UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31 , 2024
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE EXCHANGE ACT
Commission file number: 001-38728
(Exact name of registrant as specified in its charter)
Delaware 47-1685128
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
4400 Route 9 South , Suite 3100
Freehold , New Jersey 07728
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number: (732) 780-4400
Securities registered pursuant to Section 12(b)
of the Act:
Title of each Class: Trading Symbol Name of Each Exchange
Common Stock, $0.0001 par value per share ALBT The NASDAQ Capital Market
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 Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒
No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
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 Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or
issued its audit report. Yes ☐ No ☒
If securities are registered pursuant to Section
12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction
of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error
corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s
executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
No ☒
As of June 28, 2024, the last business day of the registrant’s
most recently completed second fiscal quarter, the market value of our common stock held by non-affiliates was approximately $ 2,757,095 .
The number of shares of our common stock, $0.0001
par value per share, outstanding as of March 31, 2025, was 1,651,667 .
Documents incorporated by reference: NONE
TABLE OF CONTENTS
Page
PART I
Item 1.
Business
1
Item 1A.
Risk Factors
13
Item 1B.
Unresolved Staff Comments
39
Item 1C.
Cybersecurity
39
Item 2.
Properties
40
Item 3.
Legal Proceedings
40
Item 4.
Mine Safety Disclosures
40
PART II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
41
Item 6.
[Reserved]
41
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
41
Item 7A.
Quantitative and Qualitative Disclosures About Market Risk
51
Item 8.
Financial Statements and Supplementary Data
51
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
51
Item 9A.
Controls and Procedures
51
Item 9B.
Other Information
52
Item 9C.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
52
PART III
Item 10.
Directors, Executive Officers and Corporate Governance
53
Item 11.
Executive Compensation
61
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
64
Item 13.
Certain Relationships and Related Transactions, and Director Independence
67
Item 14.
Principal Accounting Fees and Services
69
PART IV
Item 15.
Exhibits
70
Item 16.
Form 10-K Summary
80
Signatures
81
i
Cautionary Statement
Regarding Forward-Looking Statements
Certain statements in
this Annual Report on Form 10-K for the year ended December 31, 2024 may constitute “forward-looking” statements within
the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or the Private Securities Litigation Reform Act of 1995. All statements,
other than statements of historical facts, included herein and public statements by our officers or representatives, that address activities,
events or developments that our management expects or anticipates will or may occur in the future are forward-looking statements, including
but not limited to such things as future business strategy, plans and goals, competitive strengths and expansion and growth of our business.
The words “estimate,” “plan,” “anticipate,” “expect,” “intend,” “believe,”
“target,” “budget,” “may,” “can,” “will,” “would,” “could,”
“should,” “seeks,” or “scheduled to” and similar words or expressions, or negatives of these terms
or other variations of these terms or comparable language or any discussion of strategy or intention identify forward-looking statements.
Forward-looking statements address activities, events or developments that the Company expects or anticipates will or may occur in the
future and are based on current expectations and assumptions.
These statements involve
known and unknown risks, uncertainties, assumptions and other factors which may cause our actual results, performance or achievements
to be materially different from any results, performance or achievements expressed or implied by such forward-looking statements. See
our other reports filed with the Securities and Exchange Commission (the “SEC”) for more information about these and other
risks. You are cautioned against attributing undue certainty to forward-looking statements. Although we have attempted to identify important
factors that could cause actual results to differ materially from those described in forward-looking statements, there may be other factors
that cause results not to be as anticipated, estimated or intended. Although these forward-looking statements were based on assumptions
that the Company believes are reasonable when made, you are cautioned that forward-looking statements are not guarantees of future performance
and that actual results, performance or achievements may differ materially from those made in or suggested by the forward-looking statements
contained in this Annual Report on Form 10-K. In addition, even if our results, performance, or achievements are consistent with the forward-looking
statements contained in this Annual Report on Form 10-K, those results, performance or achievements may not be indicative of results,
performance or achievements in subsequent periods. Given these risks and uncertainties, you are cautioned not to place undue reliance
on these forward-looking statements. Any forward-looking statements made in this Annual Report on Form 10-K speak only as of the date
of those statements, and we undertake no obligation to update those statements or to publicly announce the results of any revisions to
any of those statements to reflect future events or developments. For information identifying important factors that could cause actual
results to differ materially from those anticipated in the forward-looking statements, see Item 1A. Risk Factors in this Annual Report
on Form 10-K.
Unless otherwise indicated, references to “we,”
“us,” “our,” “Company,” or “Avalon” mean Avalon GloboCare Corp. and its subsidiaries,
and references to “fiscal” mean the Company’s fiscal year ended December 31.
On October 28, 2024, the Company effectuated a reverse stock split
of the Company’s common stock at a ratio of 1-for-15 (the “Reverse Stock Split”). All amounts and values presented in
this Annual Report on Form 10-K have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented, unless
otherwise indicated.
ii
PART I
ITEM 1. BUSINESS
We are a commercial-stage
company dedicated to developing and delivering precision diagnostic consumer products. We are currently marketing the Keto Air breathalyzer
device and plan to develop additional diagnostic uses of the breathalyzer technology. We also provided laboratory services in 2024 and
2023, offering a broad portfolio of diagnostic tests, including drug testing, toxicology, and a broad array of test services, from general
bloodwork to anatomic pathology, and urine toxicology. We completed an acquisition of a 40% membership interest in Laboratory Services
MSO, LLC (“Lab Services MSO”), which closed in February 2023. During 2025, to preserve cash, the Company entered into discussions
with Lab Services MSO for the potential redemption of our investment and on February 26, 2025, we and Lab Services MSO entered into a
Redemption and Abandonment Agreement, whereby Lab Services MSO redeemed the 40% equity interest in Lab Services MSO held by us. Accordingly,
beginning in February 2025, we no longer offer laboratory services.
In 2024, we
initiated sales of our first diagnostic consumer product, Keto Air, a device that tests ketosis levels.
We had the following areas of focus in 2024 and 2023:
Laboratory Acquisitions
We had embarked on a laboratory rollup strategy focused on forming joint ventures and acquiring laboratories that were accretive to our
commercial strategy. As a first step, in February 2023, we acquired a 40% membership interest in Lab Services MSO. Among other things,
Lab Services MSO provides toxicology and wellness testing services, a broad portfolio of diagnostic tests, and a broad array of test services.
During 2025, to preserve cash, the Company entered into discussions with Lab Services MSO for the potential redemption of our investment
and on February 26, 2025, we and Lab Services MSO entered into a Redemption and Abandonment Agreement, whereby Lab Services MSO redeemed
the 40% equity interest in Lab Services MSO held by us. Accordingly, beginning in February 2025, we no longer offer laboratory services.
Research and Development
We are focused on bringing forward intellectual property through joint
patent filings with the Massachusetts Institute of Technology (“MIT”). We completed a sponsored research and co-development
project with MIT led by Professor Shuguang Zhang as Principal Investigator. Using the unique QTY code protein design platform, six water-soluble
variant cytokine receptors have been successfully designed and tested to show binding affinity to the respective cytokines. We currently
are focused on bringing forward the intellectual property associated with this program through joint patent submissions, new research
and development has been suspended.
Product Commercialization
We have begun the commercialization
and development of a versatile breathalyzer system.
We were granted
exclusive distributorship rights for the KetoAir from Qi Diagnostics for the following territories: North America, South America,
the EU and the UK. For our commercialization strategy, we intend to target the diabetes and obesity markets. We sell the
product through the KetoAir website and social media. We believe the KetoAir device has some competitive advantages to other methods
for measuring ketosis.
The KetoAir device is
a handheld device that allows the user to detect acetone levels in exhaled breath. The acetone level is in concentration units (ppm, part-per-million)
such that the user will know his/her real-time ketosis status: inadequate ketosis (0-3.99 ppm), mild ketosis (4-9.99 ppm), optimal ketosis
(10-40 ppm), or alarming level (> 40 ppm). The KetoAir is registered with the United States Food and Drug Administration as a Class
I medical device. The device is also paired with an “AI Nutritionist” software program (via Bluetooth connection) which is
downloadable from Google Play (for Android mobile phones, approved) and iPhone It helps users monitor and manage their ketogenic diet
and related programs. We believe the KetoAir can be an essential tool to help diabetic patients adhere to their therapeutic programs and
optimize their ketogenic dietary management.
1
Other Areas
In order to preserve
cash and focus on our core laboratory rollup strategy and product commercialization, we have currently suspended all research and development
efforts related to cellular therapy in order to redirect our funding efforts to our core business strategies outlined above.
China Operations
Due to the winding down of the medical related consulting services
segment, in November 2022, we decided to cease all operations in the People’s Republic of China (the “PRC”) with the
exception of a small administrative office, in Beijing. We do not expect nor do we plan
that we will further operate in the PRC or generate revenue from PRC operations for the foreseeable future.
The accompanying consolidated financial statements
reflect the activities of the Company and each of the following entities:
Name of Subsidiary
Place and Date of
Incorporation
Percentage of
Ownership
Principal Activities
Avalon Healthcare System, Inc. (“AHS”)
Delaware
May 18, 2015
100% held by Company
Holding company for payroll and other expenses
Avalon RT 9 Properties, LLC (“Avalon RT 9”)
New Jersey February 7, 2017
100% held by Company
Owns and operates an income-producing real property and holds and manages the corporate headquarters
Avalon (Shanghai) Healthcare Technology Co., Ltd. (“Avalon Shanghai”)
PRC April 29, 2016
100% held by AHS
Is not considered an operating entity
Genexosome Technologies Inc. (“Genexosome”)
Nevada July 31, 2017
60% held by Company
No current activities to report, dormant
Avactis Biosciences Inc. (“Avactis”)
Nevada
July 18, 2018
60% held by Company
Dormant,
is in process of being dissolved
Avactis Nanjing Biosciences Ltd. (“Avactis Nanjing”)
PRC
May 8, 2020
100% held by Avactis
Dormant,
is in process of being dissolved
Avalon Laboratory Services, Inc. (“Avalon Lab”)
Delaware
October 14, 2022
100% held by Company
Laboratory holding company with a 40% membership interest in Lab Services MSO as of December 31, 2024 (1)
Q&A Distribution LLC
(“Q&A Distribution”)
Texas
May 1, 2024
100% held by Company
Distributes KetoAir device
(1) On February 26, 2025, we and Lab Services MSO entered into a Redemption and Abandonment Agreement, whereby
Lab Services MSO redeemed the 40% equity interest in Lab Services MSO held by us.
2
Sales and Marketing
We launched sales of the KetoAir in the U.S. in
2024. We have retained a marketing expert to assist us to bring this product to market through social media, influencer promotion and
our website. We launched this product at the 2024 “KetoCon” convention which took place May 31, 2024 in Austin Texas.
Markets
Laboratory Services
During 2024 and 2023 and until February 2025,
through our membership interest in Lab Services MSO, we were focused on delivering high quality services related to toxicology and wellness
testing. The panels that we tested for were thyroid panel, comprehensive metabolic panel, kidney profile, liver function tests, and other
individual tests.
We offered our laboratory services in California,
Texas and Arizona. During 2025, to preserve cash, the Company entered into discussions with Lab Services MSO for the potential redemption
of our investment and on February 26, 2025, we and Lab Services MSO entered into a Redemption and Abandonment Agreement, whereby Lab Services
MSO redeemed the 40% equity interest in Lab Services MSO held by us. Accordingly, beginning in February 2025, we no longer offer laboratory
services.
Breathalyzer System (KetoAir)
Our current area of focus for the launch of the
KetoAir is within the U.S. We are focused on the population within the U.S. that is using the Keto Diet approach to weight loss and diabetic
management.
Avalon RT 9 Properties, LLC
We own commercial property located in Freehold,
New Jersey. This property serves as our corporate headquarters and contains several commercial tenants that generate revenue through rental
income.
Strategic Development
In late 2024, we launched an initiative seeking
transformational merger candidates. The Company determined that it had limited access to cash and it was in the best interest of shareholders
to seek a strategic merger.
Intellectual Property
Our goal is to obtain, maintain and enforce
patent rights for our products, formulations, processes, methods of use and other proprietary technologies, preserve our trade
secrets, and operate without infringing on the proprietary rights of other parties, both in the United States and abroad. Our policy
is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our current product
candidates and any future product candidates, proprietary information and proprietary technology through a combination of
contractual arrangements and patents, both in the United States and abroad. Even patent protection, however, may not always afford
us with complete protection against competitors who seek to circumvent our patents. If we fail to adequately protect or enforce our
intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish. To
this end, we require all of our employees, consultants, advisors and other contractors to enter into confidentiality agreements that
prohibit the disclosure and use of confidential information and, where applicable, require disclosure and assignment to us of the
ideas, developments, discoveries and inventions relevant to our technologies and important to our business.
3
Competition
General
Many of our existing and potential future competitors
have significantly greater financial resources and expertise in operations, research and development, manufacturing, obtaining marketing
approvals and marketing approved products than we do. Mergers and acquisitions may result in even more resources being concentrated among
a smaller number of our competitors. Smaller, or early stage, companies may also prove to be significant competitors, particularly through
collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified
scientific and management personnel, as well as in acquiring technologies complementary to, or necessary for, our programs.
We expect that our ability to compete effectively
will depend upon our ability to:
● maintain a proprietary position
for our manufacturing processes and other technology;
● produce our products in accordance
with FDA and international regulatory guidelines;
● attract and retain key personnel;
and
● build or access an adequate
sales and marketing infrastructure for any approved products.
Failure to do one or more of these activities
could have an adverse effect on our business, financial condition or results of operations.
4
Avalon RT 9 Properties, LLC
We own commercial property located in Freehold,
New Jersey. This property serves as our corporate headquarters and contains several commercial tenants that generate revenue through rental
income. The property is located on a major highway and is one of the largest buildings in the surrounding areas. It is centrally located
and maintains high occupancy. There are other commercial properties in the vicinity that offer similar amenities. However, premier executive
offices are limited and as such, we expect to continue to maintain high occupancy in the near term.
Employees
As of March 31, 2025, we employed five employees,
four of which are full time employees. None of our employees is represented by a collective bargaining arrangement.
Government Regulation
Overview
The healthcare industry in the U.S. is highly
regulated and subject to changing political, legislative, regulatory, and other influences. Further, the healthcare industry is currently
undergoing rapid change. We are uncertain how, when or in what context these new changes will be adopted or implemented. These new regulations
could create unexpected liabilities for us, could cause us or our members to incur additional costs and could restrict our or our clients’
operations. Many of the laws are complex and their application to us, our clients, or the specific services and relationships we have
with our members are not always clear. Our failure to anticipate accurately the application of these laws and regulations, or our other
failure to comply, could create liability for us, result in adverse publicity, and otherwise negatively affect our business.
Holding Foreign Companies Accountable Act
Compliance
The Holding Foreign Companies Accountable Act,
or the HFCA Act, was enacted on December 18, 2020. According to the HFCA Act, if the SEC determines that Avalon has filed audit reports
issued by a registered public accounting firm that has not been subject to inspection by the PCAOB for three consecutive years beginning
in 2021, the SEC will prohibit Avalon’s securities from being traded on a national securities exchange or in the over-the-counter
trading market in the United States.
On December 16, 2021, the PCAOB issued a Determination
Report which reported that the PCAOB is unable to inspect or investigate completely registered public accounting firms headquartered in:
(1) mainland China of the People’s Republic of China, because of a position taken by one or more authorities in mainland China;
and (2) Hong Kong, a Special Administrative Region of the PRC, because of a position taken by one or more authorities in Hong Kong.
Avalon’s auditor is M&K CPAS PLLC (M&K”), based
in Texas. M&K is registered with the PCAOB and is subject to laws in the United States pursuant to which the PCAOB conducts regular
inspections to assess their compliance with the applicable professional standards. Since M&K is located in the United States, the
PCAOB has been able to conduct inspections of M&K. In addition, M&K is not among the PCAOB registered public accounting firms
registered in mainland China or Hong Kong that are subject to PCAOB’s determination on December 16, 2021.
5
Other Healthcare Fraud and Abuse Laws
In the U.S., our activities are potentially subject
to regulation by various federal, state and local authorities in addition to the FDA, including but not limited to, the Centers for Medicare
and Medicaid Services, or CMS, other divisions of the U.S. Department of Health and Human Services (such as the Office of Inspector General
and the Health Resources and Service Administration), the U.S. Department of Justice, or the DOJ, and individual U.S. Attorney offices
within the DOJ, and state and local governments. For example, sales, marketing and scientific/educational grant programs may have to comply
with the anti-fraud and abuse provisions of the Social Security Act, the false claims laws, the privacy and security provisions of the
Health Insurance Portability and Accountability Act, or HIPAA, and similar state laws, each as amended, as applicable.
The federal Anti-Kickback Statute prohibits, among
other things, any person or entity from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or
indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase,
lease or order of any item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federal healthcare programs.
The term remuneration has been interpreted broadly to include anything of value. The Anti-Kickback Statute has been interpreted to apply
to arrangements between therapeutic product manufacturers on one hand and prescribers, purchasers, and formulary managers on the other.
There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. The exceptions
and safe harbors are drawn narrowly and practices that involve remuneration that may be alleged to be intended to induce prescribing,
purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of the
requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the
Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review
of all of its facts and circumstances. Additionally, the intent standard under the Anti-Kickback Statute was amended by the ACA to a stricter
standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order
to have committed a violation. In addition, the ACA codified case law that a claim including items or services resulting from a violation
of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act, or FCA.
The federal false claims and civil monetary penalty
laws, including the FCA, which imposes significant penalties and can be enforced by private citizens through civil qui tam actions, prohibit
any person or entity from, among other things, knowingly presenting, or causing to be presented, a false or fraudulent claim for payment
to, or approval by, the federal healthcare programs, including Medicare and Medicaid, or knowingly making, using, or causing to be made
or used a false record or statement material to a false or fraudulent claim to the federal government. A claim includes “any request
or demand” for money or property presented to the U.S. government. For instance, historically, pharmaceutical and other healthcare
companies have been prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers
would bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of
the companies’ marketing of the product for unapproved, off-label, and thus generally non-reimbursable, uses.
HIPAA created additional federal criminal statutes
that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means
of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any
healthcare benefit program, including private third-party payors, willfully obstructing a criminal investigation of a healthcare offense,
and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially
false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Like
the Anti-Kickback Statute, the ACA amended the intent standard for certain healthcare fraud statutes under HIPAA such that a person or
entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
Many states have similar, and typically more prohibitive,
fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other state programs, or, in several
states, apply regardless of the payor. Additionally, to the extent that our product candidates may in the future be sold in a foreign
country, we may be subject to similar foreign laws.
6
We may be subject to data privacy and security
regulations by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information
Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, imposes requirements relating to the privacy,
security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and
security standards directly applicable to business associates, independent contractors, or agents of covered entities that receive or
obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new
tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and
gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek
attorneys’ fees and costs associated with pursuing federal civil actions. In addition, many state laws govern the privacy and security
of health information in specified circumstances, many of which differ from each other in significant ways, are often not pre-empted by
HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance efforts.
We expect our product, after approval, may be
eligible for coverage under Medicare, the federal health care program that provides health care benefits to the aged and disabled, and
covers outpatient services and supplies, including certain pharmaceutical products, that are medically necessary to treat a beneficiary’s
health condition. In addition, the product may be covered and reimbursed under other government programs, such as Medicaid and the 340B
Drug Pricing Program. The Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national
rebate agreement with the Secretary of the Department of Health and Human Services as a condition for states to receive federal matching
funds for the manufacturer’s outpatient drugs furnished to Medicaid patients. Under the 340B Drug Pricing Program, the manufacturer
must extend discounts to entities that participate in the program. As part of the requirements to participate in certain government programs,
many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the government, such as average manufacturer
price, or AMP, and best price. Penalties may apply in some cases when such metrics are not submitted accurately and timely.
Additionally, the federal Physician Payments Sunshine
Act, or the Sunshine Act, within the ACA, and its implementing regulations, require that certain manufacturers of drugs, devices, biological
and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain
exceptions) report annually to CMS information related to certain payments or other transfers of value made or distributed to physicians
and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals
and to report annually certain ownership and investment interests held by physicians and their immediate family members. Failure to report
accurately could result in penalties. In addition, many states also govern the reporting of payments or other transfers of value, many
of which differ from each other in significant ways, are often not pre-empted, and may have a more prohibitive effect than the Sunshine
Act, thus further complicating compliance efforts.
New Legislation and Regulations
From time to time, legislation is drafted, introduced
and passed in Congress that could significantly change the statutory provisions governing the testing, approval, manufacturing and marketing
of products regulated by the FDA. In addition to new legislation, FDA regulations and policies are often revised or interpreted by the
agency in ways that may significantly affect our business and our products. It is impossible to predict whether further legislative changes
will be enacted or whether FDA regulations, guidance, policies or interpretations will be changed or what the effect of such changes,
if any, may be.
Recent Developments
Mortgage and Security
Agreement
On March 27, 2024, the Company entered into a Mortgage and Security
Agreement (the “Mast Hill Mortgage”) with Mast Hill Fund L.P. (“Mast Hill”) to secure the payment performance
and obligation under certain follow-up financing agreements described below.
In March 2024, the Company entered into follow-up financing agreements
with Mast Hill, which included the issuance of 13% senior secured promissory notes totaling $700,000 convertible into common stock, as
well as the issuance of up to 7,000 shares of common stock as a commitment fee, and warrants for the purchase of up to 8,750 shares of
common stock at an initial price per share of $30.00, and common share purchase warrants for the purchase of up to 8,077 shares of common
stock at an initial price per share of $19.50, with a total purchase price of $665,000 (the “2024 Financing Agreements”).
These agreements were made under the same terms and conditions of the prior rounds of convertible note financing in October 2023 and May
2023 (the “2023 Financing Agreements”).
On March 27, 2024, the Company also entered into a Mortgage and Security
Agreement (the “Firstfire Mortgage”) with Firstfire Global Opportunities Fund, LLC (“Firstfire”) to secure the
payment performance and obligation under the 2023 Financing Agreements.
7
Convertible Note
Financing and Mortgage and Security Agreement
On June 5, 2024, the Company entered into securities purchase agreements
(the “ Securities Purchase Agreements ”) with Mast Hill for the issuance of 13% senior secured promissory notes in the
aggregate principal amount of $2,845,000 (collectively, the “Notes”) convertible into shares of the Company’s common
stock, as well as the issuance of up to 26,800 shares of common stock as a commitment fee and warrants for the purchase of up to 146,667
shares of common stock (the “Convertible Note Financing”). The Company and its subsidiaries entered into those certain security
agreements (the “Security Agreements”), creating a security interest in certain property of the Company and its subsidiaries
to secure the prompt payment, performance and discharge in full of all of the Company’s obligations under the Notes. The transaction
closed on June 5, 2024.
Mast Hill acquired the Notes with principal amount of $2,845,000
and paid the purchase price of $2,702,750 after an original issue discount of $142,250, with a conversion price of $11.25, subject to
adjustment as provided in Notes. Also on June 5, 2024, the Company issued (i) a warrant to purchase 66,667 shares of common stock with
an exercise price of $9.75 exercisable until June 5, 2029 (the “First Warrant”), (ii) a warrant to purchase 80,000 shares
of common stock with an exercise price of $7.50 exercisable until June 5, 2029, which warrant shall be cancelled and extinguished against
payment of the Notes (the “Second Warrant” and collectively with the First Warrant, the “Warrants”), and (iii)
26,800 shares of common stock to Mast Hill as additional consideration for the purchase of the Note ( the “Commitment Shares”),
which were earned in full as of June 5, 2024. On the closing date, the Company delivered such duly executed Notes, warrants and common
stock to Mast Hill against delivery of such purchase price.
The Company used the
proceeds from the Convertible Note Financing to pay off all previously issued convertible notes to Mast Hill and Firstfire.
On June 5, 2024, the Company also entered into a Mortgage and Security
Agreement (the “Mortgage”) with Mast Hill to secure the payment, performance, and obligations under the above-mentioned Convertible
Note Financing. As of June 5, 2024, the Company was indebted to Mast Hill in the combined principal sum of $2,845,000.
On December
15, 2024, the Company and Mast Hill entered into that certain consent, acknowledgement, and waiver agreement, pursuant to which Mast Hill
waived all amortization payments required to be made under the Note, the Company paid a waiver fee of $150,000 to Mast Hill, and the Company
issued to Mast Hill a common stock purchase warrant for the purchase of up to 150,000 shares of the Company’s common stock.
At-the-Market
Offering
In June 2023, the Company entered
into a sales agreement (the “Sales Agreement”) with Roth Capital Partners, LLC (“Roth”) under which the Company
could offer and sell from time to time shares of its common stock having an aggregate offering price of up to $3.5 million. From
July 1, 2023 to August 16, 2024, we sold an aggregate of 312,285 shares of our common stock at an average price of $11.19 per share to
investors pursuant to the Sales Agreement, and received net cash proceeds of $3,388,251, net of cash paid for Roth’s commissions
and other fees of $104,992.
Reverse Stock Split & Decrease in Authorized
Shares
On October 23, 2024,
the Company filed a certificate of amendment (the “Amendment”) to its Certificate of Incorporation with the Secretary of State
of the State of Delaware to effectuate a reverse stock split of the Company’s common stock at a ratio of 1-for-15 (the “Reverse
Stock Split”), as well as the decrease in the number of shares of common stock authorized for issuance from 490,000,000 to 100,000,000.
The Amendment became effective at 5:00 p.m. ET on October 25, 2024.
8
Series C Convertible Preferred Stock
On December 13, 2024,
the Company filed a certificate of designations of preferences, rights, and limitations of Series C Convertible Preferred Stock (the “Series
C Certificate of Designations”) with the State of Delaware which provides for the designation of 10,000 shares of Series C preferred
stock of the Company, par value $0.0001 per share, upon the terms and conditions as set forth in the Series C Certificate of Designations.
Each share of Series C Preferred Stock has a stated value of $1,000 (the “Stated Value”).
The Series C Preferred
Stock shall rank (i) senior to the Company’s common stock (the “Common Stock”) and any other class or series of capital
stock of the Company created hereafter, the terms of which specifically provide that such class or series shall rank junior to the Series
C Preferred Stock, (ii) pari passu with any class or series of capital stock of the Company created hereafter specifically ranking, by
its terms, on par with the Series C Preferred Stock, (iii) pari passu with Series B Convertible Preferred Stock of the Company (the “Series
B Preferred Stock”) with respect to its rights, preferences and restrictions, and (iv) subordinate to the Series A Convertible Preferred
Stock of the Company (the “Series A Preferred Stock”).
Holders of the Series
C Preferred Stock shall be entitled to receive, and the Company shall pay, dividends on shares of Series C Preferred Stock equal (on an
as-if-converted-to-common-stock basis, disregarding for such purpose any conversion limitations hereunder) to and in the same form as
dividends actually paid on shares of the common stock when, as and if such dividends are paid on shares of the common stock.
Holders of the Series
C Preferred Stock have no voting power except as otherwise required by the Delaware General Corporation Law.
Upon any liquidation,
dissolution or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”), the holders of the Series C
Preferred Stock shall be entitled to receive out of the assets available for distribution to stockholders, (i) after and subject to the
payment in full of all amounts required to be distributed to the holders of another class or series of stock of the Company ranking on
liquidation prior and in preference to the Series C Preferred Stock, including the Series A Preferred Stock, (ii) ratably with any class
or series of stock ranking on liquidation on parity with the Series C Preferred Stock and (iii) in preference and priority to the holders
of the shares of common stock, an amount equal to 100% of the Stated Value of the Series C Preferred Stock, in proportion to the full
and preferential amount that all shares of the Series C Preferred Stock are entitled to receive.
Each share of Series
C Preferred Stock shall be convertible into common stock (the “Conversion Shares”) at a conversion per share equal to $2.41,
at the option of the holder, at any time after the later of (i) the date of the shareholder approval of the issuance of the Conversion
Shares pursuant to the rules of the Nasdaq Stock Market and (ii) the one year anniversary of the date of the first issuance of any shares
of the Series C Preferred Stock. In addition, the holder shall not have the right to convert any portion of the Series C Preferred Stock
if, after giving effect to the conversion, such holder (together with its affiliates) would beneficially own in excess of 19.99% of the
number of shares of the common stock outstanding immediately after giving effect to the issuance of the respective Conversion Shares.
York Sun Securities
Purchase Agreement
On December 19, 2024,
the Company entered into that certain securities purchase agreement (the “Securities Purchase Agreement”), with an accredited
investor, York Sun Investment Holding Limited (the “Investor”), pursuant to which the Company agreed to issue and sell to
the Investor, upon the terms and conditions set forth in the Securities Purchase Agreement, up to 7,000 shares of Series C Convertible
Preferred Stock for up to an aggregate of $7,000,000 (the “Purchase Price”), which is equal to $1,000 per share. The first
closing occurred on December 24, 2024, with respect to the Investor’s purchase of 3,500 shares of Series C Convertible Preferred
Stock in exchange for $3,500,000.
The Investor shall also
have a right of first refusal during the period beginning on the date of the Securities Purchase Agreement and continuing until such shareholder
approval is obtained, on all issuances of convertible preferred stock of the Company, excluding agreements that are in place prior to
the date of the Securities Purchase Agreement and issuances of new classes of convertible preferred stock in exchange for existing classes
of convertible preferred stock. Additionally, the Investor has the right, pursuant to the Securities Purchase Agreement to appoint one
member to, or to replace one member of, the Company’s board of directors, subject to all applicable Nasdaq rules.
The Investor’s
purchase of the remaining 3,500 shares of Series C Convertible Preferred Stock under the Securities Purchase Agreement in exchange for
an additional $3,500,000 is required to occur within 120 calendar days of the date of the Securities Purchase Agreement, subject to the
satisfaction of customary closing conditions.
9
Series D Convertible Preferred Stock
On January 6, 2025, the
Company filed a certificate of designations of preferences, rights, and limitations of Series D Convertible Preferred Stock (the “Series
D Certificate of Designations”) with the Department of State, Division of Corporations, of the State of Delaware, which provides
for the designation of 5,000 shares of Series D Preferred Stock of the Company, par value $0.0001 per share, upon the terms and conditions
as set forth in the Series D Certificate of Designations. Each share of Series D Preferred Stock has a stated value of $1,000 (the “Stated
Value”).
The Series D Preferred
Stock shall rank (i) senior to the Company’s common stock and any other class or series of capital stock of the Company created
hereafter, the terms of which specifically provide that such class or series shall rank junior to the Series D Preferred Stock, (ii) pari
passu with any class or series of capital stock of the Company created hereafter specifically ranking, by its terms, on par with the Series
D Preferred Stock, (iii) pari passu with the Series B Convertible Preferred Stock of the Company (the “Series B Preferred Stock”)
with respect to its rights, preferences and restrictions, and (iv) pari passu with the Series C Convertible Preferred Stock of the Company
(the “Series C Preferred Stock”).
Holders of the Series
D Preferred Stock have no voting power except as otherwise required by the Delaware General Corporation Law.
Upon any liquidation,
dissolution or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”), the holders of the Series D
Preferred Stock shall be entitled to receive out of the assets available for distribution to stockholders, (i) after and subject to the
payment in full of all amounts required to be distributed to the holders of another class or series of stock of the Company ranking on
liquidation prior and in preference to the Series D Preferred Stock, including the Series A Preferred Stock, (ii) ratably with any class
or series of stock ranking on liquidation on parity with the Series D Preferred Stock and (iii) in preference and priority to the holders
of the shares of Common Stock, an amount equal to 100% of the Stated Value of the Series D Preferred Stock, in proportion to the full
and preferential amount that all shares of the Series D Preferred Stock are entitled to receive.
Each share of Series
D Preferred Stock shall be convertible into common stock (the “Conversion Shares”) at a conversion per share equal to $2.41,
at the option of the holder, at any time after the Company has obtained shareholder approval for the issuance of the Conversion Shares
pursuant to the rules of the Nasdaq Stock Market. In addition, the holder shall not have the right to convert any portion of the Series
D Preferred Stock if, after giving effect to the conversion, such holder (together with its affiliates) would beneficially own in excess
of 4.99% of the number of shares of the common stock outstanding immediately after giving effect to the issuance of the respective Conversion
Shares.
Wenzhao Lu Exchange Agreement
On January
9, 2025, the Company entered into an exchange agreement with Wenzhao Lu, the Chairman of the Board of Directors of the Company, pursuant
to which Mr. Lu exchanged 9,000 shares of Series A Preferred Stock of the Company for 5,000 shares of Series D Preferred Stock of the
Company pursuant to an exemption from registration under Section 3(a)(9) of the Securities Act of 1933, as amended (the “Exchange”).
Upon consummation of the Exchange, there were no shares of Series A Preferred Stock of the Company outstanding.
Redemption Agreement
During 2025, to preserve
cash, the Company entered into discussions with Lab Services MSO for the potential redemption of our investment and on February 26, 2025,
the Company, Avalon Lab, Laboratory Services MSO, and the other parties signatory thereto, entered into a Redemption and Abandonment Agreement
(the “Redemption Agreement”), whereby Laboratory Services MSO redeemed the 40% equity interest in Laboratory Services MSO
held by Avalon Lab for cash and the surrender of its Series B Convertible Preferred Stock having a carrying value of $11,000,000 (the
“Redemption”). The aggregate cash amount to Avalon Lab for the Redemption was $1,745,000, to be paid as follows: one payment
of $95,000 at the closing of the Redemption and, beginning in March 2025, monthly payments of $75,000 until December 2026. In addition,
pursuant to the terms of the Redemption Agreement, all shares of Avalon’s Series B Convertible Preferred Stock previously issued
to SCBC Holdings LLC as partial consideration for the equity interests of Laboratory Services MSO, were permanently surrendered and relinquished
to Avalon for no additional consideration. As a result of the Redemption, beginning in February 2025, we no longer offer laboratory services.
10
Agreement and Plan
of Merger
On March 7, 2025, the
Company, Nexus MergerSub Limited, a wholly owned subsidiary of the Company (“Merger Sub”), and YOOV Group Holding Limited
(“YOOV”) entered into an Agreement and Plan of Merger (the “Merger Agreement”) pursuant to which Merger Sub will
merge with and into YOOV, with YOOV surviving the merger and becoming a direct, wholly owned subsidiary of the Company (the “Merger”).
The Merger is expected to be completed in the third quarter of 2025, subject to customary closing conditions.
Subject to the terms
and conditions of the Merger Agreement, immediately prior to the effective time of the Merger (the “Effective Time”), each
then-outstanding share of YOOV preferred shares, par value $0.10 per share, will either automatically be converted into shares of YOOV
ordinary shares, par value $0.10 per share (the “YOOV Ordinary Shares”) or canceled and cease to exist in accordance with
their terms. At the Effective Time, each then-outstanding YOOV Ordinary Share (other than any shares held in treasury and Dissenting Shares
(as defined in the Merger Agreement)) will be automatically converted into a number of shares of the Company’s common stock equal
to the Exchange Ratio. The “Exchange Ratio” will be the ratio (rounded to four decimal places), determined as follows: if
the closing price of the Company’s common stock on Nasdaq on the second trading day immediately preceding the Effective Time is
(x) less than or equal to $5.00, the Exchange Ratio shall be 60,000,000 divided by the Company Outstanding Shares (as defined in the Merger
Agreement); or (y) greater than $5.00, the Exchange Ratio shall be 54,000,000 divided by the Company Outstanding Shares.
Pursuant to the terms
of the Merger Agreement, (i) each then-outstanding share of the Company’s common stock will remain issued and outstanding after
the Effective Time and (ii) each then-outstanding option to purchase Company common stock, whether or not vested, will remain issued and
outstanding after the Effective Time. The then-outstanding shares of Series C Convertible Preferred Stock and Series D Convertible Preferred
Stock will remain outstanding in accordance with their terms. Additionally, at the Effective Time, the Company’s name will be changed
to “YOOV, Inc.”
In connection with the
Merger, the Company will seek approval of its stockholders to, among other things, (i) approve the issuance of the shares of the Company’s
common stock to be issued to YOOV shareholders in connection with the Merger pursuant to the rules of Nasdaq and (ii) amend the Company’s
certificate of incorporation to effect a reverse stock split of the Company’s common stock to the extent the Company and YOOV mutually
agree implementing such reverse stock split is necessary to meet Nasdaq’s listing requirements (collectively, the “Avalon
Stockholder Matters”).
Each of the Company
and YOOV have made customary representations, warranties and covenants in the Merger Agreement, including, among other things,
covenants relating to (i) obtaining the requisite approval of its respective stockholders, (ii) non-solicitation or facilitation of
any Takeover Proposal or Superior Proposal (as each is defined in the Merger Agreement), (iii) the conduct of its respective
business during the period between the signing of the Merger Agreement and the closing of the Merger, and (iv) the Company filing
with the SEC and causing to become effective a registration statement on Form S-4 (the “Registration Statement”) to
register the shares of the Company’s common stock to be issued in connection with the Merger.
Consummation of the Merger
is subject to certain closing conditions, including, among other things, (i) approval of the Avalon Stockholder Matters by the requisite
stockholders of the Company, (ii) adoption and approval of the Merger Agreement, and the transactions contemplated thereby, by the requisite
YOOV shareholders, (iii) the effectiveness of the Registration Statement and (iv) the listing of the Company’s common stock issuable
in connection with the Merger on Nasdaq. Each party’s obligation to consummate the Merger is also subject to other specified customary
conditions, including regarding the accuracy of the representations and warranties of the other party, subject to the applicable materiality
standard, and the performance in all material respects by the other party of its obligations under the Merger Agreement required to be
performed on or prior to the Effective Time.
The Merger Agreement
contains certain termination rights for both the Company and YOOV, including the right to terminate the Merger Agreement at any time before
the Effective Time, whether before or after the Avalon Stockholder Matters have been approved, by mutual written consent of the parties.
In addition, the Merger Agreement may be terminated at any time by either party if the Merger is not consummated on or before March 7,
2026 (the “End Date”), provided that the End Date may be extended by either party for up to 60 days in the event that the
SEC has not declared effective the Registration Statement by the date which is 60 days prior to the End Date. Upon termination of the
Merger Agreement under specified circumstances, the Company may be required to pay YOOV a termination fee of $1.0 million; however, YOOV
is not required to pay the Company a termination fee.
At the Effective Time,
the Company’s board of directors (the “Avalon Board”) is expected to consist of seven members, five of whom will be
designated by YOOV and two of whom will be designated by the Company, as provided in the Merger Agreement.
11
Voting and Support
Agreements
Concurrently with the
execution of the Merger Agreement, (i) the officers, directors and certain shareholders of YOOV (solely in their respective capacities
as YOOV shareholders) have entered into voting and support agreements with the Company and YOOV, pursuant to which such YOOV shareholders
agree, among other things to, (a) not transfer their capital stock of YOOV, subject to certain limited exceptions and (b) vote all of
their shares of capital stock of YOOV in favor of the adoption and approval of the Merger Agreement and the transactions contemplated
thereby and against, among other things, any Takeover Proposals (the “YOOV Voting Agreement”) and (ii) the officers, directors
and certain stockholders of the Company (solely in their respective capacities as the Company stockholders) have entered into voting and
support agreements with the Company and YOOV, pursuant to which such Company stockholders agree, among other things to, (a) not transfer
their capital stock of the Company, subject to certain limited exceptions and (b) vote all of their shares of Company capital stock in
favor of, among other things, the Avalon Stockholder Matters and against, among other things, any Takeover Proposals (the “Avalon
Voting Agreement”).
Lock-Up Agreements
Concurrently with the
execution of the Merger Agreement, certain directors, officers and stockholders of each of the Company and YOOV have entered into lock-up
agreements (the “Lock-Up Agreement”), pursuant to which, subject to specified exceptions, they have agreed not to transfer
their shares of the Company’s common stock during the 180-day period following the Effective Time.
Certificates of Elimination
On March 7, 2025, the
Company filed a Certificate of Elimination relating to each of the Series A Preferred Stock and the Series B Preferred Stock (the “Eliminations
of Designation”) with the Secretary of State of the State of Delaware, thereby terminating the designations of the Series A Preferred
Stock and the Series B Preferred Stock. The Eliminations of Designation were effective upon filing and eliminated from the Company’s
Amended and Restated Certificate of Incorporation all matters set forth in the previously-filed Certificates of Designations with respect
to the previously designated Series A Preferred Stock and Series B Preferred Stock.
Bylaws Amendment
On March 7, 2025, the
Board approved and adopted an amendment (the “Amendment”) to the Company’s Amended and Restated Bylaws (the “Bylaws”). The
Amendment reduces the quorum at any meeting of stockholders, except as otherwise required by law or by the Company’s Amended and
Restated Certificate of Incorporation or the Bylaws, to one-third of the voting power of the shares of capital stock outstanding and entitled
to vote at the meeting, present in person, present by remote communication, if applicable, or represented by proxy.
Corporate and Available Information
We were incorporated in Delaware. Our website
is located at http://www.avalon-globocare.com. On our website, investors can obtain, free of charge, a copy of our Annual Reports
on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, our Code of Conduct and Business Ethics, including disclosure
related to any amendments or waivers thereto, and other reports and any amendments thereto filed or furnished pursuant to Section 13(a)
or 15(d) of the Exchange Act as soon as reasonably practicable after we file such material electronically with, or furnish it to, the
SEC. None of the information posted on our website is incorporated by reference into this Annual Report on Form 10-K. The SEC also maintains
a website at http://www.sec.gov that contains reports, proxy and information statements and other information regarding us and
other companies that file materials with the SEC electronically.
12
ITEM 1A. RISK FACTORS
You should carefully consider the following
material risk factors as well as all other information set forth or referred to in this report before purchasing shares of our common
stock. Investing in our common stock involves a high degree of risk. We may not be successful in preventing the material adverse effects
that any of the following risks and uncertainties may cause. These potential risks and uncertainties may not be a complete list of the
risks and uncertainties facing us. There may be additional risks and uncertainties that we are presently unaware of, or presently consider
immaterial, that may become material in the future and have a material adverse effect on us. You could lose all or a significant portion
of your investment due to any of these risks and uncertainties.
Summary of Risk Factors
Our business is subject to numerous risks and
uncertainties that you should consider before investing in our company, as fully described below. The principal factors and uncertainties
that make investing in our company risky include, among others:
Risks Related to the Potential Merger with
YOOV
● The risk that the conditions to the closing of
the transaction are not satisfied, including the failure to obtain stockholder approval for the transaction.
● The timing, receipt and terms and conditions
of any required regulatory approvals of the Merger that could cause the parties to abandon the Merger.
● Our and YOOV’s ability to meet expectations
regarding the timing and completion of the Merger.
● Uncertainties as to the timing of the consummation
of the transaction and the ability of each of us and YOOV to consummate the transaction.
● Risks related to our continued listing on The
Nasdaq Capital Market until closing of the Merger.
● Risks that our stock price may decline significantly
if the Merger is not completed.
● The outcome of any legal proceedings that may
be instituted against us and others following the announcement of the Merger Agreement.
● Expectations regarding the strategies, prospects,
plans, expectations and objectives of management of us or YOOV for future operations of the combined company following the closing of
the Merger.
● The ability of the combined company to recognize
the benefits that may be derived from the Merger, including the commercial or market opportunity of the product candidates of YOOV and
the combined company.
● Risks related to our and YOOV’s ability
to correctly estimate their respective operating expenses and expenses associated with the transaction, uncertainties regarding the impact
any delay in the closing would have on the anticipated cash resources of the combined company upon closing and other events and unanticipated
spending and costs that could reduce the combined company’s cash resources.
● The occurrence of any event, change or other
circumstance or condition that could give rise to the termination of the Merger Agreement.
● The fact that under the terms of the Merger Agreement,
we are restrained from soliciting other acquisition proposals during the pendency of the Merger, except in certain circumstances.
● The effect of the announcement or pendency of
the Merger on our or YOOV’s business relationships, operating results and business generally, including disruption of our and YOOV’s
management’s attention from ongoing business operations due to the Merger and potential adverse reactions or changes to business
relationships resulting from the announcement or completion of the transaction.
● The risk that the Merger Agreement may be terminated
in circumstances that require us to pay a termination fee.
13
General Operating and Business Risks
● Our limited operating history
makes it difficult for us to evaluate our future business prospects and make decisions based on those estimates of our future performance.
● Our results of operations have
not resulted in profitability and we may not be able to achieve profitability going forward.
● There is substantial doubt
about our ability to continue as a going concern, which will affect our ability to obtain future financing and may require us to curtail
our operations.
● Our cash will only fund our
operations for a limited time and we will need to raise additional capital in order to support our development.
●
Joint ventures, joint ownership arrangements and other projects pose unique challenges and we may not be able to fully implement or realize synergies, expected returns or other anticipated benefits associated with such projects.
●
We must effectively manage the growth of our operations, or our company will suffer.
● Potential liability claims
may adversely affect our business.
● In accordance with our strategic
development policy, we may invest in companies for strategic reasons and may not realize a return on our investments.
● Obtaining and maintaining patent
protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental
patent agencies, and any patent protection we may obtain in the future could be reduced or eliminated for non-compliance with these requirements.
● It is difficult and costly
to protect our proprietary rights, and we may not be able to ensure their protection. If we fail to protect or enforce our intellectual
property rights adequately or secure rights to patents of others, the value of our intellectual property rights would diminish.
● If any of our trade secrets,
know-how or other proprietary information is disclosed, the value of our trade secrets, know-how and other proprietary rights would be
significantly impaired and our business and competitive position would suffer.
14
Risk Factors Related to Commercialization
Activity
●
Some of our medical device
products in the future may face significant government regulation, and there is no guarantee that our medical devices will receive
regulatory approval.
●
Even if our medical
devices receive regulatory approval, we may still face future development and regulatory difficulties.
●
If we or our current or future collaborators, manufacturers, or service providers fail to comply with healthcare laws and regulations, we or they could be subject to enforcement actions and substantial penalties, which could affect our ability to develop, market and sell our products and may harm our reputation.
●
Any medical devices we develop may become subject to unfavorable pricing regulations, third party coverage and reimbursement practices or healthcare reform initiatives, thereby harming our business.
●
The healthcare industry is heavily regulated in the U.S. at the federal, state, and local levels, and our failure to comply with applicable requirements may subject us to penalties and negatively affect our financial condition.
●
Our ability to obtain reimbursement or funding from the federal government may be impacted by possible reductions in federal spending.
Risks Related to Our Securities
● Our officers, directors and
principal stockholders own a significant percentage of our capital stock and will be able to exert significant control over matters that
are subject to stockholder approval.
● If we are unable to maintain
listing of our securities on The Nasdaq Capital Market or another reputable stock exchange, it may be more difficult for our stockholders
to sell their securities.
● The price of our common stock
may be volatile and fluctuate substantially, which could result in substantial losses for our stockholders.
● You may experience dilution
of your ownership interests because of the future issuance of additional shares of our common or preferred stock or other securities
that are convertible into or exercisable for our common or preferred stock.
Risks Related to the Potential Merger with
YOOV
Failure to complete the Merger could negatively
impact the stock price and our future business and financial results.
The parties’ respective obligations to complete
the Merger are subject to the satisfaction or waiver of a number of conditions set forth in the Merger Agreement. There can be no assurance
that the conditions to completion of the Merger will be satisfied or waived or that the Merger will be completed. If the Merger is not
completed for any reason, our ongoing businesses may be materially and adversely affected and, without realizing any of the benefits of
having completed the Merger, We would be subject to a number of risks, including the following:
● we may experience negative reactions from the
financial markets, including negative impacts on the trading price of our common stock, which could affect our ability to secure sufficient
financing in the future on attractive terms (or at all) as a standalone company, and from their respective customers, vendors, regulators
and employees, and if we are unable to obtain additional capital, we may need to cease operations, dissolve or seek protection of bankruptcy
courts;
● we may be required to pay YOOV a termination
fee of $1,000,000 if we fail to consummate the Merger under specified circumstances;
15
● we will be required to pay certain expenses incurred
in connection with the Merger, whether or not the Merger is completed;
● the Merger Agreement places certain restrictions
on the operation of our business prior to the closing of the Merger, and such restrictions, the waiver of which is subject to the consent
of YOOV, may prevent us from making certain acquisitions, taking certain other specified actions or otherwise pursuing business opportunities
during the pendency of the Merger that we would have made, taken or pursued if these restrictions were not in place; and
● matters relating to the Merger (including integration
planning) will require substantial commitments of time and resources by our management and the expenditure of significant funds in the
form of fees and expenses, which would otherwise have been devoted to day-to-day operations and other opportunities that may have been
beneficial to us as an independent company.
In addition, we could be subject to litigation
related to any failure to complete the Merger or related to any proceeding to specifically enforce our or YOOV’s obligations under
the Merger Agreement.
If any of these risks materialize, they may materially
and adversely affect our business, financial condition, financial results and stock prices.
We and YOOV will be subject to business uncertainties
and contractual restrictions while the Merger is pending.
Uncertainty about the effect of the Merger on
employees, vendors and customers may have an adverse effect on our or YOOV and consequently on the combined company after the closing
of the Merger. These uncertainties may impair our and YOOV’s ability to retain and motivate key personnel and could cause customers
and others that deal with us and YOOV, as applicable, to defer or decline entering into contracts with us or YOOV, as applicable, or making
other decisions concerning us or YOOV, as applicable, or seek to change existing business relationships with us or YOOV, as applicable.
In addition, if key employees depart because of uncertainty about their future roles and the potential complexities of the Merger, our
and YOOV’s businesses could be harmed. Furthermore, the Merger Agreement places certain restrictions on the operation of our and
YOOV’s businesses prior to the closing of the Merger, which may delay or prevent us and YOOV from undertaking certain actions or
business opportunities that may arise prior to the consummation of the Merger.
Third parties may terminate or alter existing
contracts or relationships with us or YOOV.
Each of us and YOOV has contracts with customers,
vendors and other business partners which may require us or YOOV, as applicable, to obtain consents from these other parties in connection
with the Merger. If these consents cannot be obtained, the counterparties to these contracts and other third parties with which us and/or
YOOV currently have relationships may have the ability to terminate, reduce the scope of or otherwise materially adversely alter their
relationships with either party in anticipation of the Merger, or with the combined company following the Merger. The pursuit of such
rights may result in us and YOOV suffering a loss of potential future revenue, incurring liabilities in connection with a breach of such
agreements or losing rights that are material to their businesses. Any such disruptions could limit the combined company’s ability
to achieve the anticipated benefits of the Merger. The adverse effect of such disruptions could also be exacerbated by a delay in the
completion of the Merger or the termination of the Merger.
The Merger is subject to a number of closing
conditions and, if these conditions are not satisfied, the Merger Agreement may be terminated in accordance with its terms and the Merger
may not be completed. In addition, the parties have the right to terminate the Merger Agreement under other specified circumstances, in
which case the Merger would not be completed.
The Merger is subject to a number of closing conditions
and, if these conditions are not satisfied or waived (to the extent permitted by law), the Merger will not be completed.
These conditions include, among others: (i) the
absence of certain legal impediments, (ii) effectiveness of the registration statement on Form S-4 relating to the Merger, (iv) obtaining
approval from our stockholders to (i) approve the issuance of the shares of our common stock to be issued to YOOV shareholders in
connection with the Merger pursuant to the rules of Nasdaq and (ii) amend our certificate of incorporation to effect a reverse stock split
of our common stock to the extent we and YOOV mutually agree implementing such reverse stock split is necessary to meet Nasdaq’s
listing requirements, (v) the approval of the Merger Agreement and the Merger by YOOV shareholders and (vi) the approval of the Nasdaq
listing application and the listing of the our shares on The Nasdaq Capital Market following the Merger. In addition, each party’s
obligation to complete the Merger is subject to the accuracy of the other parties’ representations and warranties in the Merger
Agreement, the other parties’ compliance, in all material respects, with their respective covenants and agreements in the Merger
Agreement.
16
The conditions to the closing of the Merger may
not be fulfilled and, accordingly, the Merger may not be completed. In addition, if the Merger is not completed by March 7, 2026, any
party may choose not to proceed with the Merger. Moreover, the parties can mutually decide to terminate the Merger Agreement at any time
prior to the consummation of the Merger, before or after receipt of the requisite approvals by our stockholders and the YOOV shareholders,
each party may elect to terminate the Merger Agreement in certain other circumstances, as set forth in the Merger Agreement. If the Merger
Agreement is terminated, we may incur substantial fees and expenses in connection with termination of such Agreement and we will not realize
the anticipated benefits of the Merger. In addition, if the Merger is not completed, we may not have sufficient capital to continue to
operate our business in the long term and may become insolvent and be required to seek the protection of the bankruptcy courts and, without
additional funding or a strategic transaction, we would likely be delisted from Nasdaq.
We or YOOV may waive one or more of the closing
conditions to the Merger without re-soliciting stockholder approval.
Each of us and YOOV has the right to waive certain
of the closing conditions to the Merger. Any such waiver may not require re-solicitation of stockholders, in which case stockholders of
us and shareholders of YOOV will not have the chance to change their votes as a result of any such waiver and we and YOOV will have the
ability to complete the Merger without seeking further stockholder approval. Any determination whether to waive any condition to the Merger,
whether stockholder approval would be re-solicited as a result of any such waiver or whether this proxy statement/prospectus would be
amended as a result of any waiver will be made us or YOOV, as applicable, at the time of such waiver based on the facts and circumstances
as they exist at that time, and any such waiver could have an adverse effect on the combined company.
Our stockholders will have a reduced ownership
and voting interest after the Merger and will exercise less influence over management.
Our stockholders, as a group have significantly
reduced ownership and voting power in the combined company compared to their current ownership and voting power in us. In particular,
upon consummation of the Merger, our stockholders, as a group, will own less than 3% of the outstanding common stock of us. In addition,
our stockholders, as a group, will be able to exercise less collective influence over the management and policies of the combined company
than they currently exercise over the management and policies of us.
The Merger Agreement limits our ability to
pursue alternatives to the Merger.
The Merger Agreement contains provisions that
make it more difficult for us to enter into alternative transactions. The Merger Agreement contains certain provisions that restrict our
ability to solicit or facilitate proposals from third parties with respect to transactions involving the financing or sale of us, or provide
non-public information to, or otherwise participate or engage in discussions or negotiations with, third parties or take certain other
actions that would reasonably be expected to lead to a third-party acquisition proposal. Further, there are only limited exceptions to
our agreement that our board of directors will not change its recommendation in favor of the adoption of the Merger Agreement. However,
at any time prior to the receipt of the requisite stockholder approval by our stockholders and the approval of the Merger Agreement and
the Merger by YOOV shareholders, in response to an unsolicited superior proposal made by a third party, Our board of directors may make
an adverse recommendation change, and terminate the Merger Agreement to enter into an alternative acquisition agreement, if it concludes
in good faith, after consultation with outside financial advisors and outside legal counsel, that the failure to take such action would
be inconsistent with the fiduciary duties of our board of directors under the circumstances and under applicable law.
17
As described above, we may be required to pay
a termination fee of $1,000,000 to YOOV if the Merger is not consummated under specified circumstances as set forth in the Merger Agreement.
Upon obtaining the requisite approvals from our stockholders and YOOV shareholders, our right to terminate the Merger Agreement in response
to a Superior Proposal (as defined in the Merger Agreement) will cease.
While we believe these provisions are reasonable,
customary and not preclusive of other offers, the provisions might discourage a third party that has an interest in acquiring all or a
significant part of us from considering or proposing such an acquisition, even if such party were prepared to pay consideration with a
higher per-share value than the currently proposed merger consideration or if such party were prepared to enter into an agreement that
may be more favorable to us or our stockholders.
Our executive officers and directors may have
interests in the Merger that are different from, or in addition to, the rights of their respective stockholders.
Our executive officers negotiated the terms of
the Merger Agreement and the board of directors approved the Merger Agreement and the Merger and recommend that each stockholder vote
in favor of the proposals to be presented at the special meeting in connection with the Merger. These executive officers and directors
may have interests in the Merger that are different from, or in addition to, our stockholders. These interests include the potential continued
employment or retention as consultants of certain executive officers of us with the combined company following the Merger, the continued
service of certain of our directors as directors of the combined company following the Merger and the indemnification of our executive
officers and directors.
We, YOOV and, subsequently, the combined company
may have difficulty attracting, motivating and retaining executives and other key employees in light of the proposed Merger.
The combined company’s success after the
Merger will depend in part on each of our and YOOV’s ability to retain key executives and other employees. Uncertainty about the
effect of the Merger on our and YOOV’s employees may have an adverse effect on each company separately and consequently, the combined
company. This uncertainty may impair the combined company’s ability to attract, retain and motivate key personnel. Employee retention
may be particularly challenging during the pendency of the Merger, as our and YOOV’s employees may experience uncertainty about
their future roles in the combined business. YOOV’s common stock
Furthermore, if any of our or YOOV’s key
employees depart or are at risk of departing, including because of issues relating to the uncertainty and difficulty of integration, financial
security or a desire not to become employees of the combined business, we or YOOV, as applicable, may have to incur significant costs
in retaining such individuals or in identifying, hiring and retaining replacements for departing employees and may lose significant expertise
and talent, and the combined company’s ability to realize the anticipated benefits of the Merger may be materially and adversely
affected. No assurance can be given that the combined company will be able to attract or retain key employees to the same extent that
we or YOOV have been able to attract or retain employees in the past.
18
We will incur significant transaction and Merger-related
transition costs in connection with the Merger.
We expect that we will incur significant, non-recurring
costs in connection with consummating the Merger and integrating the operations of the two companies post-Closing. We will incur significant
fees and expenses relating to financing arrangements and legal services (including any costs that would be incurred in defending against
any potential class action lawsuits and derivative lawsuits in connection with the Merger if any such proceedings are brought), accounting
and other fees and costs, associated with consummating the Merger. Some of these costs are payable regardless of whether the Merger is
completed. In addition, we may be required to pay a termination fee of $1,000,000 if the Merger Agreement is terminated under specified
circumstances described in the Merger Agreement. Though we continue to assess the magnitude of these costs, additional unanticipated costs
may be incurred in the Merger and the integration of the businesses of us and YOOV.
We may be the target of securities class action
and stockholder lawsuits which could result in substantial costs and may delay or prevent the Merger from being completed.
Securities class action lawsuits and stockholder
lawsuits are often brought against public companies that have entered into merger agreements. Even if the lawsuits are without merit,
defending against these claims can result in substantial costs and divert management time and resources. An adverse judgment could result
in monetary damages, which could have a negative impact on our liquidity and financial condition. Additionally, if a plaintiff is successful
in obtaining an injunction prohibiting completion of the Merger, then that injunction may delay or prevent the Merger from being completed,
which may adversely affect our or the combined company’s business, financial position and results of operations. As of the date
of this report, no such lawsuits have been filed in connection with the Merger and the parties cannot predict whether any will be filed.
General Operating and Business Risks
Our limited revenue makes it difficult for
us to evaluate our future business prospects and make decisions based on those estimates of our future performance .
We have limited operating revenue. Because of the uncertainties related
to our lack of significant revenue, we may be hindered in our ability to anticipate and timely adapt to increases or decreases in revenues
or expenses. If we make poor budgetary decisions as a result of unreliable historical data, we could be less profitable or incur losses,
which may result in a decline in our stock price.
Our results of operations have not resulted
in profitability and we may not be able to achieve profitability going forward.
We incurred net losses amounting to approximately $7.9 million and
$16.7 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of
approximately $87.7 million. If we incur additional significant losses, our stock price may decline, perhaps significantly. Our management
is developing plans to achieve profitability. Our business plan is speculative and unproven. There is no assurance that we will be successful
in executing our business plan or that even if we successfully implement our business plan, that we will be able to curtail our losses
now or in the future. Further, as we are a new enterprise, we expect that net losses will continue.
There is substantial doubt about our ability
to continue as a going concern, which will affect our ability to obtain future financing and may require us to curtail our operations.
Our financial statements as of December 31, 2024
were prepared under the assumption that we will continue as a going concern. The independent registered public accounting firm that audited
our 2024 financial statements, in their report, included an explanatory paragraph referring to our recurring losses since inception and
expressing management’s assessment and conclusion that there is substantial doubt in our ability to continue as a going concern.
Our financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our ability to continue
as a going concern depends on our ability to obtain additional equity or debt financing, attain further operating efficiencies, reduce
expenditures, and, ultimately, to generate revenue. We cannot assure you, however, that we will be able to achieve any of the foregoing.
See Note 2 to our Consolidated Financial Statements for further details.
19
Our cash will only fund our operations for
a limited time and we will need to raise additional capital in order to support our development.
We are currently operating at a loss and expect our operating costs
will increase significantly as we continue to grow our operations. The independent registered public accounting firm that audited our
2024 financial statements, in their report, included an explanatory paragraph referring to our recurring losses since inception and expressing
management’s assessment and conclusion that there is substantial doubt in our ability to continue as a going concern. At December
31, 2024, we had cash of approximately $2.9 million. We will need to raise additional capital or generate substantial revenue in order
to support our development and commercialization efforts.
If our available cash balances are insufficient
to satisfy our liquidity requirements, including due to risks described herein, we may seek to raise additional capital through equity
offerings, debt financings, collaborations or licensing arrangements. We will need to raise additional capital, and we may also consider
raising additional capital in the future to expand our business, to pursue strategic investments, to take advantage of financing opportunities,
or for other reasons, including to:
● fund development and expansion
of our operations;
● acquire, license or invest
in technologies and additional laboratories;
● acquire or invest in complementary
businesses or assets; and
● finance capital expenditures
and general and administrative expenses.
Our present and future funding requirements will
depend on many factors, including:
● our revenue growth rate and
ability to generate cash flows from operating activities;
● our sales and marketing and
research and development activities; and
● changes in regulatory oversight
applicable to our products and services.
Other than our debt facility with our
chairman, we have no arrangements or credit facilities in place as a source of funds, and there can be no assurance that we will be
able to raise sufficient additional capital on acceptable terms, or at all, and if we are not successful in raising additional
capital, we may not be able to continue as a going concern. We may seek additional capital through a combination of private and
public equity offerings, debt financings and strategic collaborations. Debt financing, if obtained, may involve agreements that
include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, that could
increase our expenses and require that our assets secure such debt. Equity financing, if obtained, could result in dilution to our
then existing stockholders and/or require such stockholders to waive certain rights and preferences. If such financing is not
available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate the development of
business opportunities and our operations and financial condition may be materially adversely affected. We can provide no assurances
that any additional sources of financing will be available to us on favorable terms, if at all. Future capital raises may dilute our
existing stockholders’ ownership and/or have other adverse effects on our operations.
If we raise additional capital by issuing equity
securities, our existing stockholders’ percentage ownership will be reduced and these stockholders may experience substantial dilution.
If we raise additional funds by issuing debt securities,
these debt securities would have rights senior to those of our common stock and the terms of the debt securities issued could impose significant
restrictions on our operations, including liens on our assets. If we raise additional funds through collaborations and licensing arrangements,
we may be required to relinquish some rights to our technologies or products, or to grant licenses on terms that are not favorable to
us.
We have significant outstanding debt obligations
and servicing these debt obligations will require a significant amount of capital, and our business may not be able to pay our substantial
debt.
As of December 31, 2024, we had approximately $8.4 million of outstanding
indebtedness. In order to service this indebtedness and any additional indebtedness we may incur in the future, we will need to generate
cash from our operating activities. Our ability to generate cash is subject, in part, to our ability to successfully execute our business
strategy, as well as general economic, financial, competitive, regulatory and other factors beyond our control. If we are unable to generate
sufficient cash to repay our debt obligations when they become due and payable, either when they mature, or in the event of a default,
we may not be able to obtain additional debt or equity financing on favorable terms, if at all, which may negatively impact our business
operations and financial condition.
If we breach any of the undertakings or default
on any of our obligations under our agreements with our lenders, our outstanding indebtedness could become immediately due and payable,
which would harm our business, financial condition and results of operations and could require us to reduce or cease operations. If our
indebtedness were to be accelerated, there can be no assurance that our assets would be sufficient to repay in full that indebtedness.
20
Our business and operations may be further
impacted by epidemics, outbreaks and other public health events.
Epidemics, outbreaks or other public health events
that are outside of our control could significantly disrupt our operations and adversely affect our financial condition. The global or
national outbreak of an illness or other communicable disease, or any other public health crisis, such as COVID-19, may cause disruptions
to our business and operations, which may include (i) shortages of employees, (ii) unavailability of contractors or subcontractors, (iii)
interruption of supplies from third parties upon which we rely, (iv) recommendations of, or restrictions imposed by government and health
authorities, including quarantines, to address an outbreak and (v) restrictions that we and our contractors, subcontractors and our customers
impose, including facility shutdowns, to ensure the safety of employees.
We depend upon key personnel and need additional
personnel.
Our success depends on the continuing
services of Wenzhao Lu, our Chairman of the Board, and David Jin, Meng Li and Luisa Ingargiola, our executive officers. The loss of
Mr. Lu, Dr. Jin, Ms. Li or Ms. Ingargiola could have a material and adverse effect on our business operations. Additionally, the
success of our operations will largely depend upon our ability to successfully attract and maintain competent and qualified key
management personnel. As with any company with limited resources, there can be no guaranty that we will be able to attract such
individuals or that the presence of such individuals will necessarily translate into profitability for us. Our inability to attract
and retain key personnel may materially and adversely affect our business operations. The supply of qualified technical,
professional, managerial and other personnel, including lab medical directors and lab operations managers, is currently constrained;
competition for qualified employees, even across different industries, is intense, including as individuals leave the job market. We
may lose, or fail to attract and retain, key management personnel, or qualified skilled technical, professional or other employees.
The same is true for patient-facing staff with specialized training required to perform activities related to specimen collection.
In the future, if competition for the services of these professionals increases, we may not be able to continue to attract and
retain individuals in its markets. Changes in key management, or the ability to attract and retain qualified personnel, as a result
of increased competition for talent, wage growth, or other market factors, could lead to strategic and operational challenges and
uncertainties, distractions of management from other key initiatives, and inefficiencies and increased costs, any of which could
adversely affect our business, financial condition, results of operations, and cash flows.
Joint ventures, joint ownership arrangements
and other projects pose unique challenges and we may not be able to fully implement or realize synergies, expected returns or other anticipated
benefits associated with such projects.
We are, and may be in the future, involved in
strategic joint ventures and other joint ownership arrangements. We may not always be in complete alignment with our joint venture or
joint owner counterparties; we may have differing strategic or commercial objectives and may be outvoted by our joint venture partners
or we may disagree on governance matters with respect to the joint venture entity or the jointly owned assets. As a result, when we enter
into joint ventures or joint ownership arrangements, we may be subject to a number of risks. In some joint ventures and joint ownership
arrangements we may not be responsible for the operation of projects and will rely on our joint venture or joint owner counterparties
for such services. Joint ventures and joint ownership arrangements may also require us to expend additional internal resources that could
otherwise be directed to other projects. If we are unable to successfully execute and manage our existing and any proposed joint venture
and joint owner arrangements, it could adversely impact our financial and operating results.
We may be undertaking, or participating with various
counterparties in, a number of projects that involve forming joint ventures and acquiring laboratories that are accretive to our commercial
strategy. Many of these projects could involve numerous regulatory, environmental, commercial, economic, political and legal uncertainties
that are beyond our control, including the following:
●
We may be unable to realize our forecasted commercial, operational or administrative synergies in connection with our joint venture and joint ownership arrangements; and
● Joint ventures and other joint
ownership arrangements may demand substantial internal resources and may divert resources and attention from other areas of our business.
As a result of these uncertainties, the anticipated
benefits associated with our joint ventures and joint ownership arrangements may not be achieved or could be delayed. In turn, this could
negatively impact our cash flow and our ability to make or increase cash distributions to our partners.
21
We must effectively manage the growth of our
operations, or our company will suffer.
To manage our growth, we believe we must continue
to implement and improve our services and products. We may not have adequately evaluated the costs and risks associated with our planned
expansion, and our systems, procedures, and controls may not be adequate to support our operations. In addition, our management may not
be able to achieve the rapid execution necessary to successfully offer our products and services and implement our business plan on a
profitable basis. The success of our future operating activities will also depend upon our ability to expand our support system to meet
the demands of our growing business. Any failure by our management to effectively anticipate, implement, and manage changes required to
sustain our growth would have a material adverse effect on our business, financial condition, and results of operations.
Our revenue and results of operations may suffer
if we are unable to attract new tenants.
We presently derive our revenue from rental revenue
from our income-producing real estate property in New Jersey. Our growth therefore depends on our ability to attract new tenants. This
depends on our ability to understand and anticipate market and pricing trends and our tenants’ needs. Our failure to attract new
tenants could materially and adversely affect our operating results.
Potential liability claims may adversely affect
our business.
Our services, which may include recommendations
and advice to organizations regarding complex business and operational processes and regulatory and compliance issues may give rise to
liability claims by our clients or by third parties who bring claims against our clients. Healthcare organizations often are the subject
of regulatory scrutiny and litigation, and we also may become the subject of such litigation based on our advice and services. Any such
litigation, whether or not resulting in a judgment against us, may adversely affect our reputation and could have a material adverse effect
on our financial condition and results of operations. We may not have adequate insurance coverage for claims against us.
In accordance with our strategic development
policy, we may invest in companies for strategic reasons and may not realize a return on our investments.
From time to time, we may make investments in companies. These investments
may be for strategic objectives to support our key business initiatives but may also be standalone investments or acquisitions. Such investments
or acquisitions could include equity or debt instruments in private companies, many of which may not be marketable at the time of our
initial investment. These companies may range from early-stage companies that are often still defining their strategic direction to more
mature companies with established revenue streams and business models. The success of these companies may depend on product development,
market acceptance, operational efficiency, and other key business factors. The companies in which we invest may fail because they may
not be able to secure additional funding, obtain favorable investment terms for future financings, or take advantage of liquidity events
such as public offerings, mergers, and private sales. If any of these private companies fails, we could lose all or part of our investment
in that company. If we determine that impairment indicators exist and that there are other-than-temporary declines in the fair value of
the investments, we may be required to write down the investments to their fair value and recognize the related write-down as an investment
loss. For the year ended December 31, 2024, we had an impairment of goodwill acquired from Lab Services MSO acquisition of approximately
$0.3 million. In the future, we could have additional impairment charges related to investments that we may make.
Our strategic transactions involve risks, and
we may not realize the expected benefits because of numerous uncertainties and risks.
We regularly consider and may enter into strategic
transactions, including mergers, acquisitions, joint ventures, investments and other growth, market and geographic expansion strategies,
with the expectation that these transactions will result in increases in sales, cost savings, synergies, and other various benefits. Our
ability to deliver the expected benefits from any strategic transaction is subject to numerous uncertainties and risks, including our
ability to integrate personnel, labor models, financial, IT and other systems successfully; disruption of our ongoing business and distraction
of management; hiring additional management and other critical personnel; and increasing the scope, geographic diversity, and complexity
of our operations. Effective internal controls are necessary to provide reliable and accurate financial reports, and the integration of
businesses may create complexity in our financial systems and internal controls and make them more difficult to manage. Integration of
businesses into our internal control system could cause us to fail to meet our financial reporting obligations. Additionally, we may recognize
material impairments in the future, including in connection with assets we have acquired or divested in a strategic transaction or charges
to earnings associated with any strategic transaction, which may materially reduce our earnings. Our shareholders may react unfavorably
to our strategic transactions and strategic transactions may also be subject to regulatory uncertainty due to the changing enforcement
landscape. We may not realize the anticipated benefits from such transactions, we may be exposed to additional liabilities of any acquired
business or joint venture, and we may be exposed to litigation in connection with the strategic transaction. Further, we may finance these
strategic transactions by incurring additional debt, which could increase leverage or impact our ability to access capital in the future.
We face intense competition which could cause us to lose market
share.
In the healthcare markets in which we operate,
we will compete with large healthcare providers who have more significant financial resources, established market positions, long-standing
relationships, and who have more significant name recognition, technical, marketing, sales, distribution, financial and other resources
than we do. The resources available to our competitors to develop new services and products and introduce them into the marketplace exceed
the resources currently available to us. This intense competitive environment may require us to make changes in our services, products,
pricing, licensing, distribution, or marketing to develop a market position.
22
If we fail to comply with our obligations in
the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business
relationships with our licensors, we could lose intellectual property rights that are important to our business.
We are party to a research agreement with the
Massachusetts Institute of Technology (“MIT”) for development of chimeric antigen receptor (CAR) technology. Although we have
halted all research and development, MIT has granted us options to non-exclusively or exclusively license MIT inventions arising under
this research agreement and we continue to maintain our joint patent applications.
Moreover, Disputes may arise regarding intellectual
property subject to a licensing agreement, including:
● the scope of rights granted
under the license agreement and other interpretation-related issues;
● the extent to which our product
candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
● the sublicensing of patent
and other rights under our collaborative development relationships;
● our diligence obligations under
the license agreement and what activities satisfy those diligence obligations;
● the inventorship and ownership
of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;
and
● the priority of invention of
patented technology.
In addition, the agreements under which we currently
license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible
to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to
be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other
obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results
of operations, and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to
maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize
the affected product candidates, which could have a material adverse effect on our business, financial conditions, results of operations,
and prospects.
We may face uncertainty and difficulty in obtaining
and enforcing our patents and other proprietary rights.
There can be no assurance that any patent applications
we file or license will be approved, or that challenges will not be instituted against the validity or enforceability of any patent licensed-in
or owned by us. Our pending and future patent applications may not result in patents being issued that protect our product candidates,
in whole or in part, or which effectively prevent others from commercializing competitive product candidates. Even if our patent applications
issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing
with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar
or alternative product candidates in a non-infringing manner. The cost of litigation to uphold the validity and prevent infringement of
a patent is substantial. Furthermore, there can be no assurance that others will not independently develop substantially equivalent technologies
not covered by patents to which we have rights or obtain access to our know-how. In addition, the laws of certain countries may not adequately
protect our intellectual property. Our competitors may possess or obtain patents on products or processes that are necessary or useful
to the development, use, or manufacture of our product candidates. There can also be no assurance that our proposed technology will not
infringe upon patents or proprietary rights owned by others, with the result that others may bring infringement claims against us and
require us to license such proprietary rights, which may not be available on commercially reasonable terms, if at all. Any such litigation,
if instituted, could have a material adverse effect, potentially including monetary penalties, diversion of management resources, and
injunction against continued manufacture, use, or sale of certain products or processes.
We rely upon non-patented proprietary know-how.
There can be no assurance that we can adequately protect our rights in such non-patented proprietary know-how, or that others will not
independently develop substantially equivalent proprietary information or techniques or gain access to our proprietary know-how. Any of
the foregoing events could have a material adverse effect on us. In addition, if any of our trade secrets, know-how or other proprietary
information were to be disclosed, or misappropriated, the value of our trade secrets, know-how and other proprietary rights would be significantly
impaired and our business and competitive position would suffer.
23
In September 2011, the Leahy-Smith America Invents
Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These
include provisions that affect the way patent applications will be prosecuted and may also affect patent litigation. In particular, under
the Leahy-Smith Act, the United States transitioned in March 2013 to a “first to file” system in which the first inventor
to file a patent application will be entitled to the patent. Third parties are allowed to submit prior art before the issuance of a patent
by the U.S. Patent and Trademark Office, or USPTO, and may become involved in opposition, derivation, post-grant and inter partes review,
or interference proceedings challenging our patent rights. An adverse determination in any such submission, proceeding or litigation could
reduce the scope of, or invalidate, our patent rights, which could adversely affect our competitive position.
The USPTO has developed new and untested
regulations and procedures to govern the full implementation of the Leahy-Smith Act, and many of the substantive changes to patent
law associated with the Leahy-Smith Act, and in particular, the “first-to-file” provisions, only became effective in
March 2013. The Leahy-Smith Act has also introduced procedures that may make it easier for third parties to challenge issued
patents, as well as to intervene in the prosecution of patent applications. Finally, the Leahy-Smith Act contains new statutory
provisions that still require the USPTO to issue new regulations for their implementation, and it may take the courts years to
interpret the provisions of the new statute. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the
operation of our business. The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the
prosecution of our patent applications and the enforcement or defense of our issued patents.
We may not be able to protect our intellectual
property rights throughout the world.
Filing, prosecuting and defending patents on our
product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some
countries outside the United States may be less extensive than those in the United States. In addition, the laws of some foreign countries
do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not
be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing
products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions
where we do not obtain patent protection to develop their own products and may also export infringing products to territories where we
have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products and
our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many companies have encountered significant problems
in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly
certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly
those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of
competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions,
whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business,
could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could
provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies
awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world
may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
Patent terms may be inadequate to protect our
competitive position on our product candidates for an adequate amount of time.
Patents have a limited lifespan. In the United
States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional
filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents
covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive products,
including generics or biosimilars. Given the amount of time required for the development, testing and regulatory review of new product
candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, any
patents we may obtain may not provide us with sufficient rights to exclude others from commercializing products similar or identical to
ours.
Obtaining and maintaining patent protection
depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent
agencies, and any patent protection we may obtain in the future could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity
fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental
patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. The USPTO and various
non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions
during the patent application process. There are situations in which non-compliance can result in abandonment or lapse of the patent
or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors
might be able to enter the market and this circumstance would have a material adverse effect on our business.
24
It is difficult and costly to protect our proprietary
rights, and we may not be able to ensure their protection. If we fail to protect or enforce our intellectual property rights adequately
or secure rights to patents of others, the value of our intellectual property rights would diminish.
Our commercial viability will depend in part on
obtaining and maintaining patent protection and trade secret protection of our product candidates, and the methods used to manufacture
them, as well as successfully defending these patents against third-party challenges. Our ability to stop third parties from making, using,
selling, offering to sell, or importing our products is dependent upon the extent to which we obtain rights under valid and enforceable
patents or trade secrets that cover these activities.
The patent positions of pharmaceutical and biopharmaceutical
companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.
No consistent policy regarding the breadth of claims allowed in biopharmaceutical patents has emerged to date in the United States. The
biopharmaceutical patent situation outside the United States is even more uncertain. Changes in either the patent laws or in interpretations
of patent laws in the United States and other countries may diminish the value of our intellectual property. Accordingly, we cannot predict
the breadth of claims that may be allowed or enforced in the patents we own. Further, if any of our patents are deemed invalid and unenforceable,
it could impact our ability to commercialize or license our technology.
The degree of future protection for our proprietary
rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain
or keep our competitive advantage. For example:
● others may be able to make
products that are similar to our product candidates but that are not covered by the claims of any patents;
● we might not have been the
first to make the inventions covered by any issued patents or patent applications;
● we might not have been the
first to file patent applications for these inventions;
● it is possible that any patent
applications we own or license will not result in issued patents;
● any issued patents may not
provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges by third parties;
● we may not develop additional
proprietary technologies that are patentable or protectable under trade secrets law; or
● the patents of others may have
an adverse effect on our business.
We also may rely on trade secrets to protect our
technology, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to
protect. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific
collaborators, and other advisors may unintentionally or willfully disclose our information to competitors. In addition, courts outside
the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent
knowledge, methods, and know-how.
We may be subject to claims challenging the
inventorship of patents and other intellectual property.
We or our licensors may be subject to claims
that former employees, collaborators or other third parties have an interest as an inventor or co-inventor in intellectual property
we own or license. For example, we or our licensors may have inventorship disputes arise from conflicting obligations of employees,
consultants or others who are involved in developing our product candidates. We may be subject to claims by third parties asserting
that our licensors, employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our
own intellectual property. Litigation may be necessary to defend against these and other claims challenging inventorship or our or
our licensors’ ownership of our owned or in-licensed patents, trade secrets or other intellectual property. If we or our
licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property
rights, such as exclusive ownership of, or right to use, intellectual property that is important to our product candidates. Even if
we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management
and other employees. Any of the foregoing could have a material adverse effect on our business, financial condition, results of
operations and prospects.
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If any of our trade secrets, know-how or other
proprietary information is disclosed, the value of our trade secrets, know-how and other proprietary rights would be significantly impaired
and our business and competitive position would suffer.
Our viability also depends upon the skills, knowledge
and experience of our scientific and technical personnel, and our consultants and advisors. To help protect our proprietary know-how and
our inventions for which patents may be unobtainable or difficult to obtain, we rely on trade secret protection and confidentiality agreements.
To this end, we require all of our employees, consultants, advisors and contractors to enter into agreements which prohibit unauthorized
disclosure and use of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments,
discoveries and inventions important to our business. These agreements are often limited in duration and may not provide adequate protection
for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure or the lawful development
by others of such information. There is no assurance that such agreements will be honored by such parties or enforced in whole or part
by the courts. We cannot be certain that others will not gain access to these trade secrets or that our patents will provide adequate
protection. Others may independently develop substantially equivalent proprietary information and techniques or otherwise gain access
to our trade secrets. In addition, enforcing a claim that a third party illegally obtained and is using any of our trade secrets is expensive
and time consuming, and the outcome is unpredictable. If any of our trade secrets, know-how or other proprietary information is improperly
disclosed, the value of our trade secrets, know-how and other proprietary rights would be significantly impaired and our business and
competitive position would suffer.
We may incur substantial costs as a result
of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights
to, or use of, our technology.
If we choose to go to court to stop a third party
from using the inventions claimed in our patents, that individual or company has the right to ask the court to rule that such patents
are invalid and/or should not be enforced against that third party. These lawsuits are expensive and would consume time and other resources,
even if we were successful in discontinuing the infringement of our patents. In addition, there is a risk that the court will decide that
these patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk
that, even if the validity of these patents is upheld, the court will refuse to stop the other party on the ground that such other party’s
activities do not infringe our rights to these patents. In addition, the U.S. Supreme Court has in the past invalidated tests used by
the USPTO in granting patents over the past 20 years. As a consequence, issued patents may be found to contain invalid claims according
to the newly revised standards. Some of our own patents may be subject to challenge and subsequent invalidation in a variety of post-grant
proceedings, particularly inter partes review, before the USPTO or during litigation under the revised criteria, which make it
more difficult to defend the validity of claims in already issued patents.
Furthermore, a third party may claim that we
or our manufacturing or commercialization partners are using inventions covered by the third party’s patent rights and may go
to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates. These
lawsuits are costly and could affect our results of operations and divert the attention of managerial and technical personnel. There
is a risk that a court could decide that we or our commercialization partners are infringing the third party’s patents and
order us or our partners to stop the activities covered by the patents. In addition, there is a risk that a court could order us or
our partners to pay the other party damages for having violated the other party’s patents. The biotechnology industry has
produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various
types of products, manufacturing processes or methods of use. The coverage of patents is subject to interpretation by the courts,
and the interpretation is not always uniform. If we are sued for patent infringement, we would need to demonstrate that our
products, manufacturing processes or methods of use either do not infringe the patent claims of the relevant patent and/or that the
patent claims are invalid, and we may not be able to do this. Proving invalidity, in particular, is difficult since it requires a
showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.
As some patent applications in the United States
may be maintained in secrecy until the patents are issued, because patent applications in the United States and many foreign jurisdictions
are typically not published until eighteen months after filing, and because publications in the scientific literature often lag behind
actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our issued patents or
our pending applications, or that we were the first to invent the technology. Our competitors may have filed, and may in the future file,
patent applications covering technology similar to ours. Any such patent applications may have priority over our patent applications or
patents, which could further require us to obtain rights to issued patents covering such technologies. If another party has filed a United
States patent application on inventions similar to ours, we may have to participate in an interference proceeding declared by the USPTO
to determine priority of invention in the United States. The costs of these proceedings could be substantial, and it is possible that
such efforts would be unsuccessful if, unbeknownst to us, the other party had independently arrived at the same or similar invention prior
to our own invention, resulting in a loss of our U.S. patent position with respect to such inventions.
26
Some of our competitors may be able to sustain
the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any
uncertainties resulting from the initiation and continuation of any litigation or inter partes review proceedings could have a
material adverse effect on our ability to raise the funds necessary to continue our operations.
Some jurisdictions in which we operate have enacted
legislation which allows members of the public to access information under statutes similar to the U.S. Freedom of Information Act. Even
though we believe our information would be excluded from the scope of such statutes, there are no assurances that we can protect our confidential
information from being disclosed under the provisions of such laws. If any confidential or proprietary information is released to the
public, such disclosures may negatively impact our ability to protect our intellectual property rights.
Breaches or compromises of our information
security systems or our information technology systems or infrastructure could result in exposure of private information, disruption of
our business and damage to our reputation, which could harm our business, results of operation and financial condition.
We utilize information security and information
technology systems and websites that allow for the secure storage and transmission of proprietary or private information regarding our
clients, patients, employees, vendors and others, including individually identifiable health information. A security breach of our network,
hosted service providers, or vendor systems, may expose us to a risk of loss or misuse of this information, litigation and potential liability.
Hackers and data thieves are increasingly sophisticated and operate large-scale and complex automated attacks, including on companies
within the healthcare industry. Although we believe that we take appropriate measures to safeguard sensitive information within our possession,
we may not have the resources or technical sophistication to anticipate or prevent rapidly-evolving types of cyber-attacks targeted at
us, our clients, our patients, or others who have entrusted us with information. Actual or anticipated attacks may cause us to incur costs,
including costs to deploy additional personnel and protection technologies, train employees, and engage third-party experts and consultants.
We invest in industry standard security technology to protect personal information. Advances in computer capabilities, new technological
discoveries, or other developments may result in the technology used by us to protect personal information or other data being breached
or compromised. To our knowledge, we have not experienced any material breach of our cybersecurity systems. If our or our third-party
service provider systems fail to operate effectively or are damaged, destroyed, or shut down, or there are problems with transitioning
to upgraded or replacement systems, or there are security breaches in these systems, any of the aforementioned could occur as a result
of natural disasters, software or equipment failures, telecommunications failures, loss or theft of equipment, acts of terrorism, circumvention
of security systems, or other cyber-attacks, we could experience delays or decreases in revenue, and reduced efficiency of our operations.
Additionally, any of these events could lead to violations of privacy laws, loss of customers, or loss, misappropriation or corruption
of confidential information, trade secrets or data, which could expose us to potential litigation, regulatory actions, sanctions or other
statutory penalties, any or all of which could adversely affect our business, and cause us to incur significant losses and remediation
costs.
We may be exposed to liabilities under the
Foreign Corrupt Practices Act, and any determination that we violated the Foreign Corrupt Practices Act or Chinese anti-corruption law
could have a material adverse effect on our business.
We are subject to the Foreign Corrupt Practice
Act, or FCPA, and other laws that prohibit improper payments or offers of payments to foreign governments and their officials and political
parties by U.S. persons and issuers as defined by the statute, for the purpose of obtaining or retaining business. We have operations
and agreements with third parties where corruption may occur. It is our policy to implement safeguards to prevent these practices by our
employees. However, our existing safeguards and any future improvements may prove to be less than effective, and the employees, consultants,
sales agents or distributors of our company may engage in conduct for which we might be held responsible.
Violations of the FCPA or other anti-corruption
laws may result in severe criminal or civil sanctions, and we may be subject to other liabilities, which could negatively affect our business,
operating results and financial condition. In addition, the United States government may seek to hold our company liable for successor
liability FCPA violations committed by companies in which we invest or that we acquire.
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Changes or disruption in services supplies,
or transportation provided by third parties have impacted and could continue to impact or adversely affect our business.
We depend on third parties to provide supplies and services critical
to our Keto Air business. We are heavily reliant on third-party ground and air travel for transport of diagnostic testing supplies. A
significant disruption to these travel systems, or our access to them, could have a material adverse effect on our business. Disruptions
to the continued supply, or increases in costs, of these products. may arise from export/import restrictions or embargoes, political or
economic instability, pressure from animal rights activists, adverse weather, natural disasters, public health crises, transportation
disruptions, cyber-attacks, or other causes, as well as from termination of relationships with suppliers or vendors for their failure
to follow our performance standards and requirements. Disruption of supply and services has impacted and could continue to impact or have
a material adverse effect on our business related to the sale of Keto Air.
Risk Factors Related to Commercialization Activity
Some of our medical device products in the
future may face significant government regulation, and there is no guarantee that our medical devices will receive regulatory approval.
The manufacturing and marketing of our potential
medical device products such as our breathalyzer system may be subject to extensive regulation by the FDA and other regulatory authorities
in the United States, as well as by regulatory authorities in other countries. In the United States, our product candidates are subject
to regulation as biological products or as combination biological products/medical devices under the Federal Food, Drug and Cosmetic Act,
the Public Health Service Act and other statutes, as outlined in the Code of Federal Regulations. Different regulatory requirements may
apply to our products depending on how they are categorized by the FDA under these laws. These regulations can be subject to substantial
and significant interpretation, addition, amendment or revision by the FDA and by the legislative process. The FDA may determine that
we will need to undertake clinical trials beyond those currently planned. Furthermore, the FDA may determine that results of clinical
trials do not support approval for the product. Similar determinations may be encountered in foreign countries. The FDA will continue
to monitor products in the market after approval, if any, and may determine to withdraw its approval or otherwise seriously affect the
marketing efforts for any such product. The same possibilities exist for trials to be conducted outside of the United States that are
subject to regulations established by local authorities and local law. Any such determinations would delay or deny the introduction of
our product candidates to the market and have a material adverse effect on our business, financial condition, and results of operations.
Certain medical devices are subject to ongoing
periodic unannounced inspection by the FDA, the Drug Enforcement Agency, other federal agencies and corresponding state agencies to ensure
strict compliance with good manufacturing practices, and other government regulations and corresponding foreign standards. We do not have
control over third-party manufacturers’ compliance with these regulations and standards, nor can we guarantee that we will maintain
compliance with such regulations in regard to our own manufacturing processes. Other risks include:
● regulatory authorities may
require the addition of labeling statements, specific warnings, a contraindication, or field alerts to physicians and pharmacies;
● regulatory authorities may
withdraw their approval of the IND or the product or require us to take our approved products off the market;
● we may be required to change
the way the product is manufactured or administered and we may be required to conduct additional clinical trials or change the labeling
of our products;
● we may have limitations on
how we promote our products; and
● we may be subject to litigation
or product liability claims.
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Even if our medical devices receive regulatory
approval in the United States, we may never receive approval or commercialize our product candidates outside of the United States. In
order to market and commercialize any product candidate outside of the United States, we must establish and comply with numerous and varying
regulatory requirements of other countries regarding manufacturing, safety and efficacy. Approval procedures vary among countries and
can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries
might differ from that required to obtain FDA approval. The regulatory approval process in other countries may include all of the risks
detailed above regarding FDA approval in the United States as well as other risks. Regulatory approval in one country does not ensure
regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the
regulatory approval process in others. Failure to obtain regulatory approval in other countries, or any delay or setback in obtaining
such approval, could have the same adverse effects detailed above regarding FDA approval in the United States. Such effects include the
risks that our product candidates may not be approved for all indications requested, which could limit the uses of our product candidates
and have an adverse effect on product sales and potential royalties, and that such approval may be subject to limitations on the indicated
uses for which the product may be marketed or require costly, post-marketing follow-up studies.
Even if our medical devices receive regulatory
approval, we may still face future development and regulatory difficulties.
Even if U.S. regulatory approval is obtained,
the FDA may still impose significant restrictions on a product’s indicated uses or marketing, or impose ongoing requirements for
potentially costly post-approval studies. If any of our products were granted accelerated approval, FDA could require post-marketing confirmatory
trials to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. FDA may withdraw
approval of a drug or indication approved under the accelerated approval pathway if a trial required to verify the predicted clinical
benefit of the product fails to verify such benefit; other evidence demonstrates that the product is not shown to be safe or effective
under the conditions of use; the applicant fails to conduct any required post-approval trial of the drug with due diligence; or the applicant
disseminates false or misleading promotional materials relating to the product. In addition, the FDA currently requires as a condition
for accelerated approval the pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of
the product.
Given the number of recent high-profile adverse safety events with
certain medical devices, the FDA may require, as a condition of approval, costly risk management programs, which may include safety surveillance,
restricted distribution and use, patient education, enhanced labeling, special packaging or labeling, expedited reporting of certain adverse
events, pre-approval of promotional materials, and restrictions on direct-to-consumer advertising. Furthermore, heightened Congressional
scrutiny on the adequacy of the FDA’s drug approval process and the FDA’s efforts to assure the safety of marketed cell based
therapy has resulted in the proposal of new legislation addressing drug safety issues. If enacted, any new legislation could result in
delays or increased costs during the period of product development, and regulatory review and approval, as well as increased
costs to assure compliance with any new post-approval regulatory requirements. Any of these restrictions or requirements could force us
to conduct costly studies or increase the time for us to become profitable. For example, any labeling approved for any of our product
candidates may include a restriction on the term of its use, or it may not include one or more of our intended indications.
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Our product candidates will also be subject to
ongoing FDA requirements for the labeling, packaging, storage, advertising, promotion, record-keeping, and submission of safety and other
post-market information on the cell based therapy. New issues may arise during a product lifecycle that did not exist, or were unknown,
at the time of product approval, such as adverse events of unanticipated severity or frequency, or problems with the facility where the
product is manufactured. Since approved products, manufacturers, and manufacturers’ facilities are subject to continuous review
and periodic inspections, these new issues post-approval may result in voluntary actions by us or may result in a regulatory agency imposing
restrictions on that product or us, including requiring withdrawal of the product from the market or for use in a clinical study. If our
product candidates fail to comply with applicable regulatory requirements, such as good manufacturing practices, a regulatory agency may:
●
issue warning letters;
●
require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions, and penalties for noncompliance;
●
impose other civil or criminal penalties;
●
suspend regulatory approval;
●
suspend any ongoing clinical trials;
●
refuse to approve pending applications or supplements to approved applications filed by us;
●
impose restrictions on operations, including costly new manufacturing requirements; or
●
seize or detain products or require a product recall.
If we or current or future collaborators, manufacturers,
or service providers fail to comply with healthcare laws and regulations, we or they could be subject to enforcement actions and substantial
penalties, which could affect our ability to develop, market and sell our products and may harm our reputation.
Although we currently are only marketing Keto Air, once our medical
devices are covered by federal health care programs, we will be subject to additional healthcare statutory and regulatory requirements
and enforcement by the federal, state and foreign governments of the jurisdictions in which we conduct our business. Healthcare providers,
physicians and third party payors play a primary role in the recommendation and prescription of any medical devices for which we obtain
marketing approval. Our future arrangements with third party payors and customers may expose us to broadly applicable fraud and abuse,
transparency, and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through
which we market, sell and distribute our therapeutic candidates for which we obtain marketing approval. Restrictions under applicable
federal and state healthcare laws and regulations include, but are not limited to, the following:
●
the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons from soliciting, receiving, offering or providing remuneration, directly or indirectly, to induce either the referral of an individual for a healthcare item or service, or the purchasing or ordering of an item or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare or Medicaid;
●
federal civil and criminal false claims laws and civil monetary penalty laws, such as the U.S. federal FCA, which imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against, individuals or entities for knowingly presenting or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA;
30
●
HIPAA includes a fraud and abuse provision referred to as the HIPAA All-Payor Fraud Law, which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
●
HIPAA, as amended by HITECH, and its implementing regulations, which impose obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding, the privacy, security, and transmission of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information;
●
federal and state consumer protection and unfair competition laws,
which broadly regulate marketplace activities and activities that potentially harm consumers; and
●
the federal Physician Payment Sunshine Act and the implementing regulations, also referred to as “Open Payments,” issued under the ACA, which require that manufacturers of pharmaceutical and biological drugs reimbursable under Medicare, Medicaid, and Children’s Health Insurance Programs report to the Department of Health and Human Services all consulting fees, travel reimbursements, research grants, and other payments, transfers of value or gifts made to physicians and teaching hospitals with limited exceptions; and
The scope and enforcement of each of these laws
is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable
precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare
companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare
industry. Responding to investigations can be time-and resource-consuming and can divert management’s attention from the business.
Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.
Ensuring that our business arrangements with third-parties
comply with applicable healthcare laws and regulations could involve substantial costs. If our operations are found to be in violation
of any such requirements, we may be subject to penalties, including civil or criminal penalties, monetary damages, the curtailment or
restructuring of our operations, or exclusion from participation in government contracting, healthcare reimbursement or other government
programs, including Medicare and Medicaid, any of which could adversely affect our financial results. Although effective compliance programs
can mitigate the risk of investigation and prosecution for violations of these laws, these risks cannot be entirely eliminated. Any action
against us for an alleged or suspected violation could cause us to incur significant legal expenses and could divert our management’s
attention from the operation of our business, even if our defense is successful. In addition, achieving and sustaining compliance with
applicable laws and regulations may be costly to us in terms of money, time and resources.
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Any medical devices we develop may become subject
to unfavorable pricing regulations, third party coverage and reimbursement practices or healthcare reform initiatives, thereby harming
our business.
The regulations that govern marketing
approvals, pricing, coverage and reimbursement for new medical devices vary widely from country to country. Some countries require
approval of the sale price of a device before it can be marketed. In many countries, the pricing review period begins after
marketing or product licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to
continuing governmental control even after initial approval is granted. Although we intend to monitor these regulations, our
programs are currently in earlier stages of development and we will not be able to assess the impact of price regulations for a
number of years. As a result, we might obtain regulatory approval for a product in a particular country, but then be subject to
price regulations that delay our commercial launch of the product and negatively impact the revenues we are able to generate from
the sale of the product in that country.
Our ability to commercialize any products successfully also will depend
in part on the extent to which coverage and reimbursement for these products and related treatments will be available from government
health administration authorities, private health insurers and other organizations. However, there may be significant delays in obtaining
coverage for newly-approved medical devices. . Moreover, eligibility for coverage does not necessarily signify that a cell based therapy
will be reimbursed in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution
costs. Also, interim payments for new cell based therapy if applicable, may be insufficient to cover our costs and may not be made permanent.
Thus, even if we succeed in bringing one or more products to the market, these products may not be considered medically necessary
or cost-effective, and the amount reimbursed for any products may be insufficient to allow us to sell our products on a competitive basis.
Because our programs are in earlier stages of development, we are unable at this time to determine their cost effectiveness, or the likely
level or method of reimbursement. In addition, obtaining coverage and reimbursement approval of a product from a government or other third-party
payor is a time-consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness
data for the use of our product on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained.
A payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Further,
one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the
product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate
return on our investment in product development. If reimbursement is not available or is available only at limited levels, we may not
be able to successfully commercialize any product candidate that we successfully develop.
Increasingly, the third party payors who reimburse
patients or healthcare providers, such as government and private insurance plans, are seeking greater upfront discounts, additional rebates
and other concessions to reduce the prices for pharmaceutical products. If the price we are able to charge for any products we develop,
or the reimbursement provided for such products, is inadequate in light of our development and other costs, our return on investment could
be adversely affected.
●
the product is reasonable and necessary for the diagnosis or treatment of the illness or injury for which the product is administered according to accepted standards of medical practice;
●
the product is typically furnished incident to a physician’s services;
●
the indication for which the product will be used is included or approved for inclusion in certain Medicare-designated pharmaceutical compendia (when used for an off-label use); and
●
the product has been approved by the FDA.
Average prices for medical devices may be reduced by mandatory discounts
or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports
of medical devices from countries where they may be sold at lower prices than in the U.S. Reimbursement rates under Medicare Part B would
depend in part on whether the newly approved product would be eligible for a unique billing code. It is difficult for us to predict how
Medicare coverage and reimbursement policies will be applied to our products in the future and coverage and reimbursement under different
federal healthcare programs are not always consistent. Medicare reimbursement rates may also reflect budgetary constraints placed on the
Medicare program.
Third party payors often rely upon Medicare coverage policies and payment
limitations in setting their own reimbursement rates. These coverage policies and limitations may rely, in part, on compendia listings
for approved therapeutics. Our inability to promptly obtain relevant compendia listings, coverage, and adequate reimbursement from both
government-funded and private payors for products that we develop and for which we obtain regulatory approval could have a material adverse
effect on our operating results, our ability to raise capital needed to commercialize products and our financial condition.
32
We expect that these and other healthcare reform measures that may
be adopted in the future, may result in more rigorous coverage criteria and lower reimbursement, and in additional downward pressure on
the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government-funded programs may
result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms
may prevent us from being able to generate revenue, attain profitability or commercialize our products, once marketing approval is obtained.
We believe that the efforts of governments and
third party payors to contain or reduce the cost of healthcare and legislative and regulatory proposals to broaden the availability of
healthcare will continue to affect the business and financial condition of pharmaceutical and biopharmaceutical companies. A number of
legislative and regulatory changes in the healthcare system in the U.S. and other major healthcare markets have been proposed, and such
efforts have expanded substantially in recent years. These developments could, directly or indirectly, affect our ability to sell our
products, if approved, at a favorable price. For example, in the United States, in 2010, the U.S. Congress passed the ACA, a sweeping
law intended to broaden access to health insurance, reduce or constrain the growth of health spending, enhance remedies against fraud
and abuse, add new transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health
industry and impose additional policy reforms. Among the provisions of the ACA addressing coverage and reimbursement of pharmaceutical
products, of importance to our potential therapeutic candidates are the following:
Separately, pursuant to the health reform legislation
and related initiatives, the Centers for Medicare and Medicaid Services, or CMS, is working with various healthcare providers to develop,
refine, and implement Accountable Care Organizations, or ACOs, and other innovative models of care for Medicare and Medicaid beneficiaries,
including the Bundled Payments for Care Improvement Initiative, the Comprehensive Primary Care Initiative, the Duals Demonstration, and
other models. The continued development and expansion of ACOs and other innovative models of care will have an uncertain impact on any
future reimbursement we may receive for approved therapeutics administered by these organizations.
The healthcare industry is heavily regulated
in the U.S. at the federal, state, and local levels, and our failure to comply with applicable requirements may subject us to penalties
and negatively affect our financial condition.
As a healthcare company, our operations and interactions
with healthcare providers may be subject to extensive regulation in the U.S., particularly if we receive FDA approval for any of its products
in the future. For example, if we receive FDA approval for a product for which reimbursement is available under a federal healthcare program
(e.g., Medicare, Medicaid), it would be subject to a variety of federal laws and regulations, including those that prohibit the filing
of false or improper claims for payment by federal healthcare programs (e.g. the federal False Claims Act), prohibit unlawful inducements
for the referral of business reimbursable by federal healthcare programs (e.g. the federal Anti-Kickback Statute), and require disclosure
of certain payments or other transfers of value made to U.S.-licensed physicians and teaching hospitals or Open Payments. We are not able
to predict how third parties will interpret these laws and apply applicable governmental guidance and may challenge our practices and
activities under one or more of these laws. If our past or present operations are found to be in violation of any of these laws, we could
be subject to civil and criminal penalties, which could hurt our business, our operations and financial condition.
The federal Anti-Kickback Statute prohibits,
among other things, any person or entity, from knowingly and willfully offering, paying, soliciting or receiving any remuneration,
directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or
arranging for the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare
programs. The term remuneration has been interpreted broadly to include anything of value. The Anti-Kickback Statute has been
interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, and formulary
managers on the other. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from
prosecution. The exceptions and safe harbors are drawn narrowly and practices that involve remuneration that may be alleged to be
intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or
safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does
not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a
case-by-case basis based on a cumulative review of all of its facts and circumstances. Our practices may not in all cases meet all
of the criteria for protection under a statutory exception or regulatory safe harbor.
33
Additionally, the intent standard under the Anti-Kickback
Statute was amended by the ACA, to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute
or specific intent to violate it in order to have committed a violation. In addition, the ACA codified case law that a claim including
items or services resulting from a violation of the federal Anti- Kickback Statute constitutes a false or fraudulent claim for purposes
of the federal FCA.
The civil monetary penalties statute imposes penalties
against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to a federal
healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.
Federal false claims and false statement laws,
including the federal FCA, prohibit, among other things, any person or entity from knowingly presenting, or causing to be presented, a
false or fraudulent claim for payment to, or approval by, the federal healthcare programs, including Medicare and Medicaid, or knowingly
making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.
A claim includes “any request or demand” for money or property presented to the U.S. government. For instance, historically,
pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly providing free product to customers
with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing
false claims to be submitted because of the companies’ marketing of the product for unapproved, off-label, and thus generally non-reimbursable,
uses.
HIPAA prohibits, among other offenses, knowingly
and willfully executing a scheme to defraud any health care benefit program, including private payors, or falsifying, concealing or covering
up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for
items or services under a health care benefit program. To the extent that we act as a business associate to a healthcare provider engaging
in electronic transactions, we may also be subject to the privacy and security provisions of HIPAA, as amended by HITECH, which restricts
the use and disclosure of patient-identifiable health information, mandates the adoption of standards relating to the privacy and security
of patient-identifiable health information, and requires the reporting of certain security breaches to healthcare provider customers with
respect to such information. Additionally, many states have enacted similar laws that may impose more stringent requirements on entities
like ours. Failure to comply with applicable laws and regulations could result in substantial penalties and adversely affect our financial
condition and results of operations.
Many states also have similar fraud and abuse
statutes or regulations that apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply
regardless of the payor. Additionally, to the extent that our product is sold in a foreign country, we may be subject to similar foreign
laws.
Our products, once approved, may be eligible
for coverage under Medicare and Medicaid, among other government healthcare programs. Accordingly, we may be subject to a number of
obligations based on their participation in these programs, such as a requirement to calculate and report certain price reporting
metrics to the government, such as average sales price (ASP) and best price. Penalties may apply in some cases when such metrics are
not submitted accurately and timely. Further, these prices for medical devices may be reduced by mandatory discounts or rebates
required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of
medical devices from countries where they may be sold at lower prices than in the United States. It is difficult to predict how
Medicare coverage and reimbursement policies will be applied to our products in the future and coverage and reimbursement under
different federal healthcare programs are not always consistent. Medicare reimbursement rates may also reflect budgetary constraints
placed on the Medicare program.
34
In order to distribute products commercially, we must comply with state
laws that require the registration of manufacturers and wholesale distributors of medical devices in a state, including, in certain states,
manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within
the state. Some states also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of
distribution, including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product
as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical and biotechnology companies
to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing,
pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other
healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and
marketing, and to prohibit certain other sales and marketing practices. All of our activities are potentially subject to federal and state
consumer protection and unfair competition laws.
If our operations are found to be in violation
of any of the federal and state healthcare laws described above or any other governmental regulations that apply to us, we may be subject
to penalties, including without limitation, civil, criminal and/or administrative penalties, damages, fines, disgorgement, exclusion from
participation in government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual
whistleblowers in the name of the government, or refusal to allow us to enter into government contracts, contractual damages, reputational
harm, administrative burdens, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which
could adversely affect our ability to operate our business and our results of operations.
Our ability to obtain reimbursement or funding
from the federal government may be impacted by possible reductions in federal spending.
U.S. federal government agencies currently face
potentially significant spending reductions. The Budget Control Act of 2011, or the BCA, established a Joint Select Committee on Deficit
Reduction, which was tasked with achieving a reduction in the federal debt level of at least $1.2 trillion. That committee did not draft
a proposal by the BCA’s deadline. As a result, automatic cuts, referred to as sequestration, in various federal programs were scheduled
to take place, beginning in January 2013, although the American Taxpayer Relief Act of 2012 delayed the BCA’s automatic cuts until
March 1, 2013. While the Medicare program’s eligibility and scope of benefits are generally exempt from these cuts, Medicare payments
to providers and Part D health plans are not exempt. The BCA did, however, provide that the Medicare cuts to providers and Part D health
plans would not exceed two percent. President Obama issued the sequestration order on March 1, 2013, and cuts went into effect on April
1, 2013. Additionally, the Bipartisan Budget Act of 2015 extended sequestration for Medicare through fiscal year 2027.
The U.S. federal budget remains in flux, which
could, among other things, cut Medicare payments to providers. The Trump Administration cost reduction initiatives may impact Medicare
and Medicaid reimbursement levels. Medicare program is frequently mentioned as a target for spending cuts. The full impact on our business
of any future cuts in Medicare or other programs is uncertain. In addition, we cannot predict any impact President Trump’s administration
and the U.S. Congress may have on the federal budget. If federal spending is reduced, anticipated budgetary shortfalls may also impact
the ability of relevant agencies, such as the FDA or the National Institutes of Health, to continue to function at current levels. Amounts
allocated to federal grants and contracts may be reduced or eliminated. These reductions may also impact the ability of relevant agencies
to timely review and approve medical devises and development, manufacturing, and marketing activities, which may delay our ability to
develop, market and sell any products we may develop.
35
Risks Related to Our Securities
Our officers, directors and principal stockholders
own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
Our officers, directors and 5% stockholders
and their affiliates beneficially own a significant percentage of our outstanding common stock. As a result, these stockholders have
significant influence and may be able to determine all matters requiring stockholder approval. For example, these stockholders may
be able to control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or
other major corporate transactions. This concentration of ownership could delay or prevent any acquisition of our company on terms
that other stockholders may desire, and may adversely affect the market price of our common stock.
If we are unable to
maintain listing of our securities on The Nasdaq Capital Market or another reputable stock exchange, it may be more difficult for our
stockholders to sell their securities.
Nasdaq requires listing
issuers to comply with certain standards in order to remain listed on its exchange. If Nasdaq should delist our securities from trading
on its exchange for any reason and we are unable to obtain listing on another reputable national securities exchange, a reduction in some
or all of the following may occur, each of which could materially adversely affect our stockholders. A delisting of our common stock is
likely to reduce the liquidity of our common stock and may inhibit or preclude our ability to raise additional financing.
The price of our common stock may be volatile
and fluctuate substantially, which could result in substantial losses for our stockholders.
Our common stock is listed on the Nasdaq Capital
Market under the symbol “ALBT.” The price of our common stock has been, and we expect it to continue to be, volatile. The
stock market in general and the market for smaller healthcare companies in particular have experienced extreme volatility that has often
been unrelated to the operating performance of particular companies. As a result of this volatility, you may not be able to sell your
shares of common stock at or above the price you paid for your shares of common stock. The market price for our common stock may be influenced
by many factors, including:
●
the success of competitive products or technologies;
●
developments related to our existing or any future collaborations;
●
regulatory or legal developments in the United States and other countries;
●
developments or disputes concerning patent applications, issued patents or other proprietary rights;
●
the recruitment or departure of key personnel;
●
actual or anticipated changes in estimates as to financial results or recommendations by securities analysts;
●
variations in our financial results or those of companies that are perceived to be similar to us;
●
changes in the structure of healthcare payment systems;
●
market conditions in the healthcare, pharmaceutical and biotechnology sectors;
●
general economic, industry and market conditions; and
●
the other factors described in this “Risk Factors” section.
Future sales of our common stock or securities
convertible or exchangeable for our common stock may cause our stock price to decline.
If our existing stockholders sell, or indicate
an intention to sell, substantial amounts of our common stock in the public market, the price of our common stock could decline. The perception
in the market that these sales may occur could also cause the price of our common stock to decline.
36
In addition, as of December 31, 2024:
● 52,479
shares of our common stock were issuable upon exercise of outstanding stock options;
● 182,996
shares of our common stock were issuable upon exercise of outstanding stock warrants;
● 60,000
shares of our common stock issuable upon conversion of our outstanding Series A Preferred
Stock;
● 194,004
shares of our common stock were issuable upon the conversion of our outstanding Series B
Convertible Preferred Stock (the “Series B Preferred Stock”), which will become
eligible for sale in the public market to the extent permitted by the provisions of various
vesting schedules, lock-up agreements and Rule 144 under the Securities Act;
● 1,452,282
shares of our common stock issuable upon conversion of our outstanding Series C Preferred
Stock;
● 227,269
shares of our common stock issuable upon conversion of our outstanding convertible notes.
If the shares we may issue from time to time upon
the exercise of outstanding options and warrants and the conversion of our outstanding Series C Preferred Stock and Series D Preferred
Stock are sold and outstanding convertible notes are issues, or if it is perceived that they will be sold, by the award recipients in
the public market, the price of our common stock could decline.
You may experience dilution of your ownership
interests because of the future issuance of additional shares of our common or preferred stock or other securities that are convertible
into or exercisable for our common or preferred stock.
As of the date of this filing, we have issued
an aggregate of (i) 3,500 shares of our newly designated Series C Preferred Stock and (ii) 5,000 shares of our newly designated Series
D Preferred Stock. In the future, we may issue our authorized but previously unissued equity securities, resulting in the dilution of
the ownership interests of our stockholders. We are authorized to issue an aggregate of 100,000,000 shares of common stock and 10,000,000
shares of “blank check” preferred stock. We may issue additional shares of our common stock or other securities that are convertible
into or exercisable for our common stock in connection with hiring or retaining employees, future acquisitions, future sales of our securities
for capital raising purposes, or for other business purposes. The future issuance of any such additional shares of our common stock may
create downward pressure on the trading price of our common stock. We expect we will need to raise additional capital in the near future
to meet our working capital needs, and there can be no assurance that we will not be required to issue additional shares, warrants or
other convertible securities in the future in conjunction with these capital raising efforts, including at a price (or exercise prices)
below the price you paid for your stock.
The ability of our Board to issue additional
stock may prevent or make more difficult certain transactions, including a sale or merger.
Our Board is authorized to issue up to 10,000,000
shares of preferred stock with powers, rights and preferences designated by it. Shares of voting or convertible preferred stock could
be issued, or rights to purchase such shares could be issued, to create voting impediments or to frustrate persons seeking to effect a
takeover or otherwise gain control of us. The rights of holders of our common stock are subject to the rights of the holders of our preferred
stock, including our newly designated Series D Preferred Stock, Series D Preferred Stock and any preferred stock that may be issued. The
ability of the Board to issue such additional shares of preferred stock, with rights and preferences it deems advisable, could discourage
an attempt by a party to acquire control of us by tender offer or other means. Such issuances could therefore deprive stockholders of
benefits that could result from such an attempt, such as the realization of a premium over the market price for their shares in a tender
offer or the temporary increase in market price that such an attempt could cause. Moreover, the issuance of such additional shares of
preferred stock to persons friendly to the Board could make it more difficult to remove incumbent managers and directors from office even
if such change were to be favorable to stockholders generally.
We are incorporated in Delaware. Certain anti-takeover
provisions of Delaware law and our charter documents as currently in effect may make a change in control of us more difficult, even if
a change in control would be beneficial to the stockholders. Delaware law also prohibits corporations from engaging in a business combination
with any holders of 15% or more of their capital stock until the holder has held the stock for three years unless, among other possibilities,
our Board approves the transaction. Our Board may use these provisions to prevent changes in the management and control of us. Also, under
applicable Delaware law, our Board may adopt additional anti-takeover measures in the future.
37
If securities or industry analysts do not publish
research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading
volume could decline.
The trading market for our common stock will be
influenced by the research and reports that industry or securities analysts publish about us or our business. We do not currently have
and may never obtain research coverage by securities and industry analysts. If no or few securities or industry analysts commence coverage
of us, the trading price for our stock would be negatively impacted. In the event we obtain securities or industry analyst coverage, if
any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property or
our stock performance, or if our operating results fail to meet the expectations of analysts, our stock price would likely decline. If
one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial
markets, which in turn could cause our stock price or trading volume to decline.
We do not anticipate paying dividends on our
common stock, and investors may lose the entire amount of their investment.
We have never declared or paid cash dividends
on our common stock, and we do not anticipate such a declaration or payment for the foreseeable future.
We expect to use future earnings, if any, to fund
business growth. Therefore, stockholders will not receive any funds absent a sale of their shares of our common stock. We cannot assure
stockholders of a positive return on their investment when they sell their shares, nor can we assure that stockholders will not lose the
entire amount of their investment.
Applicable regulatory requirements, including
those contained in and issued under the Sarbanes-Oxley Act of 2002, may make it difficult for us to retain or attract qualified officers
and directors, which could adversely affect the management of our business and our ability to obtain or retain listing of our common stock
on a national securities exchange.
We may be unable to attract and retain those qualified
officers, directors and members of board committees required to provide for effective management because of the rules and regulations
that govern publicly held companies, including, but not limited to, certifications by principal executive officers. The enactment of the
Sarbanes-Oxley Act has resulted in the issuance of a series of related rules and regulations and the strengthening of existing rules and
regulations by the SEC, as well as the adoption of new and more stringent rules by national securities exchanges. The perceived increased
personal risk associated with these changes may deter qualified individuals from accepting roles as directors and executive officers.
Further, some of these changes heighten the requirements
for board or committee membership, particularly with respect to an individual’s independence from the corporation and level of experience
in finance and accounting matters. We may have difficulty attracting and retaining directors with the requisite qualifications. If we
are unable to attract and retain qualified officers and directors, the management of our business and our ability to obtain or retain
listing of our shares of common stock on any national securities exchange could be adversely affected.
If we cannot satisfy the continued listing
requirements and other rules of The Nasdaq Capital Market, our securities may be delisted, which could negatively impact the price of
our securities and your ability to sell them.
Our common stock is listed on The Nasdaq Capital
Market under the symbol “ALBT.” In order to maintain our listing on The Nasdaq Capital Market, we are required to comply with
certain rules of the applicable trading market, including those regarding minimum stockholders’ equity, minimum share price and
certain corporate governance requirements. We may not be able to continue to satisfy the listing requirements and other applicable rules
of The Nasdaq Capital Market. If we are unable to satisfy the criteria for maintaining our listing, our securities could be subject to
delisting.
38
If our common stock is delisted from trading by
the applicable trading market we could face significant consequences, including.
● a limited availability for
market quotations for our securities;
● reduced liquidity with respect
to our securities;
● a determination that our common
stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules and possibly
result in a reduced level of trading activity in the secondary trading market for our common stock;
● limited amount of news and
analyst coverage; and
● a decreased ability to issue
additional securities or obtain additional financing in the future.
We could be subject to securities class action
litigation.
In the past, securities class action litigation
has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for
us because companies in our industry have experienced significant stock price volatility in recent years. If we face such litigation,
it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 1C. CYBERSECURITY
Cybersecurity Risk Management
We, like other companies in our industry, face
several cybersecurity risks in connection with our business. Our business strategy, results of operations, and financial condition have
not, to date, been affected by risks from cybersecurity threats. During the reporting period, we have not experienced any material cyber
incidents, nor have we experienced a series of immaterial incidents, which would require disclosure.
In the ordinary course of our business, we use,
store and process a bare minimum of data. To effectively prevent, detect, and respond to cybersecurity threats, we maintain a cyber risk
management program, which is comprised of data segregation, penetration testing, and training. The cyber risk management program falls
under the responsibility of a third party IT consultant, who has cross-functional expertise in IT management, cybersecurity, and engineering
with more than 30 years of experience (the “IT Consultant”), who reports directly to our Chief Financial Officer. Under the
guidance of the IT Consultant, we have minimized our data footprint to keep our cyber risk low.
We have implemented a cybersecurity risk management
program that is designed to limit and mitigate risks from cybersecurity threats. Our cybersecurity risk management program incorporates
several components, including employee training, periodic penetration tests, and multifactor authentications.
Governance
Under the ultimate direction of our CFO, with
oversight from the Board, we maintain a security governance structure to evaluate and address cyber risk.
Our Board is responsible for the oversight of
cybersecurity risk management. The Board delegates oversight of the cybersecurity risk management program to the Audit Committee. On a
quarterly and as-needed basis, the CFO reports to the Audit Committee on our cybersecurity risk management program, including any critical
cybersecurity risks, ongoing cybersecurity initiatives and strategies, and applicable regulatory requirements and industry standards.
The CFO also provides updates to the Audit Committee of any cybersecurity incidents (suspected or actual) and provides updates on the
incidents as well as cybersecurity risk mitigation activities as appropriate.
39
ITEM 2. PROPERTIES
Our principal offices are located at 4400 Route
9 South, Freehold, NJ 07728. The office building is owned by our subsidiary, Avalon RT 9 Properties, LLC, which is in business of owning
and operating an income-producing real property. Our property is well maintained, adequately meets our needs, and is being utilized for
its intended purpose.
We lease additional office space for operations.
Office location is not crucial to our operations, and we anticipate no difficulty in extending these leases or obtaining comparable office
space.
We are obligated under various lease agreements
providing for office space that expire at various dates through December 31, 2025. Total rent expense under these lease agreements was
approximately $127,000 and $129,000 for the years ended December 31, 2024 and 2023, respectively.
We believe that our current office space is adequate
for our current and immediately foreseeable operating needs.
ITEM 3. LEGAL PROCEEDINGS
From time to time, we are subject to ordinary
routine litigation incidental to our normal business operations. We are not currently a party to, and our property is not subject to,
any material legal proceedings, except as set forth below.
On October 25, 2017, our subsidiary, Genexosome,
entered into and closed a Stock Purchase Agreement with Beijing Jieteng (Genexosome) Biotech Co., Ltd., a corporation incorporated in
the People’s Republic of China on August 7, 2015 (“Beijing Genexosome”) which was dissolved in June 2022, and Yu Zhou,
MD, PhD, the sole shareholder of Beijing Genexosome, pursuant to which Genexosome acquired all of the issued and outstanding securities
of Beijing Genexosome in consideration of a cash payment in the amount of $450,000, of which $100,000 is still owed. Further, on October
25, 2017, Genexosome entered into and closed an Asset Purchase Agreement with Dr. Zhou, pursuant to which the Company acquired all assets,
including all intellectual property and exosome separation systems, held by Dr. Zhou pertaining to the business of researching, developing
and commercializing exosome technologies. In consideration of the assets, Genexosome paid Dr. Zhou $876,087 in cash, transferred 3,333
shares of our common stock to Dr. Zhou and issued Dr. Zhou 400 shares of common stock of Genexosome. Further, the Company had not been
able to realize the financial projections provided by Dr. Zhou at the time of the acquisition and has decided to impair the intangible
asset associated with this acquisition to zero. Dr. Zhou was terminated as Co-CEO of Genexosome on August 14, 2019. Further, on October
28, 2019, Research Institute at Nationwide Children’s Hospital (“Research Institute”) filed a Complaint in the United
States District Court for the Southern District of Ohio Eastern Division against Dr. Zhou, Li Chen, the Company and Genexosome with various
claims against the Company and Genexosome including misappropriation of trade secrets in violation of the Defend Trade Secrets Act of
2016 and violation of Ohio Uniform Trade Secrets Act. Research Institute is seeking monetary damages, injunctive relief, exemplary damages,
injunctive relief and other equitable relief. The Company intends to vigorously defend against this action and pursue all available legal
remedies. The criminal proceedings against Dr. Zhou and Li Chen have been concluded. The Company, Genexosome and the Research Institute
entered into a settlement agreement dated June 7, 2022 (the “Settlement Agreement”), whereby the Company agreed to pay the
Research Institute $450,000 on each of the sixty-day, one year and two-year anniversaries of the Settlement Date. In addition, the Company
agreed to pay the Research Institute 30% of the Company’s initial pre-tax profit of $3,333,333, 20% of the Company’s second
pre-tax profit of $3,333,333 and 10% of the Company’s third pre-tax profit of $3,333,333. The parties provided a mutual release
as well.
ITEM 4. MINE SAFETY DISCLOSURES
None.
40
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON
EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Our common stock is listed on The Nasdaq Capital
Market under the symbol “ALBT.” On March 28, 2025, the closing price of our common stock on The Nasdaq Capital Market was $5.27.
Holders of Record
As of March 31, 2025, there were approximately
237 registered holders of record of our shares of common stock, based upon information received from our stock transfer agent. However,
this number does not include beneficial owners whose shares were held of record by nominees or broker dealers.
ITEM 6. [RESERVED]
ITEM 7. MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion
and analysis of our financial condition and results of operations for the years ended December 31, 2024 and 2023 should be read in conjunction
with our consolidated financial statements and related notes to those consolidated financial statements that are included elsewhere in
this report. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve
risks and uncertainties.
Special Note Regarding
Forward-looking Statements
All statements other
than statements of historical fact included in this Annual Report Form 10-K including, without limitation, statements under “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” regarding our financial position, business strategy and
the plans and objectives of management for future operations, are forward-looking statements. When used in this Annual Report on Form
10-K, words such as “anticipate,” “believe,” “estimate,” “expect,” “intend”
and similar expressions, as they relate to us or our management, identify forward-looking statements. Such forward-looking statements
are based on the beliefs of management, as well as assumptions made by, and information currently available to, our management. Actual
results could differ materially from those contemplated by the forward-looking statements as a result of a number of factors, including
those set forth under the risk factors and business sections in this Annual Report on Form 10-K.
Overview
We are a commercial-stage
company dedicated to developing and delivering precision diagnostic consumer products. We are currently marketing the Keto Air breathalyzer
device and plan to develop additional diagnostic uses of the breathalyzer technology. In addition, we own commercial real estate that
houses our headquarters in Freehold, New Jersey.
We have the following areas of focus in 2024 and 2023:
Laboratory Acquisitions
We had embarked on
a laboratory rollup strategy focused on forming joint ventures and acquiring laboratories that were accretive to our commercial
strategy. As a first step, in February 2023, we acquired a 40% membership interest in Lab Services MSO. Among other things, Lab
Services MSO provides toxicology and wellness testing services, a broad portfolio of diagnostic tests, and a broad array of test
services. During 2025, to preserve cash, the Company entered into discussions with Lab Services MSO for the potential redemption of
our investment and on February 26, 2025, we and Lab Services MSO entered into a Redemption and Abandonment Agreement, whereby Lab
Services MSO redeemed the 40% equity interest in Lab Services MSO held by us. Accordingly, beginning in February 2025, we no longer
offer laboratory services.
Research and Development
We are focused on bringing
forward intellectual property through joint patent filings with the Massachusetts Institute of Technology (“MIT”). We completed
a sponsored research and co-development project with MIT led by Professor Shuguang Zhang as Principal Investigator. Using the unique QTY
code protein design platform, six water-soluble variant cytokine receptors have been successfully designed and tested to show binding
affinity to the respective cytokines. We currently are focused on bringing forward the intellectual property associated with this program
through joint patent submissions.
41
Product Commercialization
We have begun the commercialization
and development of a versatile breathalyzer system.
We were granted
exclusive distributorship rights for the KetoAir from Qi Diagnostics for the following territories: North America, South America,
the EU and the UK. For our commercialization strategy, we intend to target the diabetes and obesity markets. We sell the
product through the KetoAir website and social media. We believe the KetoAir device has some competitive advantages to other methods
for measuring ketosis.
The KetoAir is a handheld
device that allows the user to detect acetone levels in exhaled breath. The acetone level is in concentration units (ppm, part-per-million)
such that the user will know his/her real-time ketosis status: inadequate ketosis (0-3.99 ppm), mild ketosis (4-9.99 ppm), optimal ketosis
(10-40 ppm), or alarming level (> 40 ppm). The KetoAir is registered with the United States Food and Drug Administration as a Class
I medical device. The device is also paired with an “AI Nutritionist” software program (via Bluetooth connection) which is
downloadable from Google Play (for Android mobile phones, approved) and iPhone (the app is currently being reviewed by Apple iOS AppStore).
It helps users monitor and manage their ketogenic diet and related programs. We believe the KetoAir can be an essential tool to help diabetic
patients adhere to their therapeutic programs and optimize their ketogenic dietary management.
Other Areas
In order to preserve
cash and focus on our core laboratory rollup strategy and product commercialization, we have currently suspended all research and development
efforts related to cellular therapy in order to redirect our funding efforts to our core business strategies outlined above.
Going Concern
We are a commercial-stage company dedicated to developing and delivering
precision diagnostic consumer products. We are currently marketing the Keto Air breathalyzer device and plan to develop additional diagnostic
uses of the breathalyzer technology.
In
addition, we own commercial real estate that houses our headquarters in Freehold, New Jersey. These consolidated financial statements
have been prepared assuming that we will continue as a going concern, which contemplates, among other things, the realization of assets
and the satisfaction of liabilities in the normal course of business.
As reflected in the accompanying
consolidated financial statements, we had working capital deficit of approximately $10,646,000 at December 31, 2024 and had incurred recurring
net losses and generated negative cash flow from operating activities of approximately $7,903,000 and $4,969,000 for the year ended December
31, 2024, respectively.
We have a limited operating
history and our continued growth is dependent upon the continuation of generating rental revenue from our income-producing real estate
property in New Jersey and obtaining additional financing to fund future obligations and pay liabilities arising from ordinary course
business operations. In addition, the current cash balance cannot be projected to cover our operating expenses for the next twelve months
from the release date of this report. These matters raise substantial doubt about our ability to continue as a going concern. Our ability
to continue as a going concern is dependent on our ability to raise additional capital, implement our business plan, and generate sufficient
revenues. There are no assurances that we will be successful in our efforts to generate sufficient revenues, maintain sufficient cash
balance or report profitable operations or to continue as a going concern. We plan on raising capital through the sale of equity to implement
our business plan. However, there is no assurance these plans will be realized and that any additional financings will be available to
us on satisfactory terms and conditions, or at all.
The accompanying consolidated financial statements
do not include any adjustments related to the recoverability or classification of asset-carrying amounts or the amounts and classification
of liabilities that may result should we be unable to continue as a going concern.
42
Critical
Accounting Policies
Use
of Estimates
The preparation of
the consolidated financial statements in conformity with accounting principles generally accepted in the United States of America
(“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of
revenues and expenses during the reporting period. Changes in these estimates and assumptions may have a material impact on the
consolidated financial statements and accompanying notes. Making estimates requires management to exercise significant judgment. It
is at least reasonably possible that the estimate of the effect of a condition, situation or set of circumstances that existed at
the date of the financial statements, which management considered in formulating its estimate, could change in the near term due to
one or more future confirming events. Accordingly, the actual results could differ significantly from those estimates.
Significant estimates
during the years ended December 31, 2024 and 2023 include the useful life of investment in real estate and intangible assets, the assumptions
used in assessing impairment of long-term assets, the valuation of deferred tax assets and the associated valuation allowances, the valuation
of stock-based compensation, the assumptions used to determine fair value of warrants and embedded conversion features of convertible
note payable, and the fair value of the consideration given and assets acquired in the purchase of our equity interest in Lab Services
MSO.
Investment in Unconsolidated
Companies
We use the equity method
of accounting for our investment in, and earning or loss of, company that we do not control but over which we do exert significant influence.
We apply the equity method by initially recording these investments at cost, as equity method investments, subsequently adjusted for equity
in earnings and cash distributions.
We consider whether the
fair value of our equity method investment has declined below its carrying value whenever adverse event or change in circumstance indicates
that recorded value may not be recoverable. If we consider any decline to be other than temporary (based on various factors, including
historical financial results and the overall health of the investee), then a write-down would be recorded to estimated fair value. Impairment
of equity method investment amounted to $259,579 and $9,651,361 for the years ended December 31, 2024 and 2023, respectively.
We classify distributions
received from equity method investments using the cumulative earnings approach. Distributions received are considered returns on the investment
and classified as cash inflows from operating activities. If, however, the investor’s cumulative distributions received, less distributions
received in prior periods determined to be returns of investment, exceeds cumulative equity in earnings recognized, the excess is considered
a return of investment and is classified as cash inflows from investing activities.
Real Property Rental
We have determined that
the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) 606 does not
apply to rental contracts, which are within the scope of other revenue recognition accounting standards.
Rental income from operating
leases is recognized on a straight-line basis under the guidance of ASC 842. Lease payments under tenant leases are recognized on a straight-line
basis over the term of the related leases. The cumulative difference between lease revenue recognized under the straight-line method and
contractual lease payments are included in rent receivable on the consolidated balance sheets.
Income Taxes
We
are governed by the income tax laws of China and the United States. Income taxes are accounted for pursuant to ASC 740 “Accounting
for Income Taxes,” which is an asset and liability approach that requires the recognition of deferred tax assets and liabilities
for the expected future tax consequences of events that have been recognized in our financial statements or tax returns. The charge for
taxes is based on the results for the period as adjusted for items, which are non-assessable or disallowed. It is calculated using tax
rates that have been enacted or substantively enacted by the balance sheet date.
Deferred
tax is accounted for using the balance sheet liability method in respect of temporary differences arising from differences between
the carrying amount of assets and liabilities in the financial statements and the corresponding tax basis used in the computation of
assessable tax profit. In principle, deferred tax liabilities are recognized for all taxable temporary differences, and
deferred tax assets are recognized to the extent that it is probable that taxable profit will be available against which deductible
temporary differences can be utilized.
43
Deferred tax is calculated
using tax rates that are expected to apply to the period when the asset is realized or the liability is settled. Deferred tax is charged
or credited in the income statement, except when it is related to items credited or charged directly to equity, in which case the deferred
tax is changed to equity. Deferred tax assets and liabilities are offset when they related to income taxes levied by the same taxation
authority and we intend to settle its current tax assets and liabilities on a net basis.
Recent Accounting Standards
For details of applicable new accounting standards,
please, refer to Recent Accounting Standards in Note 3 of our consolidated financial statements accompanying this report.
RESULTS OF OPERATIONS
Comparison of Results of Operations for the
Years Ended December 31, 2024 and 2023
Real
Property Rental Revenue
For
the year ended December 31, 2024, we had real property rental revenue of $1,333,403, as compared to $1,255,681 for the year ended December
31, 2023, an increase of $77,722, or 6.2%. The increase was primarily attributable to the increase in the number of tenants occupying
the building in the year ended December 31, 2024 as compared to the year ended December 31, 2023. We expect that our revenue from real
property rent will remain at its current level with minimal increase in the near future.
Real Property Operating
Expenses
Real property operating
expenses consist of property management fees, property insurance, real estate taxes, depreciation, repairs and maintenance fees, utilities
and other expenses related to our rental properties.
For the year ended December
31, 2024, our real property operating expenses amounted to $1,065,574, as compared to $1,017,493 for the year ended December 31, 2023,
an increase of $48,081, or 4.7%. The increase was primarily attributable to an increase in electric fee of approximately $40,000 and an
increase in other miscellaneous items of approximately $8,000.
Real Property Operating
Income
Our real property operating
income for the year ended December 31, 2024 was $267,829, representing an increase of $29,641, or 12.4%, as compared to $238,188 for the
year ended December 31, 2023. The increase was primarily attributable to the increase in real property rental revenue as described above.
We expect our real property operating income will remain at its current level with minimal increase in the near future.
Loss from Equity
Method Investment – Lab Services MSO
For the year ended December
31, 2024, we had loss from our investment in Lab Services MSO of $846,588, which consists of our share of Lab Services MSO’s net
income of $79,923, and amortization of identifiable intangible assets acquired from Lab Services MSO acquisition of $666,932, and impairment
of goodwill acquired from Lab Services MSO acquisition of $259,579, which was primarily attributable to Lab Services MSO’s lower
revenues and net incomes than anticipated and the decline in our stock price and market capitalization.
For the year ended December
31, 2023, we had loss from our investment in Lab Services MSO of $8,571,647, which consists of our share of Lab Services MSO’s net
income of $1,236,391, and amortization of identifiable intangible assets acquired from Lab Services MSO acquisition of $611,356, and impairment
of goodwill acquired from Lab Services MSO acquisition of $9,196,682, which was primarily attributable to Lab Services MSO’s lower
revenues and net incomes than anticipated and the decline in our stock price and market capitalization.
44
Other Operating Expenses
For
the years ended December 31, 2024 and 2023, other operating expenses consisted of the following:
Years Ended December 31,
2024
2023
Advertising and marketing expenses
$ 237,671
$ 1,666,721
Professional fees
1,822,105
3,076,477
Compensation and related benefits
1,431,328
1,768,449
Miscellaneous taxes
233,488
57,290
Research and development
-
109,618
Directors and officers’ liability insurance premium
212,898
349,745
Travel and entertainment
109,244
166,921
Rent and related utilities
62,294
64,149
Impairment of laboratory equipment
111,033
-
Other general and administrative
128,912
160,854
$ 4,348,973
$ 7,420,224
● For the year ended December 31, 2024, advertising and marketing expenses decreased by $1,429,050, or 85.7%,
as compared to the year ended December 31, 2023. The decrease was primarily due to decreased advertising activities in the year ended
December 31, 2024. We expect that our advertising and marketing expenses will decrease in the near future as we conserve cash.
● Professional fees primarily consisted of accounting fees, audit
fees, legal service fees, consulting fees, investor relations service charges, valuation service fees and other fees. For the year ended
December 31, 2024, professional fees decreased by $1,254,372, or 40.8%, as compared to the year ended December 31, 2023, which was primarily
attributable to a decrease in consulting fees of approximately $352,000, mainly due to the decrease in use of consulting service providers
related to our acquisition of Lab Services MSO, a decrease in audit fees of approximately $174,000, due to the decreased audit services
related to our acquisition of Lab Services MSO, a decrease in accounting fees of approximately $431,000, mainly due to the decreased accounting
services related to our acquisition of Lab Services MSO, a decrease in legal service fees of approximately $385,000, mainly due to the
decreased legal services related to our acquisition of Lab Services MSO, and a decrease in other miscellaneous items of approximately
$47,000, offset by an increase in valuation fee for our equity method investment on Lab Services MSO of $135,000. We expect that our professional
fees will likely remain at their current level with minimal increase in the near future.
● For the year ended December 31, 2024, compensation and related benefits
decreased by $337,121, or 19.1%, as compared to the year ended December 31, 2023. The decrease was primarily attributable to the decreased
compensation for two of our executive officers, David Jin and Meng Li. We expect that our compensation and related benefits will remain
relatively steady, with minimal increase, in the near future .
● For the year ended December 31, 2024, miscellaneous taxes increased by $176,198, or 307.6%, as compared
to the year ended December 31, 2023. The increase was primarily attributable to increased Delaware state franchise tax. We expect that
our miscellaneous taxes will decrease in the near future.
● For the year ended December 31, 2024, research and development expenses
decreased by $109,618, or 100.0%, as compared to the year ended December 31, 2023. In the year ended December 31, 2024, we did not incur
any activity with respect to research and development projects as we redirected our funding efforts to our core business strategies discussed
above.
45
● For the year ended December 31,
2024, directors’ and officers’ liability insurance premium decreased by $136,847, or 39.1%, as compared to the year ended
December 31, 2023. The decrease was mainly due to our switching to a different insurance provider, resulting in a lower premium.
● For the year ended December 31, 2024, travel and entertainment expense
decreased by $57,677, or 34.6%, as compared to the year ended December 31, 2023. The decrease was mainly due to decreased business travel
activities in the year ended December 31, 2024 as compared to the year ended December 31, 2023.
● For the year ended December 31, 2024, rent and related utilities
expenses decreased by $1,855, or 2.9%, as compared to the year ended December 31, 2023.
● In December 2024, we assessed our laboratory equipment for any impairment and concluded that there were
indicators of impairment as of December 31, 2024 and we calculated that the estimated undiscounted cash flows were less than the carrying
amount of the laboratory equipment. Based on our analysis, we recognized an impairment loss of $111,033 for the year ended December 31,
2024, which reduced the value of laboratory equipment to zero. We did not record any impairment charge for the year ended December 31,
2023.
● Other general and administrative expenses mainly consisted of NASDAQ
listing fee, office supplies, and other miscellaneous items. For the year ended December 31, 2024, other general and administrative expenses
decreased by $31,942, or 19.9%, as compared to the year ended December 31, 2023, which was mainly attributable to a decrease in office
supplies of approximately $12,000, and a decrease in other miscellaneous items of approximately $20,000 due to our efforts at stricter
controls on corporate expenditure.
Loss from Operations
As a result of the foregoing,
for the year ended December 31, 2024, loss from operations amounted to $4,927,732, as compared to $15,753,683 for the year ended December
31, 2023, representing a decrease of $10,825,951, or 68.7%.
Other (Expense)
Income
Other (expense) income
mainly includes third party and related party interest expense, debt modification charge, change in fair value of derivative liability,
impairment of equity method investment on Epicon, gain on debts extinguishment, and other miscellaneous expense.
Other expense, net, totaled
$2,975,662 for the year ended December 31, 2024, as compared to $953,327 for the year ended December 31, 2023, an increase of $2,022,335,
or 212.1%, which was primarily attributable to an increase in third party interest expense of approximately $1,077,000, mainly driven
by the increase in amortization of debt discount and debt issuance costs of approximately $867,000 and the increased interest expense
of approximately $210,000 from third party debts, an increase in interest expense – related party of approximately $9,000, an increase
in debt modification charge of approximately $839,000, a decrease in gain on debts extinguishment of approximately $683,000, and an increase
in other expense of approximately $56,000, offset by an increase in gain from change in fair value of derivative liability of approximately
$186,000, a decrease in impairment of equity method investment on Epicon of approximately $455,000.
Income Taxes
We did not
have any income taxes expense for the years ended December 31, 2024 and 2023 since we incurred losses in these periods.
Net Loss
As
a result of the factors described above, our net loss was $7,903,394 for the year ended December 31, 2024, as compared to $16,707,010
for the year ended December 31, 2023, a decrease of $8,803,616, or 52.7%.
46
Net Loss Attributable
to Avalon GloboCare Corp. Common Shareholders
The
net loss attributable to our common shareholders was $7,903,394, or $8.44 per share (basic and diluted), for the year ended December 31,
2024, as compared to $16,707,010, or $23.80 per share (basic and diluted), for the year ended December 31, 2023, a decrease of $8,803,616,
or 52.7%.
Foreign Currency
Translation Adjustment
Our reporting currency is the
U.S. dollar. The functional currency of our parent company, AHS, Avalon RT 9, Avalon Lab, and Q&A Distribution is the U.S. dollar
and the functional currency of Avalon Shanghai is the Chinese Renminbi (“RMB”). The financial statements of our subsidiary
whose functional currency is the RMB are translated to U.S. dollars using period end rate of exchange for assets and liabilities, average
rate of exchange for revenues, costs, and expenses and cash flows, and at historical exchange rate for equity. Net gains and losses resulting
from foreign exchange transactions are included in the results of operations. As a result of foreign currency translations, which are
a non-cash adjustment, we reported a foreign currency translation loss of $273 and $18,590 for the years ended December 31, 2024 and 2023,
respectively. This non-cash loss had the effect of increasing our reported comprehensive loss in each respective period.
Comprehensive Loss
As a result
of our foreign currency translation adjustment, we had comprehensive loss of $7,903,667 and $16,725,600 for the years ended December 31,
2024 and 2023, respectively.
Liquidity and Capital
Resources
We have
a limited operating history and our continued growth is dependent upon the continuation of generating rental revenue from our income-producing
real estate property in New Jersey, as well as obtaining additional financing to fund future obligations and pay liabilities arising from
ordinary course business operations. In addition, the current cash balance cannot be projected to cover our operating expenses for the
next twelve months from the release date of this report. These matters raise substantial doubt about our ability to continue as a going
concern. Our ability to continue as a going concern is dependent on our ability to raise additional capital, implement our business plan,
and generate sufficient revenues. There are no assurances that we will be successful in our efforts to generate sufficient revenues, maintain
sufficient cash balance or report profitable operations or to continue as a going concern. As described below, we have raised additional
capital through the sale of equity and debt and we plan to raise additional capital in the future through the sale of equity or debt to
implement our business plan. However, there is no assurance these plans will be realized and that any additional financings will be available
to us on satisfactory terms and conditions, if at all.
Liquidity is the ability
of a company to generate funds to support its current and future operations, satisfy its obligations as they come due and otherwise operate
on an ongoing basis. At December 31, 2024 and 2023, we had a cash balance of approximately $2,856,000 and $285,000, respectively. These
funds are kept in financial institutions located as follows:
Country:
December 31, 2024
December 31, 2023
United States
$ 2,844,522
99.6 %
$ 280,197
98.2 %
China
11,787
0.4 %
5,203
1.8 %
Total cash
$ 2,856,309
100.0 %
$ 285,400
100.0 %
47
The following
table sets forth a summary of changes in our working capital deficit from December 31, 2023 to December 31, 2024:
December 31,
Changes in
2024
2023
Amount
Percentage
Working capital deficit:
Total current assets
$ 3,236,498
$ 850,867
$ 2,385,631
280.4 %
Total current liabilities
13,882,555
6,762,686
7,119,869
105.3 %
Working capital deficit
$ (10,646,057 )
$ (5,911,819 )
$ (4,734,238 )
80.1 %
Our working capital deficit increased
by $4,734,238 to $10,646,057 at December 31, 2024 from $5,911,819 at December 31, 2023. The increase in working capital deficit was primarily
attributable to a decrease in rent receivable of approximately $117,000 driven by collection efforts in the year ended December 31, 2024,
an increase in accrued liabilities and other payables of $161,000 mainly due to the increase in accrued Delaware state franchise tax in
the year ended December 31, 2024, an increase in accrued liabilities and other payables – related parties of approximately $526,000
mainly due to our equity method investment payable paid by a related party on our behalf, a significant increase in advance from pending
sale of noncontrolling interest – related party of approximately $2,622,000 resulting from advance received in connection with the
membership interest purchase agreement entered into in November 2023 in the year ended December 31, 2024, an increase in derivative liability
of approximately $103,000, an increase in note payable, net, of approximately $5,715,000, which was attributable to the reclassification
of note payable from non-current to current, and an increase in convertible note payable, net, of approximately $189,000, offset by n
increase in cash of approximately $2,571,000, a decrease in accrued professional fees of approximately $1,193,000 resulting from payments
made to our professional service providers in the year ended December 31, 2024, a decrease in operating lease obligation of approximately
$119,000, and a decrease in equity method investment payable of approximately $667,000 resulting from payment of $100,000 made to investee
and payment of approximately $567,000 made by a related party on our behalf in the year ended December 31, 2024.
Because
the exchange rate conversion is different for the consolidated balance sheets and the consolidated statements of cash flows, the changes
in assets and liabilities reflected on the consolidated statements of cash flows are not necessarily identical with the comparable changes
reflected on the consolidated balance sheets.
Cash
Flows for the Year Ended December 31, 2024 Compared to the Year Ended December 31, 2023
The
following table summarizes the key components of our cash flows for the years ended December 31, 2024 and 2023:
Years Ended December 31,
2024
2023
Net cash used in operating activities
$ (4,969,205 )
$ (6,504,718 )
Net cash used in investing activities
(100,000 )
(22,159 )
Net cash provided by financing activities
7,638,667
4,825,337
Effect of exchange rate on cash
1,447
(3,970 )
Net increase (decrease) in cash
$ 2,570,909
$ (1,705,510 )
Net
cash flow used in operating activities for the year ended December 31, 2024 was $4,969,205, which primarily reflected our
consolidated net loss of approximately $7,903,000, and the non-cash item adjustment, consisting of change in fair market value of
derivative liability of approximately $374,000, and the changes in operating assets and liabilities, primarily consisting of a
decrease in accrued liabilities and other payables of approximately $1,165,000 resulting from payments made to our vendors in the
year ended December 31, 2024, and a decrease in operating lease obligation of approximately $123,000, offset by a decrease in rent
receivable of approximately $131,000 driven by our collection efforts, and the non-cash items adjustment, primarily consisting of
depreciation of approximately $178,000, amortization of operating lease right-of-use asset of approximately $123,000, stock-based
compensation and service expense of approximately $522,000, loss from equity method investments of approximately $847,000 which was
mainly attributable to the amortization of identifiable intangible assets acquired from Lab Services MSO acquisition of
approximately $667,000 and the impairment of goodwill acquired from Lab Services MSO acquisition of approximately $260,000,
resulting from Lab Services MSO’s lower revenues and net incomes than anticipated and the decline in our stock price and
market capitalization, distribution of earnings from equity method investment of approximately $612,000, amortization of debt
issuance costs and debt discount of approximately $1,411,000, impairment of laboratory equipment of approximately $111,000, and debt
modification charge of approximately $689,000.
48
Net cash
flow used in operating activities for the year ended December 31, 2023 was $6,504,718, which primarily reflected our consolidated net
loss of approximately $16,707,000, and the changes in operating assets and liabilities, primarily consisting of a decrease in operating
lease obligation of approximately $113,000, and the non-cash items adjustment, consisting of change in fair market value of derivative
liability of approximately $188,000, and gain on debts extinguishment of approximately $683,000, offset by depreciation of approximately
$212,000, amortization of operating lease right-of-use asset of approximately $118,000, stock-based compensation and service expense of
approximately $1,180,000, loss from equity method investments of approximately $8,590,000 mainly due to the impairment of goodwill acquired
from Lab Services MSO acquisition resulting from Lab Services MSO’s lower revenues and net incomes than anticipated and the decline
in our stock price and market capitalization, impairment of equity method investment - Epicon of approximately $455,000 due to Epicon’s
series of operating losses and the joint venture partner unable to obtain funds to commence operations, and amortization of debt issuance
costs and debt discount of approximately $544,000 resulting from our outstanding convertible debt and note payable, and the changes in
operating assets and liabilities, primarily consisting of an increase in accrued liabilities and other payables – related parties
of approximately $106,000 driven by the increased accrued interest for related party.
We expect our cash used
in operating activities to increase in the next 12 months due to the following:
● the development and
commercialization of new products; and
● an increase
in public relations and/or sales promotions for existing and/or new brands as we expand within existing markets or enter new markets.
Net
cash flow used in investing activities was $100,000 for the year ended December 31, 2024, as compared to $22,159 for the year ended December
31, 2023. During the year ended December 31, 2024, we paid $100,000 for the acquisition of a 40% interest in Lab Services MSO. During
the year ended December 31, 2023, we made payment for purchase of property and equipment of approximately $22,000.
Net
cash flow provided by financing activities was $7,638,667 for the year ended December 31, 2024, as compared to $4,825,337 for the year
ended December 31, 2023. During the year ended December 31, 2024, we received net proceeds from the issuance of convertible debts and
warrants of approximately $3,085,000 (net of original issue discount of approximately $177,000 and cash paid for convertible note issuance
costs of approximately $283,000), an advance from the pending sale of a noncontrolling interest in a subsidiary of approximately $2,122,000,
net proceeds from equity offering of approximately $2,719,000 (net of cash paid for commission and other offering costs of approximately
$138,000), and proceeds from issuance of convertible preferred stock of $3,500,000, offset by repayments made for loan payable –
related party of $400,000, and made for convertible debts of approximately $3,388,000. During the year ended December 31, 2023, we received
proceeds from related party borrowings of $850,000, and net proceeds from issuance of convertible debt and warrants of approximately $2,238,000
(net of original issue discount of $135,000 and cash paid for convertible note issuance costs of approximately $327,000), and net proceeds
from issuance of balloon promissory note of approximately $936,000 (net of cash paid for promissory note issuance costs of approximately
$64,000), and net proceeds from equity offering of approximately $616,000 (net of cash paid for commission and other offering costs of
approximately $19,000), and advance from pending sale of noncontrolling interest in subsidiary of approximately $486,000, offset by repayments
made for convertible debt of $300,000.
The following trends
are reasonably likely to result in a material decrease in our liquidity over the near to long term:
● an increase in working capital requirements to finance our current business;
● the use of capital for acquisitions and the development of business opportunities; and
● the cost of being a public company.
49
August 2019 Credit
Facility
In the third quarter
of 2019, we entered into a $20 million credit facility (the “Line of Credit”) provided by our Chairman of the Board and a
significant (and our largest) stockholder, Wenzhao Lu. The Line of Credit allowed us to request loans thereunder and to use the proceeds
of such loans for working capital and operating expense purposes until the facility matured on December 31, 2024.
At-the-Market Offering
In June 2023, we entered
into a sales agreement (the “Sales Agreement”) with Roth Capital Partners, LLC (“Roth”) under which we may offer
and sell from time to time shares of our common stock having an aggregate offering price of up to $3.5 million. From July 1, 2023 to August
16, 2024, we sold an aggregate of 312,285 shares of our common stock at an average price of $11.19 per share to investors pursuant to
the Sales Agreement, and received net cash proceeds of $3,388,251, net of cash paid for Roth’s commissions and other fees of $104,992.
March 2024 Convertible
Note Financing
In March 2024, we entered
into a security purchase agreement with a lender (the “March 2024 Lender”) and closed on the issuance of a 13.0% senior secured
convertible promissory note in the principal amount of $700,000 (the “March 2024 Convertible Note”), as well as the issuance
of 7,000 shares of common stock as a commitment fee and warrants for the purchase of up to 16,827 shares of our common stock.
June 2024 Convertible
Note Financing
In June 2024, we entered
into a security purchase agreement with a lender (the “June 2024 Lender”) and closed on the issuance of a 13.0% senior secured
convertible promissory note in the principal amount of $2,845,000 (the “June 2024 Convertible Note”), as well as the issuance
of 26,800 shares of common stock as a commitment fee and warrants for the purchase of up to 146,667 shares of our common stock. We and
our subsidiaries also entered into security agreements in connection with issuance of the June 2024 Convertible Note, creating a security
interest in certain property of the Company and its subsidiaries to secure the prompt payment, performance and discharge in full of all
of our obligations under the June 2024 Convertible Note.
Series C Convertible
Preferred Stock Sold Pursuant to Securities Purchase Agreement
On December 19, 2024,
the Company entered into that certain securities purchase agreement (the “Securities Purchase Agreement”), with an accredited
investor, York Sun Investment Holding Limited, a British Virgin Islands company (the “Investor”), pursuant to which the Company
agreed to issue and sell to the Investor, upon the terms and conditions set forth in the Securities Purchase Agreement, up to 7,000 shares
of Series C Convertible Preferred Stock for up to an aggregate of $7,000,000 (the “Purchase Price”), which is equal to $1,000
per share. The first closing occurred on December 24, 2024, with respect to the Investor’s purchase of 3,500 shares of Series C
Convertible Preferred Stock in exchange for $3,500,000.
Each share of Series
C Convertible Preferred Stock is convertible into common stock of the Company (the “Conversion Shares”) at a conversion per
share equal to $2.41, at the option of the holder, at any time after the later of (i) the date of the shareholder approval of the issuance
of the Conversion Shares pursuant to the rules of the Nasdaq Stock Market (the “Shareholder Approval”) and (ii) the one year
anniversary of the date of the first issuance of any shares of the Series C Convertible Preferred Stock. The Company shall not be required
to issue any Conversion Shares until the Shareholder Approval is obtained by the Company. The Investor shall also have a right of first
refusal during the period beginning on the date of the Securities Purchase Agreement and continuing until such shareholder approval is
obtained, on all issuances of convertible preferred stock of the Company, excluding agreements that are in place prior to the date of
the Securities Purchase Agreement and issuances of new classes of convertible preferred stock in exchange for existing classes of convertible
preferred stock. Additionally, the Investor has the right, pursuant to the Securities Purchase Agreement to appoint one member to, or
to replace one member of, the Company’s board of directors, subject to all applicable Nasdaq rules.
50
The Investor’s
purchase of the remaining 3,500 shares of Series C Convertible Preferred Stock under the Securities Purchase Agreement in exchange for
an additional $3,500,000 is required to occur within 120 calendar days of the date of the Securities Purchase Agreement, subject to the
satisfaction of customary closing conditions.
We estimate that, based
on current plans and assumptions, our available cash will be insufficient to satisfy our cash requirements under our present operating
expectations through cash flow provided by operations and sales of equity. Other than funds received as described above and cash resources
generated from our operations, we presently have no other significant alternative source of working capital. We have used these funds
to fund our operating expenses, pay our obligations and grow our company. We will need to raise significant additional capital to fund
our operations and to provide working capital for our ongoing operations and obligations. Therefore, our future operation is dependent
on our ability to secure additional financing. Financing transactions may include the issuance of equity or debt securities, obtaining
credit facilities, or other financing mechanisms. However, the trading price of our common stock and a downturn in the U.S. equity and
debt markets could make it more difficult to obtain financing through the issuance of equity or debt securities. Even if we are able to
raise the funds required, it is possible that we could incur unexpected costs and expenses or experience unexpected cash requirements
that would force us to seek alternative financing. Furthermore, if we issue additional equity or debt securities, stockholders may experience
additional dilution or the new equity securities may have rights, preferences or privileges senior to those of existing holders of our
common stock. The inability to obtain additional capital may restrict our ability to grow and may reduce our ability to continue to conduct
business operations. If we are unable to obtain additional financing, we will be required to cease our operations. To date, we have not
considered this alternative, nor do we view it as a likely occurrence.
Foreign Currency Exchange Rate Risk
We ceased all operations
in China in 2022, with the exception of a small administrative office. We did not during the year ended December 31, 2024, and do not
expect in the foreseeable future, to generate any additional revenue from PRC operations. Thus, exchange rate fluctuations between the
RMB and the U.S. dollar do not, and are not expected to, have a material effect on us. For the years ended December 31, 2024 and 2023,
we had an unrealized foreign currency translation loss of approximately $300 and $18,600, respectively, because of changes in the exchange
rate.
Inflation
The effect of inflation
on our revenues and operating results was not significant for the years ended December 31, 2024 and 2023.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As a smaller
reporting company, as defined in Rule 12b-2 of the Exchange Act, we are not required to provide the information required by this Item.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements begin
on page F-1.
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
We maintain disclosure controls and
procedures that are designed to ensure that material information required to be disclosed in our periodic reports filed under the
Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC rules and forms and to
ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer
(“CEO”) and Chief Financial Officer (“CFO”) as appropriate, to allow timely decisions regarding required
disclosure. We carried out an evaluation, under the supervision and with the participation of our management, including the CEO and
the CFO, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rule 13(a)-15(e)
under the Exchange Act, as of the end of the period covered by this report. Our management recognizes that any controls and
procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and
management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. During
evaluation of disclosure controls and procedures as of December 31, 2024, conducted as part of our annual audit and preparation of
our annual financial statements, our management, including our CEO and CFO, conducted an evaluation of the effectiveness of the
design and operations of our disclosure controls and procedures and concluded that our disclosure controls and procedures were not
effective as of December 31, 2024 due to the reasons set forth below.
51
Management’s Report on Internal Control
over Financial Reporting
Management is responsible for the preparation
and fair presentation of the financial statements included in this report. The financial statements have been prepared in conformity with
U.S. GAAP and reflect management’s judgment and estimates concerning effects of events and transactions that are accounted for or
disclosed.
Management is also responsible for establishing
and maintaining adequate internal control over financial reporting. Our internal control over financial reporting includes those policies
and procedures that pertain to our ability to record, process, summarize and report reliable data. Management recognizes that there are
inherent limitations in the effectiveness of any internal control over financial reporting, including the possibility of human error and
the circumvention or overriding of internal control. Accordingly, even effective internal control over financial reporting can provide
only reasonable assurance with respect to financial statement presentation. Further, because of changes in conditions, the effectiveness
of internal control over financial reporting may vary over time.
Management regularly assesses our internal control over financial reporting
and did so most recently for our financial reporting as of December 31, 2024. This assessment was based on criteria for effective internal
control over financial reporting described in the Internal Control Integrated Framework issued by the Committee of Sponsoring Organizations
(COSO) of the Treadway Commission (2013). Based on this assessment, management has concluded that our internal control over financial
reporting was not effective as of December 31, 2024, due to the lack of segregation of duties resulting from our small size and inability
to perform an effective test of the operating effectiveness of the controls, including the oversight of our financial statement close
process. As a result of our Lab Services MSO transaction in February 2023, we retained additional accounting staff and hired a Controller
that worked part-time for Lab Services MSO and part-time for the Company. In addition, the Company has transitioned all email servers
to the United States to enhance this aspect of internal controls.
In light of the material weaknesses described
above, we performed additional analyses and procedures in order to conclude that our consolidated financial statements for the year ended
December 31, 2024 included in this Annual Report on Form 10-K were fairly stated in accordance with U.S. GAAP. Accordingly, management
believes that despite the material weakness identified in our internal control over financial reporting, our consolidated financial statements
for the year ended December 31, 2024 are fairly stated, in all material respects, in accordance with U.S. GAAP.
Changes in Internal Control over Financial
Reporting
Other than those described above, there were no
changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) under the Exchange Act, during the
quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting
Attestation Report of the Registered Public
Accounting Firm
This Annual Report on Form 10-K does not include
an attestation report by our independent registered public accounting firm, regarding internal control over financial reporting. As a
smaller reporting company, our internal control over financial reporting was not subject to audit by our independent registered public
accounting firm pursuant to rules of the SEC that permit us to provide only management’s report.
ITEM 9B. OTHER INFORMATION
(a) None.
(b) During the quarter ended December 31, 2024,
none of our directors or executive officers adopted or terminated a Rule 10b5-1 trading plan or a non-Rule 10b5-1 trading arrangement
(as defined in Item 408(c) of Regulation S-K).
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS
THAT PREVENT INSPECTIONS.
Not applicable.
52
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Directors and Executive Officers
Below are the names of, and certain information
regarding, our executive officers and directors.
Name
Age
Position
Wenzhao Lu
67
Chairman of the Board of Directors
David Jin, MD, PhD
57
Chief Executive Officer, President and Director
Meng Li
47
Chief Operating Officer and Secretary
Luisa Ingargiola
57
Chief Financial Officer
Steven A. Sanders
79
Director
Lourdes Felix
57
Director
Wilbert J. Tauzin II
81
Director
William B. Stilley, III
57
Director
Tevi Troy
57
Director
Directors are elected annually, to hold such office
until a successor has been duly appointed and qualified, unless an director sooner dies, resigns or is removed. Officers serve at the
discretion of the Board, subject to the terms of any employment agreement.
The principal occupation and business experience
during at least the past five years for our executive officers and directors is as follows:
Wenzhao Lu, Chairman of the Board of Directors
Mr. Wenzhao Lu has served as our Chairman of the
Board since October 10, 2016. He is a seasoned healthcare entrepreneur with extensive operational knowledge and experience in the U.S.
and Asia. He served as Chairman of the board of directors of the Daopei Medical Group (“DPMG”), from 2010 to December 2021.
Under his leadership, DPMG operated three top-ranked private hospitals (located in Beijing and Hebei), specialty hematology laboratories,
and a hematology research institute, with more than 100 partnering and collaborating hospitals in China. DPMG was founded by Professor
Daopei Lu, a renowned hematologist pioneering in hematopoietic stem cell transplant and a member of the Academy of Engineering in China.
Mr. Lu received a Bachelor of Arts from Temple University Tyler School of Arts in 1988 and subsequently worked as senior Art Director
at Ogilvy & Mather Advertising Company. Prior to joining DPMG, in 2009, Mr. Lu served as Chief Operating Officer of BioTime Asia Limited,
a subsidiary of BioTime, Inc. (NYSE American: BTX). Mr. Lu is qualified to serve as a director because of his extensive operational knowledge
of, and executive level management experience in, the healthcare industry.
53
David Jin, Chief Executive Officer, President
and Director
Dr. David Jin, MD, PhD, has served as our
Chief Executive Officer, President and as a member of our Board since September 14, 2016. From 2009 to 2017, Dr. Jin served as the
Chief Medical Officer of BioTime, Inc. (NYSE American: BTX), a clinical stage regenerative medicine company with a focus on
pluripotent stem cell technology. Dr. Jin also acts as a senior translational clinician-scientist at the Howard Hughes Medical
Institute and the Ansary Stem Cell Center at Weill Cornell Medical College of Cornell University. Prior to his current endeavors,
Dr. Jin was Chief Consultant/Advisor for various biotech/pharmaceutical companies regarding hematology, oncology, immunotherapy and
stem cell-based technology development. Dr. Jin has been Principle Investigator in more than 15 pre-clinical and clinical trials, as
well as an author/co-author of over 80 peer-reviewed scientific abstracts, articles, reviews, and book chapters. Dr. Jin studied
medicine at SUNY Downstate College of Medicine in Brooklyn, New York. He received his clinical training and subsequent faculty
tenure at the New York-Presbyterian Hospital (the teaching hospital for both Cornell and Columbia Universities) in the areas of
internal medicine, hematology, and clinical oncology. Dr. Jin was honored as Top Chief Medical Officer by ExecRank in 2012, as well
as recognized by Leading Physicians of the World in 2015. Dr. Jin is qualified to serve as a director because of his role with us,
and his extensive operational knowledge of, and executive level management experience in, the healthcare industry.
Meng Li, Chief Operating Officer and Secretary
Ms. Meng Li has served as our Chief Operating
Officer and Secretary since October 10, 2016 and served as a member of the Board from October 10, 2016 to July 9, 2018 and from April
5, 2019 through December 30, 2022. Ms. Li has over 15 years of executive experience in international marketing, branding, communications,
and media investment consultancy. Ms. Li served as Managing Director at Maxus/GroupM (a WPP Group company) where she was responsible for
business P&L and corporate management from 2006 to 2015. Prior to joining Maxus/Group M, Ms. Li worked for Zenith Media (a Publicis
Group company) from 2000 to 2006 as Senior Manager. Ms. Li received a Bachelor of Arts in International Economic Law from Dalian Maritime
University in China.
Luisa Ingargiola, Chief Financial Officer
Luisa Ingargiola has served as our Chief Financial
Officer since February 21, 2017. Ms. Ingargiola has significant experience serving as Chief Financial Officer or Audit Chair for multiple
Nasdaq and New York Stock Exchange companies. She currently serves as Director and Audit Chair for several public companies, including
ElectraMeccanica (NASDAQ:SOLO), Dragonfly Energy (DFLI) and Vision Marine (VMAR). From 2007 through 2016, Ms. Ingargiola served as the
Chief Financial Officer and then a member of the board of directors at MagneGas Corporation (Nasdaq: MNGA). Prior to 2007, Ms. Ingargiola
held various roles as Budget Director and Investment Analyst in several private companies. Ms. Ingargiola graduated in 1989 from Boston
University with a Bachelor’s degree in Business Administration and a concentration in Finance. In 1996, she received her MBA in
Health Administration from the University of South Florida. Ms. Ingargiola is qualified to serve as a Chief Financial Officer because
of her extensive knowledge corporate governance, regulatory requirements, executive leadership and knowledge of, and experience in, financing
and M&A transactions.
Steven A. Sanders, Director
Steven A. Sanders has served as a member of the Board since July 30,
2018. Since January 2017, Mr. Sanders has been Of Counsel to the law firm of Ortoli Rosenstadt LLP. From July 2007 until January 2017,
Mr. Sanders was a Senior Partner at Ortoli Rosenstadt LLP. From January 1, 2004 until June 30, 2007, he was Of Counsel to the law firm
of Rubin, Bailin, Ortoli, LLP. From January 1, 2001 to December 31, 2003, he was Counsel at the law firm of Spitzer & Feldman PC.
Mr. Sanders also serves as a member of the board of directors of Helijet International, Inc. and served as a member of the board of directors
of Electrameccanica Vehicles Corp. (NASDAQ:SOLO). Additionally, since October 2013, he has been a member of the board of directors at
the American Academy of Dramatic Arts, and, since February 2015, has been a member of the board of directors of the Bay Street Theater.
Mr. Sanders received his JD from Cornell University and his BBA from The City College of New York. Mr. Sanders is qualified to serve as
a director because of his corporate, securities and international law experience, including working with companies in the life sciences
industry.
54
Lourdes Felix, Director
Lourdes Felix has served as a member of the
Board since January 9, 2023. Ms. Felix is an entrepreneur and corporate finance executive with 30 years of combined experience in
capital markets, public accounting and in the private sector. She presently serves as Chief Executive Officer, Chief Financial
Officer, and a member of the board of directors of BioCorRx Inc., a company focused on addiction treatment solutions and related
disorders. She has been with BioCorRx Inc. since October 2012. Ms. Felix is one of the founders and President of BioCorRx
Pharmaceuticals Inc., a majority owned subsidiary of BioCorRx Inc. Prior to joining BioCorRx Inc., her experience was in the private
sector and public accounting. Ms. Felix has expertise in finance, accounting, company-wide operations, budgeting, and internal
control principles, including U.S. GAAP, SEC, and SOX compliance. She has thorough knowledge of federal and state regulations and
has successfully managed and produced SEC regulatory filings. She also has extensive experience in developing and managing financial
operations. Ms. Felix holds a Bachelor of Science degree in Accounting from the University of Phoenix. She continued her education
and is an MBA candidate at D’Amore-McKim School of Business, Northeastern University. Ms. Felix is qualified to serve as a
director because of her extensive investment and executive level management experience.
Wilbert J. Tauzin II, Director
Wilbert J. Tauzin II has served as a member of
the Board since November 1, 2017. From December 2010 until March 1, 2014, Congressman Tauzin served as a Special Legislative Counsel at
Alston & Bird LLP. From December 2004 to June 2010, Congressman Tauzin was President and Chief Executive Officer of Pharmaceutical
Research and Manufacturers of America, a trade group that serves as one of the pharmaceutical industry’s top lobbying groups. He
served 12.5 terms in the U.S. House of Representatives, representing Louisiana’s 3rd Congressional District. From January 2001 through
February 2004, Congressman Tauzin served as Chairman of the House Committee on Energy and Commerce. He also served as a senior member
of the House Resources Committee and Deputy Majority Whip. Prior to serving as a member of Congress, Congressman Tauzin was a member of
the Louisiana State Legislature, where he served as Chairman of the House Natural Resources Committee and Chief Administration Floor Leader.
He served as Lead Independent Director of LHC Group, a publicly traded provider of quality home health care, from 2005 to 2021 and retains
the role of Lead Independent Emeritus today. The Congressman also served on the board of directors of Entergy, a Fortune 500 company.
In addition, the Congressman chartered a Louisiana State Savings and Loan Association and Chaired its first board of directors. He received
a Bachelor of Arts Degree from Nicholls State University and a Juris Doctor degree from Louisiana State University. Congressman Tauzin
is qualified to serve as a director because of his extensive knowledge of the pharmaceutical industry and his experience as a director
of several publicly traded and privately held companies.
William B. Stilley, III, Director
William B. Stilley has served as a member of the Board since July 5,
2018. Mr. Stilley has been the Chief Executive Officer of Adovate, LLC since January 2023. Previously, he was Chief Executive Officer
of Purnovate, Inc., a subsidiary of Adial Pharmaceuticals, Inc. (Adial) from January 2021 until May 2023, and was Chief Executive Officer
of Adial from December 2010 until August 2022, and was a member of Adial’s board of directors from December 2010 until September
2023. From August 2008 until December 2010, he was the Vice President, Business Development and Strategic Projects at Clinical Data, Inc.
Mr. Stilley was the COO and CFO of Adenosine Therapeutics, LLC until the assets of Adenosine Therapeutics were acquired by Clinical Data,
Inc. in August 2008. Mr. Stilley has advised both public and private companies on financing and M&A transactions, has been the interim
CFO of a public company, the interim Chief Business Officer and then Advisor for Diffusion Pharmaceuticals from September 2015 through
March 2018, the audit chair for public companies, and the COO and CFO of a number of private companies. Before entering the business community,
Mr. Stilley served as Captain in the U.S. Marine Corps. Mr. Stilley has an MBA with honors from the Darden School of Business and a B.S.
in Commerce/Marketing from the McIntire School of Commerce at the University of Virginia. He currently serves on the Advisory Board of
Virginia BIO, the statewide biotechnology organization and has guest lectured at the Darden School of Business and the University School
of Engineering. Mr. Stilley is qualified to serve as a director because of his extensive knowledge of the biotechnology industry, significant
executive leadership and operational experience, and knowledge of, and experience in, financing and M&A transactions.
55
Tevi Troy, Director
Tevi Troy has served as a member of the
Board since June 4, 2018. Mr. Troy is a former Deputy Secretary of the U.S. Department of Health and Human Services. Dr. Troy is a
Senior Fellow at the Bipartisan Policy Center in Washington. He was the founder and CEO of the American Health Policy Institute and
a Senior Fellow at Hudson Institute. On August 3, 2007, Dr. Troy was unanimously confirmed by the U.S. Senate as the Deputy
Secretary of HHS. As Deputy Secretary, Dr. Troy was the chief operating officer of the largest civilian department in the federal
government, with a budget of $716 billion and over 67,000 employees. Dr. Troy has extensive White House experience, having served in
several high-level positions over a five-year period, culminating in his service as Deputy Assistant and then Acting Assistant to
the President for Domestic Policy. Dr. Troy has held high-level positions on Capitol Hill as well. From 1998 to 2000, Dr. Troy
served as the Policy Director for Senator John Ashcroft. From 1996 to 1998, Dr. Troy was Senior Domestic Policy Adviser and later
Domestic Policy Director for the House Policy Committee, chaired by Christopher Cox. In addition to his senior level government work
and health care expertise, Dr. Troy is also a best-selling presidential historian and the author of five books, including, most
recently, “Fight House: Rivalries in the White House from Truman to Trump,” which the Wall Street Journal listed as one
of the top political books of 2020. Dr. Troy’s many other affiliations include: contributing editor for Washingtonian
magazine; member of the publication committee of National Affairs; member of the Board of Fellows of the Jewish Policy Center; a
Senior Fellow at the Potomac Institute; and a member of the Bipartisan Commission on Biodefense. Dr. Troy has a B.S. in Industrial
and Labor Relations from Cornell University and an M.A. and Ph.D. in American Civilization from the University of Texas at Austin.
Dr. Troy is qualified to serve as a director because of his extensive knowledge of the healthcare industry and his significant
leadership experience.
Board Composition
Our Board is currently composed of seven directors.
Our priority in selection of board members is
identification of members who will further the interests of our stockholders through his or her established record of professional accomplishment,
the ability to contribute positively to the collaborative culture among board members, knowledge of our business and understanding of
the competitive landscape.
A majority of the authorized number of directors
constitutes a quorum of the Board for the transaction of business. However, any action required or permitted to be taken by the Board
may be taken without a meeting if all members of the Board individually or collectively consent in writing to the action.
Board Leadership Structure and Role in Risk
Oversight
The positions of our Chairman of the Board and
Chief Executive Officer are separated. Separating these positions allows our Chief Executive Officer to focus on our day-to-day business,
while allowing the Chairman of the Board to lead our Board in its fundamental role of providing advice to and independent oversight of
management. Our Board recognizes the time, effort and energy that the Chief Executive Officer must devote to his position in the current
business environment, as well as the commitment required to serve as our Chairman, particularly as our Board’s oversight responsibilities
continue to grow. Our Board also believes that this structure ensures a greater role for the independent directors in the oversight of
our Company and active participation of the independent directors in setting agendas and establishing priorities and procedures for the
work of our Board. Our Board believes its administration of its risk oversight function has not affected its leadership structure.
Although our bylaws do not require our Chairman
and Chief Executive Officer positions to be separate, our Board believes that having separate positions is the appropriate leadership
structure for us at this time and demonstrates our commitment to good corporate governance.
Risk is inherent with every business, and how
well a business manages risk can ultimately determine its success. We face a number of risks, including those described under the section
entitled “ Risk Factors ” of this report. Our Board is actively involved in oversight of risks that could affect us.
This oversight is conducted primarily by our full Board, which has responsibility for general oversight of risks.
Our Board satisfies this responsibility through
full reports by each committee chair regarding the committee’s considerations and actions, as well as through regular reports directly
from officers responsible for oversight of particular risks within our Company. Our Board believes that full and open communication between
management and the Board is essential for effective risk management and oversight.
56
Board of Director Meetings
The primary responsibility of the Board is to provide oversight, strategic
guidance, counseling, and direction to our management team. Our Board meets on a regular basis and additionally as required. Our Board
met five times in 2024. Each of the directors attended at least 75% of the aggregate of (i) the total number of meetings of our Board
(held during the period for which such directors served on the Board) and (ii) the total number of meetings of all committees of our Board
on which the director served (during the periods for which the director served on such committee or committees). We do not have a formal
policy requiring members of the Board to attend our annual meetings of stockholders. Three of our directors attended last year’s
annual meeting.
Director Independence
Our common stock is listed on The Nasdaq Capital
Market. Under the rules of The Nasdaq Capital Market, independent directors must comprise a majority of our Board. In addition, the rules
of The Nasdaq Capital Market require that all the members of such committees be independent. Members of our Audit Committee, as defined
below, must also satisfy the independence criteria set forth in Rule 10A-3 under the Exchange Act. Compensation committee members must
also satisfy the independence criteria established by The Nasdaq Capital Market in accordance with Rule 10C-1 under the Exchange Act.
Under the rules of The Nasdaq Capital Market, a director will only qualify as an “independent director” if, among other qualifications,
in the opinion of that company’s 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.
The Board has reviewed its composition, the composition
of its committees and the independence of each director. Based upon information requested from and provided by each director concerning
his or her background, employment and affiliations, including family relationships, the Board has determined that Steven A. Sanders, Lourdes
Felix, William B. Stilley, III and Tevi Troy do not, respectively, have a relationship that would interfere with the exercise of independent
judgment in carrying out the responsibilities of a director and that each of these directors is “independent” as that term
is defined under the Rules of The Nasdaq Capital Market and the SEC.
In making this determination, our Board considered
the relationships that each non-employee director has with our Company and all other facts and circumstances our Board deemed relevant
in determining their independence. We intend to comply with the other independence requirements for committees within the time periods
specified above.
Family Relationships
There are no family relationships among our directors
or executive officers.
Board Committees
The Board has established an audit committee,
a compensation committee and a nominating and corporate governance committee. Our Board may establish other committees to facilitate the
management of our business. The composition and functions of each committee named above are defined and described below. Members serve
on these committees until their resignation or until otherwise determined by our Board.
Audit Committee . We have a separately
designated standing audit committee of the Board (the “Audit Committee”), established in accordance with Section 3(a)(58)(A)
of the Exchange Act. The Audit Committee consists of William Stilley, Steven Sanders and Tevi Troy, with Mr. Stilley serving as the Chair
of the Audit Committee. The Board has determined that each director currently serving on our Audit Committee is an “independent
director” as defined by Nasdaq applicable to members of an audit committee and Rule 10A-3(b)(i) under the Exchange Act. In addition,
Mr. Stilley is an “audit committee financial expert” as defined in Item 407(d)(5) of Regulation S-K and demonstrates “financial
sophistication” as defined by Nasdaq Rules. The Audit Committee is appointed by the Board to assist with monitoring (i) the integrity
of our financial statements, (ii) our compliance with legal and regulatory requirements, and (iii) the independence and performance of
our internal and external auditors.
57
The principal functions and responsibilities of
the Audit Committee include:
● reviewing our annual audited
financial statements with management and our independent auditors, including major issues regarding accounting and auditing principles
and practices and financial reporting that could significantly affect our financial statements;
● reviewing our quarterly financial
statements with management and our independent auditor prior to the filing of our Quarterly Reports on Form 10-Q, including the results
of the independent auditors’ reviews of the quarterly financial statements;
● recommending to the Board the
appointment of, and continued evaluation of the performance of, our independent auditor;
● approving and conducting a
review of all related party transactions for potential conflict of interest situations on an ongoing basis;
● approving the fees to be paid
to our independent auditor for audit services and approving the retention of our independent auditor for non-audit services and all fees
for such services;
● reviewing periodic reports
from our independent auditor regarding our auditor’s independence, including discussion of such reports with the auditor;
● reviewing the adequacy of our
overall control environment, including internal financial controls and disclosure controls and procedures; and
● reviewing with our management
and legal counsel legal matters that may have a material impact on our financial statements or our compliance policies and any material
reports or inquiries received from regulators or governmental agencies.
During the fiscal year ended December 31, 2024, the Audit Committee
met four times. The Audit Committee is governed by a written charter, as adopted by the Board. A copy of the Audit Committee Charter is
posted under the “Investors” tab under “Corporate Governance” on our website, which is located at www.avalon-globocare.com .
Compensation Committee . The compensation
committee of the Board (the “Compensation Committee”) consists of Lourdes Felix, Steven Sanders and Tevi Troy, with Ms. Felix
serving as the Chair of the Compensation Committee. The Board has determined that each member of the Compensation Committee is considered
(i) an “independent director” as defined by Nasdaq Rules applicable to members of a compensation committee; (ii) a “non-employee
director” as defined in Rule 16b-3 promulgated under the Exchange Act; and (iii) an “outside director” as that term
is defined in Section 162(m) of the Internal Revenue Code of 1986, as amended (the “Code”). The Compensation Committee is
responsible for establishing the compensation of our senior management, including salaries, bonuses, termination arrangements, and other
executive officer benefits as well as director compensation. The Compensation Committee also administers our equity incentive plans. The
Compensation Committee works with the Chairman of the Board and our Chief Executive Officer and reviews and approves compensation decisions
regarding senior management, including compensation levels and equity incentive awards. The Compensation Committee also approves employment
and compensation agreements with our key personnel and directors. The Compensation Committee has the power and authority to conduct or
authorize studies, retain independent consultants, accountants or others, and obtain unrestricted access to management, our internal auditors,
human resources and accounting employees and all information relevant to its responsibilities.
The principal functions and responsibilities of
the Compensation Committee include:
● reviewing and approving the
Company’s compensation guidelines and structure;
● reviewing and approving, on
an annual basis, the corporate goals and objectives with respect to compensation for the Chief Executive Officer;
● reviewing and approving, on
an annual basis, the evaluation process and compensation structure for the Company’s other officers, including salary, bonus, incentive
and equity compensation;
58
● periodically reviewing and
making recommendations to the Board regarding the compensation of non-management directors; and
● developing the executive compensation
philosophy and reviewing and recommending to the Board for approval all compensation policies and compensation programs for the executive
team.
During the fiscal year ended December 31, 2024, the Compensation Committee
met two times. The Compensation Committee is governed by a written charter, as adopted by our Board. A copy of the Compensation Committee
Charter is posted under the “Investors” tab under “Corporate Governance” on our website, which is located at www.avalon-globocare.com .
Nominating and Corporate Governance Committee .
Our Nominating and Corporate Governance Committee consists of Steven Sanders, William Stilley and Tevi Troy, with Mr. Sanders serving
as the Chair of our Nominating and Corporate Governance Committee. Our Board has determined that each member of the Nominating and Governance
Committee is an “independent director” as defined by Nasdaq Rules. The Nominating and Corporate Governance Committee is generally
responsible for recommending to our full Board certain policies, procedures, and practices designed to ensure that our corporate governance
policies, procedures, and practices continue to assist the Board and our management in effectively and efficiently promoting the best
interests of our stockholders. The Nominating and Corporate Governance Committee is also responsible for selecting and recommending for
approval by our Board and our stockholders a slate of director nominees for election at each of our annual meetings of stockholders, and
otherwise for determining the board committee members and chairpersons, subject to ratification by our Board, as well as recommending
to the Board director nominees to fill vacancies or new positions on the Board or its committees that may occur or be created from time
to time, all in accordance with our bylaws and applicable law.
In identifying independent candidates, with significant
senior-level professional experience, to be nominated as potential members of our Board, the Nominating and Corporate Governance Committee
solicits candidates from the Board, senior management and others, and may engage a search firm in the process. The Nominating and Corporate
Governance Committee reviews and narrows the list of candidates and interviews potential nominees. The final candidate is also introduced
and interviewed by the Board and the lead director if one has been appointed. In general, in considering whether to recommend any particular
candidate for inclusion in our Board’s slate of recommended director nominees, the Nominating and Corporate Governance Committee
will apply the criteria set forth in our corporate governance guidelines. These criteria include the candidate’s integrity, business
acumen, commitment to understanding our business and industry, experience, conflicts of interest and the ability to act in the interests
of our stockholders. Further, specific consideration is given to, among other things, diversity of background and experience that a candidate
would bring to our Board. The Nominating and Corporate Governance Committee does not assign specific weights to particular criteria and
no particular criterion is a prerequisite for each prospective nominee. We believe that the backgrounds and qualifications of our directors,
considered as a group, should provide a composite mix of experience, knowledge and abilities that will allow our Board to fulfill its
responsibilities. Stockholders may recommend individuals to the Nominating and Corporate Governance Committee for consideration as potential
director candidates by submitting the names, together with appropriate biographical information and background materials to our Nominating
and Corporate Governance Committee. The Nominating and Corporate Governance Committee considers recommendations from stockholders if submitted
in a timely manner in accordance with the procedures set forth in our bylaws and will apply the same criteria to all persons being considered.
The principal functions and responsibilities of
the Nominating and Corporate Governance Committee include:
● developing and maintaining
our corporate governance policy guidelines;
● developing and maintaining
our Code of Business Conduct and Ethics;
● overseeing the interpretation
and enforcement of our Code of Business Conduct and Ethics for the Chief Executive Officer and Senior Financial and Accounting Officers;
● evaluating the performance
of our Board, its committees, and committee chairpersons and our directors; and
● selecting and recommending
a slate of director nominees for election at each of our annual meetings of the stockholders and recommending to the Board director nominees
to fill vacancies or new positions on the Board or its committees that may occur from time to time.
During the fiscal year ended December 31, 2024, the Nominating and
Corporate Governance Committee met one time. The Nominating and Corporate Governance Committee is governed by a written charter approved
by our Board. A copy of the Nominating and Corporate Governance Committee Charter is posted under the “Investors” tab under
“Corporate Governance” on our website, which is located at www.avalon-globocare.com .
59
Stockholder Nominations for Directorships
Stockholders may recommend individuals to the
Nominating and Corporate Governance Committee for consideration as potential director candidates by submitting their names and background
to the Secretary of the Company at the address set forth below under “Stockholder Communications” in accordance with the provisions
set forth in our bylaws. All such recommendations will be forwarded to the Nominating and Corporate Governance Committee, which will review
and only consider such recommendations if appropriate biographical and other information is provided, including, but not limited to, the
items listed below, on a timely basis.
● the name and address of record
of the security holder;
● a representation that the security
holder is a record holder of the Company’s securities, or if the security holder is not a record holder, evidence of ownership
in accordance with Rule 14a-8(b)(2) of the Exchange Act;
● the name, age, business and
residential address, educational background, current principal occupation or employment, and principal occupation or employment for the
preceding five (5) full fiscal years of the proposed director candidate;
● a description of the qualifications
and background of the proposed director candidate and a representation that the proposed director candidate meets applicable independence
requirements;
● a description of any arrangements
or understandings between the security holder and the proposed director candidate; and
● the consent of the proposed
director candidate to be named in the proxy statement relating to the Company’s annual meeting of stockholders and to serve as
a director if elected at such annual meeting.
All security holder recommendations for director
candidates must be received by the Company in the timeframe(s) set forth under the heading “Stockholder Proposals” below.
Assuming that appropriate information is timely provided for candidates recommended by stockholders, the Nominating and Corporate Governance
Committee will evaluate those candidates by following substantially the same process, and applying substantially the same criteria, as
for candidates submitted by members of the Board or other persons, as described above and as set forth in its written charter.
Compensation Committee Interlocks and Insider
Participation
None of our executive officers currently serves,
or in the past year has served, as a member of the board of directors or compensation committee of any entity that has one or more executive
officers on our board of directors or compensation committee.
Code of Ethics
We have adopted a written Code of Business Conduct
and Ethics that applies to our employees, officers and directors. A copy of the Code of Business Conduct and Ethics is posted under the
“Investors” tab under “Corporate Governance” in our website, which is located at www.avalon-globocare.com .
We intend to disclose future amendments to certain provisions of our Code of Business Conduct and Ethics, or waivers of such provisions
applicable to any principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing
similar functions, and our directors, on our website identified above or in filings with the SEC.
60
Insider trading arrangements and
policies.
We have adopted an insider trading policy that governs the purchase,
sale, and/or other transactions of our securities by our directors, officers and employees. A copy of our insider trading policy is filed
as Exhibit 19.1 to this Annual Report on Form 10-K for the fiscal year ended December 31, 2024. In addition, with regard to us trading
in our own securities, it is our policy to comply with the federal securities laws and the applicable exchange listing requirements in
all respects.
Limitation of Director Liability and Indemnification
The Delaware General Corporation Law authorizes
corporations to limit or eliminate, subject to certain conditions, the personal liability of directors to corporations and their stockholders
for monetary damages for breach of their fiduciary duties. Our Amended and Restated Certificate of Incorporation (the “Certificate
of Incorporation”) limits the liability of our directors to the fullest extent permitted by Delaware law. In addition, we have entered
into indemnification agreements with each of our directors and officers whereby we have agreed to indemnify those directors and officers
to the fullest extent permitted by law, including indemnification against expenses and liabilities incurred in legal proceedings to which
the director or officer was, or is threatened to be made, a party by reason of the fact that such director or officer is or was a director,
officer, employee or agent of the Company, provided that such director or officer acted in good faith and in a manner that the director
or officer reasonably believed to be in, or not opposed to, the best interests of the Company.
We have director and officer liability insurance
to cover liabilities our directors and officers may incur in connection with their services to us, including matters arising under the
Securities Act. Our Certificate of Incorporation and bylaws also provide that we will indemnify our directors and officers who, by reason
of the fact that he or she is one of our officers or directors, is involved in any action, suit or proceeding, whether civil, criminal,
administrative or investigative related to their board role with us.
There is no pending litigation or proceeding involving
any of our directors, officers, employees or agents in which indemnification will be required or permitted. We are not aware of any threatened
litigation or proceeding that may result in a claim for such indemnification.
Delinquent Section 16(a) Reports
Section 16(a) of the Exchange Act requires our
directors and executive, officers, and persons who are beneficial owners of more than 10% of a registered class of our equity securities,
to file reports of ownership and changes in ownership with the SEC. These persons are required by SEC regulations to furnish us with copies
of all Section 16(a) forms they file.
Based solely upon our review of copies of Forms 3, 4 and 5 furnished
to us, we believe that all of our directors, executive officers and 10% stockholders timely filed all reports required by Section 16(a)
of the Exchange Act during the fiscal year ended December 31, 2024.
ITEM 11. EXECUTIVE COMPENSATION
Executive Officer Compensation
We are currently a “smaller reporting company,”
as such term is defined in the rules promulgated under the Securities Act. We have opted to comply with the scaled down disclosure rules
applicable to smaller reporting companies which require certain compensation disclosure for (i) our principal executive officer, (ii)
our two most highly compensated executive officers, other than the principal executive officer, whose total compensation for 2024 exceeded
$100,000 and who were serving as executive officers as of December 31, 2024, and (iii) up to two additional individuals for whom disclosure
would have been provided pursuant to the foregoing clause (ii) but for the fact that the individual was not serving as an executive officer
as of December 31, 2024. We refer to these individuals as “named executive officers.” Our named executive officers for the
year ended December 31, 2024 were Dr. David Jin, Luisa Ingargiola and Meng Li. Certain information regarding their 2024 compensation is
included below.
61
2024 Summary Compensation Table
Name and principal position
Year
Salary
Stock
awards
Option
Awards
Nonequity
incentive plan
compensation
Nonqualified
deferred
compensation
earnings
All other
compensation
Total
($)
($)
($)
($)
($)
($)
($)
Dr. David Jin
2024
180,000
-
-
-
-
-
180,000
CEO
2023
330,000
-
-
-
-
-
330,000
Luisa Ingargiola
2024
350,000
-
-
-
-
-
350,000
CFO
2023
350,000
-
-
-
-
-
350,000
Meng Li
2024
205,471
-
-
-
-
-
205,471
COO
2023
280,244
-
-
-
-
-
280,244
Employment Agreements
David Jin
On December 1, 2016, the Company entered into
an Executive Employment Agreement with David Jin, the Company’s CEO and President. Pursuant to the agreement, Mr. Jin was employed
as President and Chief Executive Officer of the Company, which agreement had a term initially through November 30, 2017 unless earlier
terminated pursuant to the terms of the agreement. On February 20, 2020, the Company entered into a Letter Agreement with Dr. Jin pursuant
to which the term of Dr. Jin’s Executive Employment Agreement was extended an additional three years. During the term of the agreement,
Dr. Jin is entitled to a base salary and will be eligible for a discretionary performance bonus, equity awards and to participate in employee
benefits plans as the Company may institute from time to time at the discretion of the Board.
On January 3, 2019, the Company entered into a Letter Agreement with
Dr. Jin, pursuant to which his annual base salary set forth in his employment agreement was increased to $360,000, effective January 1,
2019. Pursuant to the agreement, Mr. Jin may be terminated for “cause” as defined and Mr. Jin may resign for “good reason”
as defined. In the event Mr. Jin is terminated without cause or resigns for good reason, the Company will be required to pay Mr. Jin all
accrued salary and bonuses, reimbursement for all business expenses and Mr. Jin’s salary for one year. In the event Mr. Jin is terminated
with cause, resigns without good reason, dies or is disabled, the Company will be required to pay Mr. Jin all accrued salary and bonuses
and reimbursement for all business expenses. Under the agreement Mr. Jin is subject to confidentiality, non-compete and non-solicitation
restrictions. This agreement has not been extended, however Dr. Jin is continuing his employment with the Company at will and otherwise
under the same terms and conditions, except that Dr. Jin agreed to a salary reduction as set forth in the table above for the years ended
December 31, 2024 and 2023 as part of the Company’s cost reduction measures.
Luisa Ingargiola
On February 21, 2017, Ms. Ingargiola and the Company
entered into an Executive Retention Agreement effective February 9, 2017, pursuant to which Ms. Ingargiola agreed to serve as Chief Financial
Officer in consideration of an annual salary. On January 3, 2019, the Company entered into a Letter Agreement with Ms. Ingargiola, pursuant
to which her annual base salary set forth in her employment agreement was increased to $350,000 effective January 1, 2019.
The employment of Ms. Ingargiola is at will and
may be terminated at any time, with or without formal cause. Pursuant to the terms of Executive Retention Agreement with Ms. Ingargiola,
the Company has agreed to provide specified severance and bonus amounts and to accelerate the vesting on her equity awards upon termination
upon a change of control or an involuntary termination, as each term is defined in the agreements.
In the event of a termination upon a change
of control, Ms. Ingargiola is entitled to receive an amount equal to 12 months of her base salary and the target bonus then in
effect for the executive officer for the year in which such termination occurs, such bonus payment to be pro-rated to reflect the
full number of months the executive remained in the Company’s employ. In addition, the vesting on any stock option held by the
executive officer will be accelerated in full. At the election of the executive officer, the Company will also continue to provide
health related employee insurance coverage for twelve months, at the Company’s expense.
62
In the event of an involuntary termination, Ms.
Ingargiola is entitled to receive an amount equal to six months of her base salary and the target bonus then in effect for the executive
officer for the six months in which such termination occurs, such bonus payment to be pro-rated to reflect the full number of months the
executive remained in the Company’s employ. Such payment will be increased to 12 months upon the one-year anniversary of the retention
agreement. In addition, the vesting on any stock option held by the executive officer will be accelerated in full. At the election of
the executive officer, the Company will also continue to provide health related employee insurance coverage for twelve months, at the
Company’s expense.
Meng Li
On January 11, 2017, Avalon Shanghai entered into
an Executive Employment Agreement with Meng Li, the Company’s COO and Secretary. Pursuant to the agreement, Ms. Li was employed
as Chief Operating Officer and President of Avalon Shanghai initially through November 30, 2019, unless earlier terminated pursuant to
the terms of the agreement. On February 20, 2020, the Company entered into a Letter Agreement with Meng Li pursuant to which the term
of Ms. Li’s Executive Employment Agreement entered between the Company’s subsidiary and Ms. Li dated January 11, 2017 was
extended an additional three years.
During the term of the agreement, Ms. Li is entitled
to a base salary and will be eligible for a discretionary performance bonus, equity awards and to participate in employee benefits plans
as the Avalon Shanghai may institute from time to time at the discretion of its Board of Directors. On January 3, 2019, the Company entered
into a Letter Agreement with Ms. Li, pursuant to which her annual base salary set forth in her employment agreement was increased to $340,000
effective January 1, 2019, except that Ms. Li agreed to a salary reduction as set forth in the table above for the years ended December
31, 2024 and 2023 as part of the Company’s cost reduction measures. Pursuant to the agreement, Ms. Li may be terminated for “cause”
as defined and Ms. Li may resign for “good reason” as defined. In the event Ms. Li is terminated without cause or resigns
for good reason, Avalon Shanghai will be required to pay Ms. Li all accrued salary and bonuses, reimbursement for all business expenses
and Ms. Li’s salary for one year. In the event Ms. Li is terminated with cause, resigns without good reason, dies or is disabled,
Avalon Shanghai will be required to pay Ms. Li all accrued salary and bonuses and reimbursement for all business expenses. Under the agreement
Ms. Li is subject to confidentiality, non-compete and non-solicitation restrictions.
Option Exercises and Stock Vested
There were no options exercised by our executive
officers or stock vested to our executive officers during the year ended December 31, 2024.
Outstanding Equity Awards at 2024 Fiscal Year
End
The following table sets forth information with respect to the outstanding
equity awards of our named executive officers at December 31, 2024:
Outstanding Equity Awards
Option Awards
Stock Awards
Name
Number of
securities
underlying
unexercised
options
(#) (Exercisable)
Number of
securities
underlying
unexercised
options
(#) (Unexercisable)
Equity
incentive
plan
awards:
Number of
securities
underlying
unexercised unearned
options
(#)
Options
exercise
price
($)
Option
expiration
Date
Number of
shares
or units
of stock
that
have not
vested
(#)
Market
value of
shares or
units of
stock
that
have
not
vested
($)
Equity
incentive
plan
awards:
Number of
unearned
shares,
units or
other
rights
that have
not vested
(#)
Equity
incentive
plan
awards:
Market or
payout
value of
unearned
shares,
units or
other
rights
that have
not vested
($)
David Jin
2,667
-
2,667
228
2/18/2030
-
-
-
-
Luisa
13,333
-
13,333
75
2/8/2027
-
-
-
-
Ingargiola
2,667
-
2,667
228
2/18/2030
-
-
-
-
Meng Li
2,000
-
2,000
228
2/18/2030
-
-
-
-
63
Policies and Practices Related to the Grant of Certain Equity Awards
Close in Time to the Release of Material Nonpublic Information
We do not have any formal policy that requires us to grant, or avoid
granting, stock options at particular times. Consistent with its annual compensation cycle, if options are to be granted, the Compensation
Committee generally seeks to grant annual stock option awards after its Annual Report on Form 10-K has been filed. The timing of any stock
option grants in connection with new hires, promotions, or other non-routine grants is tied to the event giving rise to the award (such
as an employee’s commencement of employment or promotion effective date). As a result, in all cases, the timing of grants of stock
options occurs independent of the release of any material nonpublic information, and we do not time the disclosure of material nonpublic
information for the purpose of affecting the value of executive compensation.
No stock options were issued to executive officers in 2024 during any
period beginning four business days before the filing of a periodic report or current report disclosing material non-public information
and ending one business day after the filing or furnishing of such report with the SEC.
No Pension Benefits
We do not maintain any plan that provides for
payments or other benefits to its executive officers at, following or in connection with retirement and including, without limitation,
any tax-qualified defined benefit plans or supplemental executive retirement plans.
No Nonqualified Deferred Compensation
We do not maintain any defined contribution or
other plan that provides for the deferral of compensation on a basis that is not tax-qualified.
2024 Director Compensation
The following table sets forth information concerning
the compensation earned or paid to certain of our non-employee directors during the fiscal year ended December 31, 2024:
Name
Fees
Earned or Paid in
Cash
$
Stock
Awards
$
Option
Awards
$
Non-equity
Incentive Plan
Compensation
$
Change in
Pension Value
and Non-
Qualified
Deferred
Compensation
Earnings
$
All Other
Compensation
$
Total
$
Wenzhao Lu
100,000
-
-
-
-
-
100,000
Lourdes Felix (1)
70,000
-
2,697
-
-
-
72,697
Steven A. Sanders (2)
70,000
-
2,697
-
-
-
72,697
William B. Stilley, III (3)
70,000
-
2,697
-
-
-
72,697
Wilbert J. Tauzin II (4)
25,000
-
4,697
-
-
-
29,697
Tevi Troy (5)
60,000
-
2,697
-
-
-
62,697
(1) Ms. Felix’s 2024 compensation consisted of cash of
$70,000 and 533 stock options vested and valued at $2,697.
(2) Mr. Sanders’s 2024 compensation consisted of cash of
$70,000 and 533 options vested and valued at $2,697.
(3) Mr. Stilley’s 2024 compensation consisted of cash of
$70,000 and 533 options vested and valued at $2,697.
(4) Mr. Tauzin’s 2024 compensation consisted of cash of
$25,000 and 1,333 options vested and valued at $4,697.
(5) Mr. Troy’s 2024 compensation consisted of cash of $60,000
and 533 options vested and valued at $2,697.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL
OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Equity Compensation Plan Information
Amended and Restated 2020 Stock Incentive Plan
On August 29, 2023, the Board adopted the Avalon
GloboCare Corp. Amended and Restated 2020 Stock Incentive Plan (the “Amended and Restated 2020 Plan”), subject to stockholder
approval, which was received on December 19, 2023. The Amended and Restated 2020 Plan provides for the grant of incentive stock options
that are intended to qualify under Section 422 of the Code (“ISOs”), nonstatutory stock options, stock appreciation rights,
restricted stock awards, restricted stock unit awards, performance-based stock awards and performance-based cash awards. ISOs may be granted
only to employees. All other awards may be granted to employees, including officers, and to the Company’s non-employee directors,
consultants and other advisors.
A total of 133,333 shares of our common stock
were initially available under the Amended and Restated 2020 Plan. In addition, the number of shares of our common stock reserved for
issuance under the Amended and Restated 2020 Plan automatically increases on January 1 of each year, beginning on January 1, 2024, by
1% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, or a lesser number of
shares determined by our Board. On January 1, 2024 and 2025, the number of shares of our common stock reserved for issuance under the
Amended and Restated 2020 Plan was increased by 7,333 and 14,425 shares, respectively. As of March 31, 2025, a total of 142,424 shares
of our common stock were available for issuance under the Amended and Restated 2020 Plan, including shares that are the subject of outstanding
awards as of such date.
Clawback/Recoupment. Awards granted
under the Amended and Restated 2020 Plan are subject to the requirement that the awards be forfeited or amounts repaid to the Company
after they have been distributed to the participant (i) to the extent set forth in an award agreement or (ii) to the extent covered by
any clawback or recapture policy adopted by the Company from time to time (including the Clawback Policy adopted by the Board on November
16, 2023), or any applicable laws that impose mandatory forfeiture or recoupment, under circumstances set forth in such applicable laws.
Amendment, Termination . Our Board
may at any time amend, suspend or terminate the Amended and Restated 2020 Plan for the purpose of satisfying the requirements of the Code,
or other applicable law or regulation or for any other legal purpose, provided that, without the consent of our stockholders, the Board
may not (i) increase the number of shares of our common stock available under the Amended and Restated 2020 Plan, (ii) change the group
of individuals eligible to receive awards, or (iii) extend the term of the Amended and Restated 2020 Plan.
64
2020 Incentive Stock Plan
On June 12, 2020, the Board adopted the Avalon
GloboCare Corp. 2020 Incentive Stock Plan (the “2020 Plan”), subject to stockholder approval, which was received on August
4, 2020.
The general purpose of the 2020 Plan is to provide
a means whereby eligible directors, officers, employees or consultants to the Company develop a sense of proprietorship and personal involvement
in our development and financial success, and to encourage them to devote their best efforts to our business, thereby advancing our interests
and the interests of our stockholders. We believe that the 2020 Plan advances the Company’s interests by enhancing our ability to
(i) attract, retain and reward employees, officers, directors and consultants who are in a position to make significant contributions
to our success; (ii) encourage our employees, officers, directors and consultants to take into account our long-term interests through
ownership of our shares of our common stock; and (iii) to provide incentives for such persons to exert maximum efforts for our success.
The Board has reserved 33,333 shares of our common
stock for issuance under the 2020 Plan, subject to customary adjustments for stock splits, stock dividends or similar transactions. Under
the 2020 Plan, awards may be made in the form of options to purchase shares of our common stock, as well as restricted shares of our common
stock and restricted stock units payable in shares of our common stock. Options may be granted which are intended to qualify as ISOs under
Section 422 of the Code or which are not intended to qualify as ISOs thereunder. However, ISOs may only be granted to employees. If any
option granted under the 2020 Plan terminates without having been exercised in full or if any award is forfeited, or if shares otherwise
issuable are withheld to satisfy tax withholding obligations, the number of shares of our common stock as to which such option or award
was forfeited or withheld will be available for future grants under the 2020 Plan.
The 2020 Plan is not a qualified deferred compensation
plan under Section 401(a) of the Code and is not subject to the provisions of the Employee Retirement Income Security Act of 1974.
2019 Incentive Stock Plan
On June 7, 2019, the Board adopted the Avalon
GloboCare Corp. 2019 Incentive Stock Plan (the “2019 Plan”), subject to stockholder approval, which was received on August
6, 2019. There are 33,333 shares of our common stock reserved for issuance under the 2019 Plan, subject to customary adjustments for stock
splits, stock dividends or similar transactions. As of March 31, 2025, 6,213 shares remained available for issuance under the 2019 Plan.
The following table provides information with
respect to our 2019 Plan, 2020 Plan, and Amended and Restated 2020 Plan under which equity compensation was authorized as of December
31, 2024:
Plan category
Number of
securities
to be
issued upon
exercise of
outstanding
options,
warrants
and rights
(a)
Weighted
average
exercise
price of
outstanding
options,
warrants
and rights
(b)
Number of
securities
remaining
available for
future
issuance
under equity compensation plans (excluding
securities
reflected
in column
(a))
(c)
Equity compensation plan approved by security holders
Amended and Restated 2020 Plan
12,667 (1)
$ 3.46 (2)
142,424
2020 Plan
33,221 (3)
$ 54.53 (2)
112
2019 Plan
27,120 (4)
$ 275.44 (2)
6,213
Equity compensation plans not approved by security holders
-
$ -
-
Total
73,008
$ 153.74
148,749
(1) Includes 1,867 shares of our common stock issuable upon exercise
of outstanding options and 10,800 shares of our common stock issuable pursuant to outstanding restricted stock units.
(2) The weighted average exercise price does not take into account
the shares issuable pursuant to outstanding restricted stock units, which have no exercise price.
(3) Includes 30,047 shares of our common stock issuable upon
exercise of outstanding options and 3,174 shares of our common stock issuable pursuant to outstanding restricted stock units.
(4) Includes 26,800 shares of our common stock issuable upon exercise of outstanding options and 320 shares of our common stock issuable
pursuant to outstanding restricted stock units.
Security Ownership of Certain Beneficial Owners
and Management
Beneficial ownership is determined in accordance
with the rules of the SEC and generally includes voting or investment power with respect to securities. In accordance with SEC rules,
shares of our common stock which may be acquired upon exercise of stock options or warrants which are currently exercisable or which become
exercisable within 60 days of the date of the applicable table below are deemed beneficially owned by the holders of such options and
warrants and are deemed outstanding for the purpose of computing the percentage of ownership of such person, but are not treated as outstanding
for the purpose of computing the percentage of ownership of any other person. Subject to community property laws, where applicable, the
persons or entities named in the tables below have sole voting and investment power with respect to all shares of our common stock indicated
as beneficially owned by them.
65
The following table sets forth certain information,
as of March 31, 2025 with respect to the beneficial ownership of the outstanding common stock by:
● Each of our named executive officers and directors;
● Our directors and executive officers as a group; and
● Holders of more than 5% of our common stock
Except as otherwise indicated, each of the stockholders
listed below has sole voting and investment power over the shares beneficially owned.
Name of Beneficial Owner (1)
Common Stock Beneficially Owned
Percentage of Common Stock (2)
Wenzhao Lu* (3)
238,928
14.5 %
David Jin, MD, PhD* (4)
205,667
11.7 %
Meng Li* (5)
436,334
21.2 %
Luisa Ingargiola* (6)
416,000
20.1 %
Steven A. Sanders* (7)
102,665
5.9 %
Wilbert J. Tauzin II* (8)
105,570
6.0 %
William B. Stilley III* (9)
102,665
5.9 %
Tevi Troy* (10)
102,665
5.9 %
Lourdes Felix* (11)
101,053
5.8 %
All officers and directors as a group (9 persons)
1,811,547
58.7 %
Shareholder owning 5% or more:
Vision Capital NY Inc. (12)
100,000
6.1 %
* Officer and/or director of our company
(1) Except as otherwise indicated, the address of each beneficial
owner is c/o Avalon GloboCare Corp., 4400 Route 9 South, Suite 3100, Freehold, New Jersey 07728.
(2) Applicable percentage ownership is based on 1,651,667 shares of our common stock outstanding as of March 31, 2025, together with
securities exercisable or convertible into shares of our common stock within 60 days of March 31, 2025 for each stockholder. Beneficial
ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities.
Shares of common stock that are currently exercisable or exercisable within 60 days of March 31, 2025 are deemed to be beneficially
owned by the person holding such securities for the purpose of computing the percentage of ownership of such person, but are not treated
as outstanding for the purpose of computing the percentage ownership of any other person.
(3) Wenzhao Lu holds 238,928 shares of our common stock.
(4) David Jin holds (i) 103,000 shares of our common stock and (ii)
102,667 vested options to acquire 102,667 shares of our common stock.
(5) Meng Li holds (i) 34,334 shares of our common stock and (ii)
402,000 vested options to acquire 402,000 shares of our common stock.
(6) Represents 416,000 vested options to acquire 416,000 shares
of our common stock.
(7) Represents 102,665 vested options to acquire 102,665 shares
of our common stock.
(8) Wilbert J. Tauzin II holds (i) 1,037 shares of our common stock and
(ii) 104,533 vested options to acquire 104,533 shares of our common stock.
(9) Represents 102,665 vested options to acquire 102,665 shares
of our common stock.
(10) Represents 102,665 vested options to acquire 102,665 shares
of our common stock.
(11) Represents 101,053 vested options to acquire 101,053 shares
of our common stock.
(12) Vision Capital NY Inc. holds 100,000 shares of our common stock.
Vision Capital NY Inc.’s address is 600 Pine Hollow Road #16-5B, East Norwich, NY 11732.
66
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Other than compensation arrangements for our named
executive officers and directors, we describe below each transaction or series of similar transactions, since January 1, 2023 to which
we were a party or will be a party, in which:
● the amounts involved exceeded
or will exceed the lesser of (i) $120,000 or (ii) 1% of the average total assets of the Company at year end for the last two completed
fiscal years; and
● any of our directors, executive
officers, promoters or holders of more than 5% of our capital stock, or any member of the immediate family of the foregoing persons,
had or will have a direct or indirect material interest.
Compensation arrangements for our named executive
officers and directors are described in the section entitled “Executive Compensation.”
Rental
Revenue from Related Party and Rent Receivable – Related Party
The Company leases space of its commercial real
property located in New Jersey to D.P. Capital Investments LLC, which is controlled by Wenzhao Lu, the Company’s chairman of the
Board of Directors. The term of the related party lease agreement is five years commencing on May 1, 2021 and will expire on April 30,
2026.
For both
the years ended December 31, 2024 and 2023, the related party rental revenue amounted to $50,400 and has been included in real property
rental revenue on the accompanying consolidated statements of operations and comprehensive loss. At December 31, 2024 and 2023, the related
party rent receivable totaled $0 and $124,500, respectively, which has been included in rent receivable on the accompanying consolidated
balance sheets.
Services
Provided by Related Party
From time to time, Wilbert Tauzin, a director
of the Company, and his son provide consulting services to the Company. As compensation for professional services provided, the Company
recognized consulting expenses of $63,644 and $86,528 for the years ended December 31, 2024 and 2023, respectively, which have been included
in professional fees on the accompanying consolidated statements of operations and comprehensive loss. As of both December 31, 2024 and
2023, the accrued and unpaid services charge related to this director’s son amounted to $15,000, which have been included in accrued
professional fees on the accompanying consolidated balance sheets.
Accrued Liabilities and Other Payables –
Related Parties
In 2017, the Company acquired Beijing Genexosome
for a cash payment of $450,000. As of both December 31, 2024 and 2023, the unpaid acquisition consideration of $100,000, was payable to
Dr. Yu Zhou, former director and former co-chief executive officer and 40% owner of Genexosome, and has been included in accrued liabilities
and other payables — related parties on the accompanying consolidated balance sheets.
From time to time, Lab Services MSO paid shared
expense on behalf of the Company. In addition, Lab Services MSO made a payment of $566,667 for equity method investment payable on behalf
of the Company in the year ended December 31, 2024. As of December 31, 2024 and 2023, the balance due to Lab Services MSO amounted to
$632,916 and $72,746, respectively, which has been included in accrued liabilities and other payables — related parties on the accompanying
consolidated balance sheets.
As of December 31, 2024 and 2023, $0 and $33,712
of accrued and unpaid interest related to borrowings from Wenzhao Lu, the Company’s chairman of the Board of Directors, respectively,
have been included in accrued liabilities and other payables — related parties on the accompanying consolidated balance sheets.
67
Borrowings from Related Party
Line of Credit
On August 29, 2019, the Company entered into a
Line of Credit Agreement (the “Line of Credit Agreement”) providing the Company with a $20 million line of credit (the “Line
of Credit”) from Mr. Lu, the Company’s chairman of the Board of Directors. The Line of Credit allowed the Company to request
loans thereunder and to use the proceeds of such loans for working capital and operating expense purposes until the facility matured on
December 31, 2024. The loans are unsecured and are not convertible into equity of the Company. Loans drawn under the Line of Credit bear
interest at an annual rate of 5% and each individual loan is payable three years from the date of issuance. The Company has a right to
draw down on the line of credit and not at the discretion of Mr. Lu, the related party lender. The Company may, at its option, prepay
any borrowings under the Line of Credit, in whole or in part at any time prior to maturity, without premium or penalty. The Line of Credit
Agreement includes customary events of default. If any such event of default occurs, Mr. Lu may declare all outstanding loans under the
Line of Credit to be due and payable immediately.
In the years ended December 31, 2024 and 2023,
activity recorded for the Line of Credit is summarized in the following table:
Outstanding principal under the Line of Credit at January 1, 2023
$ -
Draw down from Line of Credit
850,000
Outstanding principal under the Line of Credit at December 31, 2023
850,000
Repayment of Line of Credit
(400,000 )
Reclassification of Line of Credit to advance from related party
(450,000 )
Outstanding principal under the Line of Credit at December 31, 2024
$ -
For the years ended December 31, 2024 and 2023,
the interest expense related to related party borrowing amounted to $42,445 and $33,712, respectively, and has been reflected as interest
expense — related party on the accompanying consolidated statements of operations and comprehensive loss.
As of December 31, 2024 and 2023, the related
accrued and unpaid interest for Line of Credit was $0 and $33,712, respectively, and has been included in accrued liabilities and other
payables — related parties on the accompanying consolidated balance sheets.
Membership Interest
Purchase Agreement
On November 17, 2023,
the Company entered into a Membership Interest Purchase Agreement (the “Purchase Agreement”) with Mr. Lu, the Company’s
chairman of the Board of Directors, pursuant to which (i) Mr. Lu will acquire from the Company 30% of the total outstanding membership
interests of Avalon RT 9, a wholly owned subsidiary of the Company, for a cash purchase price of $3,000,000 (the “Acquisition”),
and (ii) for a period of twelve months following the closing of the Acquisition, Mr. Lu shall have the option to purchase from the Company
up to an additional 70% of the outstanding membership interests of Avalon RT 9 for a purchase price of up to $7,000,000 (the “Option”),
subject to the terms and conditions of a membership interest purchase agreement to be negotiated and entered into between the Purchaser
and the Company at such time that the Purchaser desires to exercise the Option. The Company received $3,108,106 and $485,714 from Wenzhao
Lu as of December 31, 2024 and 2023, respectively, which was recorded as advance from pending sale of noncontrolling interest –
related party on the accompanying consolidated balance sheets. The Acquisition is expected to be closed in the fourth quarter of 2025.
68
Policies and Procedures for Related Party Transactions
Our Board has adopted a policy that our executive
officers, directors, nominees for election as a director, beneficial owners of more than 5% of any class of our common stock, any members
of the immediate family of any of the foregoing persons and any firms, corporations or other entities in which any of the foregoing persons
is employed or is a partner or principal or in a similar position or in which such person has a 5% or greater beneficial ownership interest,
are not permitted to enter into a transaction with us without the prior consent of our Board acting through the Audit Committee or, in
certain circumstances, the Chairman of the Audit Committee. Any request for us to enter into a transaction with a related party, in which
the amount involved exceeds $100,000 and such related party would have a direct or indirect interest must first be presented to our Audit
Committee, or in certain circumstances the Chairman of our Audit Committee, for review, consideration and approval. In approving or rejecting
any such proposal, our Audit Committee, or the Chairman of our Audit Committee, is to consider the material facts of the transaction,
including, but not limited to, whether the transaction is on terms no less favorable than terms generally available to an unaffiliated
third party under the same or similar circumstances, the extent of the benefits to us, the availability of other sources of comparable
products or services and the extent of the related party’s interest in the transaction.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
M&K CPAS PLLC served as our independent auditors
for the year ended December 31, 2024. Marcum LLP (“Marcum”) served as our independent auditors for the year ended December
31, 2023.
Aggregate fees billed to the Company for professional
services rendered by M&K CPAS PLLC and Marcum LLP during the last two years were as follows:
Fee Category
2024
2023
Audit Fees (1)
Marcum
$ 287,244
$ 292,005
M&K
137,000
-
Audit Related Fees (2)
Marcum
-
198,158
M&K
-
-
Tax Fees (3)
Marcum
-
-
M&K
-
-
All Other Fees (4)
Marcum
-
-
M&K
-
-
Totals
Marcum
287,244
490,163
M&K
$ 137,000
$ -
(1) Consists of fees billed for professional services rendered for
the audit of our annual consolidated financial statements, review of our Annual Report on Form 10-K, and review of the interim consolidated
financial statements included in our Quarterly Reports on Form 10-Q, and services that are normally provided by our independent auditors
in connection with statutory and regulatory filings or engagements, including registration statements.
(2) Consists of fees billed for assurance and related services that
are reasonably related to the performance of the audit and or review of our consolidated financial statements and are not reported under
“Audit Fees”, such as audits and reviews in connection with the acquisition of Lab Services MSO.
(3) Consists of fees billed for professional services for tax compliance,
tax advice and tax planning.
(4) Consists of fees for products and services other than the services
reported above.
Pre-Approval Policy and Procedures
The current policy of the directors, acting
as the Audit Committee, is to approve the appointment of the principal auditing firm and any permissible audit-related services. The
audit and audit related fees include fees for the annual audit of the financial statements and review of financial statements
included in Quarterly Reports on Form 10-Q. Fees charged by the auditor were approved by the Board with engagement letters signed by
the Audit Committee Chairman.
The Audit Committee is responsible for the pre-approval
of audit and permitted non-audit services to be performed by the Company’s independent auditor. The Audit Committee will, on an
annual basis, consider and, if appropriate, approve the provision of audit and non-audit services by the auditor. Thereafter, the Audit
Committee will, as necessary, consider and, if appropriate, approve the provision of additional audit and non-audit services by the auditor
which are not encompassed by the Audit Committee’s annual pre-approval and are not prohibited by law. The Audit Committee has delegated
to the Chair of the Audit Committee the authority to pre-approve, on a case-by-case basis, non-audit services to be performed by the auditor.
The Audit Committee has approved all audit and permitted non-audit services performed by the auditor for the year ended December 31, 2024.
69
PART IV
ITEM 15. EXHIBITS
Exhibit
Number
Description
1.1
Open Market Sale Agreement SM , dated as of December 13, 2019, by and between Avalon GloboCare Corp. and Jefferies LLC. (incorporated by reference to Exhibit 1.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on December 13, 2019) .
2.1
Membership Interest Purchase Agreement, dated November 7, 2022, by and among the Registrant, Laboratory Services MSO, LLC, SCBC Holdings LLC, Avalon Laboratory Services, Inc., The Zoe Family Trust, Bryan Cox and Sarah Cox (incorporated by reference to Exhibit 2.1 of the Registrant’s Current Report on Form 8-K filed on November 8, 2022).
2.2
Amended and Restated Membership Interest Purchase Agreement, dated February 9, 2023 by and among the Registrant, Laboratory Services MSO, LLC, SCBC Holdings LLC, Avalon Laboratory Services, Inc., the Zoe Family Trust, Bryan Cox and Sarah Cox (incorporated by reference to Exhibit 2.1 of the Registrant’s Current Report on Form 8-K filed on February 13, 2023).
2.3
Agreement and Plan of Merger, dated March 7, 2025, by and among Avalon GloboCare Corp., Nexus MergerSub Limited and YOOV Group Holding Limited (incorporated by reference to Exhibit 2.1 to the registrant’s Current Report on Form 8-K filed on March 10, 2025).
3.1
Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 of the Current Report on Form 8-K/A filed with the Securities and Exchange Commission on April 26, 2018) .
3.2
Certificate of Amendment to the Amended and Restated Certificate of Incorporation, as amended, of Avalon GloboCare Corp. (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on January 4, 2023).
3.3
Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 of the Current Report on Form 8-K/A filed with the Securities and Exchange Commission on April 26, 2018) .
3.4
Certificate of Designation of Preferences, Rights and Limitations of the Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on November 8, 2022) .
3.5
Certificate of Designation of Preferences, Rights and Limitations of the Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed on February 13, 2023) .
3.6
Certificate of amendment dated October 23, 2024 (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed with the SEC on October 29, 2024).
3.7
Certificate of Designations of Preferences and Rights of Series C Convertible Preferred Stock of the Company, as filed on December 13, 2024, with the Department of State, Division of Corporations, of the State of Delaware (incorporated by reference to Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed with the SEC on December 19, 2024).
3.8
Certificate of Designations of Preferences and Rights of Series D Convertible Preferred Stock of the Company, as filed on January 6, 2025, with the Department of State, Division of Corporations, of the State of Delaware (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed with the SEC on January 10, 2025).
3.9
Certificate of Elimination relating to the Series A Preferred Stock, filed with the Secretary of State of Delaware on March 7, 2025 (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed with the SEC on March 10, 2025).
3.10
Certificate of Elimination relating to the Series B Preferred Stock, filed with the Secretary of State of Delaware on March 7, 2025 (incorporated by reference to Exhibit 3.2 to the registrant’s Current Report on Form 8-K filed with the SEC on March 10, 2025).
70
3.11
Amendment No. 1 to the Avalon Bylaws, as adopted and approved by the Avalon Board on March 7, 2025 (incorporated by reference to Exhibit 3.3 to the registrant’s Current Report on Form 8-K filed with the SEC on March 10, 2025).
4.1
Form of Subscription Agreement by and between Avalon GloboCare Corp. and the December 2016 Accredited Investors (incorporated by reference to Exhibit 4.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on December 21, 2016) .
4.2 †
Stock Option issued to Luisa Ingargiola dated February 21, 2017 (incorporated by reference to Exhibit 4.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on February 21, 2017) .
4.3
Form of Subscription Agreement by and between Avalon GloboCare Corp. and the March 2017 Accredited Investor (incorporated by reference to Exhibit 4.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on March 7, 2017) .
4.4
Share Subscription Agreement between Avalon GloboCare Corp., Avalon (Shanghai) Healthcare Technology Co., Ltd., Beijing DOING Biomedical Technology Co., Ltd. and Daron Liang (incorporated by reference to Exhibit 4.2 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on March 7, 2017) .
4.5
Warranty Agreement by and between Lu Wenzhao and Beijing DOING Biomedical Technology Co., Ltd., dated February 27, 2017 (incorporated by reference to Exhibit 4.3 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on March 7, 2017) .
4.6
Form of Subscription Agreement between Avalon GloboCare Corp. and the October 2017 Accredited Investors (incorporated by reference to Exhibit 4.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on October 26, 2017) .
4.7
Form of Warrant to Boustead Securities, LLC in connection with the private placements (incorporated by reference to Exhibit 4.8 of the Registration Statement on Form S-1/A filed with the Securities and Exchange Commission on July 27, 2018) .
4.8
Form of Warrant (April 2019) (incorporated by reference to Exhibit 4.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on April 26, 2019) .
4.9*
Description of Securities Registered under Section 12 of the Securities Exchange Act of 1934
4.10
Form of Subscription Agreement by and between Avalon GloboCare Corp. and Wenzhao “Daniel” Lu dated August 5, 2022 (incorporated by reference to Exhibit 4.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on August 8, 2022).
4.11
Form of Subscription Agreement by and between Avalon GloboCare Corp. and Emma Li Xu Qingbo dated August 5, 2022 (incorporated by reference to Exhibit 4.2 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on August 8, 2022).
10.1
Share Exchange Agreement dated as of October 19, 2016 by and among Avalon Healthcare System, Inc., the shareholders of Avalon Healthcare System, Inc. and Avalon GloboCare Corp. (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on October 19, 2016) .
71
10.2 †
Executive Employment Agreement, effective December 1, 2016, by and between Avalon GloboCare Corp. and David Jin (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on December 2, 2016) .
10.3
Agreement of Sale by and between Freehold Craig Road Partnership and Avalon GloboCare Corp., dated December 22, 2016 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on December 23, 2016) .
10.4 †
Executive Employment Agreement by and between Avalon (Shanghai) Healthcare Technology Ltd. and Meng Li, dated January 11, 2017 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on January 11, 2017) .
10.5 †
Executive Retention Agreement by and between Avalon GloboCare Corp. and Luisa Ingargiola, dated February 21, 2017 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on February 21, 2017) .
10.6 †
Indemnification Agreement by and between Avalon GloboCare Corp. and Luisa Ingargiola, dated February 21, 2017 (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on February 21, 2017) .
10.7 †
Director Agreement by and between Avalon GloboCare Corp. and Steven P. Sukel dated April 28, 2017 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on April 28, 2017) .
10.8 †
Director Agreement by and between Avalon GloboCare Corp. and Yancen Lu dated April 28, 2017 (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on April 28, 2017) .
10.9
Consultation Service Contract between Daopei Investment Management (Shanghai) Co., Ltd. and Avalon HealthCare System Inc. dated April 1, 2016 (English translation) (incorporated by reference to Exhibit 10.8 of Amendment No. 1 to the Registration Statement on Form S-1 filed with the Securities and Exchange Commission on July 7, 2017) .
10.10
Consultation Service Contract between Hebei Yanda Ludaopei Hospital Co., Ltd and Avalon HealthCare System Inc. dated April 1, 2016 (English translation) (incorporated by reference to Exhibit 10.9 of Amendment No. 1 to the Registration Statement on Form S-1 filed with the Securities and Exchange Commission on July 7, 2017) .
10.11
Consultation Service Contract between Nanshan Memorial Stem Cell Biotechnology Co., Ltd. and Avalon HealthCare System Inc. dated April 1, 2016 (English translation) (incorporated by reference to Exhibit 10.10 of Amendment No. 1 to the Registration Statement on Form S-1 filed with the Securities and Exchange Commission on July 7, 2017) .
10.12
Loan Agreement between Lotus Capital Overseas Limited and Avalon (Shanghai) Healthcare Technology Co., Ltd. dated April 19, 2017 (English translation) (incorporated by reference to Exhibit 10.12 of the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2017) .
10.13
Securities Purchase Agreement between Avalon GloboCare Corp. and Genexosome Technologies Inc. dated October 25, 2017 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on October 26, 2017) .
72
10.14
Asset Purchase Agreement between Genexosome Technologies Inc. and Yu Zhou dated October 25, 2017 (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on October 26, 2017) .
10.15
Stock Purchase Agreement between Genexosome Technologies Inc., Beijing Jieteng (Genexosome) Biotech Co. Ltd. and Yu Zhou dated October 25, 2017 (incorporated by reference to Exhibit 10.3 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on October 26, 2017) .
10.16 †
Executive Retention Agreement between Genexosome Technologies Inc. and Yu Zhou dated October 25, 2017 (incorporated by reference to Exhibit 10.4 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on October 26, 2017) .
10.17
Invention Assignment, Confidentiality, Non-Compete and Non-Solicit Agreement between Genexosome Technologies Inc. and Yu Zhou dated October 25, 2017 (incorporated by reference to Exhibit 10.5 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on October 26, 2017) .
10.18 †
Director Agreement by and between Avalon GloboCare Corp. and Wilbert J. Tauzin II dated November 1, 2017 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on November 7, 2017) .
10.19
Agreement between Avalon GloboCare Corp. and Tauzin Consultants, LLC dated November 1, 2017 (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on November 7, 2017) .
10.20 †
Letter Agreement by and between Avalon GloboCare Corp. and David Jin dated April 3, 2018 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on April 4, 2018) .
10.21 †
Letter Agreement by and between Avalon GloboCare Corp. and Meng Li dated April 3, 2018 (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on April 4, 2018) .
10.22
Advisory Service Contract between Ludaopei Hematology Research Institute Co., Ltd. and Avalon (Shanghai) Healthcare Technology Co., Ltd. dated April 1, 2018 (English translation) (incorporated by reference to that Form S-1 Registration Statement filed with the Securities and Exchange Commission on April 19, 2018) .
10.23
Form of Subscription Agreement by and between Avalon GloboCare Corp. and the April 2018 Accredited Investors (incorporated by reference to Exhibit 4.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on April 18, 2018).
10.24
Supplementary Agreement Related to Share Subscription by and between Avalon GloboCare Corp., Avalon (Shanghai) Healthcare Technology Co., Ltd., Beijing DOING Biomedical Technology Co., Ltd. and Daron Liang dated April 23, 2018 (English translation) (incorporated by reference to Exhibit 4.2 of the Current Report on Form 8-K/A filed with the Securities and Exchange Commission on April 26, 2018) .
10.25
Loan Extension Agreement between Lotus Capital Overseas Limited and Avalon (Shanghai) Healthcare Technology Co., Ltd. dated May 3, 2018 (English translation) (incorporated by reference to Exhibit 10.18 of the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 11, 2018) .
73
10.26 †
Director Agreement by and between Avalon GloboCare Corp. and Tevi Troy dated June 4, 2018 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on June 6, 2018) .
10.27
Joint Venture Agreement by and between Avalon (Shanghai) Healthcare Technology Co., Ltd. and Jiangsu Unicorn Biological Technology Co., Ltd. dated May 29, 2018 (English translation) (incorporated by reference to Exhibit 99.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on June 6, 2018) .
10.28 †
Director Agreement by and between Avalon GloboCare Corp. and William Stilley, III dated July 5, 2018 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on July 10, 2018) .
10.29 †
Director Agreement by and between Avalon GloboCare Corp. and Steven A. Sanders dated July 30, 2018 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on July 31, 2018) .
10.30
Loan Extension Agreement between Lotus Capital Overseas Limited and Avalon (Shanghai) Healthcare Technology Co., Ltd. dated August 3, 2018 (English translation) (incorporated by reference to Exhibit 10.30 of the Registration Statement on Form S-1/A filed with the Securities and Exchange Commission on August 7, 2018) .
10.31
Strategic Partnership Agreement between Avalon GloboCare Corp. and Weill Cornell Medical College of Cornell University dated August 6, 2018 (incorporated by reference to Exhibit 10.31 of the Registration Statement on Form S-1/A filed with the Securities and Exchange Commission on August 7, 2018) .
10.32
Equity Joint Venture Agreement by and between Avactis Biosciences, Inc., a wholly-owned subsidiary of Avalon GloboCare Corp., and Arbele Limited for the establishment of AVAR (China) BioTherapeutics Ltd. dated October 23, 2018 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on October 29, 2018) .
10.33
Letter Agreement by and between Avalon GloboCare Corp. and David Jin dated January 3, 2019 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on January 4, 2019) .
10.34
Letter Agreement by and between Avalon GloboCare Corp. and Luisa Ingargiola dated January 3, 2019 (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on January 4, 2019) .
10.35
Letter Agreement by and between Avalon (Shanghai) Healthcare Technology Co. Ltd. and Meng Li dated January 3, 2019 (incorporated by reference to Exhibit 10.3 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on January 4, 2019) .
10.36
Promissory Note issued to Daniel Lu dated Mach 18, 2019 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on March 22, 2019) .
10.37†
Director Agreement by and between Avalon GloboCare Corp. and Meng Li dated April 5, 2019 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on April 8, 2019) .
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10.38†
Director Agreement by and between Avalon GloboCare Corp. and Yue “Charles” Li dated April 5, 2019 (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on April 8, 2019) .
10.39
Form of Securities Purchase Agreement dated April 25, 2019 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on April 26, 2019) .
10.40
Revolving Line of Credit Agreement dated as of August 29, 2019 between Avalon GloboCare Corp. and Wenzhao “Daniel” Lu dated August 29, 2019 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on September 3, 2019) .
10.41
Form of Warrant Redemption and Cancellation Agreement (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on October 21, 2019) .
10.42
Letter Agreement by and between Avalon GloboCare Corp. and David Jin dated February 20, 2020 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on February 24, 2020) .
10.43
Letter Agreement by and between Avalon GloboCare Corp. and Meng Li dated February 20, 2020 (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on February 24, 2020) .
10.44
Letter Agreement by and between Avalon GloboCare Corp. and Luisa Ingargiola dated February 20, 2020 (incorporated by reference to Exhibit 10.3 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on February 24, 2020) .
10.45
Debt Settlement Agreement and Release between Avalon GloboCare Corp. and Wenzhao “Daniel” Lu (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on December 22, 2021) .
10.46
Corporate Research Agreement between Avalon GloboCare Corp. and the University of Pittsburgh of the Commonwealth System of Higher Education dated July 8, 2021 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on July 14, 2021) .
10.47
Form of Securities Purchase Agreement dated March 28, 2022 (incorporated by reference to Exhibit 10.47 of the Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 30, 2022) .
10.48
Form of Convertible Note - March 2022 (incorporated by reference to Exhibit 10.48 of the Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 30, 2022) .
10.49
Loan Extension and Modification Agreement between Avalon GloboCare Corp. and Wenzhao Lu dated March 28, 2022 (incorporated by reference to Exhibit 10.49 of the Form 10-K filed with the Securities and Exchange Commission on March 30, 2022) .
10.50
Consulting Agreement, dated February 9, 2023, by and between Laboratory Services MSO, LLC and Sarah Cox (incorporated by reference to Exhibit 10.50 to the registrant’s Annual Report on Form 10-K filed on April 15, 2024).
10.51
Form of Warrant - March 2022 (incorporated by reference to Exhibit 10.3 of the Form 8-K filed with the Securities and Exchange Commission on April 29, 2022) .
75
10.52
Amendment No. 1 to the Equity Joint Venture Agreement entered between Avalon GloboCare Corp., Avactis Biosciences Inc., Arbele Limited and Arbele Biotherapeutics Limited dated April 6, 2022 (incorporated by reference to Exhibit 10.53 of the Form 10-Q filed with the Securities and Exchange Commission on May 11, 2022) .
10.53
Letter Agreement between Avalon GloboCare Corp. and Fsunshine Trading PTE. Ltd. dated June 8, 2022 (incorporated by reference to Exhibit 10.4 of the Form 8-K filed with the Securities and Exchange Commission on June 8, 2022) .
10.54
Debt Settlement Agreement and Release between Avalon GloboCare Corp. and Wenzhao “Daniel” Lu dated July 25, 2022 (incorporated by reference to Exhibit 10.2 of the Form 8-K filed with the Securities and Exchange Commission on July 27, 2022) .
10.55
Conversion Agreement between Avalon GloboCare Corp. and Fsunshine Trading PTE. Ltd. Dated July 25, 2022 (incorporated by reference to Exhibit 10.3 of the Form 8-K filed with the Securities and Exchange Commission on July 27, 2022) .
10.56
Form of Balloon Promissory Note issued to S&P Principal LLC (incorporated by reference to Exhibit 10.1 of the Form 8-K filed with the Securities and Exchange Commission on September 8, 2022) .
10.57
Form of Mortgage and Security Agreement (incorporated by reference to Exhibit 10.2 of the Form 8-K filed with the Securities and Exchange Commission on September 8, 2022) .
10.58
Form of Guaranty (incorporated by reference to Exhibit 10.3 of the Form 8-K filed with the Securities and Exchange Commission on September 8, 2022) .
10.59
Form of Securities Purchase Agreement for the purchase of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 10.1 of the Form 8-K filed with the Securities and Exchange Commission on November 8, 2022) .
10.60
Director Agreement by and Between Avalon GloboCare Corp. and Lourdes Felix dated January 9, 2023 (incorporated by reference to Exhibit 10.1 of the Registrants Current Report on Form 8-K filed with the SEC on January 11, 2023) .
10.61
Second Amended and Restated Limited Company Agreement, dated February 9, 2023, by and among Laboratory Services MSO, LLC, SCBC Holdings LLC, the Zoe Family Trust, Bryan Cox, Sarah Cox and the members named therein (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on February 13, 2023) .
10.62
Securities Purchase Agreement, dated May 23, 2023, between Avalon GloboCare Corp. and Mast Hill Fund, L.P (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 26, 2023) .
10.63
Security Agreement, dated May 23, 2023, by and among Avalon GloboCare Corp., Avalon Healthcare System Inc., Avalon Laboratory Services, Inc., Avalon RT 9 Properties, LLC, Avactis Biosciences, Inc., Laboratory Services MSO, LLC, Genexosome Technologies Inc., International Exosome Association LLC and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 26, 2023).
10.64
Senior Secured Promissory Note, dated May 23, 2023, between Avalon Globocare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 26, 2023) .
76
10.65
First Warrant, dated May 23, 2023, by and between Avalon GloboCare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.4 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 26, 2023) .
10.66
Second Warrant, dated May 23, 2023, by and between Avalon GloboCare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.5 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 26, 2023) .
10.67
Form of Balloon Mortgage Note (incorporated by reference to Exhibit 10.6 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 26, 2023).
10.68
Form of Second Mortgage and Security Agreement (incorporated by reference to Exhibit 10.7 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 26, 2023).
10.69
Form of Guaranty (incorporated by reference to Exhibit 10.8 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 26, 2023).
10.70
Form of Hazardous Material Guaranty and Indemnification Agreement (incorporated by reference to Exhibit 10.9 of the Registrant’s Current Report on Form 8-K filed with the SEC on May 26, 2023).
10.71
Sales Agreement, dated June 16, 2023, by and between Avalon GloboCare Corp. and Roth Capital Partners, LLC. (incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on June 16, 2023) .
10.72
Securities Purchase Agreement, dated July 6, 2023, by and between Avalon Globocare Corp. and Firstfire Global Opportunities, LLC. (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on July 10, 2023).
10.73
Security Agreement, dated July 6, 2023, by and among Avalon GloboCare Corp., Avalon Healthcare System Inc., Avalon Laboratory Services, Inc., Avalon RT 9 Properties, LLC, Avactis Biosciences, Inc., Laboratory Services MSO, LLC, Genexosome Technologies Inc., International Exosome Association LLC and Firstfire Global Opportunities, LLC. (incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed with the SEC on July 10, 2023).
10.74
Senior Secured Promissory Note, dated July 6, 2023, by and between Avalon GloboCare Corp. and Firstfire Global Opportunities, LLC. (incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed with the SEC on July 10, 2023).
10.75
First Warrant dated July 6, 2023, by and between Avalon GloboCare Corp. and Firstfire Global Opportunities, LLC. (incorporated by reference to Exhibit 10.4 of the Registrant’s Current Report on Form 8-K filed with the SEC on July 10, 2023).
10.76
Second Warrant, dated July 6, 2023, by and between Avalon Globocare Corp. and Firstfire Global Opportunities, LLC. (incorporated by reference to Exhibit 10.5 of the Registrant’s Current Report on Form 8-K filed with the SEC on July 10, 2023).
10.77
Securities Purchase Agreement, dated October 9, 2023, between Avalon Globocare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on October 13, 2023).
77
10.78
Security Agreement, dated October 9, 2023, among Avalon Globocare Corp., Avalon Healthcare System Inc., Avalon Laboratory Services, Inc., Avalon RT 9 Properties, LLC, Avactis Biosciences, Inc., Laboratory Services MSO, LLC, Genexosome Technologies Inc., International Exosome Association LLC and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed with the SEC on October 13, 2023) .
10.79
Senior Secured Promissory Note, dated October 9, 2023, between Avalon Globocare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed with the SEC on October 13, 2023) .
10.80
First Warrant, dated October 9, 2023, between Avalon Globocare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.4 of the Registrant’s Current Report on Form 8-K filed with the SEC on October 13, 2023) .
10.81
Second Warrant, dated October 9, 2023, between Avalon Globocare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.5 of the Registrant’s Current Report on Form 8-K filed with the SEC on October 13, 2023) .
10.82
Securities Purchase Agreement, dated October 9, 2023, between Avalon Globocare Corp. and Firstfire Global Opportunities Fund, LLC (incorporated by reference to Exhibit 10.6 of the Registrant’s Current Report on Form 8-K filed with the SEC on October 13, 2023) .
10.83
Security Agreement, dated October 9, 2023, among Avalon Globocare Corp., Avalon Healthcare System Inc., Avalon Laboratory Services, Inc., Avalon RT 9 Properties, LLC, Avactis Biosciences, Inc., Laboratory Services MSO, LLC, Genexosome Technologies Inc., International Exosome Association LLC and Firstfire Global Opportunities Fund, LLC (incorporated by reference to Exhibit 10.7 of the Registrant’s Current Report on Form 8-K filed with the SEC on October 13, 2023) .
10.84
Senior Secured Promissory Note, dated October 9, 2023, between Avalon Globocare Corp. and Firstfire Global Opportunities Fund, LLC (incorporated by reference to Exhibit 10.8 of the Registrant’s Current Report on Form 8-K filed with the SEC on October 13, 2023) .
10.85
First Warrant, dated October 9, 2023, between Avalon Globocare Corp. and Firstfire Global Opportunities Fund, LLC (incorporated by reference to Exhibit 10.9 of the Registrant’s Current Report on Form 8-K filed with the SEC on October 13, 2023) .
10.86
Second Warrant, dated October 9, 2023, between Avalon Globocare Corp. and Firstfire Global Opportunities Fund, LLC (incorporated by reference to Exhibit 10.10 of the Registrant’s Current Report on Form 8-K filed with the SEC on October 13, 2023) .
10.87
Mortgage and Security Agreement, dated October 9, 2023, between Avalon Globocare Corp., Mast Hill Fund, L.P and Firstfire Global Opportunities Fund, LLC (incorporated by reference to Exhibit 10.11 of the Registrant’s Current Report on Form 8-K filed with the SEC on October 13, 2023) .
10.88
Membership Interest Purchase Agreement, dated November 17, 2023, between Avalon Globocare Corp. and Wenzhao Lu (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on November 22, 2023) .
10.89
Mortgage and Security Agreement, dated March 27, 2024, between Avalon Globocare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on March 27, 2024) .
10.90
Mortgage and Security Agreement, dated March 27, 2024, between Avalon Globocare Corp. and Firstfire Global Opportunities Fund, LLC (incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed with the SEC on March 27, 2024) .
78
10.91
Senior Secured Convertible Promissory Note, dated March 7, 2024, between Avalon GloboCare Corp. and Mast Hill Fund, LP (incorporated by reference to Exhibit 10.4 of the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on May 31, 2024).
10.92
Security Agreement, dated March 7, 2024, between Avalon GloboCare Corp. and Mast Hill Fund, LP.* (incorporated by reference to Exhibit 10.5 of the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on May 31, 2024).
10.93
Warrant, dated March 7, 2024, between Avalon GloboCare Corp. and Mast Hill Fund, LP.* (incorporated by reference to Exhibit 10.6 of the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on May 31, 2024).
10.94
Securities Purchase Agreement, dated June 5, 2024, between Avalon Globocare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on June 5, 2024).
10.95
Security Agreement, dated June 5, 2024, among Avalon Globocare Corp., Avalon Healthcare System Inc., Avalon Laboratory Services, Inc., Avalon RT 9 Properties, LLC, Avactis Biosciences, Inc., Genexosome Technologies Inc., International Exosome Association LLC and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on June 5, 2024).
10.96
Senior
Secured Promissory Note, dated June 5, 2024, between Avalon Globocare Corp. and Mast Hill Fund, L.P. (incorporated by reference to
Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed with the SEC on June 5, 2024).
10.97
First Warrant, dated June 5, 2024, between Avalon Globocare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed with the SEC on June 5, 2024).
10.98
Second Warrant, dated June 5, 2024, between Avalon Globocare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.5 to the Registrant’s Current Report on Form 8-K filed with the SEC on June 5, 2024).
10.99
Mortgage and Security Agreement, dated June 5, 2024, between Avalon Globocare Corp. and Mast Hill Fund, L.P. (incorporated by reference to Exhibit 10.6 to the Registrant’s Current Report on Form 8-K filed with the SEC on June 5, 2024).
10.100
Consent, Acknowledgement, and Waiver Agreement, between the Company and Holder, dated as of December 15, 2024 (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed with the SEC on December 19, 2024).
10.101
Common Stock Purchase Warrant, between the Company and Holder, dated as of December 15, 2024 (incorporated by reference to Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed with the SEC on December 19, 2024).
10.102
Securities Purchase Agreement, between the Company and Holder, dated as of December 19, 2024 (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed with the SEC on December 26, 2024).
10.103
Redemption and Abandonment Agreement, dated February 26, 2025, by and among Avalon GloboCare Corp., Avalon Laboratory Services, Inc., Laboratory Services MSO, LLC, SCBC Holdings LLC, the Zoe Family Trust, Bryan Cox and Sarah Cox (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed with the SEC on February 27, 2025).
10.104
Form of Avalon Voting and Support Agreement (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed with the SEC on March 10, 2025).
10.105
Form of YOOV Voting and Support Agreement (incorporated by reference to Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed with the SEC on March 10, 2025).
10.106
Form of Lock-Up Agreement (incorporated by reference to Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed with the SEC on March 10, 2025).
79
19.1*
Insider Trading Policy.
21.1
List of Subsidiaries (incorporated by reference to Exhibit 21.1 of the Registration Statement on Form S-1/A filed with the Securities and Exchange Commission on July 20, 2018) .
23.1*
Consent of Independent Registered Public Accounting
Firm .
23.2*
Consent of Independent Registered Public Accounting Firm.
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification of Principal Executive Officer and 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
Avalon GloboCare Corp. Compensation Recovery Policy (incorporated by reference to Exhibit 97.1 to the registrant’s Annual Report on Form 10-K filed with the SEC on April 15, 2024).
101.INS*
Inline XBRL Instance Document.
101.SCH*
Inline XBRL Taxonomy Extension Schema Document.
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104*
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
* Filed herewith
** Furnished herewith.
† Management contract or compensatory
plan or arrangement.
ITEM 16. FORM 10-K SUMMARY.
None.
80
SIGNATURES
Pursuant to the requirements of Section 13 or
15(d) of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
AVALON GLOBOCARE CORP.
Dated: March 31, 2025
By:
/s/ David K. Jin
Name:
David K. Jin
Title:
Chief Executive Officer and President
(Principal Executive Officer)
Dated: March 31, 2025
By:
/s/ Luisa Ingargiola
Name:
Luisa Ingargiola
Title:
Chief Financial Officer
(Principal Financial and Accounting Officer)
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each
individual whose signature appears below constitutes and appoints David K. Jin and Luisa Ingargiola, and each of them individually, his
or her true and lawful attorney-in-fact, with full power of substitution and re-substitution for him or her and in his or her name, place
and stead, in any and all capacities to sign any and all amendments to the Annual Report on Form 10-K and to file the same, with all exhibits
thereto, and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all
that said attorney-in-fact or his substitute may lawfully do or cause to be done by virtue thereof.
In accordance with the Exchange Act, this report
has been signed below by the following persons on March 31, 2025, on behalf of the registrant and in the capacities indicated.
Signature
Title
/s/ David K. Jin
Chief Executive Officer, President and Director
David K. Jin
(Principal Executive Officer)
/s/ Luisa Ingargiola
Chief Financial Officer
Luisa Ingargiola
(Principal Financial and Accounting Officer)
/s/ Wenzhao Lu
Chairman of the Board of Directors
Wenzhao Lu
/s/ Steven A. Sanders
Director
Steven A. Sanders
/s/ Lourdes Felix
Director
Lourdes Felix
/s/ Wilbert J. Tauzin II
Director
Wilbert J. Tauzin II
/s/ William B. Stilley III
Director
William B. Stilley III
/s/ Tevi Troy
Director
Tevi Troy
81
AVALON GLOBOCARE CORP. AND SUBSIDIARIES
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2024 and 2023
CONTENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB No. 2738 ) F-2
Report of Independent Registered Public Accounting Firm (PCAOB No. 688) F-3
Consolidated Financial Statements:
Consolidated Balance Sheets - As of December 31, 2024 and 2023 F-4
Consolidated Statements of Operations and Comprehensive Loss - For the Years Ended December 31, 2024 and 2023 F-5
Consolidated Statements of Changes in Equity - For the Years Ended December 31, 2024 and 2023 F-6
Consolidated Statements of Cash Flows – For the Years Ended December 31, 2024 and 2023 F-7
Notes to Consolidated Financial Statements F-8
F- 1
REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM
To the Board of Directors and Stockholders of Avalon GloboCare
Corp.
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheets of Avalon GloboCare Corp. (the Company) as of December 31, 2024, and the related consolidated statements of operations
and comprehensive loss, changes in equity, and cash flows for the year ended December 31, 2024, and the related notes (collectively referred
to as the financial statements). We have audited the reverse stock split presentation for year-end December 31, 2023. We have audited
note 20 in regards to the presentation of segment information for the year-ended December 31, 2023. In our opinion, the financial statements
present fairly, in all material respects, the financial position of the Company as of December 31, 2024, and the results of its operations
and its cash flows for the year ended December 31, 2024, in conformity with accounting principles generally accepted in the United States
of America. The financial statements of Avalon GloboCare Corp., as of December 31, 2023, were audited by other auditors whose report dated
April 15, 2024, expressed an unqualified opinion on those financial statements.
Going Concern
The accompanying financial statements have been
prepared assuming the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has yet
to achieve profitable operations, has negative cash flows from operating activities, and is dependent upon future issuances of equity
or other financings to fund ongoing operations all of which raises substantial doubt about its ability to continue as a going concern.
Management’s plans regarding these matters are also described in Note 2. The financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audit. 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 audit 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 audit, we are required to obtain an understanding
of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audit 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 audit 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 audit provides a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is
a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the
audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially
challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the
financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions
on the critical audit matter or on the accounts or disclosures to which it relates.
Investments
As discussed in the notes to the financial statements,
the Company has an equity method investment in an unconsolidated subsidiary.
Auditing management’s valuation of the carrying value of the
investment involves significant judgements and estimates to determine the proper value.
To evaluate the appropriateness of the valuation of the investment,
we evaluated management’s significant judgments and estimates to determine that the investment is properly valued.
/s/ M&K CPAS, PLLC
We have served as the Company’s auditor since 2024.
The Woodlands, TX
March 31, 2025
F- 2
REPORT OF INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of
Avalon GloboCare Corp.
Opinion on the Financial Statements
We have audited,
before the effects of the adjustments to retrospectively apply the reverse stock split described in Note 3, and before the effects of
the retrospective adjustment for the adoption of ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures
(“ASU 2023-07”) discussed in Note 3 and Note 20 to the consolidated financial statements, the accompanying consolidated balance
sheet of Avalon GloboCare Corp. (the “Company”) as of December 31, 2023, and the related
consolidated statements of operations and comprehensive loss, changes in equity and cash flows the year ended December 31, 2023, and the
related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements, before the
effects of the adjustments to retrospectively apply the reverse stock split described in Note 3, and before the effects of the retrospective
adjustment for the adoption of ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU
2023-07”) discussed in Note 3 and Note 20 to the consolidated financial statements, present fairly, in all material respects, the
financial position of the Company as of December 31, 2023, and the results of its operations and its cash flows for the year ended December
31, 2023, in conformity with accounting principles generally accepted in the United States of America.
We were not engaged to audit, review, or apply
any procedures to the retrospective reverse stock split described in Note 3, or retrospective adjustment for the adoption of ASU 2023-07
discussed in Note 3 and Note 20 to the consolidated financial statements, and accordingly, we do not express an opinion or any other form
of assurance about whether such retrospective adjustments are appropriate and have been properly applied. Those retrospective adjustments
were audited by other auditors.
Explanatory Paragraph – Going Concern
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company has a significant
working capital deficiency, has incurred significant losses and needs to raise additional funds to meet its obligations and sustain its
operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in
regard tao these matters are also described in Note 2. The financial statements do not include any adjustments that might result from
the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. 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 audit 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 audit we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion.
Our audit 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 audit 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 audit provides a reasonable basis for our opinion.
/s/ Marcum llp
Marcum llp
We have served as the Company’s auditor from 2019 to 2024.
New York, NY
April 15, 2024
F- 3
AVALON GLOBOCARE CORP. AND SUBSIDIARIES
CONSOLIDATED BALANCE
SHEETS
December 31,
2024
2023
ASSETS
CURRENT ASSETS:
Cash
$ 2,856,309
$ 285,400
Rent receivable
80,829
197,473
Prepaid expense and other current assets
299,360
367,994
Total Current Assets
3,236,498
850,867
NON-CURRENT ASSETS:
Operating lease right-of-use assets, net
4,709
128,250
Property and equipment, net
12,912
38,083
Investment in real estate, net
7,022,721
7,191,404
Equity method investments, net
10,636,544
12,095,020
Other non-current assets
71,794
278,912
Total Non-current Assets
17,748,680
19,731,669
Total Assets
$ 20,985,178
$ 20,582,536
LIABILITIES AND EQUITY
CURRENT LIABILITIES:
Accrued professional fees
$ 611,462
$ 1,804,100
Accrued research and development fees
153,772
208,772
Accrued payroll liability and compensation
501,258
588,722
Accrued litigation settlement
373,450
450,000
Accrued liabilities and other payables
434,117
272,915
Accrued liabilities and other payables - related parties
732,916
206,458
Operating lease obligation
10,709
129,396
Advance from pending sale of noncontrolling interest - related party
3,108,106
485,714
Equity method investment payable
-
666,667
Derivative liability
127,545
24,796
Note payable, net
5,715,447
-
Convertible note payable, net
2,113,773
1,925,146
Total Current Liabilities
13,882,555
6,762,686
NON-CURRENT LIABILITIES:
Operating lease obligation - noncurrent portion
-
4,855
Note payable, net - noncurrent portion
-
5,596,219
Loan payable - related party
-
850,000
Total Non-current Liabilities
-
6,451,074
Total Liabilities
13,882,555
13,213,760
Commitments and Contingencies (Note 21)
EQUITY:
Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized;
Series A Convertible Preferred Stock, 9,000 shares issued and outstanding at December 31, 2024 and 2023 Liquidation preference $ 9 million at December 31, 2024
9,000,000
9,000,000
Series B Convertible Preferred Stock, 11,000 shares issued and outstanding at December 31, 2024 and 2023 Liquidation preference $ 11 million at December 31, 2024
11,000,000
11,000,000
Series C Convertible Preferred Stock, 3,500 shares issued and outstanding at December 31, 2024 Liquidation preference $ 3.5 million at December 31, 2024
3,500,000
-
Common stock, $ 0.0001 par value; 100,000,000 shares authorized; 1,445,979 shares issued and 1,442,512 shares outstanding at December 31, 2024; 736,769 shares issued and 733,302 shares outstanding at December 31, 2023
145
74
Additional paid-in capital
72,023,525
67,886,082
Less: common stock held in treasury, at cost; 3,467 shares at December 31, 2024 and 2023
( 522,500 )
( 522,500 )
Accumulated deficit
( 87,673,125 )
( 79,769,731 )
Statutory reserve
6,578
6,578
Accumulated other comprehensive loss
( 232,000 )
( 231,727 )
Total Avalon GloboCare Corp. stockholders’ equity
7,102,623
7,368,776
Noncontrolling interest
-
-
Total Equity
7,102,623
7,368,776
Total Liabilities and Equity
$ 20,985,178
$ 20,582,536
See accompanying notes to the consolidated financial statements
F- 4
AVALON GLOBOCARE CORP. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the Years Ended
December 31,
2024
2023
REAL PROPERTY RENTAL REVENUE
$ 1,333,403
$ 1,255,681
REAL PROPERTY OPERATING EXPENSES
1,065,574
1,017,493
REAL PROPERTY OPERATING INCOME
267,829
238,188
LOSS FROM EQUITY METHOD INVESTMENT - LAB SERVICES MSO
( 846,588 )
( 8,571,647 )
OTHER OPERATING EXPENSES:
Advertising and marketing expenses
237,671
1,666,721
Professional fees
1,822,105
3,076,477
Compensation and related benefits
1,431,328
1,768,449
Other general and administrative expenses
857,869
908,577
Total Other Operating Expenses
4,348,973
7,420,224
LOSS FROM OPERATIONS
( 4,927,732 )
( 15,753,683 )
OTHER (EXPENSE) INCOME
Interest expense - amortization of debt discount and debt issuance costs
( 1,411,042 )
( 544,010 )
Interest expense - other
( 983,486 )
( 773,780 )
Interest expense - related party
( 42,445 )
( 33,712 )
Debt modification charge
( 838,794 )
-
Change in fair value of derivative liability
374,365
188,374
Impairment of equity method investment - Epicon
-
( 454,679 )
Gain on debts extinguishment
-
682,979
Other expense
( 74,260 )
( 18,499 )
Total Other Expense, net
( 2,975,662 )
( 953,327 )
LOSS BEFORE INCOME TAXES
( 7,903,394 )
( 16,707,010 )
INCOME TAXES
-
-
NET LOSS
$ ( 7,903,394 )
$ ( 16,707,010 )
LESS: NET LOSS ATTRIBUTABLE TO NONCONTROLLING INTEREST
-
-
NET LOSS ATTRIBUTABLE TO AVALON GLOBOCARE CORP. COMMON SHAREHOLDERS
$ ( 7,903,394 )
$ ( 16,707,010 )
NET LOSS PER COMMON SHARE ATTRIBUTABLE TO AVALON GLOBOCARE CORP. COMMON SHAREHOLDERS:
Basic and diluted
$ ( 8.44 )
$ ( 23.80 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and diluted
936,614
701,932
COMPREHENSIVE LOSS:
NET LOSS
$ ( 7,903,394 )
$ ( 16,707,010 )
OTHER COMPREHENSIVE LOSS
Unrealized foreign currency translation loss
( 273 )
( 18,590 )
COMPREHENSIVE LOSS
( 7,903,667 )
( 16,725,600 )
LESS: COMPREHENSIVE LOSS ATTRIBUTABLE TO NONCONTROLLING INTEREST
-
-
COMPREHENSIVE LOSS ATTRIBUTABLE TO AVALON GLOBOCARE CORP. COMMON SHAREHOLDERS
$ ( 7,903,667 )
$ ( 16,725,600 )
See accompanying notes to the consolidated financial statements
F- 5
AVALON
GLOBOCARE CORP. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CHANGES IN EQUITY
For
the Years Ended December 31, 2024 and 2023
Avalon GloboCare Corp. Stockholders’ Equity
Series A
Preferred Stock Series B
Preferred Stock Series C
Preferred Stock Common Stock Treasury Stock Accumulated
Number of Number of Number of Number of Additional Paid-in Number of Accumulated Statutory Other
Comprehensive Noncontrolling Total
Shares Amount Shares Amount Shares Amount Shares Amount Capital Shares Amount Deficit Reserve Loss Interest Equity
Balance, January 1, 2023 9,000 $ 9,000,000 - $ - - $ - 667,572 $ 67 $ 65,950,661 ( 3,467 ) $ ( 522,500 ) $ ( 63,062,721 ) $ 6,578 $ ( 213,137 ) $ - $ 11,158,948
To correct shares issued for adjustments for 1:10 reverse split - - - - - - 3,333 - - - - - - - - -
Issuance of Series B Convertible Preferred Stock for equity method investment - - 11,000 11,000,000 - - - - - - - - - - - 11,000,000
Issuance of common stock as convertible note payable commitment fee - - - - - - 11,333 1 236,399 - - - - - - 236,400
Sale of common stock, net - - - - - - 30,442 3 414,393 - - - - - - 414,396
Issuance of common stock for services - - - - - - 24,089 3 999,652 - - - - - - 999,655
Stock-based compensation - - - - - - - - 284,977 - - - - - - 284,977
Foreign currency translation adjustment - - - - - - - - - - - - - ( 18,590 ) - ( 18,590 )
Net loss for the year - - - - - - - - - - - ( 16,707,010 ) - - - ( 16,707,010 )
Balance, December 31, 2023 9,000 9,000,000 11,000 11,000,000 - - 736,769 74 67,886,082 ( 3,467 ) ( 522,500 ) ( 79,769,731 ) 6,578 ( 231,727 ) - 7,368,776
Issuance of common stock as convertible note payable commitment fee - - - - - - 33,800 3 320,543 - - - - - - 320,546
Sale of common stock, net - - - - - - 281,843 28 2,544,283 - - - - - - 2,544,311
Issuance of common stock upon cashless exercise of stock warrants - - - - - - 42,381 4 ( 4 ) - - - - - - -
Issuance of common stock for services - - - - - - 145,153 15 530,335 - - - - - - 530,350
Reclassification of derivative liability to equity - - - - - - - - 2,354 - - - - - - 2,354
Sale of Series C Convertible Preferred Stock - - - - 3,500 3,500,000 - - - - - - - - - 3,500,000
Issuance of pre-funded warrants - - - - - - - - 688,794 - - - - - - 688,794
Stock-based compensation - - - - - - - - 51,159 - - - - - - 51,159
Shares issued for adjustments for 1:15 reverse split - - - - - - 206,033 21 ( 21 ) - - - - - - -
Foreign currency translation adjustment - - - - - - - - - - - - - ( 273 ) - ( 273 )
Net loss for the year - - - - - - - - - - - ( 7,903,394 ) - - - ( 7,903,394 )
Balance, December 31, 2024 9,000 $ 9,000,000 11,000 $ 11,000,000 3,500 $ 3,500,000 1,445,979 $ 145 $ 72,023,525 ( 3,467 ) $ ( 522,500 ) $ ( 87,673,125 ) $ 6,578 $ ( 232,000 ) $ - $ 7,102,623
See accompanying notes to the consolidated financial statements.
F- 6
AVALON GLOBOCARE CORP.
AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Years Ended
December 31,
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 7,903,394 )
$ ( 16,707,010 )
Adjustments to reconcile net loss to
net cash used in operating activities:
Depreciation
177,917
211,720
Change in straight-line rent receivable
46,607
10,496
Amortization of operating lease right-of-use asset
122,553
118,226
Stock-based compensation and service expense
521,509
1,179,761
Loss from equity method investments
846,588
8,589,822
Distribution of earnings from equity method investment
611,888
-
Impairment of equity method investment - Epicon
-
454,679
Amortization of debt issuance costs and debt discount
1,411,042
544,010
Change in fair market value of derivative liability
( 374,365 )
( 188,374 )
Impairment of laboratory equipment
111,033
-
Debt modification charge
688,794
-
Gain on debts extinguishment
-
( 682,979 )
Changes in operating assets and liabilities:
Rent receivable
130,739
( 46,220 )
Security deposit
-
396
Deferred leasing costs
33,402
33,402
Prepaid expense and other assets
( 91,496 )
411
Accrued liabilities and other payables
( 1,165,418 )
( 16,601 )
Accrued liabilities and other payables - related parties
( 14,051 )
106,458
Operating lease obligation
( 122,553 )
( 112,915 )
NET CASH USED IN OPERATING ACTIVITIES
( 4,969,205 )
( 6,504,718 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
-
( 22,159 )
Payment for equity interest purchase
( 100,000 )
-
NET CASH USED IN INVESTING ACTIVITIES
( 100,000 )
( 22,159 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from loan payable - related party
-
850,000
Repayments of loan payable - related party
( 400,000 )
-
Proceeds from issuance of convertible debts and warrants
3,367,750
2,565,000
Payments of convertible debts issuance costs
( 282,700 )
( 327,200 )
Repayments of convertible debts
( 3,388,222 )
( 300,000 )
Proceeds from issuance of balloon promissory note
-
1,000,000
Payments of balloon promissory note issuance costs
-
( 64,436 )
Advance from pending sale of noncontrolling interest in subsidiary
2,122,392
485,714
Proceeds from equity offering
2,857,852
635,391
Disbursements for equity offering costs
( 138,405 )
( 19,132 )
Proceeds from issuance of convertible preferred stock
3,500,000
-
NET CASH PROVIDED BY FINANCING ACTIVITIES
7,638,667
4,825,337
EFFECT OF EXCHANGE RATE ON CASH
1,447
( 3,970 )
NET INCREASE (DECREASE) IN CASH
2,570,909
( 1,705,510 )
CASH - beginning of year
285,400
1,990,910
CASH - end of year
$ 2,856,309
$ 285,400
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for:
Interest
$ 1,088,512
$ 718,753
NON-CASH INVESTING AND FINANCING ACTIVITIES:
Common stock issued for accrued liabilities
$ 60,000
$ 164,871
Reclassification of advances for equity interest purchase to equity method investment
$ -
$ 9,000,000
Series B Convertible Preferred Stock issued related to equity method investment
$ -
$ 11,000,000
Accrued purchase price related to equity method investment
$ -
$ 666,667
Warrants issued as convertible notes payable finder’s fee
$ 40,900
$ 16,977
Warrants issued with convertible notes payable recorded as debt discount
$ 438,568
$ 196,193
Common stock issued as convertible notes payable commitment fee
$ 320,546
$ 236,400
Deferred financing costs in accrued liabilities
$ -
$ 202,892
Equity method investment payable paid by a related party
$ 566,667
$ -
Reclassification of deferred offering costs
$ 175,136
$ -
Settlement of derivative liability
$ 2,354
$ -
Reclassification of related party loan payable and accrued expenses to advance from related party
$ 500,000
$ -
Issuance of common stock upon cashless exercise of stock warrants
$ 4
$ -
Shares issued for adjustments for 1:15 reverse split
$ 21
$ -
See accompanying notes to the consolidated financial statements.
F- 7
AVALON GLOBOCARE CORP.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – ORGANIZATION AND NATURE
OF OPERATIONS
Avalon GloboCare Corp. (the “Company”
or “ALBT”) was incorporated under the laws of the State of Delaware on July 28, 2014.
The Company is a commercial-stage company dedicated to developing and
delivering precision diagnostic consumer products. The Company is currently marketing the Keto Air breathalyzer device and plans to develop
additional diagnostic uses of the breathalyzer technology. The Company also provided laboratory services in 2024 and 2023, offering a
broad portfolio of diagnostic tests, including drug testing, toxicology, and a broad array of test services, from general bloodwork to
anatomic pathology, and urine toxicology.
On May 18, 2015, Avalon Healthcare System, Inc.
(“AHS”) was incorporated under the laws of the State of Delaware. AHS owns 100 % of the capital stock of Avalon (Shanghai)
Healthcare Technology Co., Ltd. (“Avalon Shanghai”), which is a wholly foreign-owned enterprise organized under the laws of
the People’s Republic of China (“PRC”). Avalon Shanghai was incorporated on April 29, 2016, and was engaged in medical
related consulting services for customers. Due to the winding down of the medical related consulting services in 2022, the Company decided
to cease all operations of Avalon Shanghai and no longer has any material revenues or expenses in Avalon Shanghai. As a result, Avalon
Shanghai is no longer an operating entity.
On February 7, 2017, the Company formed Avalon
RT 9 Properties, LLC (“Avalon RT 9”), a New Jersey limited liability company. On May 5, 2017, Avalon RT 9 purchased a real
property located in Township of Freehold, County of Monmouth, State of New Jersey, having a street address of 4400 Route 9 South, Freehold,
NJ 07728. This property was purchased to serve as the Company’s world-wide headquarters for all corporate administration and operations.
In addition, the property generates rental income. Avalon RT 9 owns this office building. Avalon RT 9’s business consists of the
ownership and operation of the income-producing real estate property in New Jersey. As of December 31, 2024, the occupancy rate of the
building is 98.5 %.
On July 18, 2018, the Company formed a wholly
owned subsidiary, Avactis Biosciences Inc. (“Avactis”), a Nevada corporation, which is a patent holding company. Commencing
on April 6, 2022, the Company owns 60 % of Avactis and Arbele Biotherapeutics Limited (“Arbele Biotherapeutics”) owns 40 % of
Avactis. Avactis owns 100 % of the capital stock of Avactis Nanjing Biosciences Ltd., a company incorporated in the PRC on May 8, 2020
(“Avactis Nanjing”), which only owns a patent and is not considered an operating entity. Currently, Avactis and Avactis Nanjing
are dormant and are in process of being dissolved.
On October 14, 2022, the Company formed a wholly
owned subsidiary, Avalon Laboratory Services, Inc. (“Avalon Lab”), a Delaware company. On February 9, 2023, Avalon Lab purchased
40 % of the issued and outstanding equity interests of Laboratory Services MSO, LLC, a private limited company formed under the laws of
the State of Delaware on September 6, 2019 (“Lab Services MSO”), and its subsidiaries. Lab Services MSO, through its subsidiaries,
is engaged in providing laboratory testing services. During 2025, to preserve cash, the Company entered into discussions with Lab Services
MSO for the potential redemption of our investment and on February 26, 2025, Lab Services MSO redeemed the 40 % equity interest in Lab
Services MSO held by Avalon Lab. See Note 22 – Subsequent Events - Redemption Agreement.
On May 1,
2024, the Company formed a wholly owned subsidiary, Q&A Distribution LLC (“Q&A Distribution”), a Texas company. Q&A
Distribution is engaged in distribution of KetoAir device.
F- 8
AVALON GLOBOCARE CORP. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – ORGANIZATION AND NATURE OF
OPERATIONS (continued)
Details of the Company’s subsidiaries which
are included in these consolidated financial statements as of December 31, 2024 are as follows:
Name of Subsidiary Place and date of
Incorporation Percentage of
Ownership Principal Activities
Avalon Healthcare System, Inc. (“AHS”) Delaware
May 18, 2015 100 % held by ALBT Holding company for payroll and other expenses
Avalon RT 9 Properties LLC (“Avalon RT 9”) New Jersey
February 7, 2017 100 % held by ALBT Owns and operates an income-producing real property and holds and manages the corporate headquarters
Avalon (Shanghai) Healthcare Technology Co., Ltd. (“Avalon Shanghai”) PRC
April 29, 2016 100 % held by AHS Is not considered an operating entity
Genexosome Technologies Inc. (“Genexosome”) Nevada
July 31, 2017 60 % held by ALBT No current activities to report, dormant
Avactis Biosciences Inc. (“Avactis”) Nevada
July 18, 2018 60 % held by ALBT Dormant, is in process of being dissolved
Avactis Nanjing Biosciences Ltd. (“Avactis Nanjing”) PRC
May 8, 2020 100 % held by Avactis Dormant, is in process of being dissolved
Avalon Laboratory Services, Inc. (“Avalon Lab”) Delaware
October 14, 2022 100 % held by ALBT Laboratory holding company with a 40% membership interest in Lab Services MSO (1)
Q&A Distribution LLC (“Q&A Distribution”) Texas
May 1, 2024 100 % held by ALBT Distributes KetoAir device
(1) On February 26, 2025, the Company and Lab Services MSO entered into a Redemption and Abandonment Agreement,
whereby Lab Services MSO redeemed the 40 % equity interest in Lab Services MSO held by the Company.
NOTE
2 – BASIS OF PRESENTATION AND GOING CONCERN CONDITION
Basis of Presentation
The accompanying consolidated financial statements
and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S.
GAAP”) and with the rules and regulations of the U.S. Securities and Exchange Commission for financial information.
The Company’s consolidated financial statements
include the accounts of the Company and its subsidiaries. All significant intercompany accounts and transactions have been eliminated
in consolidation.
F- 9
AVALON GLOBOCARE CORP. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2 – BASIS OF PRESENTATION AND GOING CONCERN CONDITION (continued)
Going Concern
The Company is a commercial-stage company dedicated to developing and
delivering precision diagnostic consumer products. The Company is currently marketing the Keto Air breathalyzer device and plans to develop
additional diagnostic uses of the breathalyzer technology. In addition, the Company owns commercial real estate that houses its headquarters
in Freehold, New Jersey. These consolidated financial statements have been prepared assuming that the Company will continue as a going
concern, which contemplates, among other things, the realization of assets and the satisfaction of liabilities in the normal course of
business.
As reflected in the accompanying consolidated
financial statements, the Company had a working capital deficit of approximately $ 10,646,000 at December 31, 2024 and had incurred recurring
net losses and generated negative cash flow from operating activities of approximately $ 7,903,000 and $ 4,969,000 for the year ended December
31, 2024, respectively.
The Company has a limited operating history and
its continued growth is dependent upon the continuation of generating rental revenue from its income-producing real estate property in
New Jersey and obtaining additional financing to fund future obligations and pay liabilities arising from normal business operations.
In addition, the current cash balance cannot be projected to cover the operating expenses for the next twelve months from the release
date of this report. These matters raise substantial doubt about the Company’s ability to continue as a going concern. The ability
of the Company to continue as a going concern is dependent on the Company’s ability to raise additional capital, implement its business
plan, and generate significant revenue. There are no assurances that the Company will be successful in its efforts to generate significant
revenue, maintain sufficient cash balance or report profitable operations or to continue as a going concern. The Company plans on raising
capital through the sale of equity to implement its business plan. However, there is no assurance these plans will be realized and that
any additional financings will be available to the Company on satisfactory terms and conditions, if any.
The accompanying consolidated financial statements
do not include any adjustments related to the recoverability or classification of asset-carrying amounts or the amounts and classification
of liabilities that may result should the Company be unable to continue as a going concern.
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Use of Estimates
The preparation
of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements
and the reported amounts of revenues and expenses during the reporting period. Changes in these estimates and assumptions may have a material
impact on the consolidated financial statements and accompanying notes. Making estimates requires management to exercise significant judgment.
It is at least reasonably possible that the estimate of the effect of a condition, situation or set of circumstances that existed at the
date of the financial statements, which management considered in formulating its estimate, could change in the near term due to one or
more future confirming events. Accordingly, the actual results could differ significantly from those estimates.
Significant estimates during the years ended December
31, 2024 and 2023 include the useful life of investment in real estate and intangible assets, the assumptions used in assessing impair
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