a highly fragmented landscape of organizations who have access to human biospecimens. The competitive organizations, including:
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Healthcare providers, who
may offer access to clinical laboratory specimens, pathology laboratory specimens, biorepository specimens, or patients directly
for research; | |
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Commercial biobanks, who
purchase and maintain inventories of specimens from healthcare providers in anticipation of future requests from researchers. Some
of these organizations offer online catalogs that can be searched for specimens within their own biobanks; | |
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|
Specimen brokers, who act
as a middleman between healthcare providers and researchers on a transaction-by- transaction basis; | |
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Commercial specimen providers
who operate their own donor centers, specimen procurement groups, and cell manufacturing facilities. Some of these organizations
offer online catalogs that can be searched for specimens within their own biobanks; and | |
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Research services marketplaces
that provide access to a list of biospecimen providers but not a list of available biospecimens. These organizations allow a researcher
to fill out a specimen request form online which then gets distributed to the biospecimen providers in their marketplace. They do
not support searches for precise specimens in the services marketplace. | |
In
each of these cases, the landscape is extraordinarily fragmented, and our management estimates that most biospecimen providers have less
than 5% market share each, and no single biospecimen provider has more than a 20% market share. Most competitors are smaller organizations
with limited specimen procurement abilities. However, there are several larger biospecimen providers who are consolidating the industry
by acquiring smaller specimen providers to enable them to provide broader access to specimens and research subjects. These organizations
are well-capitalized by private equity and while they still lack a technology-based approach that enables them to search the inventories
across their biospecimen provider network, because of their broad specimen access, banked inventory, and available cash, they currently
represent our biggest competitive threat.
Specimen
providers (e.g. Discovery Life Sciences and StemExpress) maintain internal biobanks and enable researchers to search online for specimens
that reside within their own biobanks. Other research services marketplaces (e.g. Science Exchange) allow researchers to describe a specimen
request which then gets broadcast to a network of specimen providers (i.e. no searching for specimens, but rather the identification
of specimen providers who may or may not have matching specimens and the distribution of the specimen request to them). As such, we believe
that there are no other online human biospecimen marketplaces that operate in a manner similar to our business. In addition, we believe
that over the long term, the iSpecimen technology-based approach will allow us to scale faster than our competitors who rely upon manual
efforts to procure specimens. Nonetheless, we believe we will continue to face competition from: healthcare providers that have their
own inventory of biospecimens and thus offer lower prices by eliminating us and others as middlemen; commercial biobanks that have their
own inventory of biospecimens and thus may deliver samples more quickly when a researchers needs align with their existing inventory;
specimen brokers with a specific niche (e.g. infectious disease); and commercial specimen providers with their own donor centers who
may more predictably collect and deliver specimens.
**Our Intellectual
Property**
****
Intellectual
property rights are an important component of our business. While we currently do not have any patents protecting our intellectual property,
we rely on a combination of copyright, trademark, and trade secret laws in the United States and other jurisdictions, as well as confidentiality
and non-disclosure agreements and other contractual protections with employees and third parties to protect our intellectual property
rights, including our proprietary technology, brand, and know-how. We believe factors such as the technological and creative skills of
our people; our existing and evolving partnerships; the creation of new features, functionality, and services; and the frequent enhancements
to our platform have helped us to establish and will help us maintain our technology leadership position.
8
**Regulations**
****
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 subject research as well as regulations about the collection, storage, and dissemination of personal and healthcare data related
to individuals. To support compliance with regulations, we have both internal personnel and external resources who provide us with expertise
in various areas of compliance..
The following
is a general overview of the major laws and regulations pertaining to our business in the United States:
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45 CFR Part 46 Federal Policy for the Protection
of Human Subjects | |
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|
HIPAA and 45 CFR Parts 160, 162, and 164 HIPAA
Privacy Rule, Security Rule, and Breach Notification Rule | |
|
|
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21 CFR Part 11 Food and Drug Regulations
Electronic Records, Electronic Signatures | |
|
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|
21 CFR Part 50 FDA Regulations Protection
of Human Subjects | |
|
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|
21 CFR Part 56 FDA Regulations Institutional
Review Boards | |
|
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|
Other Information Laws and Regulations | |
|
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|
Other Applicable Laws | |
Most countries
have their own corresponding rules that we are also required to follow.
**45
CFR Part 46 Federal Policy for the Protection of Human Subjects The Common Rule**
****
The
Common Rule refers to regulations issued by the U.S. Department of Health and Human Services (HHS) and other federal agencies
that fund or participate in research, which regulations protect individuals participating in research. The Common Rule defines Human
Subjects Research as research involving a living individual about whom an investigator is conducting research when information
or biospecimens are obtained through intervention or interaction with the individual, or where the research uses, studies, analyzes,
or generates identifiable private information or identifiable biospecimens. For this type of research, the Common Rule stipulates: (i)
when this research must be reviewed and approved by an IRB (as well as when it may be exempt from IRB review and approval); (ii) the
requirements for an IRBs membership, authority, review procedures, record keeping, and approval criteria; (iii) when informed
consent must be obtained from a research subject for participation in research and the elements that must be communicated in an informed
consent form (as well as when consent may be waived by an IRB); and (iv) rules related to special requirements for vulnerable populations
(such as prisoners and pregnant women).
iSpecimen
is involved with both Human Subject Research and non-Human Subject Research. The collection of Research Use Only (RUO)
specimens (i.e., samples collected specifically for research via a direct intervention with the research subject and not collected as
part of routine clinical care) is considered Human Subject Research. In those cases, iSpecimen and our suppliers are subject to the Common
Rule. Therefore, all research use only specimens collected in the United States need to be collected under an IRB-approved protocol,
with informed consent (unless an IRB waives consent under appropriate regulatory standards).
iSpecimen
is not the study sponsor (i.e., research use only specimens are collected at participating healthcare providers under their own IRB-approved
protocols), we audit the site before we start procuring specimens to ensure that appropriate IRB approvals are in place.
For
international specimen collection sites, we rely on those sites to ensure they are collecting specimens in accordance with the laws in
their own jurisdictions, in addition to following basic U.S. rules related to Human Subjects Research.
9
Finally,
iSpecimen participates in Non-Human Subject Research, specifically when we collect clinical remnant samples (i.e., those specimens that
were collected originally as part of clinical care). According to the Common Rule, as long as the physical sample and any associated
dataset is de-identified before being used for research, the use of clinical remnant samples is not considered Human Subject Research
and therefore does not need IRB review and approval, nor does it require patient consent. For these samples, iSpecimen leaves it up to
each supplier to determine whether the supplier seeks patients consent or whether the supplier will inform its patients about
the suppliers use of remnant samples, or allows its patients to opt-out of their use. In all cases, we track any use limitations
that attached to a particular specimen. For researchers who only want samples from patients who have consented to allow use in research,
we only distribute specimens meeting that criteria to those researchers.
Health
Insurance Portability and Accountability Act, as amended by the Health Information Technology for Economic and Clinical Health (HITECH)
Act, all as implemented by 45 CFR Part 160, 162 and 164 (collectively, HIPAA).
HIPAA
includes several applicable rules, including the *Standards for Privacy of Individually Identifiable Health Information*(Privacy
Rule), the *Security Standards for the Protection of Electronic Protected Health Information*(Security Rule),
and the *Breach Notification Rule*(Breach Notification Rule).
The
Privacy Rule addresses the allowable uses and disclosures of an individuals PHI by Covered Entities, defined by HHS as (1) health
plans, (2) healthcare clearinghouses, and (3) healthcare providers who electronically transmit any health information in connection with
transactions for which HHS has adopted standards (such as electronic billing). The Privacy Rule also applies to Business Associates,
which include persons or entities that performs certain functions or activities that involve the use or disclosure of PHI on behalf of,
or provide certain services to, a Covered Entity. HIPAA requires Covered Entities to obtain HIPAA Business Associate Agreements with
their Business Associates.
The
Security Rule establishes a national security standard for protecting ePHI. The Security Rule requires Covered Entities and Business
Associates to implement physical, administrative, and technical safeguards to protect ePHI.
The
Breach Notification Rule pertains to Covered Entities and Business Associates that have access to PHI and requires them to provide notification
following a use or disclosure of PHI that does not comply with the Privacy Rule that compromises the security or privacy of the PHI (a
Breach).
Covered
Entities and Business Associates that fail to comply with the HIPAA standards may be subject to civil money penalties or criminal prosecution.
iSpecimen
has implemented many protocols and processes to comply with HIPAA and other data privacy and related laws and regulations. First, to
reduce the likelihood of any Breach, iSpecimen removes all ePHI prior to storing information in our datacenter so that we do not possess
PHI that is subject to HIPAA. Secondly, to the extent any PHI inadvertently remains in our datacenter, we have implemented physical,
administrative, and technical safeguards to comply with the HIPAA Security Rule. We have implemented more than eighty HIPAA privacy and
security policies at the Company to help ensure compliance with HIPAA Privacy, Security and Breach Notice rules. Thirdly, we regularly
undergo HIPAA gap analyses and security testing using external, independent firms to find weaknesses and vulnerabilities in our technology
and our data protection policies and procedures and remediate as needed. Finally, iSpecimen executes Business Associate Agreements or
Data Use Agreements with our healthcare provider partners if they might share ePHI with us. To date, iSpecimen has never had a Breach
of PHI and has never been investigated by HHS nor found to be out of compliance with HIPAA.
**21
CFR FDA Regulations**
****
The
Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction,
such as drugs, biological products, and medical devices. The FDA has its own set of rules related to the protection of human subjects
in research which may differ from the Common Rule. However, FDA does harmonize its regulations with the Common Rule whenever permitted
by law (see section 1002 of the 21st Century Cures Act, Public Law 114-255). iSpecimen follows the FDA regulations related to the protection
of research subjects, so that its customers may submit data to the FDA resulting from research performed using data and specimens provided
to the researcher by iSpecimen.
10
****
**21
CFR Part 11 Electronic Records; Electronic Signatures**
****
21
CFR Part 11 is relevant when submissions to the FDA include records in electronic form that are created, modified, maintained, archived,
retrieved, or transmitted under any records requirements set forth in FDA regulations. At a high level, Part 11 requires organizations
to implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate,
authentic, trustworthy, reliable, confidential, and generally equivalent to paper records and handwritten signatures on paper. These
rules stipulate a range of features that must be in place in computer systems that handle electronic data; standard operating procedures
relating to information technology systems and processes; system validation processes and procedures to ensure that electronic systems
operate as intended.
Although
iSpecimen defines and implements many relevant policies, processes, and technical controls, the iSpecimen Marketplace has not been certified
or audited for 21 CFR Part 11 compliance. In addition, we do not require the originating systems from whom we receive data to be 21 CFR
Part 11 compliant. While we do not represent to customers or suppliers that our systems are 21 CFR Part 11 compliant, our clients may
still submit data to the FDA that was received, stored, and transmitted in our systems.
The
vast majority of the specimens used by our customers are for projects that do not require 21 CFR Part 11 compliance, and our customers
are responsible for determining whether they require Part 11-compliant data for the particular use. For specimens that are collected
with informed consent, we audit informed consent differently for supply sites that use their own IRB or ethics committee. In the event
we are required to contact a client about a shipped specimen that is not supported by informed consent, which had not happened as of
December 31, 2025, the client would then determine whether it could use the specimen without informed consent. The failure of our Company
or our supply sites to comply with international, federal, state, and local laws and regulations could subject us to denial of the right
to conduct business, fines, criminal penalties, and/or other enforcement actions which could have a material adverse effect on our business.
**21
CFR Part 50 Protection of Human Subjects**
****
21
CFR Part 50 contains the general standards for obtaining informed consent and for human participation in clinical investigations as well
as additional safeguards for children involved in clinical investigations, when the investigations are regulated by the FDA. The regulations
specify the requirements for informed consent, exceptions to these requirements, elements of informed consent, and documentation of informed
consent. Additionally, the requirements detail additional regulations for investigations involving children. Informed consent is not
required to use de-identified specimens and data for certain FDA-regulated research, as set forth in guidance documents issued by the
FDA.
To
the extent our suppliers seek informed consent from individuals to use specimens and data for research, we will provide our clients,
upon request, with copies of our or our suppliers template informed consent forms and IRB approval prior to obtaining samples
from us. However, gaps may exist in our or our suppliers protocols and informed consent forms that make them incompatible with
this regulation and we may fail to properly audit and identify these gaps.
**21
CFR 56 Institutional Review Boards**
****
21
CFR Part 56 contains the general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations
regulated by the FDA. These regulations are intended to protect the rights and welfare of human subjects involved in such investigations
and indicate the required organization and membership of an IRB; the IRBs function and operations; record-keeping and reporting;
and administrative actions for non-compliance.
iSpecimen
does not directly conduct human subject research requiring IRB oversight and does not maintain a centralized IRB-reviewed protocol. Instead,
supply sites are responsible for obtaining and maintaining IRB approval, where applicable, under their own protocols and in compliance
with relevant regulatory requirements.
11
**Other
Information Laws and Regulations**
****
Other
information laws and regulations include all applicable laws concerning the privacy and/or security of personal information including,
but not limited to, state data breach notification laws; personal data protection laws such as the California Consumer Privacy Act of
2018, Nevada Senate Bill 220 (an amendment to the states existing online privacy policy statute) and Maines Act to Protect
the Privacy of Online Consumer Information; and all applicable Payment Card Industry Security Standards with respect to account data
protection.
Currently,
iSpecimen collects personal data on customers, suppliers, investors, employees, research subjects, Marketplace registrants, and other
individuals who interact with iSpecimen personnel or our websites. We believe we are in compliance with these data protection rules but
there remains inherent risk of a data breach of iSpecimens systems or any of our technology service and SaaS providers (such as
those organizations who provide us with customer relationship management software, marketing automation software, online file storage,
web services, email systems, accounting systems, and data aggregation and visualization services).
**Other
Applicable Laws**
****
In
addition to the above-described regulation by United States federal and state government related to Human Subject Research and data privacy
and security, there are many other U.S. and international rules that are applicable to iSpecimen. The following list contains some of
the other federal and state laws and regulations that could directly or indirectly affect our ability to operate the business:
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Occupational Safety and Health regulations and requirements; | |
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Centers for Disease Control Import Permit Program rules
related to biological agents; | |
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Shipping rules such as IATA Dangerous Goods regulations; | |
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State and local laws and
regulations for the disposal and handling of medical waste and biohazardous material; | |
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Export laws such as the
U.S. Department of Commerces Bureau of Industry and Security Export Administration Regulations, U.S. State Departments
Directorate of Defense Trade Controls, and the U.S. Department of the Treasurys Office of Foreign Assets Control in export
licensing; | |
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Import laws such as the
Customs and Border Protection Trade Act of 2002 and the Customs Modernization Act; | |
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The federal Anti-Kickback
Statute, which prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing
remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order
or recommendation of, any good or service for which payment may be made under federal healthcare programs; | |
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Federal, state, and local tax and tariff rules; | |
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Other laws and regulations administered by the FDA; | |
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Other laws and regulations administered by HHS; | |
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State and local laws and regulations governing human
subject research and clinical trials; and | |
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Other laws and regulations of which we are unaware. | |
These
laws cover areas where we may not have expertise and, in many areas, these laws are actively evolving. We, or our other third-party customers,
suppliers and/or distribution partners, may not be able to maintain regulatory compliance in such countries or may incur significant
costs in obtaining or maintaining our foreign regulatory compliance.
**International
Regulatory Environment**
****
Because
iSpecimen procures specimens from and distributes specimens to countries outside of the United States, we are subject to international
rules related to the protection of human subjects in research, data privacy and security, import and export regulations, tariffs, and
foreign rules similar to any of the aforementioned U.S. rules, as well as those of which we are unaware.
12
One
of the more prominent international regulations is the General Data Protection Regulation (GDPR) which took effect in May
2018. The GDPR regulates the collection, use, disclosure, transfer, and/or other processing of personal data of identified or identifiable
individuals located in the European Economic Areas, including the European Union (EU). This data specifically includes
personal health data that generally is provided as part of biospecimen collection studies. The GDPR imposes numerous requirements on
companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent
of the individuals to whom the personal data relates for processing (with some exceptions), allowing individuals to revoke consents granted,
enabling individuals the right to have their data erased (with some exceptions), amended, or transferred to another data controller (known
as data portability), providing information to individuals regarding data processing activities, implementing safeguards
to protect the security and confidentiality of personal data, limiting the transfer of data to countries outside of the EU, providing
notification of data breaches, and taking certain measures when engaging third-parties who may also use or process the data.
In
addition, EU member states may make their own further laws and regulations limiting the processing of personal data, including biometric,
genetic, or health data.
The
GDPR increases our obligations with respect to data collected by our EU suppliers. We generally rely upon our contractual terms with
these organizations as a means for obligating them to provide us data in accordance with the GDPR regulations. In addition to utilizing
contractual terms to obligate specimen suppliers to conform with GDPR, we generally request the international supplier fills out a pre-contract
questionnaire to understand their GDPR compliance before engaging in the contracting process and then perform a post-contract audit that
also asks about GDPR applicability and the sites conformance to the GDPR. Audit questionnaires are distributed every two years
after the initial site audit.
**Employees**
****
As of December 31, 2025, we had seven (7) employees,
one (1) of whom was engaged in sales and marketing activities, four (4) of whom were engaged in operations and fulfillment activities,
one (1) of whom was engaged in supply development and management activities, and one (1) of whom is the CEO of the Company.Our
employees are primarily located in Woburn, Massachusetts with three (3) remote sales, marketing, and supply development personnel located
elsewhere in the U.S.
As of December 31, 2024, we had twenty-four (24)
employees, one (1) of whom was engaged in research and development activities, nine (9) of whom were engaged in sales and marketing activities,
eleven (11) of whom were engaged in operations and fulfillment activities, and three (3) of whom were engaged in supply development and
management activities.Our employees are primarily located in Woburn, Massachusetts with fifteen (15) remote sales, marketing, and
supply development personnel located elsewhere in the U.S.
**Item
1A. Risk Factors**
****
*In
analyzing our Company, you should consider carefully the following risk factors, together with all of the other information included
in this Annual Report. Factors that could cause or contribute to differences in our actual results include those discussed in the following
subsection, as well as those discussed above in Managements Discussion and Analysis of Financial Condition and Results
of Operations and elsewhere throughout this Annual Report. Each of the following risk factors, either alone or taken together,
could adversely affect our business, operating results and financial condition, as well as adversely affect the value of an investment
in our Company. The risks and uncertainties described below are not the only ones we face. Additional risks not currently known to us
or other factors not perceived by us to present significant risks to our business at this time also may impair our business operations.*
**
**Risks
Related to Our Business**
****
**We
have incurred losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently
profitable, and we may never achieve or sustain profitability.**
****
We
were founded in 2009 and completed our first commercial sale in 2012. We did not start generating revenues until 2016. We are not profitable
and have incurred losses in each period since our inception in 2009. For the years ended December 31, 2025 and 2024, we reported net
losses of $10,487,532 and $12,497,805, respectively. We had an accumulated deficit of $82,350,149 as of December 31, 2025.
We
expect to continue to incur losses for the foreseeable future, and we expect these losses to increase as we continue to invest in the
growth of our business. We may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may
adversely affect our business. The magnitude of our future net losses will depend, in part, on the rate of future growth of our expenses
and our ability to generate and grow revenue. Even if we achieve profitability in a future period, we may not be able to sustain profitability
in subsequent periods. Our prior losses and expected future losses have had and will continue to have adverse effects on our stockholders
equity (deficit) and working capital.
13
**There
is substantial doubt about our ability to continue as a going concern.**
Our
audited financial statements included in this Annual Report include an explanatory paragraph that indicates that they were prepared assuming
that we would continue as a going concern. We have suffered recurring net losses and accumulated deficits as of December 31, 2025. These
conditions raise substantial doubts about our ability to continue as a going concern. Our plan for continuing as a going concern includes
improving our profitability and obtaining additional financing, including public and private placements of capital stock for additional
funding to meet our operating needs. There can be no assurance that we will be successful in our plans described above or in attracting
equity or alternative financing on acceptable terms, or if at all. These consolidated financial statements do not include any adjustments
to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should we
be unable to continue as a going concern.
**During
the year ended December 31, 2025, we identified a material weakness in our internal control over financial reporting that may cause us
to fail to meet our reporting obligations or result in material misstatements of our financial statements. If we fail to remediate this
material weakness or if we otherwise fail to establish and maintain effective control over financial reporting, our ability to accurately
and timely report our financial results could be adversely affected.**
****
We
are required to comply with the SECs rules implementing Sections 302 and 404 of the Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley
Act), which requires management to certify financial and other information in our quarterly and annual reports and provide an
annual management report on the effectiveness of our controls over financial reporting. We are also required to make assessment of our
internal controls over financial reporting pursuant to Section 404. We have included in this Annual Report managements assessment
disclosure of any material weaknesses in our internal control over financial reporting. Our independent registered public accounting
firm will not be required to attest to the effectiveness of our internal control over financial reporting until our first annual report
required to be filed with the SEC, following the later of the date we are deemed to be an accelerated filer or a large
accelerated filer, each as defined in the Exchange Act. We could be an emerging growth company for up to five years after the
date of our initial public offering (IPO).
A
material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is
a reasonable possibility that a material misstatement of our financial statements will not be prevented or detected on a timely basis.
As
described elsewhere in this Annual Report, we identified a material weakness in our internal control over financial reporting related
to a failure to design and maintain adequate controls to maintain appropriate documentation for the tax exempt status of its customers,
calculate and collect sales tax at point of sale, and subsequently report and remit in a timely manner to the relevant tax jurisdictions
sales tax obligations.
We
initiated and implemented several remediation measures including, but not limited to, (i) engaging external tax advisors to complement
internal resources and efforts and provide support in assessing the appropriate sales tax treatment associated with the Companys
products for all prior years in which the Company had generated revenue, (ii) obtaining sales tax exemption letters, representation letters
or proof of payments of compensating use tax from our customers and we have started a collection effort of these sales taxes from certain
customers who have notified the Company that they do not have a sales tax exemption letter, (iii) implementing a sales tax software platform
solution for the calculation, communication, collection, and remittance of sales tax for all non-exempt future sales, and assisting with
the collection and tracking of Voluntary Disclosure Agreements received from states where a potential sales tax liability may exist,
(iv) designing and implementing enhanced policies, procedures and controls related to the calculation, communication, collection, and
remittance of sales tax to relevant jurisdictions, and (v) training appropriate personnel in the effective design and execution of our
enhanced policies, procedures, and controls, including the importance of the ongoing, consistent effective execution of such procedures
and controls.
We
believe the measures described above should address the material weakness identified and strengthen our internal control over financial
reporting. These measures are expected to result in future costs for us. While we continue the process to implement our plan to remediate
the material weakness, we cannot predict the success of such plan or the outcome of our assessment of this plan until the remediation
initiatives have been completed and have been operating effectively for a sufficient period of time. We can give no assurance that these
measures will remediate the deficiencies in internal control or that additional material weaknesses or significant deficiencies in our
internal control over financial reporting will not be identified in the future. Our failure to implement and maintain effective internal
control over financial reporting could result in errors in our financial statements that may lead to a restatement of our financial statements
or cause us to fail to meet our reporting obligations for the year ended December 31, 2025, any of which could diminish investor confidence
in us and cause a decline in our stock price.
14
We
may identify future material weaknesses in our internal controls over financial reporting or fail to meet the demands that will be placed
upon us as a public company, including the requirements of the Sarbanes-Oxley Act, and we may be unable to accurately report our financial
results, or report them within the timeframes required by law or stock exchange regulations. We cannot assure that additional material
weaknesses will not exist or otherwise be discovered, any of which could adversely affect our reputation, financial condition and results
of operations.
**We
may likely require additional capital in the future and an inability to meet future capital needs could adversely impact our ability
to operate.**
****
We
require substantial capital to fund our business growth and we will likely need additional capital in the future to fund our operations.
In addition to investing in personnel growth commensurate with business growth, we believe we must continue to invest in the development
of our iSpecimen Marketplace platform to enhance and improve its performance, functionality, ease of use, and reliability to carry out
our business strategies. New industry standards, the availability of alternative products, and evolving life science research needs could
render our products and services obsolete and/or new third-party marketplace technology may be introduced that makes it easier for our
competitors to create their own marketplace platforms. Our success will depend, in part, on our ability to develop new products and services
and make corresponding technology enhancements that address the increasingly sophisticated and varied needs of our suppliers and customers
and respond to technological advances and emerging industry standards and practices on a cost-effective and timely basis. We cannot be
certain that additional financing will be available to us if required on favorable terms or at all. To the extent that we cannot raise
capital if needed, we may not be able to continue operations.
**Our
revenue trend is not predictive which can lead to difficulty in accurately forecasting future results.**
****
Our
revenue trend is not predictive and our ability to accurately forecast future results is limited and is impacted by a number of factors,
including:
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Our revenue is transactional
and not recurring. Researchers pay us to provide specimens when they have a need for specimens. We do not currently charge our customer
or supply chain for access to the iSpecimen Marketplace; | |
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Our revenue is significantly
concentrated and varies by customer year-over-year. There was one customer that accounted for approximately 20% of our revenue in
2025. In 2024, there was one customer that represented approximately 29% of our revenue; | |
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Researcher needs may change
over the lifetime of a project, based on the stage of the project. A research customer in one time period may not have a need for
specimens again in the next; | |
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Research projects get terminated
or suspended for a variety of reasons, including funding issues or unexpected results. Any termination or suspension of a project
may cause a corresponding cancellation or delay in purchase orders we have received for specimens; and | |
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Suppliers may not accurately
estimate how long it will take them to fulfill specimen requests, making it more difficult to accurately forecast when we will recognize
revenue on these specimen requests. | |
Many
of these are outside of our control and all of which may change from time to time. Our historical revenue results should not be taken
as predictive of future performance. There are many risks that could impact future performance resulting in variations in expected results
which could lead to a negative business impact.
**Our
growth strategy may not prove viable and we may not realize expected results.**
****
Our
business strategy is to grow by improving and expanding iSpecimens Marketplace platform. This growth is expected to come through:
(i) expansion of our platform capabilities to drive increased acquisition of annotated biospecimens through the platform, (ii) further
expansion of our customer and supplier base in and outside the United States, and (iii) expansion into new lines of business such as
patient recruitment and data licensing. Expansion of our existing business and entry into new lines of business will require a significant
investment in technology development, supply development, operations, and marketing and sales. We may not achieve market expansion and
acceptance and we may incur problems introducing new solutions and services. We may experience losses related to these investments, which
could have a material adverse effect on our results of operations.
15
Our growth
strategy involves a number of risks and uncertainties, including:
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We may not successfully
enter into contracts with healthcare providers to gain access to specimens, subjects, and data on terms favorable to us or at all.
This can limit our ability to grow in existing lines of business and expand into new lines of business; | |
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We may not obtain new customers
or may lose existing customers if we cannot offer products and services that they need on a timely basis or at all; | |
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We may fail in the development
of our technology and it may not adequately keep pace to support an expansion of our existing line of business or our entry into
new lines of businesses; | |
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The market adoption rate
of our marketplace technology may be too slow, and we may fail to get our customers and suppliers to transact for products and services
using our technology; | |
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We may fail to continue
to expand outside of the United States, especially if we are required to comply with laws and regulations that differ from geographies
in which we currently operate; | |
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We may fail to gain market acceptance for new products
or services; and/or | |
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We may lose to competitors,
some of whom may have greater resources than we do. This competition may intensify due to the ongoing consolidation in the biospecimen
industry, which may increase our costs to pursue opportunities. | |
If
we fail to properly evaluate and execute existing and new business opportunities properly, we may not achieve anticipated benefits and
may incur increased costs. There can be no assurance that we will be able to successfully capitalize on growth opportunities, which may
adversely impact our business model, revenues, results of operations, and financial condition.
**International
operation expansion could expose us to additional risks which could harm our business, prospects, results of operation, and financial
condition.**
****
We
operate internationally and expect to expand internationally. For example, we procure specimens from sites outside of the United States
and we also distribute samples to organizations located around the world. As of December 31, 2025, we had customers in 5 countries and
supply sites in 8 countries, International expansion exposes us to additional risks, including:
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changes in local political, economic, social, and labor
conditions, which may adversely affect our business; | |
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risks associated with trade
restrictions and foreign import requirements, including the importation and exportation of our solutions, as well as changes in trade,
tariffs, restrictions or requirements; | |
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heightened risks of unethical, unfair or corrupt business
practices, actual or claimed, in certain geographies; | |
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fluctuations in currency
exchange rates, which may make doing business with us less appealing as our contracts are generally denominated in U.S. dollars; | |
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greater difficulty in enforcing contracts; | |
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lack of brand awareness that can make commercializing
our products more difficult and expensive; | |
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management communication
and integration problems resulting from cultural differences and geographic dispersion; | |
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the uncertainty and limitation of protection for intellectual
property rights in some countries; | |
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increased financial accounting and reporting burdens
and complexities as a result of being a public company; | |
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lack of familiarity with
local laws, customs and practices, and laws and business practices favoring local competitors or partners; | |
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potentially different pricing
environments, longer payment cycles in some countries, increased credit risk, and higher levels of payment fraud; | |
16
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uncertainty regarding liability
for products and services, including uncertainty as a result of local laws and lack of legal precedent; | |
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different employee/employer
relationships, existence of workers councils and labor unions, and other challenges caused by distance, language, and cultural
differences, making it harder to do business in certain jurisdictions; | |
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compliance with complex
foreign and U.S. laws and regulations applicable to international operations may increase the cost of doing business in international
jurisdictions. These numerous and sometimes conflicting laws and regulations include internal control and disclosure rules, data
privacy requirements, research ethics and compliance laws, anti-corruption laws, and anti-competition regulations, among others.
Violations of these laws and regulations could result in fines and penalties, criminal sanctions against us, our officers, or our
employees, prohibitions on the conduct of our business and on our ability to offer our products and services in one or more countries,
and could also materially affect our brand, our international expansion efforts, our ability to attract and retain employees, our
business, and our operating results; and | |
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instability, disruption
or destruction in a significant geographic region, regardless of cause, including war, terrorism, riot, civil insurrection or social
unrest; and natural or man-made disasters, including famine, flood, fire, earthquake, storm or disease, including without limitation,
the war between Russia and Ukraine which started in February 2022, regions from which we obtain specimen supplies. | |
The
occurrence of any one of these risks could harm our international business and, consequently, our results of operations. Additionally,
operating in international markets requires significant management attention and financial resources. We cannot be certain that the investment
and additional resources required to operate in other countries will produce desired levels of revenue or profitability.
**We,
or the third parties who provide services for us, may be adversely affected by external events for which our business continuity plans
may not adequately prepare us.**
****
The
occurrence of severe weather, natural disasters, health epidemics, acts of war or terrorism, military conflicts such as the war between
Russia and Ukraine, and other adverse external events or conditions that impact us or the operations of third parties who provide services
for us have the potential to significantly impact our ability to conduct business. Although we have business continuity plans in place,
including an emergency succession plan, there is no guarantee that our plans can be successfully implemented. Even if we were to successfully
implement our continuity plans, we may incur substantial expenses and there is no guarantee that our business, financial condition, and
results of operations will not be materially impacted.
**We
rely upon our technology solution for the operation of our business and if our technology platform contains defects or fails to perform
as expected, we may need to suspend its availability and divert development resources, and our business and reputation may be harmed.**
****
Technology
as complex as ours may contain unknown and undetected errors or performance problems. There could be numerous reasons for performance
and quality issues including new and updated features, defects in integrated commercial and open source technologies, outages and disruptions
in the cloud infrastructure on which our platform relies, human error or malfeasance, scale constraints, design flaws, and bad actions
by external factors including security and performance related incidents. Many serious defects are frequently found during the period
immediately following introduction and initial release of new capabilities or enhancements to existing platforms. Although we attempt
to resolve errors that we believe would be considered serious by our users before making our platforms available to them, our products
are not error-free. If a significant failure occurs that prevents our customers, suppliers, or our Company from using the iSpecimen Marketplace,
our operations may be disrupted, and it may be difficult or, in certain cases, impossible for us to continue our business for a period
of time until the failure is corrected. Any performance or quality problem could result in lost revenues or delays in user acceptance
that would be detrimental to our business and reputation. We may not be able to detect and correct errors before releasing our product
commercially. Undetected errors or performance problems in our existing or future products may be discovered in the future and known
errors, considered minor by us, may be considered serious by our customers, resulting in a loss of customers and a decrease in our revenues.
**Sustainable
future revenue growth is dependent upon the development of technology solutions that enable scale and address new markets.**
****
Our
iSpecimen Marketplace technology consists of four major functional areas: data ingestion and harmonization, search, workflow management,
and administration, compliance and reporting. Each of these functional areas need continual development to both enable our current business
to scale and to enable us to enter new markets. As financial resources become available, our intention is to focus most of our engineering
resources on the development of the iSpecimen Marketplace platform for the foreseeable future. In fiscal year 2025, we incurred $2,159,815
in technology expenses, and capitalized $1,000,000 for software under development. While we have spent a significant amount of time and
resources on the development of this platform, we cannot provide any assurances of our iSpecimen Marketplaces short or long-term
success or growth and there is no assurance that the resources being allocated for the platform will be sufficient to complete planned
additional capabilities, or that such completion will result in significant revenues or profit for us. If our customers or suppliers
do not perceive this platform to be of high value and quality, we may not be able to retain them or acquire new customers or suppliers.
17
**Our
platform may become technologically obsolete or commoditized.**
****
We
must continue to enhance and improve the performance, functionality, ease of use, and reliability of our iSpecimen Marketplace platform
or it may become obsolete or commoditized. New industry standards, the availability of alternative products, and evolving life science
research needs could render our products and services obsolete and/or new third-party marketplace technology may be introduced that makes
it easier for our competitors to create their own marketplace platforms. Our success will depend, in part, on our ability to develop
new products and services that address the increasingly sophisticated and varied needs of our suppliers and customers and respond to
technological advances and emerging industry standards and practices on a cost-effective and timely basis. The development of our technology
involves significant technical and business risks. We may fail to use new technologies effectively or to adapt our proprietary technology
and systems to user requirements or emerging industry standards. If we are unable to adapt to changing market conditions, user requirements,
or emerging industry standards, we may not be able to increase our revenue and expand our business. Additionally, if existing or future
competitors develop or offer products or services that provide significant performance, price, creative or other advantages over this
platform, demand for our services through the iSpecimen Marketplace may decrease and our business, prospects, results of operations and
financial condition could be adversely affected.
**If
our security measures are breached, or if our services are subject to attacks that degrade or deny the ability of users to access our
platforms, our platforms and applications may be perceived as not being secure, customers and suppliers may curtail or stop using our
services, and we may incur significant legal and financial exposure.**
****
Our
platforms and the network infrastructure that are hosted by third-party providers involve the storage and transmission of healthcare
data as well as proprietary information about organizations and programs, and security breaches could expose us to a risk of loss of
this information, litigation, and potential liability. Our security measures may be breached due to the actions of outside parties, employee
error, malfeasance, security flaws in the third party hosting service that we rely upon, or any number of other reasons and, as a result,
an unauthorized party may obtain access to our suppliers or customers data. Although we have never had any breach of data
in our third-party providers environment, any future breach or unauthorized access could result in significant legal and financial
exposure, damage to our reputation, and a loss of confidence in the security of our platforms and applications that could potentially
have an adverse effect on our business. Because the techniques used to obtain unauthorized access, disable or degrade service, or sabotage
systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques
or to implement adequate preventative measures on a timely basis. If an actual or perceived breach of our security occurs, the market
perception of the effectiveness of our security measures could be harmed and we could lose suppliers and customers and we may have difficulty
obtaining merchant processors or insurance coverage essential for our operations.
We,
and the third-party providers upon which we rely, have experienced, and may in the future experience, cybersecurity threats, including
threats or attempts to disrupt our information technology infrastructure and unauthorized attempts to gain access to sensitive or confidential
information. Our and our third-party vendors technology systems may be damaged or compromised by malicious events, such as cyberattacks
(including computer viruses, malicious and destructive code, phishing attacks, and denial of service attacks), physical or electronic
security breaches, natural disasters, fire, power loss, telecommunications failures, personnel misconduct, and human error. Such attacks
or security breaches may be perpetrated by internal bad actors, such as employees or contractors, or by third parties (including traditional
computer hackers, persons involved with organized crime, or foreign state or foreign state- supported actors). Cybersecurity threats
can employ a wide variety of methods and techniques, which may include the use of social engineering techniques, are constantly evolving,
and have become increasingly complex and sophisticated; all of which increase the difficulty of detecting and successfully defending
against them. Furthermore, because the techniques used to obtain unauthorized access or sabotage systems change frequently and generally
are not identified until after they are launched against a target, we and our third-party providers may be unable to anticipate these
techniques or implement adequate preventative measures. Although prior cyberattacks directed at us have not had a material impact on
our financial results, and we are continuing to bolster our threat detection and mitigation processes and procedures, we cannot guarantee
that future cyberattacks, if successful, will not have a material impact on our business or financial results. While we have security
measures in place to protect our information and our customers and suppliers information and to prevent data loss and other
security breaches, there can be no assurance that in the future we will be able to anticipate or prevent security breaches or unauthorized
access of our information technology systems or the information technology systems of the third-party providers upon which we rely. Despite
our implementation of network security measures and internal information security policies, data stored on personnel computer systems
is also vulnerable to similar security breaches, unauthorized tampering or human error.
18
Many
governments and other regulatory bodies including the SEC have enacted laws requiring companies to provide notice of data security incidents
involving certain types of data, including personal data. If an actual or perceived breach of security measures, unauthorized access
to our system or the systems of the third-party providers that we rely upon, or any other cybersecurity threat occurs, we may face direct
or indirect liability, costs, or damages, contract termination, our reputation in the industry and with current and potential customers
may be compromised, our ability to attract new customers could be negatively affected, and our business, financial condition, and results
of operations could be materially and adversely affected.
We
maintain cybersecurity insurance and other types of insurance, subject to applicable deductibles and policy limits, but our insurance
may not be sufficient to cover all costs associated with a potential data security incident. We also cannot be sure that our existing
general liability insurance coverage and coverage for cyber liability or errors or omissions will continue to be available on acceptable
terms or will be available in sufficient amounts to cover one or more large claims or that the insurer will not deny coverage as to any
future claim. The successful assertion of one or more large claims against us that exceed available insurance coverage, or the occurrence
of changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements,
could harm our financial condition.
**Changes
in demand for our products and services could affect profitability.**
****
We
are fundamentally a matchmaking service provider between researchers who have needs for access to subjects, samples, and data, and healthcare
providers and other organizations that have them. Any change that either reduces the demand for our services or changes the composition
of the demand could adversely impact our financial results.
Overall
customer demand could change for many reasons outside of our control, reducing demand or making it more difficult to match up to our
supply chains capabilities. These reasons include:
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general economic downturn that impacts the research
and development budgets of biopharma; | |
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changes in the disease landscape, like COVID-19, that
affect the types of products and services needed; | |
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changes in drugs and therapies and the desire to study
subjects on these drugs and therapies; | |
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changes in diagnostic tests
performed (like genomic sequencing) that drive the need for subjects and samples with these new or novel test results; | |
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changes in data requirements, such as the need to know
specific outcomes data; | |
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overall changes in biomarker
research, such as emerging liquid biopsy or cell therapy research, that drives the need for different products and services; | |
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leadership changes within our customers resulting in
loss of sponsorship; | |
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new (alternative) products
introduced by competitors and/or developed by customers, which may have potential to reduce or replace the need for certain types
of biospecimens that we provide; | |
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competitive forces, which make it easier for customers
to find products and services elsewhere; and/or | |
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cancellation or delay of research programs, due to
funding issues or preliminary research result issues. | |
If
we fail to address these factors in a timely manner or at all, our financial results could be adversely affected.
Additionally,
overall customer demand could decrease if we fail to:
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provide high quality products and services; | |
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provide products and services at a competitive price; | |
19
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deliver products and services in a reasonable amount
of time; | |
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offer high levels of customer service; | |
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offer adjacent services that researchers want to procure
along with our existing products and services; | |
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adequately invest in sales
and marketing programs and teams to drive demand or operational support to fulfill requests; | |
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develop a large and diverse supply network to satisfy
demand; or | |
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provide a technology solution
that simplifies the biospecimen procurement process for researchers and specimen providers alike. | |
**We
incur credit risk with our customers, and we may provide them with products and services for which we do not get paid.**
****
Our
customers generally place orders for our products and services using a purchase order and we invoice our customers after they have received
the products or services from us. During this procurement process, we become obligated to pay our suppliers for any products or services
we procure from them on behalf of our customers regardless of whether our customers ultimately pay us for these products or services.
Therefore, we bear the responsibility for the credit risk of our customers. We mitigate this credit risk through procedures that evaluate
the creditworthiness of customers prior to accepting a purchase order from them. However, our procedures may not successfully identify
all those who ultimately fail to pay us for our products and services and any non-payments may negatively impact our revenues, results
of operations, and financial condition.
**Our
customer mix increases the risk of customers not paying our invoices.**
****
We
derive, and believe that we may continue to derive, a significant portion of our revenues from privately held, investor-backed biopharma
companies that are not profitable and have little operating history. These organizations may be at a higher risk of not paying for provided
products and services on a timely basis or at all. If these companies fail to pay our invoices, our profitability will be adversely impacted.
**We
rely upon relatively few customers for a significant portion of revenue and do not have a recurring revenue business model. A loss of
large customers could affect our ability to operate.**
****
We
have derived, and believe that we may continue to derive, a significant portion of our revenue from a limited number of customers that
vary each year. During the year ended December 31, 2025, one customer represented 20% of the Companys revenues, and during the
year ended December 31, 2024, one customer represented 29% of our revenue. We do not have a recurring revenue model and our customers
may buy less of our products or services depending on their research and development cycles, internal budget cycles, product and service
requirements, and competitive offerings. A major customer in one year may not purchase any of our products or services in another year,
which may adversely affect our financial performance.
**Customers
and customer prospects may be averse to using a self-service marketplace to procure specimens and may continue to require iSpecimen personnel
in the procurement process, impacting our scalability and profitability.**
****
The
iSpecimen Marketplace functions as a lead generation system to capture customer requests for specimens and as a workflow engine to allow
customers, suppliers, and our Company to track and manage specimen requests. Currently, it does not fully support self-service eCommerce
because key capabilities required to satisfy these transactions across all of our product lines, such as a pricing engine and patient-level
search, have yet to be incorporated. Therefore, currently all customer requests for specimens require assistance from iSpecimen sales
personnel. At a minimum, our sales personnel are involved in the generation of customer quotes, but they often also act in a consulting
role to help develop specimen request specifications on more complex projects or to perform searches on the customer or customer prospects
behalf.
While
we continue to invest in capabilities to support customer self-service in the iSpecimen Marketplace, we do not know when we will consider
these capabilities to be fully developed. Additionally, we do not know if researchers will utilize the iSpecimen Marketplace to transact
without the intervention of iSpecimen personnel which could limit our scalability. We may continue to invest in software which may never
provide a return on its investment and diverts resources from the development of software that drives other parts of our procurement
workflow.
20
**Our
business may be materially and adversely impacted by the reduction, delay or cancellation of orders from our customers.**
****
Our
contracts with our customers generally allow them to reduce, delay, or cancel the unfulfilled portion of their specimen order with a
two-week notice. Customers may reduce, delay, or cancel their unfulfilled orders due to a variety of reasons including they make changes
to project requirements and the open request no longer meets their needs; their budgets change or projects get cancelled; they place
orders with multiple specimen providers and cancel open orders when they have procured sufficient quantity of samples across all their
sources; or we are unable to fulfill the entire order before the project deadline. For orders received in 2025 and 2024, we fulfilled
approximately 77% and 69%, respectively, of the total value of these orders. These percentages do not take into consideration long term
or open- ended projects that are not intended to be completely fulfilled at year end. Our business, financial condition, results of operations
and cash flows may be materially and adversely impacted by the reduction, delay or cancellation of orders.
**We
have entered into contracts with U.S. government agencies and contractors which subjects us to federal contract and audit risks.**
****
We
entered into contracts with U.S. government agencies and contractors, representing approximately 0.95% and 0.2% of our total revenue
for 2025 and 2024, respectively, that may contain unfavorable termination provisions and are subject to audit and modification by the
government at its sole discretion, which subjects us to additional risks. These risks include the ability of the U.S. government to unilaterally:
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suspend or prevent us for a set period of time from
receiving new contracts or extending existing contracts; | |
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terminate our existing contracts; | |
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reduce the scope and value of our existing contracts; | |
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audit and object to our contract-related costs and
fees, including allocated indirect costs; and | |
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change certain terms and conditions in our contracts. | |
The
U.S. government may terminate any of its contracts with us either for its convenience or if we default by failing to perform in accordance
with the contract schedule and terms. Termination for convenience provisions may enable us to recover only our costs incurred or committed,
and settlement expenses and profit on the work completed prior to termination. Termination for default provisions may not permit these
recoveries and make us liable for excess costs incurred by the U.S. government in procuring undelivered items from another source.
As
a U.S. government contractor and subcontractor, we may become subject to periodic audits and reviews. Based on the results of these audits,
the U.S. government may adjust our contract-related costs and fees, including allocated indirect costs. As part of any such audit or
review, the U.S. government may review the adequacy of, and our compliance with, our internal control systems and policies, including
those relating to our purchasing, property, compensation, and/or management information systems. In addition, if an audit or review uncovers
any improper or illegal activity, we may be subject to civil and criminal penalties and administrative sanctions, including termination
of our contracts, forfeiture of profits, suspension of payments, fines and suspension or prohibition from doing business with the U.S.
government.
We
could also suffer serious harm to our reputation if allegations of impropriety were made against us. Although we have not had any government
audits and reviews to date, future audits and reviews could cause adverse effects.
**Sustainable
future revenue growth is dependent on growth in the capabilities of our supply network which we may not be able to achieve.**
****
Our
business is fundamentally a match-making business between healthcare providers who have access to subjects, samples, and data and life
science researchers who need them. Currently, we receive more requests for our products and services than we have access to in our supply
network and we are therefore supply constrained. Although we continue to allocate resources to supply development and commensurately
grow our supply network capabilities to keep pace with demand, this supply-demand imbalance could increase in the future if we do not
continue or increase our investment in this area.
Additionally,
demand for specimens we receive is becoming more specific, requiring access to a greater population of subjects, samples, and data to
find those that meet a researchers inclusion and exclusion criteria. It takes a larger network of subjects, samples, and data
to access a wide enough population of subjects to meet a growing number of requests with more stringent criteria. Delays, difficulties,
or unanticipated costs in developing our supply network capabilities necessary to successfully procure products and services could adversely
affect revenue and profitability.
21
**Sustainable
future revenue growth is dependent upon gaining access to more healthcare data from our supply network and a failure to obtain this data
may adversely affect our growth.**
****
Key
to our growth strategy is the accessibility and availability of deep medical record data from our healthcare provider supply sites. This
data is used to automate the process of matching researchers to subjects, samples, and data, and also used to automate the procurement
workflow. Currently, we have gained access to laboratory data to support the distribution of clinical lab specimens as well as biorepository
data to support the distribution of banked specimens. However, we have not gained access to deeper medical record data sets from a broad
set of healthcare providers to support custom specimen collections, clinical trial recruitment, or data licensing. Should we fail in
our ability to access deeper healthcare data, we may not be able to effectively compete in our served markets or grow as anticipated
and our business may suffer.
**The
adoption cycle of our supply network tends to be very lengthy, which may adversely affect our ability to scale rapidly and increase revenues.**
****
The
business development cycle for the adoption of our technology solution at healthcare provider supply partners can take up to 18 months
or more from initial contact with the prospect through execution of a contract. We may spend significant resources to attempt to secure
a new supply partner without successfully engaging the supply partner. Even if we are successful in securing a new supply partner, once
a contract is executed, implementation of our technology in the supply partners environment can take another several months to
a year or more. Because of the lengthy adoption cycle, we may fail to expand our supply network quickly enough to reach our revenue growth
targets.
**Potential
adverse effects from changes in the healthcare industry, including consolidations and regulatory changes, could affect access to subjects,
samples, and data and affect our growth.**
****
Changing
healthcare-related legislation and regulation may impact the fiscal stability and sustainability of our supply partners. Additionally,
many healthcare providers are consolidating to create larger healthcare systems and/or integrated healthcare delivery systems. These
changes can divert resources at our healthcare provider supply sites away from the evaluation or implementation of the iSpecimen solution
to the adoption of new infrastructure, policies, and procedures to support the changes, thereby extending their timeline to adopt the
iSpecimen solution. We cannot predict whether or when future healthcare reform initiatives at the international, federal, or state level,
consolidations, or other initiatives affecting healthcare providers businesses will be proposed, enacted, or implemented or what
impact those initiatives may have on our business, results of operations, and financial condition.
**Our
supply chain may not provide adequate resources to quickly respond to requests for specimens and delays in the procurement process can
affect our reputation, revenue, and profitability.**
****
Many
of the healthcare providers in our supply network are not-for-profit organizations whose primary business is to provide clinical care
to patients. Supporting biospecimen research may be an adjunct activity for them. These organizations may lack adequate resources to
quickly respond to our requests for specimens now and into the future. Should we and our customers experience slow turnaround times on
specimen requests, our reputation may be damaged and there may be an adverse impact on our revenue and profitability.
**We
do not control the end-to-end quality of specimens and data collected in our supply chain and quality issues can affect our reputation,
revenue, and profitability.**
****
We
rely upon our supply sites and their quality control processes to provide us with products and services that meet order specifications.
In certain situations, products are shipped directly from the supply sites to our customers. When we receive products from our supply
sites, we perform a visual inspection of the products, but we do not perform an in-depth quality control check to ensure that products
meet all specifications.
Instead,
we rely upon our customers to perform quality checks themselves and offer refunds or replacements for products that do not meet specification.
We receive products from supply sites and ship them to our customers. In 2025, the percent of specimens that met specifications was 99%
for clinical remnant specimens, 92% for banked research specimens and 99% for custom research collections. In 2024, the percent of specimens
that met specifications was 99% for clinical remnant specimens, 89% for banked research specimens and 99% for custom research collections.
Percentage of specimens that met specifications increased year over year from 2022 and then again during the year ended December 31,
2025. Following feedback from our customers, we implemented a robust return and exchange program to better meet customer needs. iSpecimen
is also terminating contracts with suppliers with lower quality specimens. Any issues with quality from our supply sites can adversely
affect our reputation, revenue, and profitability.
22
**Reliance
on relatively few supply partners for significant supplies and services could affect our ability to operate and grow.**
****
We
have derived, and believe that we may continue to derive, a significant portion of our revenues from products we procure from a limited
number of supply sites. For the year ended December 31, 2025, there was one supplier who accounted for 7% of our total cost of revenue
and three other suppliers who, together, accounted for an additional 20% of our total cost of revenue. For the year ended December 31,
2024, there was one supplier who accounted for 11% of our total cost of revenue and three other suppliers who, together, accounted for
an additional 17% of our total cost of revenue. Any change in the ability of a major supply site to provide us with products and services
(such as financial health of the supply site, key leadership, research focus, information technology, competitive demand for specimens
from third-parties, pricing structures, contract status and changes in the general economy) may adversely affect our financial performance.
**Our
supply partners inventories may become obsolete, which could have a material adverse effect upon our ability to generate revenue.**
****
During
the year ended December 31, 2025, approximately 42% of our revenue was derived from specimens that were procured from our supply partners
existing sample inventories in their biobanks. These inventories may become obsolete due to changes in regulatory requirements such as
a requirement for new consent form disclosures; changes in researcher requirements for the types of specimens, subjects, and data they
need for their studies; and/or general degradation in the quality of stored specimens. Any change in regulations, researcher needs, or
specimen quality could render our supply partners inventories obsolete and may adversely affect our financial performance.
**Specimen
collection from human subjects, including the possible occurrence of adverse events during or after tissue collection, could provide
exposure to claims and litigation.**
****
There
are inherent risks associated with collecting specimens from human subjects. Although specimen collections are completed by certified
staff according to established industry standards, specimen donors vary in their ability to tolerate specimen collection protocols and
such donors may potentially have an adverse health reaction either during or following a specimen collection. Research subjects or their
legally authorized representative may file claims related to a specimen collection and these claims could result in litigation that could
be expensive, and time consuming to defend or result in judgements that exceed the resources of the Company and its insurance coverage.
**We
procure specimens and data from organizations outside of the U.S. and as such, we rely upon these organizations to collect and distribute
specimens and data in accordance with their local regulations as well as our contractual requirements. A failure by our sites to comply
with both applicable regulations and our contractual requirements could introduce us to compliance risk.**
****
Some
of the organizations from which we procure specimens and data reside outside of the U.S. in jurisdictions that may have data protection
rules, human research protection rules, and other pertinent rules that relate to the collection and distribution of specimens and data
that vary from U.S. regulations. We, as an organization are not knowledgeable about all the pertinent rules and regulations of all of
the jurisdictions in which these sites operate, and therefore we rely upon our contractual relationships with supply sites to ensure
that they have legal responsibility for compliance with their own jurisdiction-specific regulations.
Should
any site fail to comply with the applicable regulations, we may suffer reputational risks if we have distributed specimens and data from
that site. Additionally, any compliance failure on the part of our supply sites that impacts our research customers ability to
utilize specimens and data they previously obtained from us, as well as utilize any research results, they derived from these specimens
and data, may subject us to claims by these customers. These claims could result in litigation that could be expensive to defend or result
in judgements that exceed our resources and our insurance coverage. Any such litigations and judgement could adversely affect our business,
financial condition, and results of operations.
**We
may experience delays or interruption in the shipments of our specimens due to factors outside of our control, and such disruption could
lead to lost revenue and customer satisfaction issues.**
****
We
distribute biological specimens to customers around the world. These specimens need to be delivered over a range of temperatures from
ambient to cryogenic and delivery timeframes that can be as quick as hours. We rely on third- party shipping materials (such as thermal
containers) as well as shipping services (such as FedEx) to transport specimens to our customers. Shipping materials may be defective
and third-party shipping services, including international shipping services, could become disrupted by adverse weather conditions, natural
disasters, military conflicts, flight cancellations, ground logistics issues, customs delays, and other service interruptions. Any defect
in our shipping materials or delays in shipping service times could cause damage to these specimens and render them unusable by our customers.
If we are unable to deliver our specimens in a timely matter and without damage, our revenue could be negatively impacted and our reputation
with our customers could suffer, resulting in material harm to our business.
23
The
Companys business was negatively impacted during the first half of 2022 by the ongoing war between Russia and Ukraine. At the
start of the war, the Company had approximately $1 million of purchase orders that were slated to be fulfilled by the Companys
supply network in Ukraine and Russia. This supply network shut down quickly at the start of the war. Ukrainian suppliers were disabled
due to war conditions and evacuations and some of the Companys Russian suppliers were disabled by sanctions. While the Company
mobilized to shift these purchase orders to other suppliers in the network, the process of getting specimen collections from other supply
sites took time, which caused a delay in the fulfillment of such purchase orders.
As
of December 31, 2025 and 2024, the Companys supply sites in Russia that had not been under sanctions were now accessible and the
Companys supply sites in Ukraine had mostly reopened. However, due to the uncertainty caused by the ongoing war, Ukraine suppliers
may again become inaccessible to the Company. Therefore, as long as the uncertainty continues, the Company does not use them as sole
specimen sources at a purchase order level. Alternate suppliers do not have the same favorable unit economics or specimen collection
rates. The short and long-term implications of the war are difficult to predict at this time. The imposition of more sanctions and counter
sanctions may have an adverse effect on the economic markets generally and could impact the Companys business and the businesses
of the Companys supply partners, especially those in Ukraine and Russia. Because of the highly uncertain and dynamic nature of
these events, it is not currently possible to estimate the impact of the war on the Companys business and the companies from which
the Company obtains supplies and distributes specimens.
**Our
future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel.**
****
Our
future success will depend upon our ability to retain our key management and other personnel and will also depend in large part on our
ability to attract and retain additional qualified software developers, bioinformaticists, operations personnel, sales and marketing
personnel, and business development personnel. Competition for these types of employees is intense due to the limited number of qualified
professionals and the high demand for them, particularly in the Boston, Massachusetts area where our headquarters are located. We have
in the past experienced difficulty in recruiting qualified personnel, especially in the area of sales. Failure to attract, assimilate,
and retain personnel would have a material adverse effect on our business and potential growth.
**Our
senior management team has limited experience managing a public company.**
****
Our
senior management team has limited experience managing a public company, and regulatory compliance may divert its attention from the
day-to-day management of our business. Our management team may not successfully or efficiently manage our continued transition to a public
company that will be subject to significant regulatory oversight and reporting obligations under the federal securities laws. In particular,
these obligations will require substantial attention from our senior management and could divert their attention away from the day-to-day
management of our business, which could materially and adversely impact our business operations.
****
**Our
competitors may have greater resources than us and may outspend us to grow more quickly.**
****
Our
competitors are highly fragmented and comprise of thousands of biobanks, healthcare providers, and commercial biospecimen organizations.
We expect to continue to experience significant and increasing levels of competition in the future, especially from several larger biospecimen
providers who have consolidated via mergers and acquisitions and who are well-capitalized by private equity. These organizations are
currently acquiring smaller biospecimen businesses and have larger customer bases, their own collection centers, biospecimen inventories,
larger marketing and sales budgets, and an international presence. They may also be developing their own technology solution that could
be better or less costly to develop than our own iSpecimen Marketplace, thereby eliminating one of our key competitive advantages. They
may continue to outspend us to grow more quickly and we may not be able to successfully compete with a competitor that has greater resources;
hence such competition may adversely affect our business.
**We
may lose business to competitors which have or develop their own biorepositories and/or collection centers that can meet customers
needs.**
****
Many
of our competitors have their own biorepository of specimens that they have collected or procured over time. These inventories, when
they meet a customers needs for product, almost always provide our competitors with a time-to-delivery advantage because they
can directly fulfill requests from their own inventories, whereas we must procure products through our supply network after an order
has been received from our customers. Additionally, some competitors have their own collection facilities and direct access to eligible
research subjects, which also provides a time-to-delivery advantage. We have lost and will continue to lose business to competitors when
they can provide samples more quickly than we can from our supply network.
24
**We
may face pricing pressure from competitors who may lower prices to reduce biorepository inventories or because they have more favorable
specimen acquisition costs.**
****
Many
competitors invest in biorepositories of specimens and data. These competitors may be incented to drop prices in order to more quickly
recoup their inventory carrying costs, especially when they have held inventory for longer periods of time. This may cause downward pricing
pressure on us. Additionally, some competitors may have cost advantages on some types of collections either because of more favorable
supply relationships or because they have their own collection centers, and they can likewise exert pricing pressure in the market. Lower
prices will adversely impact our revenue and gross margins.
**Our
overall business results may suffer from an economic downturn.**
****
We
rely upon researchers from biopharma companies as the primary source of our revenue. During an economic downturn, the biopharma industry
typically experiences a drop in the annual growth rate of research and development spending and allocates fewer resources towards it.
An economic downturn could adversely affect the demand for our products and services and have a corresponding impact on our revenue and
profitability. A prolonged economic downturn may cause us to reduce investment in the longer-term growth of our Company in order to reduce
short term costs.
Our
operations and performance depend on economic conditions in the United States and other countries where we do business. Deterioration
in general economic conditions could negatively affect our and our customers purchasing power.
**Our
results of operations and financial condition may be adversely impacted from high inflation rates.**
****
We
have experienced negative effects from inflation in certain areas of our business due to the recent high rates of inflation in the U.S.
and around the world. Inflation is causing the cost of employee salaries to rise and our salaries account for a significant portion of
our overall operating costs. Additionally, costs of supplies and other sales, marketing and general and administrative costs have increased
due to inflation.
Inflation
has not had a significant adverse impact on the cost of specimens due to our long-term contracts maintained with vendors, which include
revenue sharing plans. However, if inflation continues, it may have an adverse impact on the costs of our samples in the future.
**Our
timely fulfillment of customer orders may be adversely impacted due to constraints in the supply chain.**
****
Our
operations are heavily reliant on specimen availability and delays or shortages in obtaining specimens caused by constraints in the supply
chain, may adversely impact the timing and extent of our ability to fulfill our customer orders which could adversely impact our results
of operations and financial condition.
**We
may have difficulty managing growth in our business, which could adversely affect our financial condition and results of operations.**
****
Significant
growth in the size and scope of our operations could place a strain on our financial, technical, operational, and management resources.
The failure to continue to upgrade our technical, administrative, operating and financial control systems, or the occurrences of unexpected
expansion difficulties, could have a material adverse effect on our financial condition and our ability to timely execute our business
plans.
**We
have incurred losses from sales tax obligations owed to various jurisdictions by us because we did not collect taxes on taxable sales
in prior years, and we may never be able to recover the prior sales taxes from the customers.**
****
States
and other jurisdictions have varying policies regarding when a company has a taxable presence in their locale. We are required to collect
taxes on taxable sales in prior years but we failed to do so and thus have incurred losses from sales tax obligations owed to various
jurisdictions. We are in discussions with those tax jurisdictions to rectify and have made tax payments to some of those jurisdictions.
We have also reached out to our customers who owe sales taxes and recovered partial tax payments from certain customers. However, we
may never be able to recover the prior sales taxes from all the customers, which could have a material adverse effect on our financial
condition.
25
**Our
ability to utilize net operating loss carryforwards may be limited, resulting in income taxes sooner than currently anticipated.**
****
As
of December 31, 2025, we had federal net operating loss carryforwards (NOLs) of approximately $72.6 million for federal
income tax purposes of which approximately $13 million expires at various periods through 2037 and approximately $59.6 million can be
carried forward indefinitely. These NOLs may be used to offset future taxable income, to the extent we generate any taxable income, and
thereby reduce or eliminate our future federal income taxes otherwise payable. Section 382 of the Internal Revenue Code of 1986, as amended,
or the Code, imposes limitations on a corporations ability to utilize NOLs if it experiences an ownership change as defined in
Section 382. In general terms, an ownership change may result from transactions increasing the ownership of certain stockholders in the
stock of a corporation by more than 50% over a three-year period. In the event that an ownership change has occurred, or were to occur,
utilization of our NOLs would be subject to an annual limitation under Section 382 determined by multiplying the value of our stock at
the time of the ownership change by the applicable long-term tax-exempt rate as defined in the Code. Any unused annual limitation may
be carried over to later years. We may be found to have experienced an ownership change under Section 382 as a result of events in the
past or the issuance of shares of common stock in the future. If so, the use of our NOLs, or a portion thereof, against our future taxable
income may be subject to an annual limitation under Section 382, which may result in expiration of a portion of our NOLs before utilization.
**We
may acquire other businesses, products, or technologies that could disrupt our business, reduce our financial resources, or cause dilution
to our stockholders.**
****
As
part of our business strategy, we may, in the future, pursue acquisitions of businesses and assets or pursue strategic alliances and
joint ventures that leverage our core technology and industry experience to expand our offerings, increase our customer base, or increase
our supply base. We have limited experience with acquiring other companies or assets, with forming strategic alliances and joint ventures.
We may not be able to find suitable partners or acquisition candidates, and we may not be able to complete such transactions on favorable
terms, if at all. If we make any acquisitions, we may not be able to integrate these acquisitions successfully into our existing business,
and we could assume unknown or contingent liabilities. Any future acquisitions also could result in significant write-offs or the incurrence
of debt and contingent liabilities, any of which could have a material adverse effect on our financial condition, results of operations,
and cash flows. Integration of an acquired company also may disrupt ongoing operations and require management resources that would otherwise
focus on developing our existing business. We may experience losses related to acquisitions of other companies, which could have a material
adverse effect on our results of operations. We may not identify or complete these transactions in a timely manner, on a cost-effective
basis, or at all, and we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance, or joint
venture.
To
finance any acquisitions or joint ventures, we may choose to issue shares of our common stock as consideration, which would dilute the
ownership of our stockholders. If the price of our common stock is low or volatile, we may not be able to acquire other companies or
fund a joint venture project using our stock as consideration. Alternatively, it may be necessary for us to raise additional funds for
acquisitions through public or private financings. Additional funds may not be available on terms that are favorable to us, or at all.
**We
may incur significant debt, and our governing documents contain no limit on the amount of debt we may incur.**
****
Subject
to market conditions and availability, we may incur significant debt through the Purchase Agreement or other repurchase or credit facilities
(including term loans and revolving facilities), public and private debt issuances or otherwise. The amount of leverage we use will vary
depending on our available capital, our ability to obtain and access financing arrangements with lenders and our estimate of the stability
of our cash flow. Our governing documents contain no limit on the amount of debt we may incur, and we may significantly increase the
amount of leverage we utilize at any time without approval of our shareholders. The amount of leverage on individual assets may vary,
with leverage on some assets substantially higher than others. Leverage can enhance our potential returns but can also exacerbate our
losses.
****
Incurring
substantial debt could subject us to many risks that, if realized, would materially and adversely affect us, including the risk that:
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our cash
flow from operations may be insufficient to make required payments of principal of and interest on the debt or we may fail to comply
with covenants contained in our debt instruments, including the Purchase Agreement, which would likely result in (1) acceleration
of such debt (and any other debt arrangements containing a cross default or cross acceleration provision) that we may be unable to
repay from internal funds or to refinance on favorable terms, or at all, and/or (2) our inability to borrow under other financing
arrangements, even if we are current in payments on borrowings under those arrangements; | |
26
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our debt
may increase our vulnerability to adverse economic, market and industry conditions with no assurance that our investment yields will
increase to match our higher financing costs; | |
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we may
be required to dedicate a substantial portion of our cash flow from operations to payments on our debt, thereby reducing funds available
for operations, future business opportunities, distributions to our shareholders or other purposes; and | |
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we may not be able to refinance
maturing debts. | |
We
cannot be sure that our leverage strategies will be successful.
**A
failure to comply with restrictive covenants in the Purchase Agreement or our other financing arrangements would have a material adverse
effect on us, and any future financings may require us to provide additional collateral or pay down debt.**
We
are subject to various restrictive covenants contained in the Purchase Agreement and we may be subject to additional covenants in connection
with future financing arrangements. Financing arrangements that we may enter into in the future may contain similar or more restrictive
covenants. These covenants may limit our flexibility to pursue certain investments or incur additional debt. If we fail to meet or satisfy
any of these covenants, we may be in default under the agreements governing the applicable arrangements, and our lenders could elect
to accelerate our obligation to repurchase certain assets, declare outstanding amounts due and payable, terminate their commitments,
require the posting of additional collateral or enforce their rights against existing collateral. We may also be subject to cross default
and acceleration rights and, with respect to collateralized debt, the posting of additional collateral or foreclosure upon default.
**Risks
Related to Intellectual Property**
****
**We
use third-party technology licenses as part of our technology solution.**
****
The
iSpecimen Marketplace uses 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 and may need to license
additional technology in the future for use in the ongoing operations as part of our technology solution. Most of the software (including
source code) and other materials we use are distributed under a free, open source, or similar licensing model.
We also use software and services from commercial providers. However, we believe all of them are generally commercially available to
us from other parties. 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. However, there is no assurance that these third-party technology licenses will continue to be
available to us on acceptable commercial terms or at all, which could significantly harm our business, financial condition, and operating
results.
**We
use open source licenses as part of our technology solution, which may subject us to claims from third parties claiming ownership and
unauthorized use.**
****
We
use open source software in our software solutions and technology-enabled services. We may encounter claims from third parties claiming
ownership and unauthorized use of the software purported to be licensed under the open source terms, demanding release of derivative
works of open source software that could include our proprietary source code, or otherwise seeking to enforce the terms of the applicable
open source licenses. These claims could result in litigation that could be expensive to defend. If we become liable to third parties
for such claims, we could be required to make our software source code available under the applicable open source license, utilize or
develop alternative technology, or cease using, selling, offering for sale, licensing, implementing or supporting the applicable solutions
or technology-enabled services. In addition, use of certain open source software may pose greater risks than use of third-party commercial
software, as most open source licensors and distributors do not provide commercial warranties or indemnities or controls on the origin
of the software.
**We
may become subject to third parties claims alleging infringement of their patents and proprietary rights, which could be costly,
time consuming, and prevent the use of our technology solution.**
****
We
cannot assure you that third parties will not claim our current or future products or services infringe their intellectual property rights.
Any such claims, with or without merit, could cause costly litigation that could consume significant management time. As the number of
product and services offerings in our market increases and functionalities increasingly overlap, companies such as ours may become increasingly
subject to infringement claims. These claims also might require us to enter into royalty or license agreements. If required, we may not
be able to obtain such royalty or license agreements or obtain them on terms acceptable to us.
27
**We
do not have any patents protecting our intellectual property and if we are unable to protect the confidentiality of our trade secrets,
know-how and other proprietary and internally developed technology, our business could be adversely affected.**
****
Our
success depends upon our proprietary technology. We do not have registered patents on any of our technology because we do not believe
that we could obtain blocking patents and that the costs of patent monitoring and prosecution outweigh the benefits. Instead, we rely
upon software copyright laws, service marks, trade secret laws, confidentiality procedures, and contractual provisions to establish and
protect our proprietary rights as well as the skills, knowledge and experience of our technical and operational personnel, our consultants
and advisors, and contractors. Because we operate in a highly competitive industry, we rely in part on trade secrets to protect our proprietary
technology and processes. However, trade secrets are difficult to protect.
We
enter into confidentiality or non-disclosure agreements with our corporate partners, employees, consultants, collaborators, and other
advisors. These agreements generally require that the receiving party keep confidential and not disclose to third-parties confidential
information developed by the receiving party or made known to the receiving party by us during the course of the receiving partys
relationship with us. These agreements also generally provide that inventions conceived by the receiving party in the course of rendering
services to us will be our exclusive property, and we enter into assignment agreements to protect our rights. These confidentiality,
inventions and assignment agreements may be breached and may not effectively assign intellectual property rights to us. Our trade secrets
also could be independently discovered by competitors, in which case we may not be able to prevent the use of such trade secrets by our
competitors. The enforcement of a claim alleging that a party illegally obtained and was using our trade secrets could be difficult,
expensive and time consuming and the outcome would be unpredictable. In addition, effective protection of intellectual property rights
is unavailable or limited in certain foreign countries. The failure to obtain or maintain meaningful trade secret protection could adversely
affect our competitive position.
**Risks
Related to Regulatory Environment**
****
**Failure
to comply with federal and state data protection regulations could result in fines, penalties, and litigation, and have a material adverse
effect upon our business.**
****
Because
we may gain access to protected healthcare or personal data, we must comply with various data protection regulations worldwide, including
the Health Insurance Portability and Accountability Act of 1996, as amended by HITECH, and their implementing regulations at 45 CFR Parts
160-164 (collectively, HIPAA). As part of the operation of our business, we act in the capacity of a HIPAA business associate
with respect to protected health information (PHI), we receive from our healthcare provider partners. As a HIPAA business
associate, we are required to protect the privacy and confidentiality of PHI, and we are required to comply with HIPAA security regulations
requiring certain administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic
PHI (ePHI). To comply with our regulatory and contractual obligations, which may change over time, we may have to reorganize
processes and invest in new technologies. We are also required to train personnel regarding data protection requirements. If we, or any
of our employees or agents, are unable to maintain the privacy, confidentiality, and security of the PHI that is entrusted to us, we
could be subject to civil and criminal fines and sanctions imposed by the HHS or state regulatory authorities, and we could be found
to have breached our HIPAA business associate agreements with our healthcare provider suppliers. In addition to the HIPAA requirements
that we are subject to, we may be subject to similar state laws and regulations, which regulate the collection, handling, processing,
and storage of sensitive personal information. While we have never had a data breach, we cannot guarantee that it will not happen in
the future nor can we guarantee that we will always be in compliance with these regulations. Failure to comply with federal, state and
local laws and regulations could subject the Company to denial of the right to conduct business, fines, criminal penalties, and/or other
enforcement actions which would have a material adverse effect on its business. In addition, compliance with future legislation could
impose additional requirements on the Company, which may be costly*.*
**
**Failure
to comply with international laws related to data protection, such as the General Data Protection Regulation (GDPR) could
result in fines, penalties, and litigation, and have a material adverse effect upon the Companys business.**
****
We
may be required to comply with international laws, such as the GDPR. The GDPR took effect in May 2018 and regulates the collection, storage,
use, disclosure, transfer, and/or other processing of personal data of identified or identifiable individuals located in the European
Economic Area (EEA), including the EU. This data specifically includes personal health data that generally is provided
as part of biospecimen collection studies. The GDPR imposes numerous requirements on companies that process personal data, including
requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates
for processing (with some exceptions), allowing individuals to revoke consents granted, enabling individuals the right to have their
data erased (with some exceptions), amended, or transferred to another data controller (known as data portability), providing
information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality
of personal data, limiting the transfer of data to countries outside of the EU, providing notification of data breaches, and taking certain
measures when engaging third-parties who may also use or process the data. In addition, EU member states may make their own further laws
and regulations limiting the processing of personal data, including biometric, genetic or health data.
28
The
GDPR covers areas where we may not have expertise and the GDPR and the regulatory guidance enforcing GDPR may be actively evolving. We,
or our other third-party customers, suppliers and/or distribution partners, may not be able to maintain regulatory compliance with the
GDPR or may incur significant costs in obtaining or maintaining regulatory compliance. Any action brought against us for violations of
this law, even if successfully defended, could cause us to incur significant legal expenses, reputational risks, and divert our managements
attention from the operation of our business. In addition, compliance with future legislation could impose additional requirements on
the Company, which may be costly*.*
****
**Failure
to comply with federal and state laws around environmental, health and safety, biohazards and dangerous goods, and imports/exports could
result in fines, penalties, and litigation, and have a material adverse effect upon our business.**
****
Because
we receive, store, and ship specimens, we are subject to regulation under federal, state, and local laws and regulations relating to
the protection of the environment and human health and safety, including laws and regulations relating to the handling, transportation,
and disposal of specimens and infectious and hazardous waste materials, as well as regulations relating to the safety and health of laboratory
employees. Our laboratory is subject to applicable federal and state laws and regulations relating to biohazard disposal of all laboratory
specimens, and we utilize outside vendors for disposal of such specimens. In addition, the federal Occupational Safety and Health Administration
has established extensive requirements relating to workplace safety for healthcare employers whose workers may be exposed to blood-borne
pathogens such as HIV, COVID-19, and the hepatitis B virus. These requirements, among other things, require work practice controls, protective
clothing and equipment, training, medical follow-up, vaccinations, and other measures designed to minimize exposure to, and transmission
of, blood-borne pathogens. There are also federal laws related to import and export of biospecimens and related data.
Failure
to comply with federal, state and local laws and regulations could subject us to denial of the right to conduct business, fines, criminal
penalties, and/or other enforcement actions which would have a material adverse effect on our business. In addition, compliance with
future legislation could impose additional requirements on us which may be costly*.*
**
**Failure
to comply with other international laws around environmental, health and safety, biohazards and dangerous goods, imports/exports, and
other regulations could result in fines, penalties, and litigation, and have a material adverse effect upon our business.**
****
Because
we procure specimens from and distribute specimens to countries outside of the United States, we are subject to international and foreign
rules similar to any of the aforementioned U.S. rules, including those related to environmental, health and safety, biohazards, and imports/exports.
We may be unaware of those international and foreign rules.
These
laws cover areas where we may not have expertise and, in many areas, these laws are actively evolving. We, or our other third-party customers,
suppliers and/or distribution partners, may not be able to maintain regulatory compliance in such countries or may incur significant
costs in obtaining or maintaining our foreign regulatory compliance. Any action brought against us for violations of these laws or regulations,
even if successfully defended, could cause us to incur significant legal expenses, reputational risks, and divert our managements
attention from the operation of our business. In addition, compliance with future legislation could impose additional requirements on
us which may be costly.
**Failure
to comply with laws and regulations related to the protection of research subjects could result in fines, penalties, and litigation,
and have a material adverse effect upon our business.**
****
We
are subject to regulation under international, federal, state, and local laws and regulations relating to the protection of research
subjects. Federally-funded human-subject research in the United States, including the collection of identifiable human biospecimens,
is governed by 45 CFR Part 46, also known as the Health and Human Services Policy for Protection of Human Research Subjects or the Common
Rule. Use of biospecimens in certain other research is subject to FDA regulations for the Protection of Human Subjects and Institutional
Review Boards at 21 CFR Parts 50 and 56. Research funded by the National Institutes of Health (NIH) may be subject to grant
or contract requirements, as well as NIH Certificates of Confidentiality. When collecting specimens for research in the United States,
iSpecimen and its collection sites are responsible for ensuring that specimens are collected in accordance with these regulations. In
addition, other countries have their own regulations around the ethical collection of human specimens for research. While we believe
that we are in compliance with these laws, we may not be aware of all such laws or may fail to properly audit and identify gaps in compliance.
Similarly, we may find errors in our technology and processes and may fail to properly match the compliance requirements of our researchers
to the compliance requirements of our suppliers. Failure of our Company or our suppliers to comply with international, federal, state,
and local laws and regulations could subject us to denial of the right to conduct business, fines, criminal penalties, and/or other enforcement
actions which could have a material adverse effect on our business.
29
**Our
failure to comply with other laws and regulations related to our business operations also have a material adverse effect upon our business.**
****
In
addition to the above-described laws and regulations, there are many other federal, state and international laws and regulations applicable
to iSpecimen. The following list contains some of the other laws and regulations that could directly or indirectly affect our ability
to operate the business:
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Occupational Safety and Health
regulations and requirements; | |
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Centers for Disease Control
Import Permit Program rules related to biological agents; | |
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Shipping rules such as IATA
Dangerous Goods regulations; | |
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State
and local laws and regulations for the disposal and handling of medical waste and biohazardous material; | |
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Export
laws such as the U.S. Department of Commerces Bureau of Industry and Security Export Administration Regulations, U.S. State
Departments Directorate of Defense Trade Controls, and the U.S. Department of the Treasurys Office of Foreign Assets
Control in export licensing; | |
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Import
laws such as the Customs and Border Protection Trade Act of 2002 and the Customs Modernization Act; | |
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The federal
Anti-Kickback Statute, which prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving
or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the
purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs; | |
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Federal, state, and local tax
and tariff rules; | |
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Other laws and regulations
administered by the FDA; | |
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Other laws and regulations
administered by HHS; and | |
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State and local laws and regulations
governing human subject research and clinical trials. | |
These
laws cover several areas of our business and are actively evolving. We, or our other third-party customers, suppliers and/or distribution
partners, may not be able to maintain regulatory compliance or may incur significant costs in obtaining or maintaining regulatory compliance.
Any action brought against us for violations of these laws or regulations, even if successfully defended, could cause us to incur significant
legal expenses, reputational risks, and divert our managements attention from the operation of our business. In addition, compliance
with future legislation could impose additional requirements on us which may be costly*.*
**
**Failure
to comply with governmental export and import regulations could result in fines, penalties, and litigation, and have a material adverse
effect upon the Companys business.**
****
Our
products and services are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations,
U.S. Customs regulations, and various economic and trade sanctions regulations administered by the U.S. Treasury Departments Office
of Foreign Assets Controls. Exports of our products and services must be made in compliance with these laws and regulations. If we fail
to comply with these laws and regulations, we and certain of our employees could be subject to substantial civil or criminal penalties,
including the possible loss of export or import privileges; fines, which may be imposed on us and responsible employees or managers;
and, in extreme cases, the incarceration of responsible employees or managers.
In
addition, changes in our products and services or changes in applicable export or import laws and regulations may create delays in the
introduction and sale of our products and services to international markets, prevent our customers from procuring our products and services
or, in some cases, prevent the export or import of our products and services to certain countries, governments or persons altogether.
Any change in export or import laws and regulations, shift in the enforcement or scope of existing laws and regulations, or change in
the countries, governments, persons or technologies targeted by such laws and regulations could also result in decreased use of our products
and services, or in our decreased ability to export or sell our products and services to existing or potential customers. Any decreased
use of our products and services or limitation on our ability to export or sell our products and services could adversely affect our
business, financial condition and results of operations.
30
**Product
safety and product liability, including bio-hazard risks, could provide exposure to claims and litigation.**
****
Specimens
may have hazardous properties and may carry transmissible infectious agents. There are inherent risks in connection with the handling,
storage, disposal, distribution, and/or use of the specimens.
Although
we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by federal, state
and local regulation and regulations of foreign jurisdictions, the risk of accidental contamination or injury from these materials cannot
be completely eliminated. Individuals who use or come in contact with the specimens may file claims related to their use and these claims
could result in litigation that could be expensive to defend or result in judgements that exceed our resources and our insurance coverage.
Any such litigations and judgement could adversely affect our business, financial condition and results of operations.
**Risks
Related to Our Securities**
****
**There
can be no assurance that an active and liquid trading market for our common stock will continue or that we will be able to continue to
comply with Nasdaqs continued listing standards.**
****
Our
common stock began trading on Nasdaq in June 2021, as a result of our consummation of an initial public offering of our shares of common
stock. Our common stock is currently listed on Nasdaq under the symbol ISPC. There can be no assurance an active and liquid
trading market in our common stock will continue.
There
is no guarantee that we will be able to maintain such listing for any period of time by perpetually satisfying the Nasdaqs continued
listing requirements. Our failure to continue to meet these requirements may result in our common stock being delisted from Nasdaq.
****
**We
are not in compliance with Nasdaqs minimum bid price requirement, and our common stock may be delisted if we fail to regain compliance.**
On
November 19, 2025, we received notice from Nasdaq that the closing bid price of our common stock had been below $1.00 per share for 30
consecutive business days, resulting in non-compliance with Nasdaq Listing Rule 5550(a)(2). We have until May 18, 2026 to regain compliance
by maintaining a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days (or such longer period
as required by Nasdaq). If we do not regain compliance by that date, we may be eligible for an additional 180-day compliance period,
subject to meeting other listing requirements and notifying Nasdaq of our intent to cure the deficiency, which may include a reverse
stock split.
There
can be no assurance that we will regain compliance within the applicable period(s). If we fail to do so, our common stock may be delisted.
A delisting could materially and adversely affect the liquidity and market price of our common stock, reduce investor interest and analyst
coverage, and impair our ability to raise capital. If delisted, our common stock may trade on an over-the-counter market, which is generally
characterized by lower liquidity and greater volatility. We intend to monitor our stock price and evaluate options to regain compliance;
however, there can be no assurance that any such actions will be successful.
**In
the event that our common stock is delisted from Nasdaq, U.S. broker-dealers may be discouraged from effecting transactions in shares
of our common stock because it may be considered a penny stock and thus be subject to the penny stock rules.**
****
The
SEC has adopted a number of rules to regulate a penny stock that restricts transactions involving stock which is deemed
to be a penny stock. Such rules include Rules 3a51-1, 15g-1, 15g-2, 15g-3, 15g-4, 15g-5, 15g-6, 15g-7, and 15g-9 under the Exchange Act.
These rules may have the effect of reducing the liquidity of penny stocks. Penny stocks generally are equity securities
with a price of less than $5.00 per share (other than securities registered on certain national securities exchanges or traded on Nasdaq
if current price and volume information with respect to transactions in such securities is provided by the exchange or system). Our shares
of common stock may, in the future constitute, a penny stock within the meaning of the rules. The additional sales practice
and disclosure requirements imposed upon U.S. broker-dealers may discourage such broker-dealers from effecting transactions in shares
of our common stock, which could severely limit the market liquidity of such shares of common stock and impede their sale in the secondary
market.
A
U.S. broker-dealer selling a penny stock to anyone other than an established customer or accredited investor (generally,
an individual with a net worth in excess of $1,000,000 or an annual income exceeding $200,000, or $300,000 together with his or her spouse)
must make a special suitability determination for the purchaser and must receive the purchasers written consent to the transaction
prior to sale, unless the broker-dealer or the transaction is otherwise exempt. In addition, the penny stock regulations
require the U.S. broker-dealer to deliver, prior to any transaction involving a penny stock, a disclosure schedule prepared
in accordance with SEC standards relating to the penny stock market, unless the broker-dealer or the transaction is otherwise
exempt. A U.S. broker-dealer is also required to disclose commissions payable to the U.S. broker-dealer and the registered representative
and current quotations for the securities. Finally, a U.S. broker-dealer is required to submit monthly statements disclosing recent price
information with respect to any penny stock held in a customers account and information with respect to the limited
market in penny stocks.
31
You
should be aware that, according to the SEC, the market for penny stocks has suffered in recent years from patterns of fraud
and abuse. Such patterns include (i) control of the market for the security by one or a few broker- dealers that are often related to
the promoter or issuer; (ii) manipulation of prices through prearranged matching of purchases and sales and false and misleading press
releases; (iii) boiler room practices involving high-pressure sales tactics and unrealistic price projections by inexperienced
sales persons; (iv) excessive and undisclosed bid-ask differentials and markups by selling broker-dealers; and (v) the wholesale dumping
of the same securities by promoters and broker-dealers after prices have been manipulated to a desired level, resulting in investor losses.
Our management is aware of the abuses that have occurred historically in the penny stock market. Although we do not expect to be in a
position to dictate the behavior of the market or of broker-dealers who participate in the market, management will strive within the
confines of practical limitations to prevent the described patterns from being established with respect to our securities.
**The
sale of substantial shares of our common stock may depress our stock price.**
****
As
of December 31, 2025, we had 8,478,597 shares of common stock outstanding; outstanding stock options to purchase 2,901 shares of common
stock at an average price of $6.93 per share; outstanding restricted stock units of 25 shares issuable upon vesting at an average price
of $97.20; outstanding warrants to purchase 1,297,574 shares of common stock at an average price of $1.89 per share. Additionally, the
number of shares of common stock that are outstanding after our IPO also includes up to an aggregate of 65,625 shares of common stock
underlying the warrants to be offered and sold by the selling stockholders of the Company, all of which were subsequently repurchased
by us on February 13, 2024, and are no longer outstanding. We have reserved 93,475 shares to issue stock options, restricted stock or
other awards under our 2021 Stock Incentive Plan (as defined below). Sales of a substantial number of shares of our common stock could
cause the price of our common stock to fall and could impair our ability to raise capital by selling additional securities.
**Our
directors, officers and principal stockholders have significant voting power and may take actions that may not be in the best interests
of our other stockholders.**
****
As
of December 31, 2025, our officers, directors and principal stockholders each holding more than 5% of our common stock collectively controlled
approximately 0.00% of our outstanding common stock. As a result, these stockholders, if they act together, will be able to control the
management and affairs of our Company and most matters requiring stockholder approval, including the election of directors and approval
of significant corporate transactions. This concentration of ownership may have the effect of delaying or preventing a change of control,
impeding a merger, consolidation or other business combination transaction involving us and discouraging a potential acquiror from making
a tender offer or otherwise attempting to obtain control of the Company and might adversely affect the market price of our common stock.
This concentration of ownership may not be in the best interests of our other stockholders.
**Certain
provisions of our certificate of incorporation, as amended, and our bylaws, as amended, may make it more difficult for a third party
to affect a change-of-control.**
****
Our
certificate of incorporation, as amended, authorizes the board of directors (the Board) to issue up to 50,000,000 shares
of preferred stock. The preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance
by the Board without further action by the stockholders.
These
terms may include preferences as to dividends and liquidation, conversion rights, redemption rights and sinking fund provisions. The
issuance of any preferred stock could diminish the rights of holders of our common stock, and therefore could reduce the value of such
common stock. In addition, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge
with, or sell assets to, a third party. The ability of the Board to issue preferred stock could make it more difficult, delay, discourage,
prevent or make it more costly to acquire or effect a change-in-control, which in turn could prevent our stockholders from recognizing
a gain in the event that a favorable offer is extended and could materially and negatively affect the market price of our common stock.
In addition, our certificate of incorporation, as amended, provides for a staggered Board. As a consequence, only a minority of the Board
will be considered for election at every annual meeting of stockholders, which may make the removal of management more difficult and
may discourage transactions that otherwise could involve payment of a premium over prevailing market prices for our securities. Additional
provisions that may discourage unsolicited takeover proposals include (i) board vacancies may be filled by a majority of the remaining
board members, (ii) the board may adopt, repeal, rescind, alter or amend our bylaws without stockholder approval, (iii) stockholders
holding more than 15% of the outstanding shares may call a special meeting, (iv) a director may be removed from office only by the affirmative
vote of a majority of the issued and outstanding stock entitled to vote; and (v) no cumulative voting in the election of directors, which
would allow holders of less than a majority of the stock to elect some directors.
32
**Our
bylaws, as amended, designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be
initiated by our stockholders, which could limit our stockholders ability to obtain a favorable judicial forum for disputes with
us or our directors, officers, or employees.**
****
Our
bylaws, as amended, provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware
(or, if the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware) will be the exclusive
forum for: (i) any derivative action or proceeding brought on behalf of the Company; (ii) any action asserting a claim for breach of
a fiduciary duty owed by any director, officer, employee, or agent of ours to us or our stockholders; (iii) any action asserting a claim
arising pursuant to any provision of the Delaware General Corporation Law, the certificate of incorporation, or the bylaws; and (iv)
any action asserting a claim governed by the internal affairs doctrine (the Delaware Forum Provision). Our bylaws further
provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States
of America shall be the sole and exclusive forum for resolving any complaint asserting a cause of action arising under the Securities
Act (the Federal Forum Provision). In addition, our bylaws provide that any person or entity purchasing or otherwise acquiring
any interest in shares of our common stock is deemed to have notice of and consented to the Delaware Forum Provision and the Federal
Forum Provision.
Section
27 of the Exchange creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange
Act or the rules and regulations thereunder. As a result, the Delaware Forum Provision will not apply to suits brought to enforce any
duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. We note, however,
that there is uncertainty as to whether a court would enforce this provision and that investors cannot waive compliance with the federal
securities laws and the rules and regulations thereunder.
We
recognize that the Delaware Forum Provision and the Federal Forum Provision in our bylaws may impose additional litigation costs on stockholders
in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware. Additionally, the Delaware
Forum Provision and the Federal Forum Provision may limit our stockholders ability to bring a claim in a forum that they find
favorable for disputes with us or our directors, officers or employees, which may discourage such lawsuits against us and our directors,
officers and employees even though an action, if successful, might benefit our stockholders. In addition, while the Delaware Supreme
Court ruled in March 2020 that federal forum selection provisions purporting to require claims under the Securities Act be brought in
federal court were facially valid under Delaware law, there is uncertainty as to whether other courts will enforce the
Federal Forum Provision. If the Federal Forum Provision is found to be unenforceable, we may incur additional costs associated with resolving
such matters. The Federal Forum Provision may also impose additional litigation costs on stockholders who assert that the provision is
not enforceable or invalid. The Court of Chancery of the State of Delaware and the United States District Court 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 may be more or less favorable to us than our stockholders.
**Limitations
on director and officer liability and indemnification of our officers and directors by us may discourage stockholders from bringing suit
against an officer or director.**
****
Our
certificate of incorporation, as amended, and bylaws, as amended, provide that, to the fullest extent permitted by Delaware law, as it
presently exists or may be amended from time to time, a director shall not be personally liable to us or our stockholders for monetary
damages for any breach of fiduciary duty as a director. Under Delaware law, this limitation of liability does not extend to, among other
things, acts or omissions which involve intentional misconduct, fraud or knowing violation of law, or unlawful payments of dividends.
These provisions may discourage stockholders from bringing suit against a director or officer for breach of fiduciary duty and may reduce
the likelihood of derivative litigation brought by stockholders on our behalf against a director or officer.
**We
are responsible for the indemnification of our officers and directors.**
****
Should
our officers and/or directors require us to contribute to their defense, we may be required to spend significant amounts of our capital.
Our certificate of incorporation, as amended, and bylaws, as amended, also provide for the indemnification of our directors, officers,
employees, and agents, under certain circumstances, against attorneys fees and other expenses incurred by them in any litigation
to which they become a party arising from their association with or activities on behalf of our Company. This indemnification policy
could result in substantial expenditures, which we may be unable to recoup. If these expenditures are significant or involve issues which
result in significant liability for our key personnel, we may be unable to continue operating as a going concern.
33
**We
do not expect to pay dividends in the foreseeable future. Any return on investment may be limited to the value of our common stock.**
****
We
have never paid cash dividends on our common stock and do not anticipate doing so in the foreseeable future. The payment of dividends
on our common stock will depend on earnings, financial condition and other business and economic factors affecting us at such time as
our Board may consider relevant. If we do not pay dividends, our common stock may be less valuable because a return on an investment
will only occur if our stock price appreciates*.*
**
**We
may need additional capital, and the sale of additional shares of common stock or other equity securities could result in additional
dilution to our stockholders.**
****
We
may need to raise additional funds sooner than expected to fund our current operating plans. We may finance our cash needs through a
combination of equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, or other sources. In addition,
we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe that we have sufficient
funds for our current or future operating plans.
To
the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interest will be diluted,
and the terms of these securities may include liquidation or other preferences that adversely affect rights as a common stockholder.
Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our
ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise
additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may be required to relinquish
valuable rights to our technologies or future revenue streams or grant licenses on terms that may not be favorable to us. If we are unable
to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate technology
development or future commercialization efforts.
**Our
quarterly revenue tends to fluctuate, making it harder to forecast and meet investor expectations.**
****
Quarterly
revenue has been difficult to predict, has historically fluctuated, and may vary from quarter to quarter due to a variety of factors,
many of which are beyond our control. Accordingly, comparing our operating results on a period- to-period basis may not be meaningful.
Factors that may affect our quarterly revenue and operating results may include: any material changes in demand for our products and
services; changes in our supply sites ability to collect and ship specimens or our ability to retain them; changes in the number,
availability, and quality of competing products; our ability to maintain a timely delivery of high quality products and services; the
timing and amount of sales and marketing expenses incurred by us to attract new customers; changes in the economic or business prospects
of our customers or the economy generally; changes in the pricing policies of our competitors; unforeseen defects in our technology;
changes in the regulatory environment; and unforeseen costs necessary to improve and maintain our technology.
These
factors affecting our future earnings are difficult to forecast and could harm our quarterly and/or annual operating results. The change
in our earnings or general economic conditions may cause the market price of our common stock to fluctuate.
**Our
stock price may be volatile.**
****
Our
share price has been volatile in the past and may continue to be so in the future. Since our IPO, our common stock has traded at prices
ranging from $0.26 to $579.60, adjusted for the Reverse Stock Split based on a ratio of 1-for-20 as if it had occurred at the beginning
of the earliest period presented. The stock market in general has experienced extreme volatility that has often been unrelated to the
operating performance of particular companies. As a result of this volatility, investors may not be able to sell their common stock at
or above the price paid for such shares. The market price of our common stock is likely to be highly volatile and could fluctuate widely
in price in response to various risk factors, including the following:
|
|
|
changes in our industry; | |
|
|
|
ability to enhance our platform
or to add new functionality; | |
|
|
|
regulatory changes; | |
|
|
|
competitive pricing or other
pressures; | |
|
|
|
failures of our suppliers to
deliver product on time; | |
|
|
|
loss of supply partners; | |
|
|
|
additions or departures of
key personnel; | |
34
|
|
|
sales of our common stock; | |
|
|
|
our ability to execute our
business plan; | |
|
|
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operating results that fall
below expectations; | |
|
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loss of any strategic relationship
including customers, suppliers and channel partners; and/or | |
|
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economic and other external
factors. | |
In
addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the
operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of
our common stock.
**General
Risk Factors**
****
**Our
status as an emerging growth company under the JOBS Act may make it more difficult to raise capital when we need to do
it or make our common stock less attractive to investors.**
****
Because
of the exemptions from various reporting requirements provided to us as an emerging growth company, and because we will
have an extended transition period for complying with new or revised financial accounting standards, we may be less attractive to investors
and it may be difficult for us to raise additional capital as and when we need it. Investors may be unable to compare our business with
other companies in our industry if they believe that our financial accounting is not as transparent as other companies in our industry.
If we are unable to raise additional capital as and when we need it, our financial condition and results of operations may be materially
and adversely affected.
**We
have limited insurance which may not cover claims by third parties against us or our officers and directors.**
****
We
have limited directors and officers liability insurance and commercial liability insurance policies. Claims by third parties
against us may exceed policy amounts and we may not have amounts to cover these claims. Also, due to high self-insured retention costs
and deductibles, we may incur significant costs from any claim made against us before insurance policies provide coverage. Any significant
claims would have a material adverse effect on our business, financial condition, and results of operations. In addition, our limited
directors and officers liability insurance may affect our ability to attract and retain directors and officers.
**The
requirements of being a U.S. public company may strain our resources and divert managements attention.**
****
As
a public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street
Reform and Consumer Protection Act of 2010 (the Dodd-Frank Act) and Nasdaq rules. The requirements of these rules and regulations
result in significant legal and financial compliance costs, including costs associated with the employment of personnel, making some
activities more difficult, time-consuming or costly, and may also place undue strain on our personnel, systems and resources and divert
managements attention.
The
Exchange Act requires, among other things, that we file annual, quarterly, and current reports with respect to our business and financial
condition. The Sarbanes-Oxley Act requires, among other things, that we maintain disclosure controls and procedures and internal control
over financial reporting. Ensuring that we have adequate internal financial and accounting controls and procedures in place, as well
as maintaining these controls and procedures, is a costly and time-consuming effort that needs to be re-evaluated frequently.
Additionally,
various rules and regulations applicable to public companies make it more difficult and more expensive for us to maintain directors
and officers liability insurance, and we may be required to accept reduced coverage or higher deductibles or incur substantially
higher costs to maintain coverage.
**Evaluation
of internal control and remediation of potential problems will be costly and time consuming and could expose weaknesses in financial
reporting.**
****
Section
404 of the Sarbanes-Oxley Act (Section 404) requires that we evaluate our internal control over financial reporting to
enable management to report on the effectiveness of those controls annually. In connection with the Section 404 requirements, we could,
as part of that documentation, identify material weaknesses, significant deficiencies, or other areas for further attention or improvement.
35
Implementing
any appropriate changes to our internal controls may require specific compliance training for our directors, officers, and employees,
require the hiring of additional finance, accounting and other personnel, entail substantial costs to modify our existing accounting
systems, and take a significant period of time to complete. Such changes may not, however, be effective in maintaining the adequacy of
our internal controls, and any failure to maintain that adequacy, or consequent inability to produce accurate financial statements on
a timely basis, could increase our operating costs and could materially impair our ability to operate our business. Moreover, adequate
internal controls are necessary for us to produce reliable financial reports and are important to help prevent fraud. As a result, our
failure to satisfy the requirements of Section 404 on a timely basis could result in the loss of investor confidence in the reliability
of our financial statements, which in turn could cause the market value of our common stock to decline.
**Public
company compliance may make it more difficult to attract and retain officers and directors.**
****
The
Sarbanes-Oxley Act and new rules subsequently implemented by the SEC have required changes in corporate governance practices of public
companies. As a public company, we are expected to follow Sarbanes-Oxley Act regulations and other public company rules, and these rules
and regulations will increase our compliance costs and make certain activities more time consuming and costly. As a result, these rules
and regulations may make it more difficult and expensive for us to obtain director and officer liability insurance and we may be required
to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result,
it may be more difficult and costly for us to attract and retain qualified persons to serve on our Board or as executive officers.
**Item
1B. Unresolved Staff Comments**
****
Not Applicable.
**Item
1C. Cybersecurity**
****
**Cybersecurity
Risk Management and Strategy**
****
iSpecimen
maintains an Information Security Management Program (ISMP) with a primary goal to reduce risks to iSpecimen by protecting
and supporting the confidentiality, availability, and integrity of information assets including personally identifiable information.
Our cross-functional Risk Management Committee, with direction and support from our Board including the Audit Committee, works to identify,
assess, and manage material risks including those from cybersecurity threats. iSpecimen invests in administrative, technical, and physical
safeguards, including support from external solution providers and auditors, to maintain information security protections of our data
and to safeguard customers, suppliers, employees, and business partners.
**Cybersecurity
Governance**
****
The
Risk Management Committee meets on an annual basis to review the currently identified risks to the business and how they are being managed,
identify and assess any new material risks, and recommend any changes to our risk management positions. The Risk Management Committee
includes the Chief Executive Officer, and other members of our senior leadership team. The risks considered include those associated
with the use of third-party service providers. For an expanded view of the risks regarding a cybersecurity incident, please see If
our security measures are breached, or if our services are subject to attacks that degrade or deny the ability of users to access our
platforms, our platforms and applications may be perceived as not being secure, customers and suppliers may curtail or stop using our
services, and we may incur significant legal and financial exposure under the Risk Factors section of this Annual
Report.
36
**Item
2. Properties**
****
Our principal
executive office is located in 8 Cabot Road, Woburn, Massachusetts.
We
occupy approximately 2,273 square feet of office and laboratory space in Woburn, Massachusetts under a lease that expires on October
30, 2029. Our laboratory is subject to applicable federal and state laws and regulations relating to the safe handling of laboratory
specimens along with biohazard disposal, and we utilize an outside medical and biohazard disposal company for disposal of such specimens.
We believe our existing facilities meet our current needs. We will need additional office space in the future as we continue to build
our development, commercial and support teams. We believe we can find suitable additional space in the future on commercially reasonable
terms.
**Item
3. Legal Proceedings**
****
To
the knowledge of our management team, there is no material litigation, arbitration or governmental proceeding currently pending against
us or any members of our management team in their capacity as such, other than the matter described below. We may from time to time be
involved in various legal proceedings and other matters arising in the normal course of business. We may in the future institute additional
legal proceedings to enforce our rights and seek remedies, such as monetary damages, injunctive relief and declaratory relief. We cannot
predict the results of any such disputes, and despite the potential outcomes, the existence thereof may have an adverse material impact
on us because of diversion of management time and attention as well as the financial costs related to resolving such disputes.
*Focus
Technology Solutions, Inc. v. iSpecimen,; Suffolk (MA) Superior Court*
On
December 9, 2024, Focus Technologies, Inc. (Focus) filed a complaint against the Company in the Superior Court of Suffolk
County, Massachusetts, alleging non-payment under agreements dated July 29, 2022, related to the provision of information technology
services. Focus is seeking approximately $489,572 in damages, plus interest and attorneys fees. Following the filing, Focus disabled
the Companys web-based commerce platform on January 24, 2025, resulting in a shutdown of the iSpecimen Marketplace from January
25, 2025, through February 12, 2025, which was not fully resolved until early March 2025.
To
restore service, the parties entered into a settlement agreement on February 11, 2025 (the Settlement Agreement), under
which the Company agreed to pay $500,000 in nine monthly installments in exchange for the restoration of its platform. The Company made
an initial payment of $50,000 on February 12, 2025, however, Focus failed to fully restore the platform, requiring the Company to engage
a third-party developer to complete the work in early March 2025. On February 28, 2025, the Company notified Focus that it was in breach
of the Settlement Agreement and has since withheld further payments thereunder.
Focus
amended its complaint to enforce the Settlement Agreement and obtained an order for pre-judgment security in the amount of $420,000,
to be funded by 15% of revenue. This order was clarified on December 17, 2025 to require only 15% of net revenue,
with the result only $13,000 has been deposited in escrow to date. The Company has asserted counterclaims against Focus for consequential
damages arising from theFebruary 2025 service disruption and failure to perform under the agreements. On September 3, 2025, Focus reduced
their global settlement demand to $100,000, and on September 9, 2025, the Company increased their offer to $30,000, which figure was
rejected by Focus. The case remains in the discovery phase, and no trial date has been set.
While
the outcome of this matter cannot be predicted with certainty, the Company does not believe that this litigation will have a material
adverse effect on its business, financial condition, or results of operations at this time.
37
*Azenta
US, Inc. v. iSpecimen, Inc.; Suffolk (MA) Superior Court*
On
or around January 15, 2025, Azenta initiated a claim against the Company for $651,262 arising from an alleged breach of contract, and
unjust enrichment. Azenta provided sequencing services in 2023 as part of an initiative for which a market was never realized by the
Company. The Company believes that it has valid defenses to Azentas claims. Discovery has closed in this case, and the Company
expects Azenta to move for summary judgment, which the Company will defend vigorously. As of current, the Company has made an offer of
$125,000 to settle this case, but no response has been received from Azenta.
*Krisbio,
LLC v. iSpecimen, Inc.*
On
or about September 23, 2025 the Company was served with a Summons and Complaint in the matter of Krisbio, LLC v. iSpecimen, Inc. 1:25-CV-12409-JCB
in the U.S. District Court for the District of Massachusetts seeking collection of $266,380, alleging breach of contract and other quasi-contractual
claims relating to a purported Participation Agreement dated July 20, 2021, and subsequent agreements for payments for
goods and services under said Participation Agreement. The Company has answered the Complaint, and Initial disclosures have been filed
by the parties, but formal discovery has not yet begun.
*Ellenoff
Grossman & Schole, LLP v. iSpecimen, Inc.; New York County Supreme Court*
On or around November 14, 2024, EGS initiated
a claim against the Company for $425,684 arising from a breach of contract, and compensation on a quantum meruit basis amongst other things.
The Company believes that EGS claims are without legal or factual basis, and intends to vigorously defend these claims.
Subsequent
to year ended December 31, 2025, the Company settled this legal matter and the parties agreed to a $200,000 settlement pursuant to a
settlement agreement executed on February 15, 2026 (Note 14).
**Item
4. Mine Safety Disclosures**
****
Not Applicable.
38
**PART
II**
****
**Item
5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities**
****
**Market
Information**
****
Our
common stock trades on the Nasdaq Capital Market under the symbol ISPC. Trading commenced on the Nasdaq on June 17, 2021.
**Holders**
****
On April 1, 2026, there were 68 holders of record of our common stock.
**Dividends**
****
We
currently intend to retain all available funds and any future earnings to fund the development, commercialization, and growth of our
business, and therefore we do not anticipate declaring or paying any cash dividends on any class of our common stock in the foreseeable
future. Any future determination as to the declaration and payment of dividends, if any, will be at the discretion of our Board, subject
to compliance with contractual restrictions and covenants in the agreements governing our current and future indebtedness. Any such determination
will also depend upon our business prospects, results of operations, financial condition, cash requirements and availability, and other
factors that our Board may deem relevant.
**Securities
Authorized for Issuance under Equity Compensation Plans**
****
The
information required by Item 201(d) of Regulation S-K is set forth in Part III of this Annual Report on Form 10-K and is incorporated
herein.
**Purchases
of Equity Securities by the Issuer and Affiliated Parties**
****
None.
**Item
6. Reserved**
****
**Item
7. Managements Discussion and Analysis of Financial Condition and Results of Operations**
****
The
following discussion and analysis of the Companys financial condition and results of operations should be read in conjunction
with the financial statements and the notes thereto contained elsewhere in this Annual Report. Certain information contained in the discussion
and analysis set forth below includes forward-looking statements that involve risks and uncertainties.
39
**Overview**
****
We
were incorporated in 2009 under the laws of the state of Delaware. Our mission is to accelerate life science research and development
via a single global marketplace platform, the iSpecimen Marketplace, which connects researchers to subjects, specimens, and associated
data. We are headquartered in Woburn, Massachusetts. We operate as one operating and reporting segment.
In
addition to creating a single global platform where both specimen providers and researchers can connect, the platform automates the process
of searching for and selecting specimens for research. The platform taps into healthcare provider data to gain insights into the available
samples in biobanks or laboratories, or to gain insights into the patient populations to support specimen collections directly from research
subjects. The platform receives de-identified data from electronic medical records, laboratory information systems, and other healthcare
data sources of available specimens and research subjects and harmonizes the data across all participating organizations.
Researchers
can search this data using our intuitive, web-based user interface to obtain specimens more efficiently. They can instantly find the
specific specimens they need for their studies, request quotes for these specimens or for custom collections directly from research subjects,
place orders, and track and manage their specimens and associated data across projects.
Biospecimen
providers also gain efficiencies using the iSpecimen Marketplace, not only because the platform provides instant access to a large researcher
base, but because the technology orchestrates the bioprocurement workflow from specimen request to fulfillment. Specimen providers can
access intuitive dashboards to view requests, create proposals, and track and manage their orders.
Finally,
the platform helps with administrative and reporting functions for researchers, suppliers, and our internal personnel, including user
and compliance management.
The
iSpecimen Marketplace is composed of four major functional areas: search, workflow, data, and administration and reporting. As capital
is made available to do so, we continue to invest in the evolution of these areas to improve engagement with the platform and liquidity
across it. 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.
The
iSpecimen Marketplace currently supports the supply chain management and bioprocurement process for specimens and associated data. We
generate revenue by procuring various specimens from hospitals, laboratories, and other supply sites comprising our network, and delivering
them to our medical research customers using our proprietary software to identify and locate the required specimens. Costs paid to acquire
specimens from hospitals and laboratories generally vary depending upon the sample type, collection requirements, and data provided.
We generally operate in a just in time fashion, meaning we procure specimens from our suppliers and distribute specimens
to our customers after we obtain an order for specimens from a research client. Generally, we do not speculatively purchase and bank
samples in anticipation of future, unspecified needs. We believe our approach offers many advantages over a more traditional inventory-based
supplier business model where biorepositories take inventory risks, and where inventory turnover and cash conversion cycles can be lengthy.
**Private
Placement Offering**
****
On
December 1, 2021, we closed on a private placement offering (PIPE) for gross proceeds of approximately $21 million, before
deducting approximately $1.4 million for underwriting discounts and commissions and estimated offering expenses, for (i) an aggregate
of 87,500 shares of common stock and (ii) warrants, which are exercisable for an aggregate of up to 65,625 shares of common stock, all
of which were repurchased by us on February 13, 2024, and are no longer outstanding.
On
July 31, 2025, the Company entered into a securities purchase agreement with certain accredited investors, pursuant to which the Company
agreed to issue and sell, in a private placement (the Private Placement), an aggregate of 1,559,828 securities, comprised
of (i) 267,379 shares of Common Stock at a purchase price of $1.122 per Share, and (ii) pre-funded warrants to purchase up to 1,292,449
shares of Common Stock at a purchase price of $1.1219 per Share, for aggregate gross proceeds of $1,749,998, before deducting placement
agent fees and other offering expenses. The pre-funded warrants are immediately exercisable until such time as the pre-funded warrants
are exercised in full. The Private Placement closed on August 4, 2025.
40
**At
the Market Offering**
****
On
March 5, 2024, we entered into an At the Market Offering Agreement (the ATM Agreement) with Rodman & Renshaw LLC as
agent (the Sales Agent) pursuant to which we may issue and sell shares of our common stock, having an aggregate offering
price of up to $1,500,000 (the ATM Shares), from time to time through the Sales Agent. The ATM Shares when issued will
be registered pursuant to our shelf registration statement on Form S-3 (File No 333- 265976), which became effective on July 12, 2022.
We sold the ATM Shares, from time to time, pursuant to the ATM Agreement, in transactions that are at the market offerings
as defined in Rule 415(a)(4) promulgated under the Securities Act. During the year ended December 31, 2024, we issued 199,004 shares
of common stock for gross proceeds of approximately $1,494,000 under the ATM Agreement. In connection with the ATM Offering, we incurred
offering costs of approximately $255,000, resulting in net proceeds of approximately $1,239,000.
**Reverse
Stock Split**
On
October 9, 2023, we received a notification from Nasdaq that our Common Stock failed to maintain a minimum bid price of $1.00 over the
previous 30 consecutive business days as required by the Listing Rules of The Nasdaq Stock Market.
On
July19, 2024, our stockholders approved a proposal to amend our Fourth Amended and Restated Certificate of Incorporation to effect
a reverse stock split of our issued and outstanding shares of common stock, as well as any shares of common stock held by the Company
in treasury, at a ratio in the range from 1-for-10 to 1-for-20.
On
August19, 2024, the Board approved a one-for-twenty (1:20) reverse stock split of our issued and outstanding shares of common stock.
On September13, 2024, we filed with the Secretary of State of the State of Delaware a Certificate of Amendment to our Certificate
of Incorporation to effect the Reverse Stock Split. The Reverse Stock Split became effective on September13, 2024, and our common
stock began trading on a split-adjusted basis on Nasdaq on September16, 2024.
On
October 1, 2024, we received a notification from Nasdaq that the Staff has determined that for the last 11 consecutive business days,
from September 16, 2024 to September 30, 2024, the closing bid price of our Common Stock was $1.00 per share or greater. Accordingly,
we regained compliance with Listing Rule 5559(a)(2).
Except
as otherwise indicated, all references to our common stock, share data, per share data and related information have been adjusted for
the Reverse Stock Split ratio of 1-for-20 as if they had occurred at the beginning of the earliest period presented. The Reverse Stock
Split combined each 20 shares of our outstanding common stock and treasury shares into one share of common stock without any change in
the par value per share, and the Reverse Stock Split correspondingly adjusted, among other things, the exercise rate of our warrants
and options into our common stock. No fractional shares were issued in connection with the Reverse Stock Split, and any fractional shares
resulting from the Reverse Stock Split were rounded up to the nearest whole share.
**Debt
Financing**
****
On
September19, 2024, we entered into the Purchase Agreement with the Lender. Pursuant to the provisions of the Purchase Agreement,
the Lender agreed to provide a loan to us in the amount of $1,000,000 and we agreed to issue to the Lender a promissory note in the principal
amount of $1,000,000 payable within 12months after the date of issuance, with interest accruing and payable at a rate of 18% per
annum. The Purchase Agreement contains customary representations and warranties and obligates the Lender to provide an additional loan
to us, in the form of a revolving line of credit of up to $1,000,000, upon our initial filing of a Registration Statement for an underwritten
or best-efforts public offering for gross proceeds of at least $5,000,000. On September25, 2024, we and the Lender closed the transactions
described in the Purchase Agreement, the Lender provided funds to the Company in the net amount of $959,980 and we issued the Note to
the Lender in the principal amount of $1,000,000. WestPark Capital, Inc. (WestPark) served as the placement agent in connection
with the Loan and was paid a placement agent fee in the amount of $40,020 for its services.
On October
31, 2024, we paid off the outstanding principal balance of $1,000,000 and accrued interest of $18,000 on the Note.
**Securities
Offering on Form S-1**
****
On
October 29, 2024, we entered into a placement agency agreement (the Placement Agency Agreement) with WestPark. (the Placement
Agent), and a securities purchase agreement (the Securities Purchase Agreement) with investorspursuant to
which we agreed to issue and sell, in a reasonablebest efforts public offering(the Offering)
(i) 132,814 shares (the Shares)of our common stock, par value $0.0001 per share (the Common Stock)
at an offering price of $2.999 per share, and (ii) pre-funded warrants to purchase up to 1,533,852 shares of Common Stock (the Pre-Funded
Warrants) at an offering price of $3.00 per Share, less $0.0001 per Pre-Funded Warrant, for aggregate gross proceeds of $4,998,464
(or $4,999,998 assuming the full exercise of the Pre-Funded Warrants), before deducting placement agent fees and other offering expenses.The
Offering closed on October 31, 2024.
41
As
part of its compensation for acting as Placement Agent for the Offering, we paid the Placement Agent a cash fee of 4.0% of the aggregate
gross proceeds plus reimbursement of certain expenses and legal fees.The Company incurred offering costs of approximately $419,983
and settled non-offering related legal fees of approximately $93,837, resulting in net proceeds of approximately $3,485,754.
The
securities sold in the Offering were offered and sold pursuant to a registration statement onForm S-1 (File No. 333-282736), which
was filed with the Securities and Exchange Commission (the Commission) on October 18, 2024, and subsequently declared effective
by the Commission on October 29, 2024.
**Underwritten
Offering**
On
July 23, 2025, the Company entered into an underwriting agreement with WestPark (the Underwriter), pursuant to which the
Company agreed to issue and sell, in an underwritten public offering, an aggregate of 5,714,283 securities, consisting of (i) 1,482,644
shares of Common Stock, and (ii) pre-funded warrants to purchase up to 4,231,639 shares of Common Stock, at an exercise price of $0.0001
per share. The securities were sold at a public offering price of $0.70 per share (or $0.6999 per pre-funded warrant), for gross proceeds
of $3,999,574, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The pre-funded
warrants are immediately exercisable until such time as the pre-funded warrants are exercised in full. The offering closed on July 25,
2025.
As
part of its compensation for acting as Underwriter for the offering, the Company paid the Underwriter a cash fee of4.0% of the
aggregate gross proceeds plus reimbursement of certain expenses and legal fees. The Company incurred offering costs of approximately
$419,983 and settled non-offering related legal fees of approximately $93,837, resulting in net proceeds of approximately $3,485,754.
**Impact
of the Current Economy**
****
The
Companys financial performance is subject to global economic conditions and their impact on levels of spending by our customer
research organizations, particularly discretionary spending for procurement of specimens used for research. Economic recessions may have
adverse consequences across industries, including the health and biospecimen industries, which may adversely affect our business and
financial condition. We increased our allowance for doubtful accounts in accounts receivables by $25,634 as of December 31, 2025 due
to certain customers either lack liquidity or have filed for bankruptcy. We have enhanced procedures related to our credit check process
for new and existing customers in fiscal year 2025 to mitigate the risk to future collectability of receivables.
Changes
in general market, economic and political conditions in domestic and foreign economies or financial markets, including fluctuation in
stock markets resulting from, among other things, trends in the economy and inflation, as are being currently experienced, may result
in a reduction in researchers demand for specimens due to the research organizations inability to obtain funding.
To
further address the current market conditions, we have taken steps, which include but are not limited to, reevaluating our pricing in
order to be more competitive, creating campaigns to highlight and fast-track high demand items, enhancing internal team communications
to accelerate the sales cycle, moving to a new line of business structure organized by our internal categorization of biospecimen suppliers
capabilities to increase efficiency in operations, implementation of next day quotes to increase conversion ratios of quotes to purchase
orders, and initiation of efforts to decrease expenditures through reductions in our workforce.
We
believe that our business will continue to be resilient through a continued industry-wide economic slowdown in life science research,
and that we will continue to work on improving our liquidity to address our financial obligations and alleviate possible adverse effects
on our business, financial condition, results of operations or prospects.
**Impact
of the Russian-Ukrainian War on Our Operations**
****
Our
business was negatively impacted during the first half of 2022 by the ongoing war between Russia and Ukraine. At the start of the war,
we had approximately $1 million of purchase orders that were slated to be fulfilled by our supply network in Ukraine and Russia. This
supply network was shut down at the start of the war. Ukrainian suppliers were disabled due to war conditions and evacuations and some
of our Russian suppliers were disabled by sanctions. While we mobilized to shift these purchase orders to other suppliers in the network,
the process of specimen collections from other supply sites took time, which caused a delay in the fulfillment of such purchase orders.
Alternate suppliers do not have the same favorable unit economics or specimen collection rates, and this also impacted our margins. Additionally,
key resources were diverted from operations to resolving the re-fulfillment issues caused by the conflict.
42
As
of December 31, 2025, our supply sites in Russia that had not been under sanctions were accessible and our supply sites in Ukraine were
mostly reopened. However, logistics and transportation of specimens out of the country of Ukraine remains challenging and not as economically
feasible as they were prior to the beginning of the war. Due to the uncertainty caused by the ongoing war, Ukrainian and Russian suppliers
may again become inaccessible to us. Therefore, as long as the uncertainty continues, our policy is to ensure at a purchase order level
that an order is not solely sourced from the two countries. The short and long-term implications of the war are difficult to predict
as of the date of this Annual Report. The imposition of more sanctions and counter sanctions may have an adverse effect on the economic
markets generally and could impact our business and the businesses of our supply partners, especially those in Ukraine and Russia. Because
of the highly uncertain and dynamic nature of these events, it is not currently possible to estimate the impact of the war on our business
and the companies from which we obtain supplies and distribute specimens.
**Known
Trends, Demands, Commitments, Events or Uncertainties Impacting Our Business**
****
*Chief
Executive Officer Initiatives*
**
The
Companys mission remains to accelerate life sciences research and development, pursuant to a single global marketplace platform.
Executive management of the Company continues to review the Companys structure, processes, and resources to evaluate and identify
areas for improvement, and has been focused on creating and ensuring a runway for growth and scale for the business.
During
the year ended December 31, 2025, the Company continued its efforts, which had begun in 2023, to decrease its capital and operational
expenditures by cutting costs and right sizing the Company through a reduction in workforce while streamlining operations and rationalizing
resources to focus on key market opportunities. The reduction in workforce since January 1, 2024 through December 31, 2025, cumulatively
resulted in an estimated reduction in monthly compensation costs of approximately 67% and technology costs of approximately 25% during
the year ended December 31, 2025 when compared to year ended December 31, 2024.
During
the year ended December 31, 2023, we performed operational process improvement activities to increase collaboration within and between
departments. We moved to a line of business structure organized by our internal categorization of biospecimen suppliers capabilities,
which has increased efficiency in our operations and throughout the Company. We continue to see benefits from this move.
We
completed the implementation of a next day quote system in the third quarter of 2023 and we continue to see positive results in 2024
and 2025, as evidenced by increased conversion ratios of quotes to purchase orders of 44%. Previously, it took an extended number of
days to complete a feasibility study in order to provide a customer quote, which negatively impacted the time to convert a quote to a
purchase order.
While
we are committed to developing our technology, we are investing at a significantly lower level in 2025 when compared to 2024 and prior
years, while we focus on growing our revenues through key market opportunities and assessing our capital raise prospects.During
the years ended December 31, 2025 and 2024, we capitalized approximately $Nil and $653,000, respectively,of internally developed
software costs and $1,000,000 and $Nil, respectively, of software under development.These investments have resulted in multiple
process improvements, streamlining workflows and providing deeper insights into orders for all users of our marketplace.
We
have shifted our focus from high volume to high value suppliers that meet our newly defined costs, quality and speed requirements. We
established business criteria that focus on supplier capabilities and revenue growth strategies as well as technology criteria for integrating
onto our iSpecimen Marketplace platform and participating with us. In the year ended December 31, 2024, we terminated 180 supplier agreements
and are in the final stages of what we call our supplier network refresh project. This has resulted in fewer key suppliers,
supported by our lean workforce and processes more effectively. We have been reengaging our suppliers in more meaningful manner which
assisted us in the implementation of our next day quote system. We now have a key supplier program whereby we proactively engage with
the suppliers to promote our business through marketing campaigns and supplier organizations offerings.
Going
forward, we will leverage the hard work detailed above to support a sales overhaul. As we wrap up several operationally focused projects,
we will now be re-organizing the commercial end of the business. This starts with a new account-based sales approach and the introduction
of an outbound sales team to ensure we are meeting our customers and prospects where they are. We are also bringing marketing and sales
closer to enable the same efficiencies within the commercial organization, the same way that our line of business realignment brought
to the operational side of the business this past year. This refined approach and tighter internal integration will continue to accelerate
our next day quote program and deepen customer relationships for increased predictability.
43
Our
strategic business intelligence initiatives have enabled us to understand our market and business better than ever before. We now have
the capabilities to use data to know how and where to grow. We will continue adjusting the shape of the business toward our core competencies
and the market. We can better use key insights from our sales data to understand market needs to assess areas where we lose deals today,
through multiple lenses, in order to adjust our supplier network and marketing efforts accordingly. Conversely, this strategy will also
allow us to assess areas where we win with an eye toward expanding deeper into those market niches or disease states.
Following
the completion of our supplier network refresh efforts, we will have a better than ever understanding of our key supplier capabilities,
specifically focused on their pricing, quality, and speed. Using this information and the outputs of our strategic business intelligence
capabilities, we will continue to be able to increase the speed of an opportunity through our sales funnel and our conversion ratios,
which we believe will continue to grow our revenue.
**Components
of Our Results of Operations**
****
**Revenue**
****
We
generate revenue by procuring various specimens from hospitals, laboratories, and other supply sites, for our medical research customers
using our proprietary software, the iSpecimen Marketplace, to identify, locate, and ultimately validate the required specimens to our
customers requested specifications. The Companys performance obligation is to procure a specimen meeting the customer specification(s)
from a supplier, on a best efforts basis, for our customer at the agreed price per specimen as indicated in the customer
contract with the Company. We do not currently charge suppliers or customers for the use of our proprietary software. Each customer will
execute a material and data use agreement with the Company or agree to online purchase terms, each of which includes terms such as specimen
and data use, shipment terms, payment and cancellation terms. These are then supplemented by purchase orders that specify specimen requirements
including detailed inclusion/exclusion criteria, quantities to be collected, and pricing. Collectively, these customer agreements represent
the Companys contracts with its customer. Generally, contracts have fixed unit pricing. For certain specimen orders, a refundable
customer deposit may be required prior to order fulfillment depending on project set-up requirements, presented as deferred revenue.
The Company expects to recognize the deferred revenue within the next twelve months.
We
recognize revenue over time, as we have created an asset with no alternative use and we have an enforceable right to payment for performance
completed to date. At contract inception, we review a contract and related order upon receipt to determine if the specimen ordered has
an alternative use to us. Generally, specimens ordered do not have an alternative future use to us and our performance obligation is
satisfied when the related specimens are accessioned. We use an output method to recognize revenue for specimens with no alternative
future use. The output is measured based on the number of specimens accessioned.
Customers
are typically invoiced upon shipment. Depending on the quantity of specimens ordered, it may take several accounting periods to completely
fulfill a purchase order. In other words, there can be multiple invoices issued for a single purchase order, reflecting the specimens
being accessioned over time. However, specimens are generally shipped as soon as possible after they have been accessioned.
During
2024, the Company recognized its revenue when the related specimens are delivered.
**Cost
of Revenue**
****
Cost
of revenue primarily consists of the purchase price to acquire specimens from hospitals and laboratories, inbound and outbound shipping
costs, supply costs related to samples, payment processing and related transaction costs, costs paid to the supply sites to support sample
collections, amortization of capitalized sequenced data costs and other assets related to sequenced data. Shipping costs upon receipt
of products from suppliers are recognized in cost of revenue.
**Technology**
****
Technology
costs include consulting fees, payroll and related expenses for employees involved in the development and implementation of our technology;
software license and system maintenance fees, outsourced data center costs, data management costs, amortization of internally developed
software, and other expenses necessary to support technology initiatives. Collectively, these costs reflect the efforts we make to offer
a wide variety of products and services to our customers. Technology and data costs are generally expensed as incurred.
A
portion of technology costs are related to research and development. Costs incurred for research and development are expensed as incurred,
except for software development costs that are eligible for capitalization. Research and development costs primarily include salaries
and related expenses, in addition to the cost of external service providers.
44
**Sales
and Marketing**
****
Sales
and marketing costs primarily consist of payroll and related expenses for personnel engaged in marketing and selling activities, including
salaries and sales commissions, travel expenses, public relations and social media costs, ispecimen.com website development and maintenance
costs, search engine optimization fees, advertising costs; direct marketing costs, trade shows and events fees, marketing and customer
relationship management software, and other marketing-related costs.
**Supply
Development**
****
We
have agreements with supply partners that allow us to procure specimens from them and distribute these samples to customers. Supply development
costs primarily include payroll and related expenses for personnel engaged in the development and management of this supply network,
related travel expenses, regulatory compliance costs to support the network, and other supply development and management costs.
**Fulfillment**
****
Fulfillment
costs primarily consist of those costs incurred in operating and staffing operations and customer service teams, including costs attributable
to assess the feasibility of specimen requests, creating and managing orders, picking, packaging, and preparing customer orders for shipment,
responding to inquiries from customers, and laboratory equipment and supplies.
**General
and Administrative**
****
General
and administrative expenses primarily consist of costs for corporate functions, including payroll and related expenses for human resources,
legal, finance, and executive teams, associated software licenses, facilities, and equipment expenses, such as depreciation and amortization
expense and rent, outside legal expenses, insurance costs, and other general and administrative costs.
**Financial
Operations Overview and Analysis for the Years Ended December 31, 2025 and 2024**
****
**Comparison
of the Years Ended December 31, 2025 and 2024**
****
|
| |
| | |
| | |
Change | | |
|
| |
2025 | | |
2024 | | |
Dollars | | |
Percentage | | |
|
Revenue | |
$ | 1,928,998 | | |
$ | 9,291,115 | | |
$ | (7,362,117 | ) | |
| (79 | )% | |
|
Operating expenses: | |
| | | |
| | | |
| | | |
| | | |
|
Cost of revenue | |
| 1,904,888 | | |
| 5,302,712 | | |
| (3,397,824 | ) | |
| (64 | )% | |
|
Technology | |
| 2,159,815 | | |
| 3,530,291 | | |
| (1,370,476 | ) | |
| (39 | )% | |
|
Sales and marketing | |
| 2,295,501 | | |
| 4,945,269 | | |
| (2,649,768 | ) | |
| (54 | )% | |
|
Supply development | |
| 246,979 | | |
| 537,888 | | |
| (290,909 | ) | |
| (54 | )% | |
|
Fulfillment | |
| 827,501 | | |
| 1,635,724 | | |
| (808,223 | ) | |
| (49 | )% | |
|
General
and administrative | |
| 3,472,233 | | |
| 6,067,276 | | |
| (2,595,043 | ) | |
| (43 | )% | |
|
Total
operating expenses | |
| 10,906,917 | | |
| 22,019,160 | | |
| (11,112,243 | ) | |
| (50 | )% | |
|
Loss from operations | |
| (8,977,919 | ) | |
| (12,728,045 | ) | |
| (3,750,126 | ) | |
| (29 | )% | |
|
Other (income) expense, net | |
| | | |
| | | |
| | | |
| | | |
|
Interest expense | |
| (1,949 | ) | |
| (173,771 | ) | |
| 171,822 | | |
| 99 | % | |
|
Interest income | |
| 3,748 | | |
| 44,133 | | |
| (40,385 | ) | |
| (92 | )% | |
|
Interest and penalties on
sales tax liability | |
| (7,969 | ) | |
| (46,303 | ) | |
| 38,334 | | |
| 100 | % | |
|
Other
income (expense), net | |
| (1,505,443 | ) | |
| 406,181 | ) | |
| (1,909,624 | ) | |
| (470 | )% | |
|
Total other income,
net | |
| (1,509,613 | ) | |
| 230,240 | | |
| (1,739,853 | ) | |
| (756 | )% | |
|
Net loss | |
$ | (10,487,532 | ) | |
$ | (12,497,805 | ) | |
$ | (2,010,273 | ) | |
| (16 | )% | |
****
**Revenue**
****
Revenue
decreased by approximately $7,362,000, or 79%, from approximately $9,291,000 for the year ended December 31, 2024 to approximately $1,929,000
for the year ended December 31, 2025. This was primarily due to the decrease of 17,714, or approximately 77%, in specimen count from
23,139 specimens in fiscal 2024 to 5,425 specimens in fiscal 2025. The effect of the decrease in specimen count also caused the average
selling price per specimen to decrease by $46, or 11%, from approximately $402 during the year ended December 31, 2024 to $356 during
the year ended December 31, 2025. The significant decline in revenue was mainly due to decrease in customers orders and procurement
during the year ended December 31, 2025.
45
**Cost
of Revenue**
****
Cost
of revenue decreased by approximately $3,398,000, or 64%, from approximately $5,303,000 for the year ended December 31, 2024 to approximately
$1,905,000 for the year ended December 31, 2025 which was attributable to an approximately 64% decrease in the number of specimens delivered
for the current year as compared to the accessioned specimens in the prior year, offset by an approximately $47, or 21%, increase in
the average cost per specimen.
**Technology**
****
Technology
expenses decreased by approximately $1,370,000, or 39%, from approximately $3,530,000 for the year ended December 31, 2024 to approximately
$2,160,000 for the year ended December 31, 2025. The decrease was related to decrease in amortization expense of internally developed
software of approximately $491,000, payroll and related expenses of approximately $887,000 and general operating expenses related to
technology expenses of approximately $1,000, which was partially offset by the increase in professional fees of approximately $9,000.
Technology
expenditures capitalized as internallydeveloped software costs increased by approximately $347,000, or 53%, from approximately
$653,000 for the year ended December 31, 2024 to $1,000,000 for the year ended December 31, 2025 due to installation of a new platform
to modernize the Companys internallydeveloped software, as part of the digital transformation program in 2025 when compared
to the reductions in workforce stemming from our decision to invest in the software at a significantly lower level in 2025 and 2024.
**Sales
and Marketing Expenses**
****
Sales
and marketing expenses decreased by approximately $2,650,000, or 54%, from approximately $4,945,000 for the year ended December 31, 2024
to approximately $2,296,000 for the year ended December 31, 2025. The decrease was primarily attributable to decrease in payroll and
related expenses of approximately $1,713,000, advertising and promotions expense of approximately $296,000 and external marketing expense
of approximately $649,000, which was partially offset by the increase in general operating expenses related to sales and marketing of
approximately $3,000.
**Supply
Development**
****
Supply
development expenses decreased by approximately $291,000, or 54%, from approximately $538,000 for the year ended December 31, 2024 to
approximately $247,000 for the year ended December 31, 2025. The decrease was primarily attributable to a decrease in professional fees
of approximately $119,000 and payroll and related expenses of approximately $172,000.
**Fulfillment**
****
Fulfillment
costs decreased by approximately $808,000, or 49%, from approximately $1,636,000 for the year ended December 31, 2024 to approximately
$828,000 for the year ended December 31, 2025. The decrease was primarily attributable to a decrease in professional fees of approximately
$19,000 and payroll and related expenses of approximately $821,000 for personnel engaged in pre-sales feasibility assessments and order
fulfillment, which was partially offset by the general operating expenses related to fulfillment of approximately $32,000.
**General
and Administrative Expenses**
****
General
and administrative expenses decreased by approximately $2,595,000, or 43%, from approximately $6,067,000 for the year ended December
31, 2024 to approximately $3,472,000 for the year ended December 31, 2025. The decrease was attributable to a decrease in compensation
costs of approximately $647,000, professional fees of approximately $133,000 and utilities and facilities expenses of approximately $93,000,
doubtful account expense of approximately $646,000, taxes and insurance of approximately $388,000 and franchise tax of approximately
$310,000, which was partially offset by the increase in general operating expenses of approximately $120,000, amortization of approximately
$3,000, and write-off of IDS of approximately $274,000.
**Other
Income (expense), net**
****
Other
income (expense), net, increased by approximately $1,740,000, or 756%, from approximately $1,510,000 other income for the year ended
December 31, 2024 to approximately other expense, net of $240,000, for the year ended December 31, 2025. The increase in other income
(expense), net, was attributable to a decrease of other income of approximately $1,503,000, decrease in interest and penalties on sales
tax liability of approximately $38,000, decrease in interest expense of approximately $172,000, partially offset by a decrease in interest
income of approximately $40,000.
46
**Liquidity
and Capital Resources**
****
|
| |
December31, | | |
December31, | | |
Change | | |
|
| |
2025 | | |
2024 | | |
Dollars | | |
Percentage | | |
|
Balance Sheet Data: | |
| | | |
| | | |
| | | |
| | | |
|
Cash and cash equivalents | |
$ | 6,880,835 | | |
$ | 1,878,408 | | |
$ | 5,002,427 | | |
| 266 | % | |
|
Working capital (deficiency) | |
| 723,284 | | |
| (2,182,488 | ) | |
| 2,905,772 | | |
| (133 | )% | |
|
Total assets | |
| 9,531,410 | | |
| 9,350,230 | | |
| 181,180 | | |
| 2 | % | |
|
Total stockholders equity | |
$ | 3,088,231 | | |
| 3,311,008 | | |
$ | (222,777 | ) | |
| (7 | )% | |
****
|
| |
Years
Ended December31, | | |
Change | | |
|
| |
2025 | | |
2024 | | |
Dollars | | |
Percentage | | |
|
Statement of Cash Flow Data: | |
| | |
| | |
| | |
| | |
|
Net cash flows used in operating
activities | |
$ | (4,240,608 | ) | |
$ | (8,263,713 | ) | |
$ | 4,023,105 | | |
| (49 | )% | |
|
Net cash flows provided by (used in) investing
activities | |
| (1,000,454 | ) | |
| 1,979,554 | | |
| (2,980,008 | ) | |
| (151 | )% | |
|
Net cash flows provided
by financing activities | |
| 10,243,489 | | |
| 5,818,901 | | |
| 4,424,588 | | |
| 76 | % | |
|
Net increase (decrease)
in cash and cash equivalents | |
$ | 5,002,427 | | |
$ | (465,258 | ) | |
$ | 5,467,685 | | |
| | | |
****
**Capital
Resources**
We
have recurring losses since inception. As of December 31, 2025, our available cash totaled approximately $6,881,000, which represented
an increase of approximately $5,002,000 from approximately $1,878,000, as of December 31, 2024. We had working capital of approximately
$723,000, an accumulated deficit of approximately $82,350,000, cash and cash equivalents of approximately $6,881,000 and accounts payable
and accrued expenses of approximately $5,982,000. Our continued viability is dependent on the ability to successfully obtain additional
working capital and/or ultimately attain profitable operations. During the year ended December 31, 2025, the Company continued its efforts,
which had begun in 2023, to decrease its capital and operational expenditures by cutting costs and right sizing the Company through a
reduction in workforce while streamlining operations and rationalizing resources to focus on key market opportunities. The reduction
in workforce since January 1, 2024 through December 31, 2025, cumulatively resulted in an estimated reduction in monthly compensation
costs of approximately 67% and technology costs of approximately 25% during the year ended December 31, 2025 when compared to year ended
December 31, 2024. While we plan to improve our sales and revenues, we are taking steps to significantly reduce and manage expenditures
to improve our financial position and ensure continued funding of operations. However, as certain elements of our operating plan are
not within our control, we are unable to assess their probability. In the year ended December 31, 2025, we engaged in raising capital
through equity financing as discussed in Note 10.
We
may be unsuccessful in increasing our revenues or contain our operating expenses, or we may be unable to raise additional capital on
commercially favorable terms. Our failure to generate additional revenues or contain operating costs would have a negative impact on
our business, results of operations and financial condition and our ability to continue as a going concern. If we do not generate enough
revenue to provide an adequate level of working capital, our business plan will be scaled down further.
These
conditions raise substantial doubt regarding our ability to continue as a going concern for a period of one year after the date of this
Annual Report. Managements plan to mitigate the conditions that raise substantial doubt includes generating additional revenues
through its revenue enhancement projects, deferring certain projects and capital expenditures and eliminating certain future operating
expenses for us to continue as a going concern. However, there can be no assurance that we will be successful in completing any of these
options. As a result, managements plans cannot be considered probable and thus do not alleviate substantial doubt about our ability
to continue as a going concern.
47
**Cash Flows**
****
**Operating
Activities**
****
For
the year ended December 31, 2025, net cash used in operating activities was approximately $4,241,000, which consisted of a net loss of
approximately $10,488,000 offset by non-cash charges of approximately $4,133,000, which included approximately $1,471,000 related to
amortization of internally developed software, approximately $21,000 in stock-based compensation, approximately $60,000 in bad debt expense,
approximately $68,000 related to depreciation of property and equipment, approximately $192,000 related to amortization of other intangible
assets, approximately $1,871,000 related to write-off of internally developed software, approximately $525,000 related to write-off of
other intangible assets which were offset by approximately $75,000 of write-off of accounts payable.
Total
changes in assets and liabilities of approximately $2,114,000 were attributable to an approximately $1,336,000 decrease in accounts receivable,
an approximately $45,000 increase in inventory, an approximately $194,000 decrease in prepaid expenses, an approximately $59,000 decrease
in operating lease right-of-use asset, and an approximately $1,240,000 increase in accounts payable, offset by an approximately $550,000
decrease in accrued expenses, an approximately $43,000 decrease in operating lease liability, and an approximately $168,000 decrease
in deferred revenue.
For
the year ended December 31, 2024, net cash used in operating activities was approximately $8,264,000, which consisted of a net loss of
approximately $12,498,000 offset by non-cash charges of approximately $4,737,000, which included approximately $2,037,000 related to
amortization of internally developed software, approximately $250,000 in stock-based compensation, approximately $706,000 in bad debt
expense, approximately $66,000 related to depreciation of property and equipment, approximately $700 for loss from sales of available-for-sale
securities, approximately $60 for loss on disposal of property and equipment, approximately $327,000 of write-off of internally developed
software, an approximately $1,188,000 increase in write-off of accounts receivable-unbilled and approximately $192,000 related to amortization
of other intangible assets, which were offset by approximately $29,000 of accretion of discount on available-for-sale securities.
Total
changes in assets and liabilities of approximately $503,000 were attributable to an approximately $272,000 increase in accounts payable,
an approximately $506,000 increase in accounts receivable - unbilled, an approximately $127,000 decrease in operating lease right-of-use
asset, and an approximately $27,000 decrease in prepaid expenses, approximately $16,000 decrease in security deposit, offset by an approximately
$903,000 increase in accounts receivable, an approximately $372,000 decrease in accrued expenses, an approximately $120,000 decrease
in operating lease liability, and an approximately $55,000 decrease in deferred revenue.
**Investing
Activities**
****
Net
cash used in investing activities was approximately $1,000,000 for the year ended December 31, 2025, which consisted of approximately
$1,000,000 of capitalization of intangible assets under development and $454 purchase of property and equipment. We intend to continue
to use our existing cash to grow our supply network, increase our marketing and sales presence, scale our operations, and for working
capital and general corporate purposes.
During
the year ended December 31, 2024, we invested approximately $653,000 in further developing our iSpecimen Marketplace technology, in comparison
to the cash invested during the year ended December 31, 2023 of approximately $3,767,000.
Net
cash provided by investing activities was approximately $1,980,000 for the year ended December 31, 2024 consisted of approximately $3,150,000
of proceeds from sale and maturities of available-for-sale securities, which were offset by approximately $461,000 of purchases of available-for-sale
securities, approximately $653,000 of capitalization of internally developed software, approximately $25,000 of purchases of leasehold
improvements and approximately $32,000 of purchases of property and equipment.
**Financing
Activities**
****
Net
cash provided by financing activities was approximately $10,243,000 for the year ended December 31, 2025, which consisted of approximately
$1,750,000 of proceeds received from the issuance of common stock in connection with the PIPE financing, approximately $4,000,000 of
proceeds from issuance of common stock in connection with Securities Purchase Agreement, approximately $5,500,000 of proceeds received
from the issuance of Series C convertible preferred stock in connection with PIPE financing, offset by approximately $1,006,000 for the
payment of offering costs in connection with the on-going at the market offering.
48
Net
cash provided by financing activities was approximately $5,819,000 for the year ended December 31, 2024, which consisted of approximately
$1,494,000 of proceeds from issuance of common stock in connection with at the market offering agreement, approximately $398,000 of proceeds
from issuance of common stock in connection with Securities Purchase Agreement, approximately $4,600,000 of proceeds from pre-funded
warrants, which were offset by approximately $255,000 of payment of offering costs in connection with the issuance of common stock in
connection with at the market offering agreement, approximately $366,000 of payment of offering costs in connection with the issuance
of common stock in connection with pre-funded warrants and common shares and approximately $53,000 of repurchase of common stock exercisable
under PIPE warrants.
**Effects
of Inflation and Supply Chain Shortages**
****
Our
operations are heavily reliant on specimen availability, and as a result, we often receive more requests than we can fulfill. While the
Company is subject to these types of supply chain constraints that are specific to the specimen industry, we have not been materially
affected by the more common supply chain issues currently affecting the economy, specifically surrounding transportation.
We
have experienced negative effects of inflation in certain areas of our business due to the high rates of inflation in the worlds
current economy. This inflation is affecting employee salaries, which account for a significant portion of our operating costs. Additionally,
the costs of supplies have been affected by inflation; however, these costs are not significant to the Companys results.
Inflation
has not had a significant impact on the cost of specimens due to our long-term contracts maintained with vendors, which include revenue
sharing plans.
**Critical
Accounting Policies and Estimates**
****
We
have chosen accounting policies that we believe are appropriate to accurately and fairly report our operating results and financial condition
in conformity with GAAP. We apply these accounting policies in a consistent manner. Our significant accounting policies are discussed
in Note 2 of our financial statements.
The
application of critical accounting policies requires that we make estimates and assumptions that affect the reported amounts of assets,
liabilities, revenues and expenses and related disclosures. These estimates and assumptions are based on historical experience and other
market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. We evaluate these estimates and
assumptions on an ongoing basis. If actual results ultimately differ from previous estimates, the revisions are included in results of
operations in the period in which the actual amounts become known. The following accounting policies involve estimates that are considered
critical due to the level of subjectivity and judgment involved, as well as the impact on our financial position and results of operations.
**Internally
Developed Software**
****
We
capitalize certain internal and external costs incurred during the application development stage of internal use software projects until
the software is ready for its intended use. Amortization of the asset commences when the software is complete and placed into service
and is recorded in operating expenses. We amortize completed internal-use software over its estimated useful life of five years on a
straight-line basis. Costs incurred during the planning, training and post-implementation stages of the software development life cycle
are classified as technology and expensed to operations as incurred. Costs that do not meet the capitalization criteria are expensed
as incurred. We performed an impairment analysis of our internally developed software as of the measurement date of December 31, 2024
and concluded that a small portion the net book value of the asset is not recoverable. During the year ended December 31, 2025, such
portion were written off and reduced the net book value estimates by $1,871,000 (2024 - $327,000).
**Sequenced
Data Cost**
****
We
capitalize the purchase cost of sequenced data. The sequenced data is a new product, and its anticipated future gross revenues are currently
yet to be fully quantifiable. Due to certain factors such as uncertainty related to technological advancement in precision medicine,
which may limit the long term economic viability of the asset, we determined that an estimated useful life of five years would be appropriate
for the asset. Therefore, the sequenced data will be amortized on a straight-line basis over an estimated useful life of five years.
The costs paid to the third party sequencer are the only costs capitalized and all other costs are expensed as incurred.
49
**Stock-based
Compensation**
****
We
record stock-based compensation for options granted to employees, non-employees, and to members of the Board for their services on the
Board based on the grant date fair value of awards issued, and the expense is recorded on a straight-line basis over the requisite service
period. Forfeitures are recognized when they occur.
We
use the Black-Scholes-Merton option pricing model to determine the fair value of stock options. The use of the Black-Scholes-Merton option-pricing
model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common
stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common stock. We
have concluded that its historical share option exercise experience does not provide a reasonable basis upon which to estimate expected
term. Therefore, the expected term was determined according to the simplified method, which is the average of the vesting tranche dates
and the contractual term. Due to the lack of company specific historical and implied volatility data, the estimate of expected volatility
is primarily based on the historical volatility of a group of similar companies that are publicly traded. For these analyses, companies
with comparable characteristics are selected, including enterprise value and position within the industry, and with historical share
price information sufficient to meet the expected life of the stock-based awards. We compute the historical volatility data using the
daily closing prices for the selected companies shares during the equivalent period of the calculated expected term of its stock-based
awards. The risk-free interest rate is determined by reference to U.S. Treasury zero-coupon issues with remaining maturities similar
to the expected term of the options. We have not paid, and do not anticipate paying, cash dividends on shares of our common stock. There
were no material changes to our estimates as of December 31, 2025.
****
**Recent
Accounting Standards**
****
For information
on recent accounting standards, see Note 2 to our financial statements.
**JOBS Act
Transition Period**
****
On
April 5, 2012, the JOBS Act was enacted. 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 certain accounting standards until those
standards would otherwise apply to private companies.
We
have elected not to opt out of such extended transition period, which means that when a standard is issued or revised and
it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies
adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to opt out of such
extended transition period or (ii) no longer qualify as an emerging growth company.
We
are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS
Act. Subject to certain conditions set forth in the JOBS Act, as an emerging growth company, we intend to rely on certain
of these exemptions, including without limitation, (i) providing an auditors attestation report on our system of internal controls
over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted
by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditors report providing additional information about
the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company
until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii)
December 31, 2026; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years;
or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
**Item
7A. Quantitative and Qualitative Disclosures About Market Risk**
****
Not required
for smaller reporting companies.
50
**Item
8. Financial Statements and Supplementary Data**
****
**Index
to Financial Statements**
**iSpecimen
Inc.**
****
|
|
Page | |
|
Report of Independent Registered Public Accounting Firm (PCAOB ID:
6797) |
F-2 | |
|
Balance Sheets as of December 31,
2025 and 2024 |
F-3 | |
|
Statements of Operations and Comprehensive
Loss for the years ended December 31, 2025 and 2024 |
F-4 | |
|
Statements of Changes in Stockholders
Equity for the years ended December 31, 2025 and 2024 |
F-5 | |
|
Statements of Cash Flows for the years
ended December 31, 2025 and 2024 |
F-6 | |
|
Notes to Financial Statements |
F-7 | |
****
F-1
****
**Report
of Independent Registered Public Accounting Firm**
****
Board
of Directors and Shareholders
iSpecimen,
Inc.
8
Cabot Road
Woburn,
Massachusetts 02420
**Opinion
on the Financial Statements**
We
have audited the accompanying balance sheets of iSpecimen, Inc. (the Company) as of December 31, 2025 and 2024, and the
related statements of operations and comprehensive loss, changes in stockholders equity, and cash flows for each of the two years
in the period ended December 31, 2025, and the related notes (collectively referred to as the financial statements). In
our opinion, the financial statements present fairly, in all material respects, the financial position of iSpecimen, Inc. as of December
31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025,
in conformity with accounting principles generally accepted in the United States of America.
**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 from operations, negative cash flows from operations and has
a significant accumulated deficit, that raises substantial doubt about its ability to continue as a going concern. Management's plans
in regard to these matters are also 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 entitys management. Our responsibility is to express an opinion on these 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 the 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 entity'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.
**Critical
Audit Matters**
Critical
audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and
(2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/
Bush & Associates CPA LLC
We
have served as the Company's auditor since 2025.
Las
Vegas, Nevada
April
1, 2026
PCAOB
ID Number 6797
****
F-2
**PART
I FINANCIAL INFORMATION**
**Item
1. Financial Statements**
****
**iSpecimenInc.**
**Balance
Sheets**
****
|
| |
December31,
2025 | | |
December31,
2024 | | |
|
ASSETS | |
| | |
| | |
|
Current assets: | |
| | |
| | |
|
Cash
and cash equivalents | |
$ | 6,880,835 | | |
$ | 1,878,408 | | |
|
Accounts receivable and other receivables, net of allowance for doubtful accounts of $646,067 and $620,433 at December 31, 2025 and 2024, respectively | |
| 48,298 | | |
| 1,444,636 | | |
|
Inventory | |
| | | |
| 45,110 | | |
|
Prepaid
expenses and other current assets | |
| 25,457 | | |
| 219,782 | | |
|
Total
current assets | |
| 6,954,590 | | |
| 3,587,936 | | |
|
Property
and equipment, net | |
| 25,543 | | |
| 93,563 | | |
|
Internally
developed software, net | |
| 1,270,017 | | |
| 4,611,954 | | |
|
Intangible
assets under development | |
| 1,000,000 | | |
| | | |
|
Other
intangible assets, net | |
| | | |
| 716,700 | | |
|
Operating
lease right-of-use asset | |
| 269,160 | | |
| 327,977 | | |
|
Security
deposits | |
| 12,100 | | |
| 12,100 | | |
|
Total
assets | |
$ | 9,531,410 | | |
$ | 9,350,230 | | |
|
LIABILITIES
AND STOCKHOLDERS EQUITY | |
| | | |
| | | |
|
Current
liabilities: | |
| | | |
| | | |
|
Accounts
payable | |
$ | 5,362,604 | | |
$ | 4,197,561 | | |
|
Accrued
expenses | |
| 619,242 | | |
| 1,168,786 | | |
|
Operating
lease current obligation | |
| 56,925 | | |
| 43,369 | | |
|
Deferred
revenue | |
| 192,535 | | |
| 360,708 | | |
|
Total
current liabilities | |
| 6,231,306 | | |
| 5,770,424 | | |
|
Operating
lease long-term obligation | |
| 211,873 | | |
| 268,798 | | |
|
Total
liabilities | |
| 6,443,179 | | |
| 6,039,222 | | |
|
| |
| | | |
| | | |
|
Commitments
and contingencies (See Note 9) | |
| | | |
| | | |
|
| |
| | | |
| | | |
|
Stockholders
equity | |
| | | |
| | | |
|
Common stock, $0.0001 par value, 200,000,000 shares authorized, 8,480,147 issued and 8,478,597 outstanding at December 31, 2025 and 1,698,454 issued and 1,696,904 outstanding at December 31, 2024 | |
| 848 | | |
| 170 | | |
|
Series C convertible preferred stock, $0.0001 par value 50,000,000 shares authorized, 6,875 issued and outstanding at December 31, 2025 and Nil issued and outstanding as at December 31, 2024 | |
| 1 | | |
| | | |
|
Additional
paid-in capital | |
| 85,437,703 | | |
| 75,173,627 | | |
|
Treasury stock, 1,550 shares at December 31, 2025 and 2024, at cost | |
| (172 | ) | |
| (172 | ) | |
|
Accumulated
other comprehensive income | |
| | | |
| | | |
|
Accumulated
deficit | |
| (82,350,149 | ) | |
| (71,862,617 | ) | |
|
Total
stockholders equity | |
| 3,088,231 | | |
| 3,311,008 | | |
|
Total
liabilities and stockholders equity | |
$ | 9,531,410 | | |
$ | 9,350,230 | | |
See
accompanying notes to these financial statements.
Reflects
retroactive effect of a 1-for-20 reverse stock split on September 13, 2024.
F-3
**iSpecimenInc.**
**Statements
of Operations and Comprehensive Loss**
****
|
| |
YearsEndedDecember31, | | |
|
| |
2025 | | |
2024 | | |
|
Revenue | |
$ | 1,928,998 | | |
$ | 9,291,115 | | |
|
Operating
expenses: | |
| | | |
| | | |
|
Cost of revenue | |
| 1,904,888 | | |
| 5,302,712 | | |
|
Technology | |
| 2,159,815 | | |
| 3,530,291 | | |
|
Sales
and marketing | |
| 2,295,501 | | |
| 4,945,269 | | |
|
Supply
development | |
| 246,979 | | |
| 537,888 | | |
|
Fulfillment | |
| 827,501 | | |
| 1,635,724 | | |
|
General
and administrative | |
| 3,472,233 | | |
| 6,067,276 | | |
|
Total
operating expenses | |
| 10,906,917 | | |
| 22,019,160 | | |
|
| |
| | | |
| | | |
|
Loss
from operations | |
| (8,977,919 | ) | |
| (12,728,045 | ) | |
|
| |
| | | |
| | | |
|
Other
income (expense), net | |
| | | |
| | | |
|
Interest
expense | |
| (1,949 | ) | |
| (173,771 | ) | |
|
Interest
income | |
| 3,748 | | |
| 44,133 | | |
|
Interest
and penalties on sales tax liability | |
| (7,969 | ) | |
| (46,303 | ) | |
|
Other
income (expense), net | |
| (1,503,443 | ) | |
| 406,181 | | |
|
Total
other income, net | |
| (1,509,613 | ) | |
| 230,240 | | |
|
| |
| | | |
| | | |
|
Net
loss | |
$ | (10,487,532 | ) | |
$ | (12,497,805 | ) | |
|
| |
| | | |
| | | |
|
Other
comprehensive loss: | |
| | | |
| | | |
|
Net
loss | |
$ | (10,487,532 | ) | |
$ | (12,497,805 | ) | |
|
Unrealized
loss on available-for-sale securities | |
| | | |
| (840 | ) | |
|
Total
other comprehensive loss | |
| | | |
| (840 | ) | |
|
Comprehensive
loss | |
$ | (10,487,532 | ) | |
$ | (12,498,645 | ) | |
|
| |
| | | |
| | | |
|
Net
loss per share - basic and diluted | |
$ | (2.28 | ) | |
$ | (17.58 | ) | |
|
| |
| | | |
| | | |
|
Weighted
average shares of common stock outstanding - basic and diluted | |
| 4,602,461 | | |
| 710,852 | | |
See
accompanying notes to these financial statements.
Reflects
retroactive effect of a 1-for-20 reverse stock split on September 13, 2024.
F-4
**iSpecimen
Inc.**
****
**Statements
of Changes in Stockholders Equity**
****
|
| |
| Year
Ended December 31, 2025 | | |
|
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| Accumulated | | |
| | | |
| | | |
|
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| Additional | | |
| Other | | |
| | | |
| Total | | |
|
| |
| Preferred
Stock | | |
| CommonStock | | |
| Treasury
Stock | | |
| Paid-In | | |
| Comprehensive | | |
| Accumulated | | |
| Stockholders | | |
|
| |
| Shares | | |
| Amount | | |
| Shares | | |
| Amount | | |
| Shares | | |
| Amount | | |
| Capital | | |
| Income | | |
| Deficit | | |
| Equity | | |
|
Balance
at December 31, 2023 | |
| | | |
$ | | | |
| 454,169 | | |
$ | 45 | | |
| 1,550 | | |
$ | (172 | ) | |
$ | 69,105,176 | | |
$ | 840 | | |
$ | (59,364,812 | ) | |
$ | 9,741,077 | | |
|
Stock-based
compensation expense | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| 101,844 | | |
| | | |
| | | |
| 101,844 | | |
|
Vesting
of restricted stock | |
| | | |
| | | |
| 1,958 | | |
| | | |
| | | |
| | | |
| 147,831 | | |
| | | |
| | | |
| 147,831 | | |
|
Repurchase
of common stock exercisable under PIPE Warrants | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| (52,500 | ) | |
| | | |
| | | |
| (52,500 | ) | |
|
Issuance
of common stock | |
| | | |
| | | |
| 132,814 | | |
| 13 | | |
| | | |
| | | |
| 398,429 | | |
| | | |
| | | |
| 398,442 | ) | |
|
Issuance
of common stock in connection with At The Market Offering Agreement | |
| | | |
| | | |
| 199,004 | | |
$ | 20 | | |
| | | |
| | | |
$ | 1,494,394 | | |
| | | |
$ | | | |
$ | 1,494,414 | | |
|
Issuance
of common stock through exercise of warrants | |
| | | |
| | | |
| 734,221 | | |
| 74 | | |
| | | |
| | | |
| 4,599,948 | | |
| | | |
| | | |
| 4,600,022 | ) | |
|
Offering
costs in connection with At The Market Offering Agreement | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| (255,288 | ) | |
| | | |
| | | |
| (255,288 | ) | |
|
Offering
costs in connection with issuance of common shares and warrants | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| (366,189 | ) | |
| | | |
| | | |
| (366,189 | ) | |
|
Unrealized
loss on available-for-sale securities | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| (840 | ) | |
| | | |
| (840 | ) | |
|
Reverse
stock split adjustment | |
| | | |
| | | |
| 174,738 | | |
| 18 | | |
| | | |
| | | |
| (18 | ) | |
| | | |
| | | |
| | | |
|
Net
loss | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| (12,497,805 | ) | |
| (12,497,805 | ) | |
|
Balance
at December 31, 2024 | |
| | | |
$ | | | |
| 1,696,904 | | |
$ | 170 | | |
| 1,550 | | |
$ | (172 | ) | |
$ | 75,173,627 | | |
$ | | | |
$ | (71,862,617 | ) | |
$ | 3,311,008 | | |
|
Stock-based
compensation expense | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| 1,338 | | |
| | | |
| | | |
| 1,338 | | |
|
Vesting
of restricted stock | |
| | | |
| | | |
| 400 | | |
| | | |
| | | |
| | | |
| 19,928 | | |
| | | |
| | | |
| 19,928 | | |
|
Issuance
of common stock in connection with Underwritten financing | |
| | | |
| | | |
| 1,482,644 | | |
| 148 | | |
| | | |
| | | |
| 1,037,702 | | |
| | | |
| | | |
| 1,037,850 | | |
|
Issuance
of common stock in connection with PIPE financing | |
| | | |
| | | |
| 267,379 | | |
| 27 | | |
| | | |
| | | |
| 299,972 | | |
| | | |
| | | |
| 299,999 | | |
|
Issuance
of common stock through exercise of prefunded warrants | |
| | | |
| | | |
| 6,323,719 | | |
| 632 | | |
| | | |
| | | |
| 4,411,091 | | |
| | | |
| | | |
| 4,411,723 | | |
|
Issuance
of Series C convertible preferred stock in connection with PIPE financing | |
| 6,875 | | |
| 1 | | |
| | | |
| | | |
| | | |
| | | |
| 5,499,999 | | |
| | | |
| | | |
| 5,500,000 | | |
|
Offering
costs in connection with the completion of financings | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| (1,006,083 | ) | |
| | | |
| | | |
| (1,006,083 | ) | |
|
Reversal
of issued common stock through exercise of prefunded warrants due to error on issuance | |
| | | |
| | | |
| (1,292,449 | ) | |
| (129 | ) | |
| | | |
| | | |
| 129 | | |
| | | |
| | | |
| | | |
|
Net
loss | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| (10,487,532 | ) | |
| (10,487,532 | ) | |
|
Balance
at December 31, 2025 | |
| 6,875 | | |
$ | 1 | | |
| 8,478,597 | | |
$ | 848 | | |
| 1,550 | | |
$ | (172 | ) | |
$ | 85,437,703 | | |
$ | | | |
$ | (82,350,149 | ) | |
$ | 3,088,231 | | |
****
See
accompanying notes to these financial statements.
Reflects
retroactive effect of a 1-for-20 reverse stock split on September 13, 2024.
F-5
**iSpecimenInc.**
****
**Statements
of Cash Flows**
****
|
| |
Years
Ended December 31, | | |
|
| |
2025 | | |
2024 | | |
|
CASH FLOWS FROM OPERATING
ACTIVITIES: | |
| | | |
| | | |
|
Net
loss | |
$ | (10,487,532 | ) | |
$ | (12,497,805 | ) | |
|
Adjustments
to reconcile net loss to net cash used in operating activities: | |
| | | |
| | | |
|
Stock-based
compensation expense | |
| 21,266 | | |
| 249,675 | | |
|
Amortization
of internally developed software | |
| 1,470,873 | | |
| 2,036,981 | | |
|
Amortization
of other intangible assets | |
| 191,555 | | |
| 191,555 | | |
|
Depreciation
of property and equipment | |
| 68,474 | | |
| 65,712 | | |
|
Bad
debt expense | |
| 59,863 | | |
| 705,724 | | |
|
Write-off
of other intangible assets | |
| 525,145 | | |
| | | |
|
Write-off
of accounts receivable unbilled | |
| | | |
| 1,187,964 | | |
|
Write-off
of accounts payable | |
| (75,000 | ) | |
| | | |
|
Write-off
of internally developed software | |
| 1,871,064 | | |
| 327,387 | | |
|
Non-cash
interest income related to accretion of discount on available-for-sale securities | |
| | | |
| (28,976 | ) | |
|
Loss
from sales of available-for-sale securities | |
| | | |
| 680 | | |
|
Loss
on disposal of property and equipment | |
| | | |
| 58 | | |
|
Change
in operating assets and liabilities: | |
| | | |
| | | |
|
Accounts
receivable unbilled | |
| | | |
| 505,931 | | |
|
Accounts
receivable | |
| 1,336,475 | | |
| (903,329 | ) | |
|
Inventory | |
| 45,110 | | |
| | | |
|
Prepaid
expenses and other current assets | |
| 194,325 | | |
| 27,187 | | |
|
Operating
lease right-of-use asset | |
| 58,817 | | |
| 127,006 | | |
|
Security
deposit | |
| | | |
| 15,501 | | |
|
Accounts
payable | |
| 1,240,043 | | |
| 272,123 | | |
|
Accrued
expenses | |
| (549,544 | ) | |
| (371,821 | ) | |
|
Operating
lease liability | |
| (43,369 | ) | |
| (120,203 | ) | |
|
Deferred
revenue | |
| (168,173 | ) | |
| (55,063 | ) | |
|
Net
cash used in operating activities | |
| (4,240,608 | ) | |
| (8,263,713 | ) | |
|
| |
| | | |
| | | |
|
CASH
FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | | |
|
Capitalization
of intangible asset under development | |
| (1,000,000 | ) | |
| (653,288 | ) | |
|
Purchase
of property and equipment | |
| (454 | ) | |
| (31,546 | ) | |
|
Purchase
of leasehold improvements included in operating lease right-of-use asset | |
| | | |
| (25,000 | ) | |
|
Purchase
of available-for-sale securities | |
| | | |
| (460,932 | ) | |
|
Proceeds
from sales and maturities of available-for-sale securities | |
| | | |
| 3,150,320 | | |
|
Net
cash provided by (used in) investing activities | |
| (1,000,454 | ) | |
| 1,979,554 | | |
|
| |
| | | |
| | | |
|
CASH
FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | | |
|
Proceeds
from issuance of common stock in connection with At the Market Offering Agreement | |
| | | |
| 1,494,414 | | |
|
Proceeds
from issuance of common stock in with Securities Purchase Agreement | |
| 3,999,574 | | |
| 398,442 | | |
|
Proceeds
from pre-funded warrants | |
| | | |
| 4,600,022 | | |
|
Proceeds
from issuance of common stock in connection with private placement | |
| 1,749,998 | | |
| | | |
|
Proceeds
from issuance of Series C convertible preferred stock in connection with PIPE financing | |
| 5,500,000 | | |
| | | |
|
Payment
of offering costs in connection with the issuance of common stock in connection with At the Market Offering Agreement | |
| | | |
| (255,288 | ) | |
|
Payment
of offering costs in connection with the issuance of common stock in connection with pre-funded warrants and common shares | |
| (1,006,083 | ) | |
| (366,189 | ) | |
|
Repurchase
of common stock purchase warrants exercisable under PIPE warrants | |
| | | |
| (52,500 | ) | |
|
Net
cash provided by financing activities | |
| 10,243,489 | | |
| 5,818,901 | | |
|
| |
| | | |
| | | |
|
Net increase
(decrease) in cash and cash equivalents | |
| 5,002,427 | | |
| (465,258 | ) | |
|
Cash
and cash equivalents at beginning of year | |
| 1,878,408 | | |
| 2,343,666 | | |
|
Cash
and cash equivalents at end of year | |
$ | 6,880,835 | | |
$ | 1,878,408 | | |
|
| |
| | | |
| | | |
|
Supplemental
disclosure of cash flow information: | |
| | | |
| | | |
|
Cash
paid for interest | |
$ | 1,948 | | |
$ | 14,358 | | |
|
Supplemental
disclosure of non-cash investing and financing activities: | |
| | | |
| | | |
|
Non-cash
amounts of lease liabilities reducing from terminating right-of-use assets | |
$ | | | |
$ | 321,805 | | |
|
Non-cash
adjustment to reduce lease liabilities and right-of-use assets due to lease termination | |
$ | | | |
$ | 85,679 | | |
|
Stock
issuance costs included in accounts payable and accrued expenses | |
$ | | | |
$ | 7,023 | | |
See
accompanying notes to these financial statements.
F-6
**iSpecimenInc.**
**Notesto
Financial Statements**
**1.
NATURE OF BUSINESS AND BASIS OF PRESENTATION**
****
**Business**
iSpecimen
Inc. (iSpecimen or the Company) was incorporated in 2009 under the laws of the state of Delaware. The Company
has developed and launched a proprietary online marketplace platform that connects medical researchers who need access to subjects, samples,
and data, with hospitals, laboratories, and other organizations who have access to them. iSpecimen is a 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 biospecimens available (but not easily accessible) in healthcare provider organizations worldwide. The iSpecimen
Marketplace platform was designed to solve this problem and transform the biospecimen procurement process to accelerate medical discovery.
The Company is headquartered in Woburn, Massachusetts and its principal market is North America. The Company operates asoneoperating
and reporting segment.
**Basis
of Presentation**
The
Companys financial statements have been prepared in conformity with generally accepted accounting principles in the United States
of America (GAAP). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found
in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting
Standards Board (FASB).
**Reverse
Stock Split**
On
October 9, 2023, the Company received a notification from Nasdaq that its Common Stock failed to maintain a minimum bid price of $1.00
over the previous 30 consecutive business days as required by the Listing Rules of The Nasdaq Stock Market.
On
July 19, 2024, the Companys stockholders approved a proposal to amend the Companys Fourth Amended and Restated Certificate
of Incorporation (the Certificate of Incorporation) to effect a reverse stock split of the Companys issued and outstanding
shares of common stock, as well as any shares of common stock held by the Company in treasury, at a ratio in the range from 1-for-10
to 1-for-20.
On
August 19, 2024, the Companys board of directors approved a one-for-twenty (1:20) reverse stock split of the Companys issued
and outstanding shares of common stock (the Reverse Stock Split). On September 13, 2024, the Company filed with the Secretary
of State of the State of Delaware a Certificate of Amendment to the Companys Certificate of Incorporation to effect the Reverse
Stock Split. The Reverse Stock Split became effective on September 13, 2024, and the Companys common stock began trading on a
split-adjusted basis on Nasdaq on September 16, 2024.
On
October 1, 2024, the Company received a notification from Nasdaq that the Staff has determined that for the last 11 consecutive business
days, from September 16, 2024 to September 30, 2024, the closing bid price of the Companys Common Stock was $1.00 per share or
greater. Accordingly, the Company has regained compliance with Listing Rule 5559(a)(2).
Except
as otherwise indicated, all references to the Companys common stock, share data, per share data and related information has been
adjusted for the Reverse Stock Split ratio of 1-for-20 as if they had occurred at the beginning of the earliest period presented. The
Reverse Stock Split combined each 20 shares of our outstanding common stock and treasury shares into one share of common stock without
any change in the par value per share, and the Reverse Stock Split correspondingly adjusted, among other things, the exercise rate of
our warrants and options into the Companys common stock. No fractional shares were issued in connection with the Reverse Stock
Split, and any fractional shares resulting from the Reverse Stock Split were rounded up to the nearest whole share.
F-7
**iSpecimenInc.**
**Notesto
Financial Statements**
**Going
Concern Uncertainty and Managements Plan**
The
Company has recognized recurring losses since inception. As of December 31, 2025, the Company had positive working capital of$723,284,
an accumulated deficit of $82,350,149, cash and cash equivalents of $6,880,835, and accounts payable and accrued expenses of$5,981,846.
Since inception, the Company has relied upon raising capital and its revenues to finance operations.
The
future success of the Company is dependent on its ability to successfully obtain additional working capital and/or to ultimately attain
profitable operations. During the year ended December 31, 2025, the Company continued its efforts, which had begun in 2023, to decrease
its capital and operational expenditures by cutting costs and right sizing the Company through a reduction in workforce while streamlining
operations and rationalizing resources to focus on key market opportunities. The reductions in workforce since January 1, 2024 through
December 31, 2025, cumulatively resulted in an estimated reduction in monthly compensation costs of approximately 67% and technology
costs of approximately 39% during the year December 31, 2025 when compared to the year ended December 31, 2024. While the Company plans
to improve its sales and revenues, the Company is taking steps to significantly reduce and manage expenditures to improve its financial
position and ensure continued funding of operations. However, as certain elements of the Companys operating plan are not within
the Companys control, the Company is unable to assess their probability of success. During the year ended December 31, 2025, the
Company engaged in raising capital through equity financing as discussed in Note 10.
The
Company may be unsuccessful in increasing its revenues or contain its operating expenses, or it may be unable to raise additional capital
on commercially favorable terms. The Companys failure to generate additional revenues or contain operating costs would have a
negative impact on the Companys business, results of operations and financial condition and the Companys ability to continue
as a going concern. If the Company does not generate enough revenue to provide an adequate level of working capital, its business plan
will be scaled down further.
These
conditions raise substantial doubt regarding the Companys ability to continue as a going concern for a period of one year from
the date these financial statements are issued. Managements plan to mitigate the conditions that raise substantial
doubt includes generating additional revenues, deferring certain projects and capital expenditures and eliminating certain future operating
expenses for the Company to continue as a going concern. However, there can be no assurance that the Company will be successful in completing
any of these options. As a result, managements plans cannot be considered probable and thus do not alleviate substantial doubt
about the Companys ability to continue as a going concern.
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability
and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the
uncertainties described above.
F-8
**iSpecimenInc.**
**Notesto
Financial Statements**
**2. SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES**
****
**Use
of Estimates**
The
preparation of the Companys financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the amounts reported in the financial statements and accompanying notes. The Company utilizes certain estimates in the determination
of the deferred tax valuation allowances, revenue recognition, stock-based compensation, allowance for doubtful accounts, accrued expenses,
and the useful lives of internally developed software and sequenced data. The Company bases its estimates on historical experience and
other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ
from such estimates.
****
**Concentrations
of Credit Risk - Suppliers**
****
For
the year ended December 31, 2025, no supplier accounted for 10% of the Companys total purchases (cost of revenues). For the year
ended December 31, 2024, one supplier (Supplier B) accounted for approximately 11.32% of the Companys total purchases (cost of
revenues). No other supplier accounted for 10% or more of total purchases (cost of revenues) in either 2025 or 2024.
The
Company sources certain specimen types and related services from a limited number of suppliers. The loss of any of the significant suppliers
described above, or a disruption or reduction in the volume of specimens or services they provide, could adversely affect the Companys
ability to fulfill customer orders on a timely basis and could have a material adverse effect on the Companys business, financial
condition, and results of operations.
****
**Investments**
The
Companys investments are considered to be available-for-sale and are recorded at fair value. Unrealized gains and losses are included
in accumulated other comprehensive income. Purchases and sales of securities are reflected on a trade-date basis. Realized gains or losses
are released from accumulated other comprehensive income and into earnings on the statement of operations, and amortization of premiums
and accretion of discounts on the U.S treasury bills are recorded in interest expense or income, respectively.
The
Company continually monitors the difference between its cost basis and the estimated fair value of its investments. The Companys
accounting policy for impairment recognition requires other-than-temporary impairment charges to be recorded when it determines that
it is more likely than not that it will be unable to collect all amounts due according to the contractual terms of the fixed maturity
security or that the anticipated recovery in fair value of the equity security will not occur in a reasonable amount of time. Impairment
charges on investments are recorded based on the fair value of the investments at the measurement date or based on the value calculated
using a discounted cash flow model. Credit-related impairments on fixed maturity securities that the Company does not plan to sell, and
for which it is not more likely than not to be required to sell, are recognized in net income. Any non-credit related impairment is recognized
as a component of other comprehensive income. Factors considered in evaluating whether a decline in value include: the length of time
and the extent to which the fair value has been less than cost; the financial condition and near-term prospects of the issuer; and the
likelihood that it will be required to sell the investment.
****
**Fair
Value Measurements**
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes
the inputs to valuation methodologies used to measure fair value:
|
|
|
Level 1 Valuations
based on quoted prices for identical assets and liabilities in active markets. | |
|
|
|
Level 2 Valuations
based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities
in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs
that are observable or can be corroborated by observable market data. | |
|
|
|
Level 3 Valuations
based on unobservable inputs reflecting the Companys own assumptions, consistent with reasonably available assumptions made
by other market participants. These valuations require significant judgment. | |
For
certain financial instruments, including cash and cash equivalents, accounts receivable, and accounts payable, the carrying amounts approximate
their fair values as of December31, 2025 and 2024, respectively, because of their short-term nature.
F-9
****
**iSpecimenInc.**
**Notesto
Financial Statements**
**Revenue
Recognition and Accounts Receivable**
The
Company recognizes revenue using the five-step approach as follows: (1)identify the contract with the customer, (2)identify
the performance obligations in the contract, (3)determine the transaction price, (4)allocate the transaction price to the
performance obligations in the contract and (5)recognize revenue when (or as) the Company satisfies the performance obligations.
The
Company generates revenue by procuring various specimens from hospitals, laboratories, and other supply sites, for the Companys
customers using the Companys proprietary software, the iSpecimen Marketplace, to identify, locate, and ultimately validate the
required specimens to the Companys customers requested specifications. The Companys performance obligation is to
procure a specimen meeting the customers specification(s)from a supplier, on a best efforts basis, for the
Companys customer at the agreed price per specimen as indicated in the customers contract with the Company. The Company
does not currently charge suppliers or customers for the use of the Companys proprietary software. Each customer will execute
a material and data use agreement with the Company or agree to online purchase terms, each of which includes terms such as specimen and
data use, shipment terms, payment, and cancellation terms. These are then supplemented by purchase orders that specify specimen requirements
including detailed inclusion/exclusion criteria, quantities to be collected, and pricing. Collectively, these customer agreements represent
the Companys contracts with its customers. Generally, contracts have fixed unit pricing. For certain specimen orders, a refundable
customer deposit may be required prior to order fulfillment depending on project set-up requirements, which is presented as deferred
revenue. The Company expects to recognize the deferred revenue as revenue when the Company performs its service obligation.
Specimen
collections occur at supply sites within the Companys network. Collection is when the specimen has been removed,
or collected from the patient or donor. A specimen is often collected specifically for a particular Company order. Once
collected, the specimen is assigned by the supplier to the Company and control of the specimen passes to the Company. Accession
is the process whereby a collected specimen and associated data are registered and assigned in the iSpecimen Marketplace to a particular
customer order, which can occur while a specimen is at the supplier site or while at the Company site and it is when control of the specimen
passes to the customer. Suppliers may ship specimens to the Company or directly to the customer if specimens must be delivered within
a short time period (less than 24 hours after collection) or shipping to the Company is not practical.
The
Company has evaluated principal versus agent considerations as part of the Companys revenue recognition policy. The Company has
concluded that it acts as principal in the arrangement as it manages the procurement process from beginning to end and determines which
suppliers will be used to fulfill an order, usually takes physical possession of the specimens, sets prices for the specimens, and bears
the responsibility for customer credit risk.
The
Company recognizes revenue over time, as the Company has created an asset with no alternative use to the Company, which has an enforceable
right to payment for performance completed to date. At contract inception, the Company reviews a contract and related order upon receipt,
to determine if the specimen ordered has an alternative use by the Company. Generally, specimens ordered do not have an alternative future
use to the Company and the performance obligation is satisfied when the related specimens are delivered. In the rare circumstances where
specimens do have an alternative future use, the Companys performance obligation is satisfied at the time of shipment.
Customers
are generally invoiced upon shipment. Depending on the quantity of specimens ordered, it may take several accounting periods to completely
fulfill a purchase order. In other words, there can be multiple invoices issued for a single purchase order, reflecting the specimens
being delivered over time.
Once
a specimen that has no alternative future use and for which the Company has an enforceable right to payment, has been accessioned, the
Company records the offset to revenue in accounts receivable unbilled. Once the specimen has been shipped and invoiced, a reclassification
is made from accounts receivable - unbilled to accounts receivable.
Customers
are generally given fourteendays from the receipt of specimens to inspect the specimens to ensure compliance with specifications
set forth in the purchase order documentation. Customers are entitled to either receive replacement specimens or receive reimbursement
of payments made for such specimens. The Company has a nominal history of returns for nonacceptance of specimens delivered. When this
occurs, the Company gives the customer a credit for the returns. The Company has not recorded a returns allowance.
**Significant
customers**
For
the year ended December 31, 2025, one customer (Customer A) accounted for approximately 19.57% of the Companys total revenues.
For the year ended December 31, 2024, one customer (Customer B) accounted for approximately 21.64% of the Companys total revenues.
No other customer accounted for 10% or more of total revenues in either 2025 or 2024.
As
of December 31, 2025, one customer accounted for 28.16% or more of gross accounts receivable. As of December 31, 2024, one accounted
for approximately 17.01% of gross accounts receivable. No other customer accounted for 10% or more of gross accounts receivable at that
date.
The
loss of any of the customers described above, a significant reduction in their purchases, or difficulties collecting outstanding amounts
due from these customers could have a material adverse effect on the Companys business, financial condition, and results of operations.
F-10
**iSpecimenInc.**
**Notesto
Financial Statements**
The
following table summarizes the Companys revenue for the years ended December 31, 2025 and 2024:
|
| |
Years
ended December31, | | |
|
| |
2025 | | |
2024 | | |
|
Specimens - contracts with customers | |
$ | 1,735,000 | | |
$ | 9,104,950 | | |
|
Shipping and other | |
| 193,998 | | |
| 186,165 | | |
|
Revenue | |
$ | 1,928,998 | | |
$ | 9,291,115 | | |
The
Company carries its accounts receivable at the invoiced amount less an allowance for doubtful accounts. On a periodic basis, the Company
evaluates its accounts receivable to determine if an allowance for doubtful accounts is necessary, based on the current expected credit
loss model. Receivables are written off when deemed uncollectible, with any future recoveries recorded as income when received. As of
December 31, 2025 and 2024, the Company had an allowance for doubtful accounts of $646,067 and $620,433, respectively.
The
Company applies the practical expedient to account for shipping and handling activities as fulfillment cost rather than as a separate
performance obligation. Shipping and handling costs incurred are included in cost of revenue.
Since
2024, the Company recognized its revenue when the related specimens are delivered.
****
**Internally
Developed Software, Net**
The
Company capitalizes certain internal and external costs incurred during the application development stage of internal-use software projects
until the software is ready for its intended use. Amortization of the asset commences when the software is complete and placed into service
and is recorded in operating expenses. The Company amortizes completed internal-use software over its estimated useful life of five years
on a straight-line basis. Costs incurred during the planning, training and post-implementation stages of the software development life
cycle are classified as technology costs and are expensed to operations as incurred.
**Intangible
assets under development**
During
the year 2025, the Company internally develop its AI-powered Inventory Agent, a purpose-built tool designed to help accelerate the process
of reviewing incoming biospecimen requests and matching them with available inventory across its global supplier network. The Company
paid $1,000,000 during the year for the completion of milestone 1. The amount was recognized as intangible asset under development and
is not in use. The Company recognized $Nil amortization in relation to the new platform.
The
Company performs the impairment test on an annual basis, or when events or changes in circumstances indicate that its carrying value
may not be recoverable, and an impairment loss shall be recognized if the carrying amount of the intangible assets are not recoverable
and its carrying amount exceeds its fair value.
****
**Other
Intangible Assets, Net**
The
Company procures data generated from sequencing of Formalin-Fixed Paraffin-Embedded (FFPE) blocks from a third-party sequencer
which the Company licenses to its customers with the sale of FFPE blocks at an additional cost. The sequenced data is also organized
to form a database of research content that is available for sale through a subscription model. The Company has determined that the sequenced
data is an intangible asset and capitalizes the cost to procure the sequenced data. The sequenced data is amortized to cost of revenue
over an estimated useful life of five years on a straight-line basis. The costs paid to the third-party sequencer are the only costs
capitalized and all other related costs are expensed to operations as incurred.
****
**Impairment
of Long-Lived Assets**
Management
reviews long-lived assets for impairment when circumstances indicate the carrying amount of an asset may not be recoverable. An impairment
loss is recognized when expected cash flows are less than the assets carrying value. Long-lived assets consist of property and
equipment, internal-use software and other intangible assets. No impairment charges were recorded for the years ended December 31, 2025
and 2024.
****
**Inventory**
The
Company does not speculatively purchase and bank samples in anticipation of future, unspecified needs. The Company procures specimens
from its suppliers and distributes specimens to its Customers after they obtain an order for specimens from a research client. Therefore,
the Company does not take possession of or inspect the quality of the specimens, given that they are shipped directly from the supply
site. For this reason, the Company does not have a substantive inventory risk. However, whenever delivered specimens do not meet the
specifications required by the Customers, these specimens are returned as per the Companys return policy or discarded for replacement.
The Company capitalizes the costs of all returned and rejected specimens that were not requested for replacements.
****
F-11
**iSpecimenInc.**
**Notesto
Financial Statements**
****
As
at December 31, 2024, the inventory consists of several types of human biospecimens biofluids (plasma/serum) and solid tissues
(blocks/curls). During the year ended December 31, 2025, the Company capitalized net additional costs of approximately $42,000 of returned
specimens and recognized inventory obsolescence and write-off for a total of approximately $6,000.
Management
reviews inventory assets for impairment when circumstances indicate the carrying amount of an asset may not be recoverable. During the
year ended December 31, 2025, the Company performs the impairment test and concluded that an impairment loss must be recognized because
most of the remaining specimens are obsolete and that those returned specimens are very difficult to sell to other Customers and are
deemed no longer recoverable. The Company recorded for the impairment as inventory reserve.
**Debt
Issuance Costs**
Debt
issuance costs are recorded net against the related debt and amortized to interest expense over the life of the related debt.
**Stock-Based
Compensation**
The
Company records stock-based compensation for options granted to employees, non-employees, and to members of the board of directors for
their services to the Company based on the grant date fair value of awards issued, and the expense is recorded on a straight-line basis
over the requisite service period. Forfeitures are recognized when they occur.
The
Company uses the Black-Scholes-Merton option pricing model to determine the fair value of stock options. The use of the Black-Scholes-Merton
option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility
of the common stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common
stock. The Company has concluded that its historical share option exercise experience does not provide a reasonable basis upon which
to estimate expected term. Therefore, the expected term was determined according to the simplified method, which is the average of the
vesting tranche dates and the contractual term. Due to the lack of Company-specific historical and implied volatility data, the estimate
of expected volatility is primarily based on the historical volatility of a group of similar companies that are publicly traded. For
these analyses, companies with comparable characteristics are selected, including enterprise value and position within the industry,
and with historical share price information sufficient to meet the expected life of the stock-based awards. The Company computes the
historical volatility data using the daily closing prices for the selected companies shares during the equivalent period of the
calculated expected term of its stock-based awards.
The
risk-free interest rate is determined by reference to U.S. Treasury zero-coupon issues with remaining maturities similar to the expected
term of the options. The Company has not paid, and does not anticipate paying, cash dividends on shares of its common stock.
The
fair value of the Companys common stock is equal to the closing price on the specified grant date.
****
**Restricted
Stock Units (RSUs)**
The
Company recognizes stock-based compensation expense from RSUs ratably over the specified vesting period. The fair value of RSUs is determined
to be the closing share price of the Companys common stock on the grant date.
****
**Common
Stock Warrants**
The
Company accounts for common stock warrants as either equity instruments or liabilities, depending on the specific terms of the warrant
agreement. The warrants shall be classified as a liability if (1) the underlying shares are classified as liabilities or (2) the entity
can be required under any circumstances to settle the warrant by transferring cash or other assets. The measurement of equity-classified
non-employee stock-based payments is generally fixed on the grant date and are considered compensatory.For additional discussion
on warrants, see Note 10.
****
**Net
Loss Per Share**
Basic
net loss per share is calculated by dividing the net loss applicable to common stockholders by the weighted-average number of shares
of common stock outstanding during the year, without consideration for common stock equivalents. Diluted net loss per share is calculated
by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the
year, determined using the treasury-stock method. Therefore, basic and diluted net loss per share applicable to common stockholders were
the same for all periods presented.
F-12
**iSpecimen
Inc.**
**Notes
to Financial Statements**
The
table below provides information on shares of the Companys common stock issuable upon vesting and exercise, as of December 31:
|
| |
2025 | | |
2024 | | |
|
Shares
issuable upon vesting of RSUs | |
| 25 | | |
| 822 | | |
|
Shares issuable upon exercise
of stock options | |
| 2,901 | | |
| 8,460 | | |
|
Shares
issuable upon exercise of pre-funded warrants to purchase common stock | |
| 1,292,449 | | |
| | | |
|
Shares
issuable upon exercise of Lender Warrant (defined below) to purchase common stock | |
| 625 | | |
| 625 | | |
|
Shares
issuable upon exercise of Underwriter Warrant (defined below) to purchase common stock | |
| 4,500 | | |
| 4,500 | | |
**Recently
Adopted Accounting Standards**
In
August2020, the FASB issued ASU No.2020-06, *Accounting for Convertible Instruments and Contracts in an Entitys
Own Equity*(ASU 2020-06), which simplifies an issuers accounting for convertible instruments by reducing the
number of accounting models that require separate accounting for embedded conversion features. ASU 2020-06 also simplifies the settlement
assessment that entities are required to perform to determine whether a contract qualifies for equity classification and makes targeted
improvements to the disclosures for convertible instruments and earnings-per-share (EPS) guidance. This update will be effective for
the Companys fiscalyears beginning after December15, 2023, and interim periods within those fiscalyears. Early
adoption is permitted, but no earlier than fiscalyears beginning after December15, 2020, and interim periods within those
fiscalyears. Entities can elect to adopt the new guidance through either a modified retrospective method of transition or a fully
retrospective method of transition. The Company adopted this standard as of January 1, 2024. ASU 2020-06 did not have a material impact
on the Companys financial statements.
In
November 2023, the FASB issued ASU No.2023-07, *Improvements to Reportable Segment Disclosures* (ASU 2023-07),
which provides amendments to improve reportable segment disclosures requirements. ASU 2023-07 expands public entities segment
disclosures by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker
and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items,
and interim disclosures of a reportable segments profit or loss and assets. All disclosure requirements under ASU 2023-07 are
also required for public entities with a single reportable segment. The amendments in ASU 2023-07 are effective for fiscal years beginning
after December 15, 2023, with early adoption permitted. The Company adopted ASU 2023-07 effective January 1, 2024. The adoption of this
guidance did not have a material impact on the Companys related disclosures.
**3.
AVAILABLE-FOR-SALE SECURITIES**
The
Companys U.S. Treasury bills that were classified as available-for-sale securities fully matured during the year ended December
31, 2024. There werenoavailable securities as of December 31, 2025 and 2024.
The
Company recorded $680of realized losses in the year ended December 31, 2024.
F-13
**iSpecimen
Inc.**
**Notes
to Financial Statements**
**4.
PROPERTY AND EQUIPMENT, NET**
Property
and equipment, net consisted of the following at the dates indicated:
|
| |
December31, | | |
December31, | | |
|
| |
2025 | | |
2024 | | |
|
Website | |
$ | 285,377 | | |
$ | 285,377 | | |
|
Computer
equipment and purchased software | |
| 91,786 | | |
| 91,332 | | |
|
Equipment | |
| 19,291 | | |
| 19,291 | | |
|
Furniture
and fixtures | |
| 26,982 | | |
| 26,982 | | |
|
Leasehold
improvements | |
| 12,646 | | |
| 12,646 | | |
|
Total
property and equipment | |
| 436,082 | | |
| 435,628 | | |
|
Accumulated
depreciation | |
| (410,539 | ) | |
| (342,065 | ) | |
|
Total
property and equipment, net | |
$ | 25,543 | | |
$ | 93,563 | | |
Depreciation
expense for property and equipment was $68,474and $65,712for the years ended December 31, 2025 and 2024, respectively.
**5. INTERNALLY
DEVELOPED SOFTWARE, NET**
During
the year ended December 31, 2024, the Company capitalized $653,288of internally developed software costs in connection with the
development and continued enhancement of the technology platform and web interfaces. Capitalized costs primarily consist of payroll and
payroll-related costs for the Companys employees.
During
the year ended December 31, 2025, the Company capitalized $1,000,000 of its internally developed software in connection with the digital
transformation of the technology platform and web interfaces. Capitalized costs consist of fees paid for the installation of a new platform
to modernize the Companys infrastructure, the first phase of its digital transformation program.
The
Company recognized $1,470,873 and $2,036,981 of amortization expense associated with capitalized internally developed software costs
during the years ended December 31, 2025 and 2024, respectively. Accumulated amortization associated with capitalized internally developed
software costs as of December 31, 2025 and 2024 was $10,472,608 and $9,001,736, respectively.
During
the year ended December 31, 2025, the Company capitalized $1,000,000 in connection to internal software under development.
**6.
OTHER INTANGIBLE ASSETS, NET**
During
the year ended December 31, 2024, the Company did not sequence any FFPE blocks and therefore did not capitalize any sequenced data as
other intangible assets. The Company licenses to its customers, at an additional cost, the sequenced data associated with the sequenced
FFPE blocks with the sale of said FFPE blocks. The sequenced data is also organized to form a database of research content that is available
for sale to the Companys customers through a subscription model.
During
the year ended December 31, 2025, the Company did not sequence any FFPE blocks and therefore did not capitalize any sequenced data as
other intangible assets. The Company recognized $191,555of amortization expense associated with the capitalized sequenced data
during the years ended December 31, 2025 and 2024. Accumulated amortization associated with the capitalized sequenced data was $432,630
as of December 31, 2025 and $241,075 as of December 31, 2024.
During
the year ended December 31, 2025, the Company write-off the net value of other intangible assets of approximately $525,000.
F-14
**iSpecimen
Inc.**
**Notes
to Financial Statements**
**7.
DEBT FINANCING**
****
On
September 19, 2024, the Company entered into a note purchase agreement (the Note Purchase Agreement) with a lender (the
Lender). Pursuant to the provisions of the Purchase Agreement, the Lender agreed to provide a loan to the Company in the
amount of $1,000,000 (the Loan) and the Company agreed to issue to the Lender a promissory note in the principal amount
of $1,000,000 payable within 12 months after the date of issuance, with interest accruing and payable at a rate of 18% per annum (the
Note). The Note Purchase Agreement contains customary representations and warranties and obligates the Lender to provide
an additional loan to the Company, in the form of a revolving line of credit of up to $1,000,000, upon our initial filing of a Registration
Statement for an underwritten or best-efforts public offering for gross proceeds of at least $5,000,000. On September 25, 2024, the Company
and the Lender closed the transactions described in the Note Purchase Agreement, the Lender provided funds to the Company in the net
amount of $959,980 and the Company issued the Note to the Lender in the principal amount of $1,000,000. WestPark Capital, Inc. (WestPark)
served as the placement agent in connection with the Loan and was paid a placement agent fee in the amount of $40,020 for its services.
Debt
issuance costs related to the Note totaled $140,020which comprised of placement agent fee of $40,020and legal costs of $100,000.
The debt issuance cost will be amortized over the loan term of 12 months. The amortization expense which is included in interest expense
on the statement of operations, totaled $140,020for the year ended December 31, 2024.
On
October 31, 2024, the Company paid off the outstanding principal balance of $1,000,000 and accrued interest of $18,000 on the Note.
**8.
FAIR VALUE MEASUREMENTS**
As
of December 31, 2025 and 2024, the Company did not have any assets or liabilities measured at fair value on a recurring basis.
**9. COMMITMENTS
AND CONTINGENCIES**
****
**Leases**
On
July 2, 2024, the Company entered into a new operating lease (the Woburn Lease) of office space in Woburn, Massachusetts
(the Woburn Premises) for a term of five years and two months, commencing on September 1, 2024, and terminating on October
30, 2029. The Company has a one-time option to extend the term of the Woburn Lease for one additional term of five years, provided that
the Company is not in arrears in any payment of rent, the payment of any outstanding invoice, or otherwise in default. On June 28, 2024,
the Company exercised a termination option included in the lease agreement of its former office space in Lexington, Massachusetts, and
terminated the lease effective August 31, 2024.
Right-of-use
assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term.
ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot
be readily determined, its incremental borrowing rate. The Company used the interest rate of 8% stated in the lease agreement to discount
its real estate lease liabilities.
There
are no material residual guarantees associated with any of the Companys leases, and there are no significant restrictions or covenants
included in the Companys lease agreements. There was no sublease rental income for the year ended December 31, 2025, and the Company
is not the lessor in any lease arrangement, and there were no related-party lease agreements.
**Lease
Costs**
****
The
table below presents certain information related to the lease costs for the Companys operating lease for the year ended December
31, 2025:
|
Operating lease expense | |
$ | 82,121 | | |
|
Short-term lease expense | |
| | | |
|
Total
lease cost | |
$ | 82,121 | | |
F-15
**iSpecimen
Inc.**
**Notes
to Financial Statements**
**Lease
Position as of December 31, 2025**
**
Right-of-use
lease assets and lease liabilities for the Companys operating lease as of December 31, 2025 were recorded in the balance sheet
as follows:
****
|
Assets | |
| | |
|
Operating
lease right-of-use assets | |
$ | 269,160 | | |
|
Total
lease assets | |
$ | 269,160 | | |
|
| |
| | | |
|
Liabilities | |
| | | |
|
Current liabilities: | |
| | | |
|
Operating lease liability
current portion | |
$ | 56,925 | | |
|
Non-current liabilities: | |
| | | |
|
Operating
lease liability net of current portion | |
| 211,873 | | |
|
Total
lease liability | |
$ | 268,798 | | |
**Lease
Terms and Discount Rate**
****
The
table below presents certain information related to the weighted average remaining lease term and the weighted average discount rate
for the Companys operating lease as of December 31, 2025:
| Weighted average remaining lease term (in years) operating lease | | | 3.83 | | |
| Weighted average discount rate operating lease | | | 8.00 | % | |
**Undiscounted
Cash Flows**
Future lease
payments included in the measurement of lease liabilities on the balance sheet are as follows:
|
2026 | |
$ | 76,372 | | |
|
2027 | |
| 80,190 | | |
|
2028 | |
| 84,200 | | |
|
Thereafter | |
| 73,675 | | |
|
Total future minimum lease payments | |
| 314,437 | | |
|
Less
effect of discounting | |
| (45,639 | ) | |
|
Present value of future
minimum lease payments | |
$ | 268,798 | | |
Rent
expense for the years ended December 31, 2025 and 2024 amounted to $85,513 and $156,591, respectively.
****
**Cash
Flows**
****
Supplemental
cash flow information related to the operating lease for the year ended December 31, 2025 was as follows:
|
Non-cash operating lease expense
(operating cash flow) |
|
$ |
58,817 |
| |
|
Change in operating lease liabilities (operating cash
flow) |
|
$ |
(43,369 |
) | |
F-16
**iSpecimen
Inc.**
**Notes
to Financial Statements**
**Sales
Tax Payable**
The
majority of the Companys customers are researchers, universities, hospitals, and not-for-profit entities that were believed by
the Company to have a sales and use tax exemption that generally excludes them from paying sales taxes. The main types of specimens the
Company sells are blood, blood plasma, human tissue, human parts, and human bodily fluids and only a few of these products are typically
not taxable in some states regardless of the buyers tax exemption status. The Company historically has not collected sales tax
in states where it had sales. Had the Company contemporaneously collected and remitted sales tax for all customers and in all jurisdictions
where it would have been required, there would have been no material impact on the Companys financial statements.
As
a result of an entity-wide risk assessment process that commenced in the second quarter of 2023, the Company engaged external tax consultant
advisors to complement internal resources and efforts to provide support in assessing the appropriate sales tax treatment associated
with the Companys products for all prior years in which the Company had generated revenue, to assist with the facilitation and
tracking of Voluntary Disclosure Agreements (VDAs) in jurisdictions where a potential tax liability may exist and to assist
with the implementation of a sales tax software platform solution for the calculation, communication, collection, and remittance of sales
tax for all non-exempt future sales.
From
the Companys inception through the filing date of this Quarterly Report, the Company now believes that an obligation to collect
and remit sales tax existed for certain of its sales of products to certain of its customers. The Company has analyzed its product sales,
on an invoice-by-invoice and customer-by-customer basis, to determine which products are subject to sales tax in each jurisdiction, and
determining which of its customers are exempt from sales tax, and which customers who were not exempt from sales tax have already paid
compensating use tax to the appropriate jurisdiction. Part of this process includes requesting and obtaining exemption letters or representations
from its customers or proof of payment of their compensating use tax. As the Company continues to make progress on this project, certain
customers have notified the Company that they are not exempt from the payment of sales tax and have not remitted use tax and the Company
has started to invoice such customers for past sales tax due.
In
2023, the Company established and accrued a reliable point estimate with a maximum potential of the sales tax liability of approximately
$707,000and the related interests and penalties of approximately $215,000in accrued expenses on the balance sheet. The estimated
liability represents the estimated tax liability for sales made to customers who have notified the Company that they are not exempt from
sales taxes and customers who have not responded to Companys request to provide a sales exemption letter. As of December 31, 2023,
the Company had also recovered approximately $359,000of prior taxes from certain customers who do not have a sales tax exemption.
During the year ended December 31, 2023, the Company recognized a loss of approximately $564,000in its statement of operations
and comprehensive loss related to the sales tax liability. The Company continued to pursue nonresponsive customers with the expectation
that over time, further exemption letters or representations will be received that will reduce the liability.
During
the year ended December 31, 2024, the Company received additional sales tax exemption letters or representations from customers. In addition
to this, the Company received confirmation from certain tax jurisdictions in which it had previously accrued a potential tax liability
that its specimens are exempt from tax in those jurisdictions, therefore, the Company reversed the accrued liability associated with
those jurisdictions. The Company also registered in certain states and commenced the filing and remittance of sales taxes. These factors
contributed to the reduction of the sales tax liability to approximately $405,000and the related interests and penalties to approximately
$119,000as of December 31, 2024. During the year ended December 31, 2024, the Company had recovered approximately $512,000of
prior taxes from certain customers who do not have a sales tax exemption. The Company commenced VDA filings with certain tax jurisdictions
in the year ended December 31, 2024, during which it started remitting its sales tax obligations.
During
the year ended December 31, 2025, the Company received additional sales tax certificates from customers. As of December 31, 2025, the
Company has a sales tax liability of approximately $319,000 and related interests and penalties of approximately $8,000.
As
of December 31, 2025, the Company recovered approximately $546,000 of prior taxes from certain customers who do not have a sales tax
exemption. The Company did not recognize any additional loss in its statement of operations and comprehensive loss related to the sales
tax liability during the year ended December 31, 2025.
F-17
**iSpecimen
Inc.**
**Notes
to Financial Statements**
**Legal
Proceedings**
From
time to time the Company is involved in litigation, claims, and other proceedings arising in the ordinary course of business. Such litigation
and other proceedings may include, but are not limited to, actions relating to employment law and misclassification, intellectual property,
commercial or contractual claims, or other consumer protection statutes. Litigation and other disputes are inherently unpredictable and
subject to substantial uncertainties and unfavorable resolutions could occur. As of December 31, 2025, there were legal disputes filed
against the Company.
*Resignation
of Chief Information Officer and Filing of Demand for Arbitration*
On
July 25, 2024, Benjamin Bielak, the Companys Chief Information Officer until his resignation on July 14, 2024, initiated a Demand
for Arbitration against the Company with the American Arbitration Association, pursuant to the dispute resolution provisions contained
in Mr. Bielaks employment agreement. The terms and conditions of Mr. Bielaks employment with the Company were governed
by his employment agreement.
In
his Demand for Arbitration, Mr. Bielak claims that the Company failed to provide him with certain bonus payments allegedly due to him
for work performed in 2023 and 2024. Mr. Bielak also claims that the Company failed to provide him with severance payments allegedly
due pursuant to the provisions of his employment agreement. The total amount of Mr. Bielaks claim for alleged damages is $586,800
plus attorneys fees and interest.
During
the year ended December 31, 2025, the Company settled this legal matter and the parties agreed to a $215,000settlement pursuant
to a settlement agreement executed on January 30, 2025.
*EGS-EllenoffGrossman&ScholeLLP
(EGS)*
**
Onor aroundNovember 14, 2024,EGSinitiateda
claimagainst the Companyfor$425,684 arising from abreach of contract,andcompensation on aquantummeirutbasis
amongst other things.The Company believes that EGS claims are without legal or factualbasis, andintends to vigorously
defend these claims.
Subsequent
to year ended December 31, 2025, the Company settled this legal matter and the parties agreed to a $200,000 settlement pursuant to a
settlement agreement executed on February 15, 2026 (Note 14).
*Settlement
Agreement with Focus Technology Solutions, LLC*
On
December 9, 2024, Focus Technologies, Inc. (Focus) filed a complaint against the Company in the Superior Court of Suffolk
County, Massachusetts, alleging non-payment under agreements dated July 29, 2022, related to the provision of information technology
services. Focus is seeking approximately$489,572in damages, plus interest and attorneys fees. Following the filing,
Focus disabled the Companys web-based commerce platform on January 24, 2025, resulting in a shutdown of the iSpecimen Marketplace
from January 25, 2025, through February 12, 2025.
To
restore service, the parties entered into a settlement agreement on February 11, 2025 (the Settlement Agreement), under
which the Company agreed to pay $500,000in nine monthly installments in exchange for the restoration of its platform. The Company
made an initial payment of $50,000on February 12, 2025. However, Focus failed to fully restore the platform, requiring the Company
to engage a third-party developer to complete the work in early March 2025. On February 28, 2025, the Company notified Focus that it
was in breach of the Settlement Agreement and has since withheld further payments.
Focus
has sought to amend its complaint to enforce the Settlement Agreement and has requested pre-judgment security in the amount of $450,000.
The Company is opposing these efforts and intends to assert counterclaims against Focus for consequential damages arising from the service
disruption and failure to perform under the agreements. While the outcome of this matter cannot be predicted with certainty, the Company
does not believe that this litigation will have a material adverse effect on its business, financial condition, or results of operations
at this time.
On
April 10, 2025, the Court partially granted Focus Motion for Pre-Judgment Security. The Company is required to open a dedicated
bank account by April 20, 2025 and deposit15% of revenue starting one month after the account opening up to $420,000.
On
September 3, 2025, Focus reduced their global settlement demand to $100,000, and on September 9, 2025, the Company increased their offer
to $30,000, which figure was rejected by Focus. Focus filed a Motion for Judgment on the Pleadings on September 12, 2025, which the Company
opposed, and which was denied by the Court on September 28, 2025 without a hearing. On December 17, 2025, the Court clarified its April
Order to adopt the Companys interpretation of the pre-judgment security deposit requirement, which now allows the Company to not
make any deposits when net monthly revenue is negative.
F-18
**iSpecimen
Inc.**
**Notes
to Financial Statements**
The
Company will continue to seek relief from the pre-judgment security, and its counterclaim against Focus is still pending.
*AzentaUS,
Inc. (Azenta)*
**
On
or aroundJanuary15, 2025, Azenta initiated a claim against the Company for$651,262 arising from abreach of contract,
andunjust enrichmentbasis amongst other things.The Company believes that Azentas claims are without legal or
factual basis. Discovery has closed in this case, and the Company expects Azenta to move for summary judgment, which the Company will
defend vigorously. As of current, the Company has made an offer of $125,000 to settle this case, but no response has been received from
Azenta.
*Krisbio,
LLC (Krisbio)*
On
or about September 23, 2025 the Company was served with a Summons and Complaint in the matter of Krisbio, LLC v. iSpecimen, Inc. 1:25-CV-12409-JCB
in the U.S. District Court for the District of Massachusetts seeking collection of $266,380, alleging breach of contract and other quasi-contractual
claims relating to a purported Participation Agreement dated July 20, 2021, and subsequent agreements for payments for
goods and services under said Participation Agreement. The Company has answered the Complaint, and discovery has not yet begun.
**10.STOCKHOLDERS
EQUITY**
The
Companys authorized capital is 250,000,000 shares, of which (1) 200,000,000 shares are common stock, par value $0.0001 per share
and (2) 50,000,000 shares are preferred stock, par value $0.0001 per share, which may, at the sole discretion of the Companys
board of directors, be issued in one or more series.
****
**Reverse
Stock Split**
On
August 19, 2024,the Companys board of directors approved a one-for-twenty (1:20) reverse stock split of the Companys
issued and outstanding shares of common stock.On September 13, 2024, the Company filed with the Secretary of State of the State
of Delaware a Certificate of Amendment to the Companys Certificate of Incorporation to effect the Reverse Stock Split. The Reverse
Stock Split became effective on September 13, 2024, and the Companys common stock began trading on a split-adjusted basis on Nasdaq
on September 16, 2024.
**Preferred
Stock**
****
On
December 30, 2025, the Company and the Purchasers have entered into the Agreement pursuant to which the Purchasers have agreed to purchase
an aggregate of 6,875 shares of Series C Convertible Preferred Stock of the Company (the Series C Preferred Shares) for
an aggregate purchase price of $800 per Series C Preferred Share for aggregate gross proceeds of $5,500,000.00. The Series C Preferred
Shares are convertible into shares of common stock, par value $0.0001 per share (the Common Stock).
Pursuant
to that certain Placement Agency Agreement, dated as of December 30, 2025, by and between the Company and E.F. Hutton & Co. (EF
Hutton), the Company paid EF Hutton a cash fee of4.0% of the aggregate gross proceeds plus reimbursement of certain expenses
and legal fees. The Company incurred offering costs of approximately $415,000, resulting in net proceeds of approximately $5,085,000.
****
**At
the Market Offering**
On
March 5, 2024, the Company put in place an at the market offering agreement (the ATM Agreement) which allowed the Company
to issue and sell shares of its common stock, having an aggregate offering price of up to $1,500,000(the ATM Shares),
from time to time through the Sales Agent (the ATM Offering). During the year ended December 31, 2024, the Company sold199,004ATM
Shares for gross proceeds of approximately $1,494,000under the ATM Agreement. The Company incurred offering costs of approximately
$255,000, resulting in net proceeds of approximately $1,239,000.
**Securities
Offering on Form S-1**
On
October 29, 2024, the Company entered into a placement agency agreement (the Placement Agency Agreement) with WestPark
(the Placement Agent), and a securities purchase agreement (the Securities Purchase Agreement) with investors
pursuant to which the Company agreed to issue and sell (i)132,814shares of the Companys common stock, par value $0.0001per
share (the Common Stock) at an offering price of $2.999per share, and (ii) pre-funded warrants to purchase up to1,533,852shares
of Common Stock at an offering price of $3.00per Share, less $0.0001per pre-funded warrant, for aggregate gross proceeds
of $4,998,464(or $4,999,998assuming the full exercise of the pre-funded warrants), before deducting placement agent fees
and other offering expenses. The offering closed on October 31, 2024.
F-19
**iSpecimen
Inc.**
**Notes
to Financial Statements**
As
part of its compensation for acting as Placement Agent for the Offering, the Company paid the Placement Agent a cash fee of4.0%
of the aggregate gross proceeds plus reimbursement of certain expenses and legal fees. The Company incurred offering costs of approximately
$366,189, resulting in net proceeds of approximately $4,632,275.
**Underwritten
Offering**
On
July 23, 2025, the Company entered into an underwriting agreement with WestPark (the Underwriter), pursuant to which the
Company agreed to issue and sell, in an underwritten public offering, an aggregate of 5,714,283 securities, consisting of (i) 1,482,644
shares of Common Stock, and (ii) pre-funded warrants to purchase up to 4,231,639 shares of Common Stock, at an exercise price of $0.0001
per share. The securities were sold at a public offering price of $0.70 per share (or $0.6999 per pre-funded warrant), for gross proceeds
of $3,999,574, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The pre-funded
warrants are immediately exercisable until such time as the pre-funded warrants are exercised in full. The offering closed on July 25,
2025.
As
part of its compensation for acting as Underwriter for the offering, the Company paid the Underwriter a cash fee of4.0% of the
aggregate gross proceeds plus reimbursement of certain expenses and legal fees. The Company incurred offering costs of approximately
$419,983 and settled non-offering related legal fees of approximately $93,837, resulting in net proceeds of approximately $3,485,754.
**Private
Placement Offering**
On
July 31, 2025, the Company entered into a securities purchase agreement with certain accredited investors, pursuant to which the Company
agreed to issue and sell, in a private placement (the Private Placement), an aggregate of 1,559,828 securities, comprised
of (i) 267,379 shares of Common Stock at a purchase price of $1.122 per Share, and (ii) pre-funded warrants to purchase up to 1,292,449
shares of Common Stock at a purchase price of $1.1219 per Share, for aggregate gross proceeds of $1,749,998, before deducting placement
agent fees and other offering expenses. The pre-funded warrants are immediately exercisable until such time as the pre-funded warrants
are exercised in full. The Private Placement closed on August 4, 2025.
The
Company incurred offering costs of approximately $100,000, resulting in net proceeds of approximately $1,749,998.
**Stock
Options**
There
were no options exercised during the years ended December 31, 2025 and 2024.
****
**Warrants**
**
*Underwriter
Warrants*
In
connection with the Companys underwriting agreement with ThinkEquity, a division of Fordham Financial Management, Inc. (ThinkEquity)
and the representative of the Companys IPO underwriters, the Company entered into a warrant agreement to purchase up to4,500shares
of common stock to several affiliates of ThinkEquity (the Underwriter Warrants). The Underwriter Warrants are exercisable
at a per share exercise price of $200.00and are exercisable at any time and from time to time, in whole or in part, during the
four- and one-half year period commencing180days from the effective date of the IPO registration statement. The Underwriter
Warrants became exercisable on or after December 16, 2021 (six months from the effective date of the offering) and expire on June 15,
2026. Upon issuance of the Underwriter Warrants, as partial compensation for its services as an underwriter, the fair value of approximately
$0.4million was recorded as equity issuance costs in the year ended December 31, 2021. As of December 31, 2025, the Underwriter
Warrants had not been exercised and had a weighted average exercise price of $200.00per share and a remaining weighted average
time to expiration of0.46year.
**
*Lender
Warrant*
In
connection with the loan agreement entered into with Western Alliance Bank (the Lender) on August 13, 2021, the Company
issued a warrant (the Lender Warrant) to the Lender to purchase625shares of common stock of the Company. The
Lender Warrant is exercisable at a per share exercise price of $160.00and is exercisable at any time on or after August 13, 2021
through August 12, 2031. The Company determined that the Lender Warrant was equity classified. As of December 31, 2025, the Lender Warrant
had not been exercised and had a weighted average exercise price of $160.00per share and a remaining weighted average time to expiration
of5.62years.
**
F-20
**
**iSpecimen
Inc.**
**Notes
to Financial Statements**
**
*PIPE
Warrants*
On
December 1, 2021, the Company completed a private placement (the PIPE) in which the Company issued warrants (the PIPE
Warrants) to purchase up to an aggregate of 65,625 shares of common stock. These PIPE Warrants have an exercise price of $260.00
per share and are immediately exercisable upon issuance and will expire on the five and one-half-year
anniversary of the issuance date.
On
February 13, 2024, the Company entered into certain warrant repurchase and termination agreements with the holders of the PIPE Warrants
to repurchase the PIPE Warrants for a purchase price equal to $0.80multiplied by the number of shares of common stock issuable
pursuant to such PIPE Warrants. In connection with such repurchases, all past, current and future obligations of the Company relating
to the PIPE Warrants were released, discharged and are of no further force or effect.
A summary
of total warrant activity during the year ended December 31, 2025 is as follows:
| | | | | | | | | Weighted | | |
| | | | | | Weighted | | | Average Remaining | | |
| | | Warrants Outstanding | | | Average Exercise Price | | | Contractual Term in Years | | |
| Balance at December 31,2023 | | | 70,750 | | | $ | 255.30 | | | | 3.47 | | |
| Granted | | | 799,631 | | | | 3.00 | | | | | | |
| Exercised | | | | | | | | | | | | | |
| Repurchased | | | (65,625 | ) | | | 0.80 | | | | | | |
| Balance at December31,2024 | | | 804,756 | | | | 4.22 | | | | 2.09 | | |
| Granted | | | 1,292,449 | | | | 1.12 | | | | | | |
| Exercised | | | (799,631 | ) | | | 3.00 | | | | | | |
| Balance at December 31, 2025 | | | 1,297,574 | | | $ | 1.89 | | | | 1.09 | | |
**11.STOCK-BASED
COMPENSATION**
****
**Stock
Incentive Plans**
**
*2021
Plan*
In
March 2021, the Company adopted the iSpecimen Inc. 2021 Stock Incentive Plan, which was subsequently amended in June 2021 and then on
May 25, 2022 (the 2021 Plan). The 2021 Plan was adopted to enhance the Companys ability to attract, retain and motivate
employees, officers, directors, consultants, and advisors by providing such persons with equity ownership opportunities and performance-based
incentives. The 2021 Plan authorizes options, restricted stock, RSUs and other stock-based awards. The Companys board of directors,
or any committee to which the board of directors delegates such authority, has the sole discretion in administering, interpreting, amending,
or accelerating the 2021 Plan. Awards may be made under the 2021 Plan for up to 30,400 shares of the Companys common stock, and
the 2021 Plan was made effective with the completion of the IPO.
On
May 24, 2023, at the Companys annual meeting of stockholders, the stockholders approved an amendment to the 2021 Plan to increase
the number of shares under the 2021 Plan from 30,400 shares of common stock to 93,475 shares of common stock.
During
the years ended December 31, 2025 and 2024,Niland5,521equity awards were granted under the 2021 Plan, respectively.
As of December 31, 2025, there were73,180shares of common stock available for future grants under the 2021 Plan.
*2013
Plan*
The
iSpecimen Inc. 2013 Stock Incentive Plan (the 2013 Plan) was adopted on April 12, 2013 and subsequently amended on July
29, 2015. The aggregate number of shares of common stock that may be issued pursuant to the 2013 Plan was 85,679.
Noequity
awards were granted under the 2013 Plan during the years ended December 31, 2025 and 2024. According to the 2013 Plan, which was adopted
by the Companys board of directors on April 12, 2013, no awards shall be granted under the 2013 Plan after the completion of ten
years from the date on which the 2013 Plan was adopted by the Companys board of directors. Therefore, as of April 13, 2023, no
further shares had been granted under the 2013 Plan.
F-21
**iSpecimen
Inc.**
**Notes
to Financial Statements**
**Stock
Options**
The
following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes-Merton option pricing model
during the years ended December 31:
|
|
|
2025 |
|
2024 |
| |
|
Assumptions: |
|
|
|
|
| |
|
Risk-free
interest rate |
|
|
|
3.49% 4.56% |
| |
|
Expected
term (in years) |
|
|
|
0.27 4.00 |
| |
|
Expected
volatility |
|
|
|
57.28% 58.71% |
| |
|
Expected
dividend yield |
|
|
|
|
| |
A
summary of stock option activity under the 2021 Plan and 2013 Plan is as follows:
| | | | | | | | | Weighted | | | | | |
| | | | | | | | | Average | | | | | |
| | | Options Outstanding | | | Weighted Average Exercise Price | | | Remaining Contractual Term inYears | | | Aggregate Intrinsic Value | | |
| Balance at December 31, 2024 | | | 8,460 | | | | 33.20 | | | | 5.20 | | | | | | |
| Granted | | | | | | | | | | | | | | | | | |
| Exercised | | | | | | | | | | | | | | | | | |
| Cancelled/forfeited | | | (5,559 | ) | | | 24.27 | | | | | | | | | | |
| Balance at December 31, 2025 | | | 2,901 | | | $ | 50.31 | | | | 6.93 | | | $ | | | |
| | | | | | | | | | | | | | | | | | |
| Options exercisable at December 31, 2025 | | | 2,777 | | | $ | 51.96 | | | | 6.87 | | | $ | | | |
The
aggregate intrinsic value in the table above represents the difference between the Companys stock price as of the balance sheet
date and the exercise price of each in-the-money option on the last day of the period. No stock options were exercised during the years
ended December 31, 2025 and 2024.
No
stock options granted during the year ended December 31, 2025. The weighted average grant date fair value of stock options issued in
the year ended December 31, 2024 was $7.30. The following table sets forth the recorded stock options compensation expense of the Company
during the years ended December 31, 2025 and 2024:
|
| |
Years
Ended December 31, | | |
|
Operating expenses: | |
2025 | | |
2024 | | |
|
Technology | |
$ | | | |
$ | 2,639 | | |
|
Sales and marketing (recovery) | |
| (39 | ) | |
| 1,168 | | |
|
Supply development | |
| 84 | | |
| 1,904 | | |
|
Fulfillment | |
| 1,158 | | |
| 1,976 | | |
|
General and administrative | |
| | | |
| 41,807 | | |
|
Total
stock options expense | |
$ | 1,203 | | |
$ | 49,494 | | |
As
of December 31, 2025 and 2024, a total of $696 and $10,094 unamortized compensation expense is being recognized over the remaining requisite
service period of 2.50 and 2.72 years, respectively.
F-22
**iSpecimen
Inc.**
**Notes
to Financial Statements**
**Restricted
Stock Units**
A
summary of RSUs activity under the 2021 Plan and 2013 Plan is as follows:
|
| |
| | |
Weighted | | |
|
| |
RSUs
Outstanding | | |
Average
Grant Date Fair Value | | |
|
Unvested Balance at December 31,2024 | |
| 822 | | |
$ | 132.34 | | |
|
Granted | |
| | | |
| | | |
|
Vested | |
| (400 | ) | |
| 112.99 | | |
|
Forfeited | |
| (397 | ) | |
| 108.87 | | |
|
Unvested Balance at December 31, 2025 | |
| 25 | | |
$ | 97.20 | | |
The
Company recorded RSUs compensation expense during the years ended December 31, 2025 and 2024 as follows:
|
| |
Years
Ended December 31, | | |
|
Operating expenses: | |
2025 | | |
2024 | | |
|
Technology | |
$ | 2,691 | | |
$ | 57,073 | | |
|
Sales and marketing | |
| 9,126 | | |
| 46,744 | | |
|
Supply development | |
| | | |
| 399 | | |
|
Fulfillment | |
| 11,866 | | |
| 38,666 | | |
|
General and administrative
(recovery) | |
| (3,620 | ) | |
| 57,299 | | |
|
Total
RSU expense | |
$ | 20,063 | | |
$ | 200,181 | | |
As
of December 31, 2025 and 2024, the total unrecognized stock-based compensation expense related to unvested RSUs was $875 and $83,804,
and it is expected to be recognized on a straight-line basis over a weighted average period of approximately0.25and 0.96
year, respectively.
**12.INCOME
TAXES**
There
was no provision for income taxes for the years ended December 31, 2025 and 2024 due to the Companys operating losses and a full
valuation allowance on deferred tax assets.
The
Company completed research and development studies covering all taxyears currently under the applicable statute of limitations.
Significant
components of the Companys deferred tax assets and liabilities as of December 31 are as follows:
|
| |
2025 | | |
2024 | | |
|
Deferred tax assets: | |
| | |
| | |
|
Operating
loss carryforwards | |
$ | 17,786,885 | | |
$ | 15,387,300 | | |
|
Research and development
tax credit | |
| 2,220,972 | | |
| 2,155,100 | | |
|
Other | |
| 892,216 | | |
| 868,700 | | |
|
Total
deferred tax assets | |
| 20,900,073 | | |
| 18,411,100 | | |
|
Deferred tax liability: | |
| | | |
| | | |
|
Other | |
| (73,500 | ) | |
| (80,500 | ) | |
|
Intangibles | |
| (59,400 | ) | |
| (124,800 | ) | |
|
Total
deferred tax liabilities | |
| (132,900 | ) | |
| (205,300 | ) | |
|
Net deferred tax assets
before valuation allowance | |
| 20,767,173 | | |
| 18,205,800 | | |
|
Valuation allowance | |
| (20,767,173 | ) | |
| (18,205,800 | ) | |
|
Net deferred tax asset | |
$ | | | |
$ | | | |
F-23
**iSpecimen
Inc.**
**Notes
to Financial Statements**
The
Company has provided a valuation allowance against the deferred tax assets as it has incurred significant losses since its inception.
Management currently believes that it is more likely than not that the deferred tax assets will not be realized in the future. The change
in the valuation allowance during 2024 was an increase of $3,044,600.
As
of December 31, 2025 and December 31, 2024, the Company had federal net operating loss carryforwards of approximately $72,600,000 and
$62,300,000, respectively, of which approximately $13,000,000expires at various periods through 2037 and approximately $59,600,000can
be carried forward indefinitely. As of December 31, 2025 and December 31, 2024, the Company had state net operating loss carryforwards
of approximately $39,767,000 and $35,600,000, respectively, that expire at various periods through 2045, respectively. At December 31,
2025 and December 31, 2024, the Company had federal and state tax credits of approximately $2,221,000 and $2,031,000, respectively, available
for future periods that expire at various periods through 2045. The Company has recorded a full valuation allowance against net deferred
income tax assets due to a history of losses generated since inception.
Due
to changes in ownership provisions of the Internal Revenue Code, the availability of the Companys NOL carryforwards may be subject
to annual limitations under Section 382 of the Internal Revenue Code against taxable income in the future period, which could substantially
limit the eventual utilization of such carryforwards.
The
Company applies the standards on uncertainty in income taxes. The Company did not have any significant unrecognized tax benefits during
the year ended December 31, 2025. The Companys U.S. federal operating losses have occurred since its inception and as such, tax
years subject to potential tax examination could apply from that date because the utilization of net operating losses from prior years
opens the relevant year to audit by the IRS and/or state taxing authorities.
The
Companys income tax provision was computed using the federal statutory rate and average state statutory rates, net of related
federal benefit. The following represents a reconciliation of the statutory income tax rates to the effective rates at December 31:
|
| |
2025 | | |
2024 | | |
|
Reconciliation to statutory rates | |
| | |
| | |
|
Expected federal
income taxes benefit at statutory rates | |
| (21.0 | )% | |
| (21.0 | )% | |
|
Expected state tax benefit
at statutory rates, net of federal benefit | |
| (6.4 | ) | |
| (6.4 | ) | |
|
Change
in valuation allowance | |
| 27.4 | | |
| 27.4 | | |
|
Income tax expense (benefit) | |
| | % | |
| | % | |
**13.
SEGMENT AND GEOGRAPHIC INFORMATION**
****
Operating
segments are defined as components of an enterprise for which separate financial information is available and evaluated regularly by
the chief operating decision maker, which is our Chief Executive Officer, in deciding how to allocate resources and in assessing performance.
We manage our business globally within one operating segment in accordance with ASC Topic 280, Segment Reporting (ASC 280).
Segment information is consistent with how management reviews the business, makes investing and resource allocation decisions and assesses
operating performance.
The
Company has one reportable segment biospecimens. The Company derive its revenue by procuring specimens from its healthcare provider
network and then distributing these annotated biospecimens to its research client base.
Set
out below is information about the assets and liabilities as at December 31, 2025 and 2024 and profit or loss from each segment for the
year ended December 31, 2025 and 2024.
|
| |
December31,
2025 | | |
December31,
2024 | | |
|
Financial statement line item: | |
| | |
| | |
|
Reportable segment assets | |
$ | 9,531,410 | | |
$ | 9,350,230 | | |
|
Reportable segment liabilities | |
| 6,443,179 | | |
| 6,039,222 | | |
F-24
**iSpecimen
Inc.**
**Notes
to Financial Statements**
|
| |
Year
Ended December 31, | | |
|
| |
2025 | | |
2024 | | |
|
Financial statement line item: | |
| | |
| | |
|
Revenues
from external customers | |
$ | 1,928,998 | | |
$ | 9,291,115 | | |
|
Less: | |
| | | |
| | | |
|
Cost
of revenue, excluding amortization | |
| 1,713,333 | | |
| 5,111,157 | | |
|
Technology
expenses, excluding amortization | |
| 688,942 | | |
| 1,493,310 | | |
|
Sales
and marketing expenses | |
| 2,295,501 | | |
| 4,945,269 | | |
|
Supply
development expenses | |
| 246,979 | | |
| 537,888 | | |
|
Fulfillment
expenses | |
| 827,501 | | |
| 1,635,724 | | |
|
Other
segment items (a) | |
| 4,907,202 | | |
| 5,595,383 | | |
|
Depreciation
& amortization expense | |
| 1,730,902 | | |
| 2,294,248 | | |
|
Interest
expense | |
| 1,949 | | |
| 173,771 | | |
|
Interest
income | |
| (3,748 | ) | |
| (44,133 | ) | |
|
Interest
and penalties on sales tax liability | |
| 7,969 | | |
| 46,303 | | |
|
Income
tax expense | |
| | | |
| | | |
|
Reportable
segment income (loss) | |
$ | (10,487,532 | ) | |
$ | (12,497,805 | ) | |
|
(a) | Other segment items included in reportable segment net loss consists mainly of general and administrative expenses for corporate functions, such as insurance expenses, associated software licenses, other payroll and related expenses for human resources, legal, finance and executive teams, other consulting and professional fees for corporate services rendered, other marketing expenses, franchise tax, other gains and losses, and other overhead expense. |
|
The
Companys reportable business segment sell their goods in four geographic locations:
|
|
|
Americas | |
|
|
|
Europe | |
|
|
|
Middle East/Africa | |
|
|
|
Asia Pacific | |
The
following table represents the percentage of total revenue by geographic area, based on the location of the customer for the years ended
December 31, 2025 and 2024, respectively.
|
|
|
2025 |
|
|
2024 |
| |
|
Americas |
|
|
94.74 |
% |
|
|
85.13 |
% | |
|
Europe, Middle East and Africa |
|
|
2.88 |
% |
|
|
12.71 |
% | |
|
Asia Pacific |
|
|
2.38 |
% |
|
|
2.16 |
% | |
**14.
SUBSEQUENT EVENT**
On February 15, 2026, the Company signed a settlement
agreement pursuant to the existing legal matter with EGS. On or around November 14, 2024, EGS initiated a claim against the Company
for $425,684 arising from a breach of contract, and compensation on a quantum meruit basis amongst other things. Per Agreement, the parties
agreed to a $200,000 settlement in full satisfaction of all claims.
F-25
**Item
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure**
****
None.
**Item
9A. Controls and Procedures**
****
**Evaluation
of Disclosure Controls and Procedures**
****
Disclosure
controls and procedures are designed to ensure that information required to be disclosed by us in our Exchange Act reports is recorded,
processed, summarized, and reported within the time periods specified in the SECs rules and forms, and that such information is
accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer or persons performing
similar functions, as appropriate to allow timely decisions regarding required disclosure.
Under
the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted
an evaluation of the effectiveness of our disclosure controls and procedures as of December 31, 2025, as such term is defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act. These controls and procedures are designed to provide reasonable assurance that the information
required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported
within the time periods specified in the SECs rules and forms and that such information is accumulated and communicated to our
management, including our principal executive officer and principal financial and accounting officer, in a manner to allow timely decisions
regarding required disclosures. Based on this evaluation, management has concluded that our disclosure controls and procedures were not
effective as of December 31, 2025 due to a material weakness in internal control over financial reporting. We discuss this material weakness
and the steps we have taken to remedy such weakness in our discussion of internal control over financial reporting below.
**Managements
Annual Report on Internal Control Over Financial Reporting**
****
Our
management, with the participation of our principal executive officer and our principal financial officer, is responsible for establishing
and maintaining adequate internal control over financial reporting as defined in Rules 13a- 15(f) and 15d-15(f) under the Exchange Act.
Our management conducted an assessment of the effectiveness of our internal control over financial reporting based on the criteria set
forth in Internal ControlIntegrated Framework (2013) issued by the Committee of Sponsoring Organizations of the
Treadway Commission. Based on this assessment, management concluded that our internal control over financial reporting was not effective
as of December 31, 2025 due to the following material weakness in internal control over financial reporting:
The
Company did not design and maintain adequate controls to maintain appropriate documentation for the tax exempt status of its customers,
calculate and collect sales tax at point of sale, and subsequently report and remit in a timely manner to the relevant tax jurisdictions
sales tax obligations.
Notwithstanding
the existence of the material weakness described above, management believes that the audited financial statements included in this Annual
Report fairly present, in all material respects, our financial position, results of operations and cash flows as of and for the periods
presented, in conformity with GAAP.
51
**Managements
Plan for Remediation**
****
The
material weakness described above was identified as a result of an entity-wide risk assessment process that commenced in the quarter
ended June 30, 2023. The Company is in the process of implementing a remediation plan to improve our internal control over financial
reporting and to remediate the related control deficiencies that led to the material weakness. In response to these deficiencies, management,
with the oversight of the Audit Committee of the Board of Directors, has identified and implemented steps to remediate the material weakness.
The
Company began implementing the remediation plan during the second quarter of fiscal year 2023 and this remediation is ongoing as of the
date of this Annual Report. The following remedial measures are designed to address the material weakness and to continue to improve
our internal control over financial reporting.
|
|
|
We have engaged external
tax advisors to complement internal resources and efforts and provide support in assessing the appropriate sales tax treatment associated
with the Companys products for all prior years in which the Company had generated revenue. | |
|
|
|
We have begun obtaining
sales tax exemption letters, representation letters or proof of payments of compensating use tax from our customers and we have started
a collection effort of these sales taxes from certain customers who have notified the Company that they do not have a sales tax exemption
letter. | |
|
|
|
We have begun implementing
a sales tax software platform solution for the calculation, collection, and remittance of sales tax for all non-exempt future sales,
and assisting with the collection and tracking of Voluntary Disclosure Agreements received from states where a potential sales tax
liability may exist. | |
|
|
|
We have begun designing
and implementing enhanced policies, procedures and controls related to the calculation, communication, collection, and remittance
of sales tax to relevant jurisdictions. | |
|
|
|
We have begun training
appropriate personnel in the effective design and execution of our enhanced policies, procedures, and controls, including the importance
of the ongoing, consistent effective execution of such procedures and controls. | |
We
are committed to the remediation of the material weakness and expect to successfully implement enhanced control processes. However, as
we continue to evaluate, and work to improve our internal control over financial reporting, management may determine that additional
measures to address control deficiencies or modifications to the remediation plan are necessary. Therefore, we cannot assure you when
we will be able to fully remediate such weakness, nor can we be certain that additional actions will not be required or what the costs
may be of any such additional actions. Moreover, we cannot assure you that additional material weaknesses will not arise in the future.
**Changes
in Internal Control Over Financial Reporting**
****
We
are in the process of implementing certain changes to our internal controls to remediate the material weakness described above. During
the fourth quarter of 2024, the Company underwent leadership transitions at the director and officer levels. To mitigate any risks associated
with these changes, the Board has increased its oversight of company payments and financial transactions. Except as noted above, there
were no changes in the Companys internal control over financial reporting during the fourth quarter of the year ended December
31, 2024 that have materially affected, or are reasonably likely to materially affect, the Companys internal control over financial
reporting.
**Item
9B. Other Information**
****
None.
**Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections**
****
Not Applicable.
52
**Part
III**
****
**Item
10. Directors, Executive Officers, and Corporate Governance**
****
The following is a list of our directors and executive officers as
of April 1, 2026, along with the specific information required by Rule 14a-3 of the Exchange Act:
|
Name |
|
Age |
|
Position | |
|
Katharyn (Katie) Field |
|
43 |
|
President,
Chief Executive Officer, Secretary, and Treasurer | |
|
Yuying Liang |
|
36 |
|
Chief
Financial Officer | |
|
Avtar
Dhaliwal |
|
31 |
|
Director | |
|
Anthony
Lau |
|
40 |
|
Director | |
|
Mr.
Arphing (Tommy) Lee |
|
35 |
|
Director | |
**Katharyn (Katie) Field** been serving as
our President since February 2025 and was previously a director from September 2024 until her appointment as President. In November 2025,
Ms. Field was appointed as Chief Executive Officer, Secretary, and Treasurer of the Company and prior to that she was President of the
Company. Ms. Field has a background which includes positions spanning both the private and public sectors and brings a wealth of experience
and expertise in strategy consulting and executive leadership. Ms. Field was the chief executive officer and Chairman of Halo Collective
Inc., a cannabis company, where she has served since May 2019, and an Executive Director at Akanda Corporation (Nasdaq: AKAN), a medical
cannabis company, where she has served since June 2022. Previously, she served as a director of Elegance Brands from March 2021 until
March 2022. She has held positions at renowned organizations such as The White House in the office of the public liaison, The Brookings
Institution as a manager of operations, and Bain & Company as a consultant. In 2014, Ms. Field entered the cannabis industry and played
a pivotal role in the procurement, build-out, and sale of one of the original vertically integrated licensed medical marijuana treatment
centers in Florida. Subsequently, she operated a strategy consulting practice focused on cannabis and served as Executive Vice President
of Corporate Development at MariMed from 2018 to 2019. Ms. Field holds an MBA in Economics from Columbia Business School and a BA in Public
Policy with honors from Stanford University. Ms. Field is well-qualified to serve as CEO of the Company due to her experience and expertise
in strategy consulting and executive leadership.
**Yuying
Liang**has been serving as our Chief Financial Officer since December 2024. Ms. Liang is the Principal and Director of Canmore Financial
Services Inc. and Yuying Liang Professional Corp. with significant experience in corporate accounting, financial reporting, and CFO services.
Ms. Liang has worked extensively with public and private companies across multiple sectors, providing financial leadership and strategic
guidance. Ms. Liang holds a Bachelor of Business Administration from Simon Fraser University and holds the professional designation of
chartered professional accountant (CPA). Ms. Liang is CFO and Director of Modern Plant Based Foods Inc., Montego Resources Inc. and Ultra
Brands Ltd.; the CFO of BlockchainK2 Corp, Goldhills Holding Ltd., Intact Gold Corp., Kincora Copper Limited and Transatlantic Mining
Corp.
**Avtar
Dhaliwal** has been serving as our director since September 2024. Mr. Dhaliwal has served as a director and a member of the compensation
committee of the board of Halo Collective Inc. since March 2022, which is a cannabis extraction company that develops and manufactures
quality cannabis oils and concentrates, and he has been a member of its audit committee of the board in August 2024. Since August 2024,
Mr. Dhaliwal has been a director of Advent Technologies Holdings Inc., a US corporation that develops, manufactures, and assembles complete
fuel cell systems as well as supplying customers with critical components for fuel cells in the renewable energy sector. Since December
2021, Mr. Dhaliwal has been the Chief Executive Officer of Modern Plant Based Foods, a Canadian food company that offers a portfolio
of plant-based products. Previously, Mr. Dhaliwal worked in operations and logistics with Modern Plant Based Foods Inc. beginning in
October 2019, and has also been the Chief Executive Officer of Pontus Protein Ltd., an agricultural food and technology company focused
on creating and acquiring the best technology, since March 2022. From January 2024 until May 2024, Mr. Dhaliwal was the Chief Executive
Officer and a director of Trilogy AI, a company committed to transforming the beauty industry through its artificial intelligence technology.
Mr. Dhaliwal holds a Bachelor of Science in Biology from the University of British Columbia Okanagan. Mr. Dhaliwal is well-qualified
to serve on the Board due to his management experience across multiple industries.
53
**Anthony
Lau**has been serving as a director of the Company since June 2025. He also serves on the Audit Committee and the Nominating
and Corporate Governance Committee of the Board. Mr. Lau currently serves as Director, Chief Executive Officer, and Chief Financial Officer
of Remington Resources, Inc., a Canadian resource company, a position he has held since 2021. He brings to the Board significant leadership
and financial management experience, having overseen corporate strategy, operations, and capital markets activities in his executive
role. Mr. Lau received his undergraduate degree from the British Columbia Institute of Technology. Mr. Lau is well-qualified to serve
on the Board due to his extensive experience as a senior executive and director of a public company, with expertise in corporate governance,
finance, and executive management.
****
**Mr.
Arphing (Tommy) Lee**has been serving as our director since November 2025. Mr. Lee, 34, is a management consultant and professional
engineer with extensive experience leading large-scale, multidisciplinary transformation initiatives across the technology, energy, and
resources sectors. Since March 2025, Mr. Lee serves as Project Manager/Senior Technical Consultant Management Operating Systems
of Fuse Advisors, a Canadian boutique engineering consulting company, where he designs and implements integrated systems that define
how large organizations plan, execute, and continuously improve their work. Mr. Lee has served as an advisor on the UBC Mining Industry
Advisory Council (IAC) for the Norman B. Keevil Institute of Mining Engineering since May 2023. Previously, he served at Accenture, a
leading global professional services company, as Mining & Natural Resources Manager from May 2024 to March 2025 and as Mining &
Natural Resources Consultant from August 2022 to May 2024; AMC Consultants, a global mining consultancy firm, as Senior Mining Engineer
from September 2021 to August 2022; ABH Engineering, a mining engineering company offering geology, mining, and processing services,
as Senior Mining Engineer from March 2021 to September 2021; Baffinland Iron Mines, a Canadian mining company, as Short Range & Mid-Range
Mine Planner from November 2018 to September 2021; and at organizations such as Imperial Oil and Barrick Gold in mining engineering roles.
Mr. Lee holds a Bachelor of Applied Science, Mining and Mineral Processing Engineering from the University of British Columbia and holds
the designation of registered professional engineer (P.Eng). Mr. Lee is well-qualified to serve on the Board due to his extensive engineering
experience and background in corporate strategy, operational excellence, and the design and implementation of management systems that
enable organizations to operate with precision and efficiency.
**Family
Relationships**
****
There are
no family relationships among any of our executive officers or directors.
**Composition
of our Board of Directors**
****
Our
Board currently consists of three (3) directors. Our certificate of incorporation, as amended, and bylaws, as amended, provide that our
Board can consist of any number of directors as voted on and approved by the Board. Our Board is divided into three classes, designated
as Class I, Class II and Class III directors, with only one class of directors being elected in each year and each class serving a three-year
term. The term of office of the Class I directors, consisting of Ms. Yang and Mr. Lim will expire at our 2025 annual meeting of stockholders.
The term of office of the Class II directors, consisting of Mr. Dhaliwal, will expire at our 2026 annual meeting of stockholders. When
considering whether directors have the experience, qualifications, attributes or skills, taken as a whole, to enable our Board to satisfy
its oversight responsibilities effectively in light of our business and structure, the Board focuses primarily on each persons
background and experience as reflected in the information discussed in each of the directors individual biographies set forth
above. We believe that our directors provide an appropriate mix of experience and skills relevant to the size and nature of our business.
**Director
Independence**
****
As
our common stock is listed on the Nasdaq Capital Market, our determination of the independence of directors is made using the definition
of independent director contained in Nasdaq Listing Rule 5605(a)(2). Our Board has affirmatively determined that each of
Mr. Dhaliwal, Mr. Lau, and Mr. Lee are independent directors, as that term is defined in the Nasdaq rules. Under
the Nasdaq rules, our Board must be composed of a majority of independent directors. Additionally, subject to certain limited
exceptions, our Boards audit, compensation, and nominating and corporate governance committees also must be composed of all independent
directors.
Audit
committee members must also satisfy the independence criteria set forth in Rule 10A-3 under the Exchange Act. Under the rules of Nasdaq,
a director will only qualify as an independent director if, in the opinion of that companys 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.
To
be considered to be 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 capacity as a member of our audit committee, our Board, or any other committee of our Board: (1) accept, directly
or indirectly, any consulting, advisory, or other compensatory fee from the listed company or any of its subsidiaries; or (2) be an affiliated
person of the listed company or any of its subsidiaries.
54
**Committees
of Our Board of Directors**
****
Our
Board directs the management of our business and affairs, as provided by Delaware law, and conducts its business through meetings of
the Board and standing committees. We have a standing audit committee, compensation committee, and nominating and corporate governance
committee. In addition, from time to time, special committees may be established under the direction of the Board when necessary to address
specific issues.
**Audit
Committee**
****
We
have established an audit committee of the Board. Mr. Lau, Mr. Dhaliwal and Mr. Lee serve as members of our audit committee, and Mr.
Lau chairs the audit committee. Each member of the audit committee is financially literate, and our Board has determined that Mr. Lau
qualifies as an audit committee financial expert as defined in applicable SEC rules and has accounting or related financial
management expertise.
We
have adopted an audit committee charter that is available to stockholders on the Companys website at https://investors.ispecimen.com/governance-documents,
which details the principal functions of the audit committee, including:
|
|
|
reviewing and discussing
with management and the independent auditor the annual audited financial statements, and recommending to the Board whether the audited
financial statements should be included in our Form 10-K; | |
|
|
|
discussing with management
and the independent auditor significant financial reporting issues and judgments made in connection with the preparation of our financial
statements; | |
|
|
|
discussing with management major risk assessment and
risk management policies; | |
|
|
|
monitoring the independence of the independent auditor; | |
|
|
|
verifying the rotation
of the lead (or coordinating) audit partner having primary responsibility for the audit and the audit partner responsible for reviewing
the audit as required by law; | |
|
|
|
reviewing and approving all related-party transactions; | |
|
|
|
inquiring and discussing with management our compliance
with applicable laws and regulations; | |
|
|
|
pre-approving all audit
services and permitted non-audit services to be performed by our independent auditor, including the fees and terms of the services
to be performed; | |
|
|
|
appointing or replacing the independent auditor; | |
|
|
|
determining the compensation
and oversight of the work of the independent auditor (including resolution of disagreements between management and the independent
auditor regarding financial reporting) for the purpose of preparing or issuing an audit report or related work; | |
|
|
|
establishing procedures
for the receipt, retention and treatment of complaints received by us regarding accounting, internal accounting controls or reports
which raise material issues regarding our financial statements or accounting policies; and | |
|
|
|
approving reimbursement
of expenses incurred by our management team in identifying potential target businesses. | |
The
Board reviews the Nasdaq listing standards definition of independence for audit committee members on an annual basis and has determined
that all current members of our audit committee are independent (as independence is currently defined in Rule 5605(c)(2)(A)(i) and (ii)
of the Nasdaq listing standards).
**Compensation
Committee**
****
We have established a compensation committee
of the Board. Mr. Lau and Mr. Dhaliwal serve as members of our compensation committee. Mr. Lau chairs the compensation committee.
55
We
have adopted a compensation committee charter that is available to stockholders on the Companys website at *https://investors.ispecimen.com/governance-documents*,
which details the principal functions of the compensation committee, including:
|
|
|
reviewing and approving
on an annual basis the corporate goals and objectives relevant to our Chief Executive Officers compensation, evaluating our
Chief Executive Officers performance in light of such goals and objectives and determining and approving the remuneration
(if any) of our Chief Executive Officer based on such evaluation; | |
|
|
|
reviewing and approving
the compensation of all our other executive officers; | |
|
|
|
reviewing our executive
compensation policies and plans; | |
|
|
|
implementing and administering
our incentive compensation equity-based remuneration plans; | |
|
|
|
assisting management in
complying with our proxy statement and annual report disclosure requirements; | |
|
|
|
approving all special perquisites,
special cash payments and other special compensation and benefit arrangements for our executive officers and employees; | |
|
|
|
if required, producing
a report on executive compensation to be included in our annual proxy statement; and | |
|
|
|
reviewing, evaluating and
recommending changes, if appropriate, to the remuneration for directors. | |
Notwithstanding
the foregoing, no compensation of any kind, including finders, consulting or other similar fees, will be paid to any of our existing
stockholders, officers, directors or any of their respective affiliates, prior to, or for any services they render in order to effectuate
the consummation of an initial business combination. Accordingly, it is likely that prior to the consummation of an initial business
combination, the compensation committee will only be responsible for the review and recommendation of any compensation arrangements to
be entered into in connection with such initial business combination.
The
charter also provides that the compensation committee may, in its sole discretion, retain or obtain the advice of a compensation consultant,
independent legal counsel or other adviser and will be directly responsible for the appointment, compensation and oversight of the work
of any such adviser. However, before engaging or receiving advice from a compensation consultant, external legal counsel or any other
adviser, the compensation committee will consider the independence of each such adviser, including the factors required by Nasdaq and
the SEC.
**Nominating
and Corporate Governance Committee**
****
We have established a nominating and corporate
governance committee of the Board. Mr. Dhaliwal, Mr. Law, and Mr. Lee serve as members of our nominating and corporate governance committee.
Mr. Dhaliwal chairs the nominating and corporate governance committee.
We
have adopted a nominating and corporate governance committee charter that is available to stockholders on the Companys website
at https://investors.ispecimen.com/governance-documents, which details the principal functions of the nominating and corporate governance
committee, and which provides that persons to be nominated to serve as directors:
|
|
|
should have demonstrated
notable or significant achievements in business, education or public service; | |
|
|
|
should possess the requisite
intelligence, education and experience to make a significant contribution to the Board and bring a range of skills, diverse perspectives
and backgrounds to its deliberations; and | |
|
|
|
should have the highest
ethical standards, a strong sense of professionalism and intense dedication to serving the interests of the stockholders. | |
The
nominating and corporate governance committee will consider several qualifications relating to management and leadership experience,
background and integrity and professionalism in evaluating a persons candidacy for membership on the Board. The nominating committee
may require certain skills or attributes, such as financial or accounting experience, to meet specific Board needs that arise from time
to time and will also consider the overall experience and makeup of its members to obtain a broad and diverse mix of Board members. The
nominating committee does not distinguish among nominees recommended by stockholders and other persons.
56
**Compensation
Committee Interlocks and Insider Participation**
****
None
of the members of our compensation committee is or has been an officer or employee of our company. None of our executive officers currently
serves, or in the past year has served, as a member of the Boards compensation committee (or other board committee performing
equivalent functions) of any entity that has one or more of its executive officers serving on our Board or compensation committee. See
the section titled *Item 13. Certain Relationships and Related Transactions, and Director Independence* for information
about related party transactions involving members of our compensation committee or their affiliates.
**Code of
Conduct and Ethics**
****
We
have adopted a written code of business conduct and ethics 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 copy of the code of business conduct and ethics has been posted on our website, www.ispecimen.com. In addition, we post on our website
all disclosures that are required by law or the Nasdaq listing standards concerning any amendments to, or waivers from, any provision
of the code. The information on or accessed through our website is deemed not to be incorporated in this Annual Report or to be part
of this Annual Report.
**Item
11. Executive Compensation**
****
The
following discussion of compensation arrangements should be read with the compensation tables and related disclosures set forth below.
This discussion contains forward-looking statements that are based on our current plans and expectations regarding future compensation
programs, see Special Note Regarding Forward-Looking Statements. Actual compensation programs that we adopt may differ
materially from the programs summarized in this discussion.
The
discussion below includes a review of our compensation decisions with respect to fiscal years 2025 and 2024 for our named executive
officers, or NEOs, namely our principal executive officer, our two other most highly compensated executive officers and two additional
persons for whom disclosure would have been provided but for the fact that they were not serving as our executive officers as of December
31, 2025.
In
2025 and 2024, we compensated our NEOs through base salary, as described below. Our officers are also eligible for the standard benefits
programs we offer all employees.
**Summary
Compensation Table**
****
The
following table sets forth information regarding compensation awarded to, earned by or paid to each of our named executive officers for
fiscal years 2025 and 2024.
|
| |
| |
| | |
| | |
Stock | | |
Option | | |
Allother | | |
| | |
|
| |
| |
Salary | | |
Bonus | | |
awards | | |
awards | | |
compensation | | |
Total | | |
|
Name and
Principal Position | |
Year | |
($) | | |
($) | | |
($) | | |
($)(1) | | |
($) | | |
($) | | |
|
Robert
Bradley Lim (1) | |
2025 | |
$ | 242,386 | | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
$ | 242,386 | | |
|
Former
Chief Executive Officer, Treasurer, Secretary and Director | |
2024 | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
|
Katharyn
(Katie) Field (2) | |
2025 | |
$ | 203,077 | | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
$ | 203,077 | | |
|
President,
Chief Executive Officer, Treasurer, Secretary and former Director | |
2024 | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
|
Yuying
Liang (3) | |
2025 | |
$ | 314,516 | | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
$ | 314,516 | | |
|
Chief
Financial Officer | |
2024 | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
$ | | | |
|
1) | Robert
Lim was appointed as Chief Executive Officer on December 12, 2024 and resigned on November
7, 2025. |
|
|
2) |
Katharyn (Katie) Field
was appointed as President in February 2025 and as Chief Executive Officer, Secretary, and Treasurer on November 7, 2025. | |
|
|
| |
|
3) |
Yuying
Liang was appointed as Chief Financial Officer on December 13, 2024. | |
****
**Employment
Agreements**
****
We
have entered into independent consulting agreements with each of our Chief Executive Officer and Chief Financial Officer. and have also
entered into an employment agreement with our President.
57
*Katharyn
Field*
**
We
entered into an employment agreement with Ms. Field, effective as of February 28, 2025, appointing her as President of the Company. The
agreement provides for an annual base salary of $240,000, payable in accordance with the Companys standard payroll schedule. Ms.
Field is also eligible to participate in the Companys Stock Incentive Plan and receive standard fringe benefits available to full-time
employees. Under the terms of the agreement, Ms. Fields employment is at-will and may be terminated by either party with thirty
(30) days notice. On November 7, 2025, Ms. Field was appointed as the Chief Executive Officer, Secretary, and Treasurer of the
Company, effective immediately.
*Robert
Bradley Lim*
**
We
entered into an independent contractor agreement with Mr. Lim, effective as of December 9, 2024, through his personal corporation, 1513932
B.C. Ltd., a company incorporated under the laws of the Province of British Columbia, Canada appointing him as Chief Executive Officer
of the Company and a member of the Board of Directors, which, by its terms, will remain in effect from year to year and may be terminated
by the Board of Directors of the Company at any time with or without notice, and with or without cause.
Under
the terms of the Agreement, the Company will pay 1513932 B.C. Ltd. an annual fee of $270,000, payable in equal monthly installments of
$22,500.
This
Agreement does not create an employer-employee, partnership, or joint venture relationship between the parties. Mr. Lim will be entitled
to severance payments. If the Mr. Lim is to be terminated by the Company without Cause, or in the event that the Mr. Lim terminates this
Agreement for Good Reason, the Company agrees to provide the Contractor with severance payment equivalent of $67,500.
On
December 27, 2024, by written consent, the Board of Directors appointed Mr. Lim to the additional roles of Treasurer and Secretary of
the Company in accordance with the Companys Second Amended and Restated Bylaws. There were no changes to Mr. Lims compensation
or other terms of employment in connection with this appointment. On November 7, 2025, Mr. Lim stepped down as Chief Executive Officer,
Secretary, and Treasurer of the Company and resigned as a member of the Board, effective immediately.
*Yuying
Liang*
**
We
entered into an engagement agreement with Ms. Liang, effective as of December 13, 2024, appointing her as Chief Financial Officer, which,
by its terms, will remain in effect from year to year unless amended in writing by both parties or terminated by 60 days written notice
from either party.
If
there should be a Change of Control, Ms. Liang may terminate its obligations under this engagement within 90 days following the Change
of Control by giving 30 days-notice in writing to the Company.
For
the purposes of this engagement, a Change of Control shall be deemed to have occurred when: a person becomes a control
person (as defined in the Securities Act); a majority of the directors are not individuals nominated by the Companys then
incumbent Board of Directors; or any person or group of persons acquires the ability, directly or indirectly to direct the management
and policies of the Company through: the legal or beneficial ownership of voting securities; the right to appoint managers, directors
or corporate management; contract; operating agreement; voting trust.
Under
the terms of this agreement, Ms. Liang is paid an approximate annual base salary of $300,000, which is to be paid on a monthly basis
of $25,000 plus applicable taxes. Should any circumstances cause fees to exceed the proposed amount Ms. Liang will inform the Company
in advance to obtain the approval of such additional fees. If such approval is not obtained, the Company will not be billed outside the
proposed amount.
58
**Non-Employee
Director Compensation**
****
The
following table sets forth information regarding the total compensation paid to our current non-employee directors during 2025 for their
service on our Board. Our directors who are employed by us do not receive any additional compensation for serving on our Board.
|
| |
| | |
| | |
| | |
Non-equity | | |
Non qualified | | |
| | |
| | |
|
| |
Fees | | |
| | |
| | |
incentive | | |
deferred | | |
| | |
| | |
|
| |
earned | | |
| | |
Option | | |
plan | | |
compensation | | |
Allother | | |
| | |
|
| |
or paid | | |
Stock | | |
awards | | |
compensation | | |
earnings | | |
compensation | | |
| | |
|
Name
and Principal Position | |
incash($) | | |
awards($) | | |
($)(10) | | |
($) | | |
($) | | |
($) | | |
Total($) | | |
|
Avtar
Dhaliwal(1) | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
|
Director | |
$ | 31,456 | | |
$ | | | |
$ | | | |
| | | |
| | | |
| | | |
$ | 31,456 | | |
|
Siyun
Yang(2) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
|
Director | |
$ | 25,762 | | |
$ | | | |
$ | | | |
| | | |
| | | |
| | | |
$ | 25,762 | | |
|
Anthony
Lau(3) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
|
Director | |
$ | 16,380 | | |
$ | | | |
$ | | | |
| | | |
| | | |
| | | |
$ | 16,380 | | |
|
Arphing
(Tommy) Lee(4) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
|
Director | |
$ | 4,035 | | |
$ | | | |
$ | | | |
| | | |
| | | |
| | | |
$ | 4,035 | | |
|
John
Brooks(5) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
|
Former
Director | |
$ | 14,766 | | |
$ | | | |
$ | | | |
| | | |
| | | |
| | | |
$ | 14,766 | | |
|
Katharyn
Field(6) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
|
Former
Chairman of the Board and Director | |
$ | 4,861 | | |
$ | | | |
$ | | | |
| | | |
| | | |
| | | |
$ | 4,861 | | |
|
Richard
Paolone(7) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
|
Former
Director | |
$ | 17,269 | | |
$ | | | |
$ | | | |
| | | |
| | | |
| | | |
$ | 17,269 | | |
|
1) | Avtar
Dhaliwal was appointed on September 26, 2024. |
|
|
2) | Siyun
Yang was appointed on February 19, 2025. Ms.Yang resigned on February 17, 2026. |
|
|
3) | Anthony
Lau was appointed on June 20, 2025. |
|
|
4) | Arphing
(Tommy) Lee was appointed on November 7, 2025. |
|
|
5) | John.
L Brooks III was appointed in June 2021 and resigned on June 18, 2025. |
|
|
6) | Katharyn
Field was appointed on September 26, 2024 and resigned on February 19, 2025 to serve as the
Companys President. |
|
|
7) | Richard
Palone was appointed on September 26, 2024 and resigned on June 18, 2025. |
|
On
July 30, 2021, our Board adopted and approved a director compensation policy (the Initial Non-Employee Director Compensation Policy),
which provided for each of the non-employee directors (i) an annual retainer of $20,000, payable quarterly, (ii) equity compensations
(including NSOs with a vesting schedule of three years to purchase 13,525 shares of common stock at the fair market value and annual
RSUs which vested in four equal quarterly tranches) under the 2021 Plan, and (iii) travel expense reimbursement. The Initial Non-Employee
Director Compensation Policy was amended, as of November 30, 2022, in an Amended and Restated Non-Employee Director Compensation Policy.
The Amended and Restated Non-Employee Director Compensation Policy provides for each of the non-employee directors:
(i)
an initial non-qualified ten-year stock option grant upon commencement of service on the Board equal to (x) 834 shares multiplied by
(y) the number of months (including the month of commencement of service on the Board) that such director will serve during his or her
first calendar year at an exercise price equal to 100% of the fair market value of our common stock vesting in four equal quarterly installments
and subject to certain adjustments;
(ii)
an annual non-qualified ten-year stock option grant on each January 2nd equal to 10,000 shares of our common stock at an exercise price
equal to 100% of the fair market value of our common stock vesting in four equal quarterly installments and subject to certain adjustments;
(iii)
an annual cash retainer of $20,000 plus an additional (x) $7,500 for each Board committee on which a director serves as chair and (y)
$3,500 for each Board committee on which a director serves, but is not chair, which cash retainer is payable in for equal quarterly payments;
and
(iv)
travel expense reimbursement.
59
**Indemnification
Agreements**
****
We
have entered into indemnification agreements with our directors and executive officers that require us to indemnify them against expenses,
judgments, fines, settlements and other amounts that any such person becomes legally obligated to pay (including with respect to a derivative
action) in connection with any proceeding, whether actual or threatened, to which such person may be made a party by reason of the fact
that such person is or was a director or officer of us or any of our affiliates, provided such person acted in good faith and in a manner
such person reasonably believed to be in, or not opposed to, our best interests. We maintain a directors and officers liability
insurance policy. The policy insures directors and officers against unindemnified losses arising from certain wrongful acts in their
capacities as directors and officers and reimburses us for those losses for which we have lawfully indemnified the directors and officers.
The policy contains various exclusions.
**Outstanding
Equity Awards at Fiscal Year End**
****
The
following table sets forth information regarding all outstanding stock options and restricted stock held by each of our named executive
officers as of December 31, 2025:
|
| |
OptionAwards | |
Stock
awards | | |
|
| |
Numberof | | |
Numberof | | |
| | |
| |
Number of | | |
Marketvalue | | |
|
| |
securities | | |
securities | | |
| | |
| |
shares | | |
of shares | | |
|
| |
underlying | | |
underlying | | |
| | |
| |
of units of | | |
of units of | | |
|
| |
unexercised | | |
unexercised | | |
| | |
| |
stock that | | |
stock that | | |
|
| |
options(#) | | |
options(#) | | |
Optionexercise | | |
Option | |
have not | | |
have not | | |
|
Name | |
exercisable | | |
unexercisable | | |
price($) | | |
expirationdate | |
vested
(#) | | |
vested
($) | | |
|
John Brooks | |
| 500 | | |
| | | |
$ | 28.20 | | |
January 2, 2033 | |
| | | |
$ | | | |
|
John Brooks | |
| 500 | | |
| | | |
$ | 10.50 | | |
January 2, 2034 | |
| | | |
| | | |
|
John Brooks | |
| 677 | | |
| | | |
$ | 160.00 | | |
July 29, 2031 | |
| | | |
| | | |
|
Avtar Dhaliwal | |
| 168 | | |
| | | |
$ | 5.12 | | |
September 24, 2034 | |
| | | |
| | | |
|
Kathryn Field | |
| 168 | | |
| | | |
$ | 5.12 | | |
September 24, 2034 | |
| | | |
| | | |
|
Richard Paolone | |
| 168 | | |
| | | |
$ | 5.12 | | |
September 24, 2034 | |
| | | |
| | | |
**Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Equity Incentive Plans**
****
Our
Board has adopted, and our stockholders have approved, the iSpecimen Inc. 2013 Stock Incentive Plan and 2021 Plan. The number of shares
issued, number of shares reserved for issuance, number of shares underlying outstanding stock options and number of shares remaining
available for future issuance under each plan, as of December 31, 2025, are as follows:
|
| |
| | |
| | |
| | |
| | |
Numberof | | |
|
| |
| | |
| | |
Numberof | | |
| | |
Shares | | |
|
| |
Numberof | | |
| | |
Shares | | |
WeightedAverage | | |
Remaining | | |
|
| |
Shares | | |
| | |
underlying | | |
Exercise Price | | |
Availablefor | | |
|
| |
Reservedfor | | |
Numberof | | |
Outstanding | | |
of Outstanding | | |
Future | | |
|
Plan | |
Issuance | | |
SharesIssued | | |
Options | | |
Options | | |
Issuance | | |
|
2013 Stock Incentive Plan | |
| 15,451 | | |
| 2,028 | | |
| 7,770 | | |
| 34.60 | | |
| | | |
|
2021 Stock Incentive Plan | |
| 93,475 | | |
| 20,295 | | |
| 2,901 | | |
| 6.93 | | |
| 73,180 | | |
The
2013 Stock Incentive Plan was adopted by our Board and approved by our stockholders on April 12, 2013 to enhance our ability to attract,
retain and motivate employees, officers, directors, consultants and advisors by providing such persons with equity ownership opportunities
and performance-based incentives. The 2013 Stock Incentive Plan similarly authorizes options, restricted stock, restricted stock units
and other stock-based awards and grants our Board, or any committee to which the Board delegates such authority, the sole discretion
in administering, interpreting, amending or accelerating the 2013 Stock Incentive Plan. Further, our Board may delegate to one or more
officers of the Company the power to grant awards and exercise such other powers under the 2013 Stock Incentive Plan as the Board may
determine, provided, that the maximum number of awards to be granted and the maximum number of shares issuable to any one participant
by such officer or officers are fixed by the Board. No officer may designate himself or herself as a recipient of any such awards.
Awards
may be made under the 2013 Stock Incentive Plan for up to 309,029 shares of our common stock. The shares of common stock underlying any
unexercised award shall again be available for the grant of awards under the 2013 Stock Incentive Plan, subject to any limitations under
the Code. No participant may be granted awards, over the ten-year term of the 2013 Stock Incentive Plan, equating to more than an aggregate
of 50% of the shares of common stock available under the 2013 Stock Incentive Plan.
60
Our
Board may grant participants of the 2013 Stock Incentive Plan options to purchase our common stock and determine the terms of such options
(including the number of shares of common stock to be covered by each option, the exercise price of each option and the conditions and
limitations applicable to the exercise of each option). Incentive stock options and nonqualified stock options to purchase common stock
may also be awarded under the 2013 Stock Incentive Plan. Any incentive stock options that, in the aggregate, become exercisable for the
first time in any one calendar year for shares of common stock with an aggregate fair market value of more than $100,000 are deemed to
be nonstatutory or nonqualified stock options. These options may not be granted at less than the fair market value of our common stock
(or 110% of the fair market value if an incentive stock option is granted to any stockholder who owns beneficially more than 10% of the
voting power of all classes of the issued and outstanding stock).
Our
Board may also grant shares of restricted stock or restricted stock units. Participants holding shares of restricted stock are entitled
to all ordinary cash dividends paid with respect to such shares unless otherwise provided by our Board. Further, within 120 days of the
termination of a participants employment, for any reason, the Company may purchase any shares of unvested restricted stock awards
at the lower of the original purchase or issue price to the participant, or the fair market value.
In
addition, other stock-based awards including stock appreciation rights, bonus stock, phantom stock awards and stock units may be issued,
entitling recipients to receive shares of common stock to be delivered in the future. Such other stock-based awards may be available
as a form of payment in the settlement of other awards granted under the 2013 Stock Incentive Plan or as payment in lieu of compensation
to which a participant is otherwise entitled. The 2013 Stock Incentive Plan also provides for substitute awards (the 2013 Substitute
Awards), which may be issued in connection with a merger or acquisition. The 2013 Substitution Awards may substitute any options
or other stock or stock-based awards granted by any merged or acquired entity or its affiliate on such terms as our Board deems appropriate.
In
the event of any stock split, reverse stock split, reclassification of shares, spin-off or similar change in capitalization or any dividend
or distribution other than an ordinary cash dividend, the number and class of securities, exercise price per share and the terms of each
outstanding award are to be adjusted equitably by the Company as determined by our Board. In the event of a reorganization, merger liquidation
or similar transaction, the Board as the discretion to provide that awards are assumed, substituted, terminated immediately prior to
the consummation of such event, declare them exercisable or provide cash consideration for such award.
We
have the right to repurchase awards in the event a participant is terminated or leaves the Company regardless of the reason or cause.
*Amended
and Restated 2021 Stock Incentive Plan*
**
On
June 16, 2021, our Board and stockholders approved the 2021 Plan. Our Board approved certain amendments to the 2021 Plan, which were
approved by the stockholders on May 25, 2022 and on May 24, 2023, respectively. On May 25, 2022, the Companys stockholders approved
amendments to the 2021 Plan to (i) set the maximum number of shares of the Companys common stock that may be awarded to participants
under the 2021 Plan as incentive stock options at 608,000 shares of common stock, (ii) revise the language relating to annual increases
in the number of shares reserved for issuances of awards under the 2021 Plan so that it more clearly reflects the intent of such adjustment
and (iii) make certain other non-material changes to the 2021 Plan.
On
May 24, 2023, the stockholders approved an amendment to the 2021 Plan to (i) remove the automatic annual increase in the number of shares
of common stock reserved for issuance under the 2021 Plan on each anniversary date of the 2021 Plan, in the event that 5% of the number
of shares of common stock issued and outstanding on that date is more than the number of shares of common stock then currently reserved
for issuance under the 2021 Plan, (ii) provide for the recoupment or clawback of awards granted under the 2021 Plan and (iii) increase
the number of shares of common stock reserved for issuance with respect to awards granted under the 2021 Plan from 608,000 shares of
common stock to 1,869,500 shares of common stock. The following is summary of the principal features of the 2021 Plan.
The
purpose of the 2021 Plan is to enable us to offer our employees, officers, directors and consultants whose past, present and/or potential
future contributions to us have been, are, or will be important to its success, an opportunity to acquire a proprietary interest in our
Company. The various types of incentive awards that may be provided under the plan are intended to enable our Company to respond to changes
in compensation practices, tax laws, accounting regulations and the size and diversity of its business.
61
The
2021 Plan grants our Board, or any committee to which the Board delegates such authority the sole discretion in administering, interpreting,
amending or accelerating the 2021 Plan. The committee is comprised solely of non-employee directors, as defined in Rule
16b-3 under the Exchange Act. Subject to the provisions of the 2021 Plan, the committee will determine, among other things, the persons
to whom from time to time awards may be granted, the specific type of awards to be granted, the number of shares subject to each award,
share prices, any restrictions or limitations on the awards, and any vesting, exchange, surrender, cancellation, acceleration, termination,
exercise or forfeiture provisions related to the awards.
There
are 1,869,500 shares of common stock available for issuance under the 2021 Plan. The maximum number of shares of common stock that may
be awarded under the 2021 Plan as incentive stock options is 1,671,290 shares. Shares of common stock subject to other awards that are
forfeited or terminated will be available for future award grants under the 2021 Plan. If a holder pays the exercise price of a stock
option by surrendering any previously owned shares of common stock or arranges to have the appropriate number of shares otherwise issuable
upon exercise withheld to cover the withholding tax liability associated with the stock option exercise, the number of shares available
under the plan may be increased by the lesser of (i) the number of such surrendered shares and shares used to pay taxes; and (ii) the
number of shares purchased under such stock option.
We
may grant awards under the 2021 Plan to employees, officers, directors, and consultants who are deemed to have rendered, or to be able
to render, significant services to us and who are deemed to have contributed, or to have the potential to contribute, to its success.
An incentive stock option may be granted under the plan only to a person who, at the time of the grant, is an employee of our Company
or our subsidiaries.
*Options.*The 2021 Plan provides both for incentive stock options as defined in Section 422 of the Code, and for options not
qualifying as incentive options, both of which may be granted with any other stock-based award under the plan. The committee determines
the exercise price per share of common stock purchasable under an incentive or non-qualified stock option, which may not be less than
100% of the fair market value on the day of the grant or, if greater, the par value of a share of common stock. However, the exercise
price of an incentive stock option granted to a person possessing more than 10% of the total combined voting power of all classes of
our stock may not be less than 110% of the fair market value on the date of grant. The aggregate fair market value of all shares of common
stock with respect to which incentive stock options are exercisable by a participant for the first time during any calendar year (under
all of the plans), measured at the date of the grant, may not exceed $100,000.
An
incentive stock option may only be granted within 10 years from the effective date of the 2021 Plan. An incentive stock option may only
be exercised within ten years from the date of the grant, or within five years in the case of an incentive stock option granted to a
person who, at the time of the grant, owns common stock possessing more than 10% of the total combined voting power of all classes of
our stock.
*Stock
Appreciation Rights.* Under the 2021 Plan, we may grant stock appreciation rights to participants who have been, or are being, granted
stock options under the plan as a means of allowing the participants to exercise their stock options without the need to pay the exercise
price in cash, or we may grant them alone and unrelated to an option. In conjunction with non-qualified stock options, stock appreciation
rights may be granted either at or after the time of the grant of the non-qualified stock options. In conjunction with incentive stock
options, stock appreciation rights may be granted only at the time of the grant of the incentive stock options. A stock appreciation
right entitles the holder to receive a number of shares of common stock having a fair market value equal to the excess fair market value
of one share of common stock over the exercise price of the related stock option, multiplied by the number of shares subject to the stock
appreciation rights. The granting of a stock appreciation right in tandem with a stock option will not affect the number of shares of
common stock available for awards under the plan. In such event, the number of shares available for awards under the plan will, however,
be reduced by the number of shares of common stock acquirable upon exercise of the stock option to which the stock appreciation right
relates.
*Restricted
Stock.*Under the 2021 Plan, we may award shares of restricted stock either alone or in addition to other awards granted under the
plan. The committee determines the persons to whom grants of restricted stock are made, the number of shares to be awarded, the price
(if any) to be paid for the restricted stock by the person receiving the stock from us, the time or times within which awards of restricted
stock may be subject to forfeiture, the vesting schedule and rights to acceleration thereof, and all other terms and conditions of the
restricted stock awards.
The
2021 Plan will require that all shares of restricted stock awarded to the holder remain in our physical custody until the restrictions
have terminated and all vesting requirements with respect to the restricted stock have been fulfilled. We will retain custody of all
dividends and distributions made or declared with respect to the restricted stock during the restriction period. A breach of any restriction
regarding the restricted stock will cause a forfeiture of the restricted stock and any retained dividends and distributions. Except for
the foregoing restrictions, the holder will, even during the restriction period, have all of the rights of a stockholder, including the
right to vote the shares.
62
*Restricted
Stock Units.* Under the 2021 Plan, we may also award restricted stock units. Restricted stock units are the right to receive shares
of common stock at a future date in accordance with the terms of such grant upon the attainment of certain conditions specified by the
committee, which include substantial risk of forfeiture and restrictions on their sale or other transfer by the participant. Restrictions
or conditions could also include, but are not limited to, the attainment of performance goals, continuous service with our Company, the
passage of time or other restrictions or conditions. The committee determines the persons to whom grants of restricted stock units are
made, the number of restricted stock units to be awarded, the time or times within which awards of restricted stock units may be subject
to forfeiture, the vesting schedule and rights to acceleration thereof, and all other terms and conditions of the restricted stock units
awards. The value of the restricted stock units may be paid in shares, cash, or a combination of both, as determined by the committee.
*Other
Stock-Based Awards.* Under the 2021 Plan, we may grant other stock-based awards, subject to limitations under applicable law that
are denominated or payable in, valued in whole or in part by reference to, or otherwise based on, or related to, shares of common stock,
as deemed consistent with the purposes of the plan. These other stock-based awards may be in the form of purchase rights, shares of common
stock awarded that are not subject to any restrictions or conditions, convertible or exchangeable debentures or other rights convertible
into shares of common stock and awards valued by reference to the value of securities of, or the performance of, one of our subsidiaries.
These other stock-based awards may include performance shares or options, whose award is tied to specific performance criteria. These
other stock-based awards may be awarded either alone, in addition to, or in tandem with any other awards under the 2021 Plan or any of
our other plans.
**Beneficial
Ownership of Our Common Stock**
****
The following table sets forth certain information regarding the beneficial
ownership of our outstanding shares of common stock, as of April 1, 2026 by: (i) each of our directors, (ii) each of our named executive
officers (as defined by Item 402(a)(3) of Regulation S-K promulgated under the Exchange Act), (iii) all of our directors and named executive
officers as a group, and (iv) each person known to us to beneficially own more than 5% of our outstanding shares of common stock.
Beneficial
ownership has been determined in accordance with Rule 13d-3 under the Exchange Act. The percentages in the table have been calculated
on the basis of treating as outstanding for a particular person, all shares of our common stock outstanding on that date and all shares
of our common stock issuable to that holder in the event of exercise of outstanding options, warrants, rights or conversion privileges
owned by that person at that date which are exercisable within sixty (60) days of that date. Except as otherwise indicated, the persons
listed below have sole voting and investment power with respect to all shares of our common stock owned by them, except to the extent
that power may be shared with a spouse.
|
| |
Number of Shares of | |
Approximate | | |
|
| |
CommonStockBeneficially | |
Percentageof | | |
|
Name
and Address of Beneficial Owner(1) | |
Owned | |
Class(2) | | |
|
Director and Executive
Officers | |
| |
| | |
|
Katharyn Field | |
Nil | |
| 0.00 | % | |
|
Avtar Dhaliwal | |
Nil | |
| 0.00 | % | |
|
Siyun Yang | |
Nil | |
| 0.00 | % | |
|
Anthony Lau | |
Nil | |
| 0.00 | % | |
|
Arphing (Tommy) Lee | |
Nil | |
| 0.00 | % | |
|
Yuying Liang | |
Nil | |
| 0.00 | % | |
|
All Directors and Officers
as a Group (6 persons) | |
Nil | |
| * | | |
|
5% or
Greater Stockholders | |
| |
| | | |
|
N/A | |
Nil | |
| 0.00 | % | |
|
* | Less
than 1%* |
|
**Changes
in Control**
****
There
are no arrangements, known to the Company, including any pledge by any person of securities of the Company, the operation of which may
at a subsequent date result in a change in control of the Company.
63
**Item
13. Certain Relationships and Related Transactions, and Director Independence**
**Transactions
with Related Persons**
During
the fiscal years ended December 31, 2025 and 2024, there have not been, nor are there currently proposed, any transaction in which we
are or were a participant, the amount involved exceeds the lesser of $120,000 or 1% of the average of the total assets at December 31,
2025, and any of our directors, executive officers, holders of more than 5% of our common stock, or any immediate family member of any
of the foregoing had or will have a direct or indirect material interest.
**Related
Person Transaction Policy**
We
have adopted a related person transaction policy that sets forth our procedures for the identification, review, consideration and approval
or ratification of related person transactions. For purposes of our policy only, a related person transaction is a transaction, arrangement
or relationship, or any series of similar transactions, arrangements or relationships, in which we and any related person are, were or
will be participants in which the amount involved exceeds the lesser of $120,000 or 1% of our total assets at year-end for our last two
completed fiscal years. Transactions involving compensation for services provided to us as an employee or director are not covered by
this policy. A related person is any executive officer, director or beneficial owner of more than 5% of any class of our voting securities,
including any of their immediate family members and any entity owned or controlled by such persons.
Under
the policy, if a transaction has been identified as a related person transaction, including any transaction that was not a related person
transaction when originally consummated or any transaction that was not initially identified as a related person transaction prior to
consummation, our management must present information regarding the related person transaction to our audit committee, or, if audit committee
approval would be inappropriate, to another independent body of our board of directors, for review, consideration and approval or ratification.
The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related
persons, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to
or from, as the case may be, an unrelated third party or to or from employees generally. Under the policy, we will collect information
that we deem reasonably necessary from each director, executive officer and, to the extent feasible, significant shareholder to enable
us to identify any existing or potential related-person transactions and to effectuate the terms of the policy. In addition, under our
code of business conduct and ethics, our employees and directors will have an affirmative responsibility to disclose any transaction
or relationship that reasonably could be expected to give rise to a conflict of interest. In considering related person transactions,
our audit committee, or other independent body of our board of directors, will take into account the relevant available facts and circumstances
including, but not limited to:
|
|
|
the risks, costs and benefits
to us; | |
|
|
|
the impact on a directors
independence in the event that the related person is a director, immediate family member of a director or an entity with which a
director is affiliated; | |
|
|
|
the availability of other
sources for comparable services or products; and | |
|
|
|
the terms available to
or from, as the case may be, unrelated third parties or to or from employees generally. | |
The
policy requires that, in determining whether to approve, ratify or reject a related person transaction, our audit committee, or other
independent body of our board of directors, must consider, in light of known circumstances, whether the transaction is in, or is not
inconsistent with, our best interests and those of our shareholders, as our audit committee, or other independent body of our board of
directors, determines in the good faith exercise of its discretion.
Director
Independence
Our
Board of Directors has undertaken a review of the independence of each director and considered whether each director has a material relationship
with us that could compromise his or her ability to exercise independent judgment in carrying out his or her responsibilities. As a result
of this review, our Board of Directors determined that Mr. Dhaliwal, Mr. Lau and Mr. Lee are independent directors
as defined under the applicable rules and regulations of the SEC and the listing requirements and rules of the Nasdaq Stock Market. In
making these determinations, our Board of Directors reviewed and discussed information provided by the directors and us with regard to
each directors business and personal activities and relationships as they may relate to us and our management, including the beneficial
ownership of our capital stock by each non-employee director and any affiliates.
64
**Employee,
Officer and Director Hedging**
****
We
maintain a policy on insider trading that applies to all shares of our capital stock held by any director, officer or employee. The policy
requires that all directors, officers and employees receive our pre-clearance before engaging in any transactions involving our shares
of capital stock and prohibits all directors, officers or employees from taking part in any hedging transactions.
**Piggyback
Registration Rights**
****
We
have granted certain parties piggyback registration rights under a certain investors rights agreement, dated as of August 22,
2014, by and among us and certain investors, a certain Series A preferred stock subscription agreement, a certain registration rights
agreement, dated as of November 28, 2021, by and among us and the selling stockholders in connection with our private placement offering
in December 2021 (the PIPE Stockholders), and a certain underwriting agreement, dated June 16, 2021, by and between us
and ThinkEquity, a division of Fordham Financial Management, Inc., subject to certain requirements and customary conditions. There is
currently an effective registration statement registering the shares of common stock held by the PIPE Stockholders, if any.
**Anti-Takeover
Effects of Certain Provisions of Our Certificate of Incorporation and Bylaws**
****
Provisions
of our bylaws could make it more difficult to acquire us by means of a merger, tender offer, proxy contest, open market purchases, removal
of incumbent directors and otherwise. These provisions, which are summarized below, are expected to discourage types of coercive takeover
practices and inadequate takeover bids and to encourage persons seeking to acquire control of us to first negotiate with us. We believe
that the benefits of increased protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal
to acquire or restructure us outweigh the disadvantages of discouraging takeover or acquisition proposals because negotiation of these
proposals could result in an improvement of their terms.
*Vacancies.*
Newly created directorships resulting from any increase in the number of directors and any vacancies on the Board resulting from death,
resignation, disqualification, removal or other cause shall be filled by a majority of the remaining directors on the Board.
*Bylaws.*
Our certificate of incorporation and bylaws authorizes the Board to adopt, repeal, rescind, alter or amend our bylaws without stockholder
approval.
*Removal.*Except as otherwise provided, a director may be removed from office only by the affirmative vote of the holders of not less than
a majority of the voting power of the issued and outstanding stock entitled to vote.
*Calling
of Special Meetings of Stockholders.* Our bylaws provide that special meetings of stockholders for any purpose or purposes may be
called at any time only by the Board or by our Secretary following receipt of one or more written demands from stockholders of record
who own, in the aggregate, at least 15% the voting power of our outstanding stock then entitled to vote on the matter or matters to be
brought before the proposed special meeting.
*Cumulative
Voting.* Our certificate of incorporation does not provide for cumulative voting in the election of directors, which would allow holders
of less than a majority of the stock to elect some directors.
*Staggered
Board.* Our bylaws provided that our Board is divided into three classes with only one class of directors being elected in each year
and each class (except for those directors appointed prior to the Annual Meeting) serving a three-year term. As a result, only a minority
of the Board will be considered for election at every annual meeting of stockholders, which may make the removal of management more difficult
and may discourage transactions that otherwise could involve payment of a premium over prevailing market prices for our securities.
65
**Choice
of Forum**
****
Our
bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware
(or, if the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware) will be the exclusive
forum for: (i) any derivative action or proceeding brought on behalf of the Company; (ii) any action asserting a claim for breach of
a fiduciary duty owed by any director, officer, employee, or agent of ours to us or our stockholders; (iii) any action asserting a claim
arising pursuant to any provision of the Delaware General Corporation Law, the certificate of incorporation, or the bylaws; and (iv)
any action asserting a claim governed by the internal affairs doctrine (the Delaware Forum Provision). The bylaws further
provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States
of America shall be the sole and exclusive forum for resolving any complaint asserting a cause of action arising under the Securities
Act (the Federal Forum Provision). In addition, the bylaws provide that any person or entity purchasing or otherwise acquiring
any interest in shares of our common stock is deemed to have notice of and consented to the Delaware Forum Provision and the Federal
Forum Provision.
Section
27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the
Exchange Act or the rules and regulations thereunder. As a result, the Delaware Forum Provision will not apply to suits brought to enforce
any duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. We note,
however, that there is uncertainty as to whether a court would enforce this provision and that investors cannot waive compliance with
the federal securities laws and the rules and regulations thereunder.
We
recognize that the Delaware Forum Provision and the Federal Forum Provision in the bylaws may impose additional litigation costs on stockholders
in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware. Additionally, the Delaware
Forum Provision and the Federal Forum Provision may limit our stockholders ability to bring a claim in a forum that they find
favorable for disputes with us or our directors, officers or employees, which may discourage such lawsuits against us and our directors,
officers and employees even though an action, if successful, might benefit our stockholders. In addition, while the Delaware Supreme
Court ruled in March 2020 that federal forum selection provisions purporting to require claims under the Securities Act be brought in
federal court were facially valid under Delaware law, there is uncertainty as to whether other courts will enforce the
Federal Forum Provision. If the Federal Forum Provision is found to be unenforceable, we may incur additional costs associated with resolving
such matters. The Federal Forum Provision may also impose additional litigation costs on stockholders who assert that the provision is
not enforceable or invalid. The Court of Chancery of the State of Delaware and the United States District Court 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 may be more or less favorable to us than our stockholders.
**Indemnification
of Directors and Officers**
****
We
are incorporated in the State of Delaware. The certificate of incorporation and bylaws provide that, to the fullest extent permitted
by Delaware law, as it presently exists or may be amended from time to time, a director shall not be personally liable to us or our stockholders
for monetary damages for any breach of fiduciary duty as a director. And under Delaware law, this limitation of liability does not extend
to, among other things, acts or omissions which involve intentional misconduct, fraud or knowing violation of law, or unlawful payments
of dividends. So these provisions may discourage stockholders from bringing suit against a director or officer for breach of fiduciary
duty and may reduce the likelihood of derivative litigation brought by stockholders on our behalf against a director or officer.
The
certificate of incorporation and bylaws also provide for the indemnification of our directors, officers, employees, and agents, under
certain circumstances, against attorneys fees and other expenses incurred by them in any litigation to which they become a party
arising from their association with or activities on behalf of the Company. As such, should our officers and/or directors require us
to contribute to their defense, we may be required to spend significant amounts of our capital. This indemnification policy could therefore
result in substantial expenditures, which we may be unable to recoup. If these expenditures are significant or involve issues which result
in significant liability for our key personnel, we may be unable to continue operating as a going concern.
66
Furthermore,
we intend to enter into indemnification agreements with our directors and executive officers that require us to indemnify them against
expenses, judgments, fines, settlements and other amounts that any such person becomes legally obligated to pay (including with respect
to a derivative action) in connection with any proceeding, whether actual or threatened, to which such person may be made a party by
reason of the fact that such person is or was a director or officer of us or any of our affiliates, provided such person acted in good
faith and in a manner such person reasonably believed to be in, or not opposed to, our best interests. We maintain a directors
and officers liability insurance policy. The policy insures directors and officers against unindemnified losses arising from certain
wrongful acts in their capacities as directors and officers and reimburses us for those losses for which we have lawfully indemnified
the directors and officers. The policy contains various exclusions.
**Listing**
****
Our
common stock is listed on Nasdaq under the symbol ISPC.
**Transfer
Agent**
The
transfer agent and registrar for our common stock is Broadridge Corporate Issuer Solutions LLC. The transfer agent and registrars
address is 1155 Long Island Avenue, Edgewood, New York, NY 11717 and its telephone number is 1-877-830- 4932.
**Item
14. Principal Accountant Fees and Services Audit, Audit-Related and All Other Fees**
****
The
table below shows the aggregate fees billed for professional services for the audits and audit-related fees of the Companys annual
financial statements included in this Annual Report for the years ended December 31, 2025 and 2024, respectively, by Bush & Associates.
|
| |
2025 | | |
2024 | | |
|
Audit fees(1) | |
$ | 250,000 | | |
$ | 426,875 | | |
|
Audit-Related fees(2) | |
| 140,000 | | |
| 132,000 | | |
|
Total | |
$ | 390,000 | | |
$ | 558,875 | | |
|
(1) | This
category includes the audit of our annual financial statements, reviews of our financial
statements included in our Form 10-Qs and services that are normally provided by our independent
registered public accounting firm in connection with its engagements for those fiscal periods. |
|
|
(2) | This
category consists of assurance and related services by our independent registered public
accounting firm that are reasonably related to the performance of the audit or review of
our financial statements and are not reported above under Audit Fees. The services
for the fees disclosed under this category include consents regarding equity issuance. |
|
67
**Part
IV**
****
**Item
15. Exhibits and Financial Statement Schedules**
****
|
|
1. |
Financial Statements
- We have filed the following documents in Item 8 of this Annual Report: | |
|
|
Page | |
|
Report of Independent
Registered Public Accounting Firm (PCAOB ID: 6797) |
F-2 | |
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Balance Sheets |
F-3 | |
|
Statements of Operations |
F-4 | |
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Statements of Changes in Convertible
Preferred Stock and Stockholders Equity |
F-5 | |
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Statements of Cash Flows |
F-6 | |
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Notes to Financial Statements |
F-7 | |
|
|
2. |
Financial Statement
Schedules - All other schedules are omitted because they are not required, or the required information is included in the
financial statements or notes thereto. | |
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3. |
Exhibits -
For a list of exhibits filed with this Annual Report, refer to the exhibit index below. The exhibits listed in the Exhibit Index
are filed or incorporated by reference as part of this Annual Report. | |
68
|
No. |
|
Description
of Exhibit | |
|
3.1 |
|
Fourth
Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Companys Form 8-K filed
with the SEC on June 22, 2021). | |
|
3.2 |
|
Second
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 of the Companys Form 8-K filed with the SEC on June
22, 2021). | |
|
4.1 |
|
Form
of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 of the Company s Form 8-K filed with the SEC on
November 29, 2021). | |
|
4.2 |
|
Warrant
to Purchase Stock Western Alliance Bank (incorporated by reference as Exhibit 10.2 to the Companys Form 8-K filed
with the SEC on August 16, 2021). | |
|
4.3 |
|
Description
of Securities (incorporated by reference to Exhibit 4.3 of the Companys Form 10-K filed with the SEC on March 22, 2022). | |
|
4.4 |
|
Senior
Note, dated as of September 25, 2024 (incorporated by reference to Exhibit 4.1 of the Companys Form 8-K filed with the SEC
on September 25, 2024). | |
|
4.5 |
|
Form
of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Companys Form 8-K filed with the SEC on October 31,
2024). | |
|
10.1 |
|
Loan
and Security Agreement (incorporated by reference to Exhibit 10.1 of the Companys Form 8-K filed with the SEC on August 16,
2021). | |
|
10.2 |
|
Warrant
to Purchase Common Stock issued to Western Alliance Bank on August 13, 2021 (incorporated by reference to Exhibit 10.2 of the Companys
Form 8-K filed with the SEC on August 16, 2021). | |
|
10.3 |
|
Securities
Purchase Agreement, dated November 28, 2021, by and between the Company and the purchasers named therein (incorporated by reference
to Exhibit 10.1 of the Companys Form 8-K filed with the SEC on November 29, 2021). | |
|
10.4 |
|
Registration
Rights Agreement, dated November 28, 2021, by and between the Company and the investors named therein (incorporated by reference
to Exhibit 10.2 of the Companys Form 8-K filed with the SEC on November 29, 2021). | |
|
10.5 |
|
Placement
Agency Agreement, dated November 28, 2021, by and between the Company and ThinkEquity LLC (incorporated by reference to Exhibit 10.3
of the Companys Form 8-K filed with the SEC on November 29, 2021). | |
|
10.6 |
|
iSpecimen
Inc. 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 of the Company s Form S-1/A (File No. 333-250198)
with the SEC on December 31, 2020). | |
|
10.7 |
|
iSpecimen
Inc. 2013 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 of the Company s Form S-1/A (File No. 333-250198)
with the SEC on December 31, 2020). | |
|
10.8 |
|
Form
of Indemnification Agreement, by and between the Company and certain directors and executive officers (incorporated by reference
to Exhibit 10.3 of the Companys Form S-1/A (File No. 333-250198) with the SEC on December 31, 2020). | |
|
10.9 |
|
Form
of Confidentiality , Non-Competition And Assignment Agreement, by and between iSpecimen Inc. and each of its employees (incorporated
by reference to Exhibit 10.4 of the Companys Form S-1/A (File No. 333-250198) with the SEC on December 31, 2020). | |
|
10.10 |
|
Lease
between the Company and Bedford Street LLC (incorporated by reference to Exhibit 10.5 of the Companys Form S-1/A (File No.
333-250198) with the SEC on December 31, 2020). | |
|
10.11 |
|
Form
of Series A Preferred Stock Subscription Agreement (incorporated by reference to Exhibit 10.6 of the Companys Form S-1/A (File
No. 333-250198) with the SEC on December 31, 2020). | |
|
10.12 |
|
Capital
Commitment Agreement, dated September 1, 2012 (incorporated by reference to Exhibit 10.7 of the Companys Form S-1/A (File
No. 333-250198) with the SEC on December 31, 2020). | |
|
10.13 |
|
Form
of Series B Preferred Stock Purchase Agreement, dated August 22, 2014 (incorporated by reference to Exhibit 10.8 of the Companys
Form S-1/A (File No. 333-250198) with the SEC on December 31, 2020). | |
|
10.14 |
|
Form
of Investors Rights Agreement for Series A-1 Preferred Stock and Series B Preferred Stock Investors (incorporated by reference
to Exhibit 10.9 of the Companys Form S-1/A (File No. 333- 250198) with the SEC on December 31, 2020). | |
|
10.15 |
|
Form
of Convertible Note Subscription Agreement (incorporated by reference to Exhibit 10.10 of the Companys Form S-1/A (File No.
333-250198) with the SEC on December 31, 2020). | |
|
10.16 |
|
Form
of Unsecured Convertible Promissory Note (incorporated by reference to Exhibit 10.11 of the Companys Form S-1/A (File No.
333-250198) with the SEC on December 31, 2020). | |
|
10.17 |
|
Unsecured
Convertible Promissory Note, dated December 29, 2017, issued by the Company to Anna- Maria and Stephen Kellen Foundation, Inc. (incorporated
by reference to Exhibit 10.12 of the Companys Form S-1/A (File No. 333-250198) with the SEC on December 31, 2020). | |
|
10.18 |
|
Omnibus
Amendment to Unsecured Convertible Notes and Subscription Agreement, dated August 3, 2018, by and among the Company , Andrew L. Ross,
Anna-Maria and Stephen Kellen Foundation, Inc., and OBF Investments, LLC (incorporated by reference to Exhibit 10.13 of the Companys
Form S-1/A (File No. 333-250198) with the SEC on December 31, 2020). | |
69
|
10.19 |
|
Second
Omnibus Amendment to Unsecured Convertible Notes and Subscription Agreement, dated May 1, 2019, by and among iSpecimen Inc., Andrew
L. Ross, Anna-Maria and Stephen Kellen Foundation, Inc., and OBF Investments, LLC (incorporated by reference to Exhibit 10.14 of
the Companys Form S- 1/A (File No. 333-250198) with the SEC on December 31, 2020). | |
|
10.20 |
|
Third
Omnibus Amendment to Unsecured Convertible Notes and Subscription Agreement, dated November 15, 2019, by and among iSpecimen Inc.,
Andrew L. Ross, Anna-Maria and Stephen Kellen Foundation, Inc., and OBF Investments, LLC (incorporated by reference to Exhibit 10.15
of the Companys Form S-1/A (File No. 333-250198) with the SEC on December 31, 2020). | |
|
10.21 |
|
Fourth
Omnibus Amendment to Unsecured Convertible Notes and Subscription Agreement, dated September 19, 2020, by and among iSpecimen Inc.,
Andrew L. Ross, Anna-Maria and Stephen Kellen Foundation, Inc., and OBF Investments, LLC (incorporated by reference to Exhibit 10.16
of the Companys Form S-1/A (File No. 333-250198) with the SEC on December 31, 2020). | |
|
10.22 |
|
Form
of Note Subscription Agreement for Secured Bridge Debt (incorporated by reference to Exhibit 10.17 of the Companys Form S-1/A
(File No. 333-250198) with the SEC on December 31, 2020). | |
|
10.23 |
|
Form
of Secured Promissory Note for Secured Bridge Debt (incorporated by reference to Exhibit 10.18 of the Companys Form S-1/A
(File No. 333-250198) with the SEC on December 31, 2020). | |
|
10.24 |
|
First
Amendment to Note Subscription Agreements and Secured Promissory Notes, dated May 1, 2019, by and among the Company and Note Investors
(incorporated by reference to Exhibit 10.19 of the Companys Form S-1/A (File No. 333-250198) with the SEC on December 31,
2020). | |
|
10.25 |
|
Second
Amendment to Note Subscription Agreements and Secured Promissory Notes, dated November 15, 2019, by and among the Company and Note
Investors (incorporated by reference to Exhibit 10.20 of the Companys Form S-1/A (File No. 333-250198) with the SEC on December
31, 2020). | |
|
10.26 |
|
Third
Amendment to Note Subscription Agreements and Secured Promissory Notes, dated June 15, 2020, by and among the Company and Note Investors
(incorporated by reference to Exhibit 10.21 of the Companys Form S-1/A (File No. 333-250198) with the SEC on December 31,
2020). | |
|
10.27 |
|
Fourth
Amendment to Note Subscription Agreements and Secured Promissory Notes, dated October 1, 2020, by and among the Company and Note
Investors (incorporated by reference to Exhibit 10.22 of the Companys Form S-1/A (File No. 333-250198) with the SEC on December
31, 2020). | |
|
10.28 |
|
Fifth
Amendment to Note Subscription Agreements and Secured Promissory Notes, dated March 15, 2021, by and among the Company and Note Investors
(incorporated by reference to Exhibit 10.23 of the Companys Form S-1/A3 (File No. 333-250198) with the SEC on April 2, 2021). | |
|
10.29 |
|
iSpecimen
Inc. Second Amended and Restated 2021 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 of the Companys Form
8-K filed with the SEC on May 26, 2022). | |
|
10.30# |
|
Executive
Employment Agreement by and between the Company and Christopher lanelli (incorporated by reference to Exhibit 10.25 of the Companys
Form S-1/A3 (File No. 333-250198) with the SEC on April 2, 2021). | |
|
10.31# |
|
Executive
Employment Agreement by and between the Company and Jill Mullan (incorporated by reference to Exhibit 10.26 of the Companys
Form S-1/A3 (File No. 333-250198) with the SEC on April 2, 2021). | |
|
10.32# |
|
Executive
Employment Agreement by and between the Company and Tracy Curley (incorporated by reference to Exhibit 10.27 of the Companys
Form S-1/A3 (File No. 333-250198) with the SEC on April 2, 2021). | |
|
10.33# |
|
Employment
Agreement by and between the Company and Benjamin Bielak (incorporated by reference to Exhibit 10.28 of the Companys Form
S-1/A3 (File No. 333-250198) with the SEC on April 2, 2021). | |
|
10.34 |
|
Factoring
Agreement, dated January 1, 2021, by and between iSpecimen Inc. and Versant Funding, LLC (incorporated by reference to Exhibit
10.29 of the Companys Form S-1/A4 (File No. 333-250198) filed with the SEC on April 27, 2021). | |
|
10.35 |
|
Waiver
Agreement, dated April 29, 2022, by and between the Company and Western Alliance Bank (incorporated by reference to Exhibit
10.1 of the Companys Form 8-K filed with the SEC on April 29, 2022). | |
|
10.36# |
|
First
Amendment to Executive Employment Agreement, dated as of June 20, 2022, between the Company and Christopher Ianelli (incorporated
by reference to Exhibit 10.1 of the Companys Form 8-K filed with the SEC on June 21, 2022). | |
|
10.37# |
|
First
Amendment to Executive Employment Agreement, dated as of June 20, 2022, between the Company and Jill Mullan (incorporated by reference
to Exhibit 10.2 of the Companys Form 8-K filed with the SEC on June 21, 2022). | |
|
10.38# |
|
First
Amendment to Executive Employment Agreement, dated as of June 20, 2022, between the Company and Tracy Curley (incorporated by reference
to Exhibit 10.3 of the Companys Form 8-K filed with the SEC on June 21, 2022). | |
|
10.39# |
|
First
Amendment to Executive Employment Agreement, dated as of June 20, 2022, between the Company and Benjamin Bielak (incorporated by
reference to Exhibit 10.4 of the Companys Form 8-K filed with the SEC on June 21, 2022). | |
|
10.40+# |
|
First
Amended and Restated Executive Employment Agreement, dated October 24, 2022, by and between Tracy Wilson Curley and iSpecimen Inc.
(incorporated by reference to Exhibit 10.1 of the Companys Form 8-K filed with the SEC on October 28, 2022). | |
70
|
10.41 |
|
First
Restated Noncompetition, Nonsolicitation, Nondisclosure and Inventions Agreement, dated October 24, 2022, by and between Tracy Wilson
Curley and iSpecimen Inc. (incorporated by reference to Exhibit 10.2 of the Companys Form 8-K filed with the SEC on October
28, 2022). | |
|
10.42+# |
|
First
Amended and Restated Executive Employment Agreement, dated October 24, 2022, by and between Benjamin Bielak and iSpecimen Inc. (incorporated
by reference to Exhibit 10.3 of the Companys Form 8-K filed with the SEC on October 28, 2022). | |
|
10.43 |
|
First
Restated Noncompetition, Nonsolicitation, Nondisclosure and Inventions Agreement, dated October 24, 2022, by and between Benjamin
Bielak and iSpecimen Inc. (incorporated by reference to Exhibit 10.4 of the Companys Form 8-K filed with the SEC on October
28, 2022). | |
|
10.44+ |
|
Separation
Agreement, dated October 24, 2022, by and between Christopher Ianelli and iSpecimen Inc. (incorporated by reference to Exhibit 10.5
of the Companys Form 8-K filed with the SEC on October 28, 2022). | |
|
10.45+ |
|
Separation
Agreement effective October 24, 2022, by and between Jill Mullan and iSpecimen Inc. (incorporated by reference to Exhibit 10.6 of
the Companys Form 8-K filed with the SEC on October 28, 2022). | |
|
10.46 |
|
Note
Purchase Agreement, dated as of September 19, 2024 (incorporated by reference to Exhibit 10.1 of the Companys Form 8-K filed
with the SEC on September 25, 2024). | |
|
10.47 |
|
Form
of Placement Agency Agreement, dated as of October 29, 2024 (incorporated by reference to Exhibit 10.1 of the Companys Form
8-K filed with the SEC on October 31, 2024). | |
|
10.48 |
|
Form
of Securities Purchase Agreement, dated as of October 29, 2024 (incorporated by reference to Exhibit 10.2 of the Companys
Form 8-K filed with the SEC on October 31, 2024). | |
|
10.49 |
|
Investor
Relations Agreement, dated October 31, 2024, by and between the Company and IR Agency LLC (incorporated by reference to Exhibit 10.3
of the Companys Form 8-K filed with the SEC on October 31, 2024). | |
|
14 |
|
Form
of Code of Business Conduct and Ethics (incorporated by reference to Exhibit 14 of the Companys Form S-1/A4 (File No. 333-250198)
filed with the SEC on April 27, 2021). | |
|
23.1* |
|
Consent of Bush & Associates CPA LLC. | |
|
31.1* |
|
Certification
of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a), as adopted Pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. | |
|
31.2* |
|
Certification
of Principal Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a), 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. | |
|
97.1 |
|
iSpecimen
Inc. Executive Compensation Clawback Policy (Adopted on October 27, 2023) (incorporated by reference to Exhibit 97.1 of the Companys
Form 10-K filed with the SEC on March 13, 2024). | |
|
101.INS* |
|
Inline XBRL Instance Document. | |
|
101.CAL* |
|
Inline XBRL Taxonomy Extension
Calculation Linkbase Document. | |
|
101.SCH* |
|
Inline XBRL Taxonomy Extension
Schema Document. | |
|
101.DEF* |
|
Inline XBRL Taxonomy Extension
Definition Linkbase Document. | |
|
101.LAB* |
|
Inline XBRL Taxonomy Extension
Labels Linkbase Document. | |
|
101.PRE* |
|
Inline XBRL Taxonomy Extension
Presentation Linkbase Document. | |
|
104* |
|
Cover Page Interactive
Data Filethe cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are
embedded within the Inline XBRL document. | |
|
* | Filed
herewith. |
|
|
** | Furnished
herewith. |
|
|
+ | Schedules
and exhibits have been omitted pursuant to Items 601(a)(5) and 601(b)(2) of Regulation S-K.
The Company agrees to furnish supplementally a copy of any omitted schedule or exhibit to
the SEC upon request. |
|
|
# | Indicates
management contract or compensatory plan or arrangement. |
|
**Item
16. Form 10-K Summary**
****
None.
71
**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 April 1, 2026.
|
|
iSPECIMEN, INC. | |
|
|
| |
|
|
By: |
/s/
Katharyn Field | |
|
|
|
Katharyn Field | |
|
|
|
Chief Executive Officer | |
Pursuant to the requirements of the Securities Exchange Act of 1934,
this report has been signed below on April 1, 2026, by the following persons on behalf of the registrant and in the capacities indicated:
|
Signature |
|
| |
|
|
|
| |
|
/s/ Katharyn
Field |
|
Chief Executive Officer, Treasurer and Secretary | |
|
Katharyn Field |
|
| |
|
|
|
| |
|
/s/ Yuying
Liang |
|
Principal Accounting and Financial Officer | |
|
Yuying Liang |
|
| |
|
|
|
| |
|
/s/ Anthony
Lau |
|
Director | |
|
Anthony Lau |
|
| |
|
|
|
| |
|
/s/ Avtar
Dhaliwal |
|
Director | |
|
Avtar Dhaliwal |
|
| |
|
|
|
| |
|
/s/ Arphing
(Tommy) Lee |
|
Director | |
|
Arphing (Tommy) Lee |
|
| |
72