Item 2. Management’s Discussion and Analysis
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Safe
Harbor Statement under the Private Securities Litigation Reform Act of 1995: This Quarterly Report on Form 10-Q contains
forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under
Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include statements with respect to our beliefs,
plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and
unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance
or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking
statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can
identify these forward-looking statements through our use of words such as “may,” “will,” “can,”
“anticipate,” “assume,” “should,” “indicate,” “would,” “believe,”
“contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,”
“point to,” “project,” “predict,” “could,” “intend,” “target,”
“potential” and other similar words and expressions of the future. Accordingly, factors that may affect our results include,
but are not limited to:
●
our dependence on product
candidates that are still in an early development stage;
●
our ability to successfully
complete research and further development, including preclinical and clinical studies;
●
our anticipated timing
for preclinical development, regulatory submissions, commencement and completion of clinical trials and product approvals;
●
our ability to negotiate
strategic partnerships, where appropriate, for our product candidates;
●
our ability to manage multiple
clinical trials for a variety of product candidates at different stages of development;
●
the cost, timing, scope
and results of ongoing preclinical and clinical testing;
●
our expectations of the
attributes of our product and development candidates, including pharmaceutical properties, efficacy, safety and dosing regimens;
●
the cost, timing and uncertainty
of obtaining regulatory approvals for our product candidates;
●
the availability, cost,
delivery and quality of clinical management services provided by our clinical research organization partners;
●
the availability, cost,
delivery and quality of clinical and commercial-grade materials produced by our own manufacturing facility or supplied by contract
manufacturers, suppliers and partners;
●
our ability to commercialize
our product candidates and the growth of the markets for those product candidates;
●
our ability to develop
and commercialize products before competitors that are superior to the alternatives developed by such competitors;
●
our ability to develop
technological capabilities, including identification of novel and clinically important targets, exploiting our existing technology
platforms to develop new product candidates and expand our focus to broader markets for our existing targeted therapeutics;
●
our ability to raise sufficient
capital to fund our preclinical and clinical studies and to meet our long-term liquidity needs, on terms acceptable to us, or at
all. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may have to delay or discontinue the
development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, discontinue or delay our commercial
manufacturing efforts, discontinue or delay our efforts to expand into additional indications for our product candidates, license
out programs earlier than expected, raise funds at significant discount or on other unfavorable terms, if at all, or sell all or
part of our business;
●
our ability to protect
our intellectual property rights and our ability to avoid intellectual property litigation, which can be costly and divert management
time and attention;
●
our ability to develop
and commercialize products without infringing upon the intellectual property rights of third parties;
31
●
heightened competition
from commercial clinical testing companies, IDNs, physicians and others;
●
increased pricing pressure
from customers, including payers and patients, and changing relationships with customers, payers, suppliers or strategic partners;
●
impact of changes in payment
mix, including increased patient financial responsibility and any shift from fee-for-service to discounted, capitated or bundled
fee arrangements;
●
adverse actions by the
government, including healthcare reform that focuses on reducing healthcare costs but does not recognize the value and importance
to healthcare of clinical testing or innovative solutions, unilateral reduction of fee schedules payable to us, unilateral recoupment
of amounts allegedly owed and competitive bidding;
●
the impact of increased
prior authorization programs;
●
adverse results from pending
or future government investigations, lawsuits or private actions, which include in particular, monetary damages, loss or suspension
of licenses or criminal penalties;
●
the impact of the COVID-19
pandemic on our business or on the economy generally; and
●
a decline in economic conditions,
including the impact of an inflationary environment.
All
forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue
reliance on any forward-looking statements, which speak only as of the filing date of this Quarterly Report on Form 10-Q or the date
of the document incorporated by reference into this Quarterly Report on Form 10-Q. We have no obligation, and expressly disclaim any
obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events
or otherwise. We have expressed our expectations, beliefs and projections in good faith, and we believe they have a reasonable basis.
However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.
The
following discussion and analysis of our financial condition and results of operations for the three and nine months ended September
30, 2024 and 2023 should be read in conjunction with our condensed consolidated financial statements and related notes to those condensed
consolidated financial statements that are included elsewhere in this Quarterly Report on Form 10-Q.
Overview
We
are a commercial stage company dedicated to developing and delivering innovative, transformative, precision diagnostics and clinical
laboratory services. We are working toward establishing a leading role in the innovation of diagnostic testing, utilizing proprietary
technology to deliver precise, genetics-driven results. As a first step into the laboratory market, we completed an acquisition of a
40% membership interest in Laboratory Services MSO, LLC (“Lab Services MSO”), which closed in February 2023.
We
have the following areas of focus:
Laboratory
Acquisitions
We
have embarked on a laboratory rollup strategy focused on forming joint ventures and acquiring laboratories that are accretive to our
commercial strategy. As a first step, in February 2023, we acquired a 40% membership interest in Lab Services MSO.
●
Lab Services MSO is focused
on delivering high quality services related to toxicology and wellness testing and provides 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.
Specific capabilities include STAT blood testing, qualitative drug screening, genetic testing, urinary testing, and sexually transmitted
disease testing. The panels that Lab Services MSO tests for are thyroid panel, comprehensive metabolic panel, kidney profile, liver
function tests, and other individual tests. Through Lab Services MSO, we use fast, accurate, and efficient equipment to provide practitioners
with the tools to quickly determine if a patient is following their designated treatment plan. In most instances, we are able to
provide a practitioner with qualitative drug class results the same day the sample is received. Lab Services MSO provides a menu
of extensive chemistry tests that physicians can use to obtain information to better treat their patients and maintain their overall
wellness. Lab Services MSO has developed a premier reputation for customer service and fast turnaround times.
●
Lab Services MSO is also
focused on commercialization of genetic-based proprietary testing. The first area of focus in this area is confirmatory genetic testing
during toxicology screening and genetic testing to screen for addictive propensity. Lab Services MSO laboratory plans to focus on
diagnostic testing utilizing proprietary technology to deliver precise genetic driven results.
●
In the third quarter of
2023, Lab Services MSO acquired Merlin Technologies, Inc., which is a medical equipment retail company.
32
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.
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 plan to 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 and expect initial sales to occur in the United States.
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
The
Company is a commercial stage company dedicated to developing and delivering innovative, transformative, precision diagnostics and clinical
laboratory services. The Company is working to establish a leading role in the innovation of diagnostic testing, utilizing proprietary
technology to deliver precise, genetics-driven results. The Company also provides laboratory services through its 40% equity investment
in Lab Services MSO, 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.
In
addition, we own commercial real estate that houses our headquarters in Freehold, New Jersey. We also have income from equity method
investment through our 40% interest in Lab Services MSO. These condensed 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 condensed consolidated financial statements,
we had working capital deficit of approximately $10,935,000 at September 30, 2024 and had incurred recurring net losses and generated
negative cash flow from operating activities of approximately $5,179,000 and $3,891,000 for the nine months ended September 30, 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 income from equity method investment through our 40% interest in Lab Services MSO 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 Quarterly
Report on Form 10-Q. 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.
33
The
accompanying condensed 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.
Critical
Accounting Policies
Use
of Estimates
The
preparation of the condensed 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 condensed
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 three and nine months ended September
30, 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 Company
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 for the nine months ended September 30, 2024.
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 condensed 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.
34
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.
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 condensed consolidated financial statements accompanying this Quarterly Report on Form 10-Q.
RESULTS
OF OPERATIONS
Comparison
of Results of Operations for the Three and Nine Months Ended September 30, 2024 and 2023
Real
Property Rental Revenue
For
the three months ended September 30, 2024, we had real property rental revenue of $345,159, as compared to $331,290 for the three months
ended September 30, 2023, an increase of $13,869, or 4.2%. For the nine months ended September 30, 2024, we had real property rental
revenue of $987,634, as compared to $934,360 for the nine months ended September 30, 2023, an increase of $53,274, or 5.7%. The increase
was primarily attributable to the increase in the number of tenants occupying the building in the three and nine months ended September
30, 2024 as compared to the three and nine months ended September 30, 2023. We expect that our revenue from real property rent will remain
at its current quarterly 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 three months ended September 30, 2024, our real property operating expenses amounted to $245,528, as compared to $288,083 for the
three months ended September 30, 2023, a decrease of $42,555, or 14.8%. The decrease was primarily due to a decrease in repairs and maintenance
fee of approximately $30,000, and a decrease in utilities of approximately $14,000, offset by an increase in other miscellaneous items
of approximately $1,000.
For
the nine months ended September 30, 2024, our real property operating expenses amounted to $794,142, as compared to $781,931 for the
nine months ended September 30, 2023, an increase of $12,211, or 1.6%. The increase was primarily due to an increase in utilities of
approximately $13,000, offset by a decrease in other miscellaneous items of approximately $1,000.
Real
Property Operating Income
Our
real property operating income for the three months ended September 30, 2024 was $99,631, representing an increase of $56,424, or 130.6%,
as compared to $43,207 for the three months ended September 30, 2023. The increase was primarily attributable to an increase in real
property rental revenue and a decrease in real property operating expenses as described above. Our real property operating income for
the nine months ended September 30, 2024 was $193,492, representing an increase of $41,063, or 26.9%, as compared to $152,429 for the
nine months ended September 30, 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 quarterly level with minimal increase in the near future.
(Loss)
income from Equity Method Investment – Lab Services MSO
For
the three months ended September 30, 2024, we had loss from our investment in Lab Services MSO of $447,909, which consists of our share
of Lab Services MSO’s net loss of $21,597, and amortization of identifiable intangible assets acquired from Lab Services MSO acquisition
of $166,733, 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.
35
For
the three months ended September 30, 2023, we had income from our investment in Lab Services MSO of $354,500, which consists of our share
of Lab Services MSO’s net income of $558,244 and amortization of identifiable intangible assets acquired from Lab Services MSO
acquisition of $203,744.
For
the nine months ended September 30, 2024, we had loss from our investment in Lab Services MSO of $669,777, which consists of our share
of Lab Services MSO’s net income of $90,001, and amortization of identifiable intangible assets acquired from Lab Services MSO
acquisition of $500,199, 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 nine months ended September 30, 2023, we had income from our investment in Lab Services MSO of $370,060, which consists of our share
of Lab Services MSO’s net income of $913,378 and amortization of identifiable intangible assets acquired from Lab Services MSO
acquisition of $543,318.
We
purchased 40% of Lab Services MSO on February 9, 2023. In the third quarter of 2023, Lab Services MSO acquired Merlin Technologies, Inc.
which is a medical equipment retail company. Lab Services MSO has also opened a new laboratory, Veritas Laboratories LLC (“Veritas”).
Veritas is a CLIA-certified and COLA-accredited laboratory located in Scottsdale, Arizona that offers a wide range of high-quality testing,
including drug testing, genetic testing, urinary testing and COVID-19 PCR testing. We expect to continue to receive income from our investment
in Lab Services MSO in the near future.
Other
Operating Expenses
For
the three and nine months ended September 30, 2024 and 2023, other operating expenses consisted of the following:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Advertising and marketing expenses
$ 144,734
$ 437,750
$ 252,394
$ 1,634,720
Professional fees
303,332
435,144
1,190,125
2,659,895
Compensation and related benefits
343,360
469,959
1,054,164
1,375,637
Miscellaneous taxes
12,000
8,960
266,498
49,291
Research and development
-
-
-
110,160
Directors and officers’ liability insurance premium
38,768
72,835
177,381
280,438
Travel and entertainment
33,789
61,631
78,198
179,583
Rent and related utilities
15,764
15,338
46,770
48,599
Other general and administrative
29,936
37,226
75,571
146,997
$ 921,683
$ 1,538,843
$ 3,141,101
$ 6,485,320
● For
the three months ended September 30, 2024, advertising
and marketing expenses decreased by $293,016, or 66.9%, as compared to the three months ended
September 30, 2023. For the nine months ended September 30, 2024, advertising and marketing
expenses decreased by $1,382,326, or 84.6%, as compared to the nine months ended September
30, 2023. The decrease was primarily due to decreased advertising activities in the three
and nine months ended September 30, 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 three
months ended September 30, 2024, professional fees decreased by $131,812, or 30.3%, as compared
to the three months ended September 30, 2023, which was primarily attributable to a decrease
in legal service fees of approximately $155,000, mainly due to the decreased legal services
related to our acquisition of Lab Services MSO, offset by an increase in other miscellaneous
items of approximately $23,000. For the nine months ended September 30, 2024, professional
fees decreased by $1,469,770, or 55.3%, as compared to the nine months ended September 30,
2023, which was primarily attributable to a decrease in consulting fees of approximately
$547,000, 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 $126,000, due
to the decreased audit services related to our acquisition of Lab Services MSO, a decrease
in accounting fees of approximately $454,000, mainly due to the decreased accounting services
related to our acquisition of Lab Services MSO, a decrease in legal service fees of approximately
$409,000, mainly due to the decreased legal services related to our acquisition of Lab Services
MSO, and a decrease in other miscellaneous items of approximately $61,000, offset by an increase
in valuation fee for our equity method investment on Lab Services MSO of $127,000. We expect
that our professional fees will likely remain at their current quarterly level with minimal
increase in the near future.
36
● For
the three months ended September 30, 2024, compensation and related benefits decreased by
$126,599, or 26.9%, as compared to the three months ended September 30, 2023. For the nine
months ended September 30, 2024, compensation and related benefits decreased by $321,473,
or 23.4%, as compared to the nine months ended September 30, 2023. The decrease was primarily
attributable to the decreased compensation for two of our named 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 three months ended September 30, 2024, miscellaneous taxes increased by $3,040, or 33.9%,
as compared to the three months ended September 30, 2023. For the nine months ended September
30, 2024, miscellaneous taxes increased by $217,207, or 440.7%, as compared to the nine months
ended September 30, 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 three months ended September 30, 2024 and 2023, we did not incur any research and development
activity. For the nine months ended September 30, 2024, research and development expenses
decreased by $110,160, or 100.0%, as compared to the nine months ended September 30, 2023.
In the nine months ended September 30, 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.
● For
the three months ended September 30, 2024, Directors and Officers’ Liability Insurance
premium decreased by $34,067, or 46.8%, as compared to the three months ended September 30,
2023. For the nine months ended September 30, 2024, Directors and Officers’ Liability
Insurance premium decreased by $103,057, or 36.7%, as compared to the nine months ended September
30, 2023. The decrease was mainly due to our switching to a different insurance provider,
resulting in a lower premium.
● For the
three months ended September 30, 2024, travel and entertainment expense decreased by $27,842,
or 45.2%, as compared to the three months ended September 30, 2023. For the nine months ended
September 30, 2024, travel and entertainment expense decreased by $101,385, or 56.5%, as
compared to the nine months ended September 30, 2023. The decrease was mainly due to decreased
business travel activities in the three and nine months ended September 30, 2024 as compared
to the corresponding periods in 2023.
● For
the three months ended September 30, 2024, rent and
related utilities expenses increased by $426, or 2.8%, as compared to the three months ended
September 30, 2023. For the nine months ended September 30, 2024, rent and related utilities
expenses decreased by $1,829, or 3.8%, as compared to the nine months ended September 30,
2023. The decrease was attributable to decreased rental rate in the nine months ended September
30, 2024.
● Other
general and administrative expenses mainly consisted
of NASDAQ listing fee, office supplies, and other miscellaneous items. For the three months
ended September 30, 2024, other general and administrative expenses decreased by $7,290,
or 19.6%, as compared to the three months ended September 30, 2023, due to our efforts at
stricter controls on corporate expenditure. For the nine months ended September 30, 2024,
other general and administrative expenses decreased by $71,426, or 48.6%, as compared to
the nine months ended September 30, 2023, which was mainly attributable to a decrease in
fees paid to government agencies and Financial Industry Regulatory Authority of approximately
$31,000, a decrease in office supplies of approximately $16,000, and a decrease in other
miscellaneous items of approximately $24,000 due to our efforts at stricter controls on corporate
expenditure.
Loss
from Operations
As
a result of the foregoing, for the three months ended September 30, 2024, loss from operations amounted to $1,269,961, as compared to
$1,141,136 for the three months ended September 30, 2023, representing an increase of $128,825, or 11.3%.
As
a result of the foregoing, for the nine months ended September 30, 2024, loss from operations amounted to $3,617,386, as compared to
$5,962,831 for the nine months ended September 30, 2023, representing a decrease of $2,345,445, or 39.3%.
Other
(Expense) Income
Other
(expense) income mainly includes third party and related party interest expense, change in fair value of derivative liability, impairment
of equity method investment on Epicon, and other miscellaneous expense.
Other expense, net, totaled $409,239 for the three months ended September
30, 2024, as compared to $343,939 for the three months ended September 30, 2023, an increase of $65,300, or 19.0%, which was primarily
attributable to an increase in third party interest expense of approximately $108,000, mainly driven by the increase in amortization of
debt discount and debt issuance costs of approximately $80,000 and the increased interest expense of approximately $28,000 from third
party debts, a decrease in other income of approximately $39,000, offset by an increase in gain from change in fair value of derivative
liability of approximately $82,000.
37
Other expense, net, totaled $1,561,353 for the nine months ended September
30, 2024, as compared to $1,189,045 for the nine months ended September 30, 2023, an increase of $372,308, or 31.3%, which was primarily
attributable to an increase in third party interest expense of approximately $1,024,000, mainly driven by the increase in amortization
of debt discount and debt issuance costs of approximately $825,000 and the increased interest expense of approximately $199,000 from third
party debts, an increase in interest expense – related party of approximately $9,000, 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 $252,000, a decrease in impairment
of equity method investment on Epicon of approximately $464,000.
Income
Taxes
We
did not have any income taxes expense for the three and nine months ended September 30, 2024 and 2023 since we incurred losses in these
periods.
Net
Loss
As a result of the factors described
above, our net loss was $1,679,200 for the three months ended September 30, 2024, as compared to $1,485,075 for the three months ended
September 30, 2023, an increase of $194,125, or 13.1%.
As a result of the factors described
above, our net loss was $5,178,739 for the nine months ended September 30, 2024, as compared to $7,151,876 for the nine months ended September
30, 2023, a decrease of $1,973,137, or 27.6%.
Net
Loss Attributable to Avalon GloboCare Corp. Common Shareholders
The net
loss attributable to our common shareholders was $1,679,200, or $1.82 per share (basic and diluted), for the three months ended September
30, 2024, as compared to $1,485,075, or $2.06 per share (basic and diluted), for the three months ended September 30, 2023, an increase
of $194,125, or 13.1%.
The net loss attributable to
our common shareholders was $5,178,739, or $6.45 per share (basic and diluted), for the nine months ended September 30, 2024, as compared
to $7,151,876, or $10.34 per share (basic and diluted), for the nine months ended September 30, 2023, a decrease of $1,973,137, or 27.6%.
Foreign
Currency Translation Adjustment
Our
reporting currency is the U.S. dollar. The functional currency of our parent company, AHS, Avalon RT 9, and Avalon Lab 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 gain of $3,043 and a foreign currency translation loss of $8,685 for
the three months ended September 30, 2024 and 2023, respectively. As a result of foreign currency translations, which are a non-cash
adjustment, we reported a foreign currency translation gain of $2,829 and a foreign currency translation loss of $16,026 for the nine
months ended September 30, 2024 and 2023, respectively. This non-cash gain/loss had the effect of decreasing/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 $1,676,157 and $1,493,760 for the three months ended September 30, 2024 and 2023, respectively.
As a result of our foreign currency translation adjustment, we had
comprehensive loss of $5,175,910 and $7,167,902 for the nine months ended September 30, 2024 and 2023, respectively.
38
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 and income from equity method investment through our equity interest in Lab Services MSO, 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 Quarterly Report on Form 10-Q. 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 September 30, 2024 and December 31, 2023, we had a cash balance of approximately $1,024,000
and $285,000, respectively. These funds are kept in financial institutions located as follows:
Country:
September 30, 2024
December 31, 2023
United States
$ 1,018,477
99.4 %
$ 280,197
98.2 %
China
5,720
0.6 %
5,203
1.8 %
Total cash
$ 1,024,197
100.0 %
$ 285,400
100.0 %
The
following table sets forth a summary of changes in our working capital deficit from December 31, 2023 to September 30, 2024:
September 30,
December 31,
Changes in
2024
2023
Amount
Percentage
Working capital deficit:
Total current assets
$ 1,396,821
$ 850,867
$ 545,954
64.2 %
Total current liabilities
12,332,173
6,762,686
5,569,487
82.4 %
Working capital deficit
$ (10,935,352 )
$ (5,911,819 )
$ (5,023,533 )
85.0 %
Our working capital deficit increased by $5,023,533 to $10,935,352
at September 30, 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 $120,000 driven by collection efforts in the nine months ended September 30, 2024, an increase in
accrued liabilities and other payables of $288,000 mainly due to the increase in accrued Delaware state franchise tax in the nine months
ended September 30, 2024, an increase in accrued liabilities and other payables – related parties of approximately $507,000 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 $2,022,000 resulting from advance received in connection with the membership
interest purchase agreement entered into in November 2023 in the nine months ended September 30, 2024, an increase in note payable, net,
of approximately $4,719,000, which was attributable to the reclassification of note payable from non-current to current, and an increase
in convertible note payable, net, of approximately $211,000, offset by an increase in cash of approximately $739,000, a decrease in accrued
professional fees of approximately $1,191,000 resulting from payments made to our professional service providers in the nine months ended
September 30, 2024, a decrease in accrued payroll liability and compensation of approximately $201,000, 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 nine months ended September 30, 2024.
Because
the exchange rate conversion is different for the condensed consolidated balance sheets and the condensed consolidated statements of
cash flows, the changes in assets and liabilities reflected on the condensed consolidated statements of cash flows are not necessarily
identical with the comparable changes reflected on the condensed consolidated balance sheets.
Cash
Flows for the Nine Months Ended September 30, 2024 Compared to the Nine Months Ended September 30, 2023
The
following table summarizes the key components of our cash flows for the nine months ended September 30, 2024 and 2023:
Nine Months Ended
September 30,
2024
2023
Net cash used in operating activities
$ (3,890,993 )
$ (5,708,402 )
Net cash used in investing activities
(100,000 )
(22,171 )
Net cash provided by financing activities
4,726,942
4,091,323
Effect of exchange rate on cash
2,848
(9,889 )
Net increase (decrease) in cash
$ 738,797
$ (1,649,139 )
39
Net cash flow used in operating
activities for the nine months ended September 30, 2024 was $3,890,993, which primarily reflected our consolidated net loss of approximately
$5,179,000, and the non-cash items adjustment, primarily consisting of change in fair market value of derivative liability of approximately
$381,000, and the changes in operating assets and liabilities, primarily consisting of a decrease in accrued liabilities and other payables
of approximately $1,176,000 resulting from payments made to our vendors in the nine months ended September 30, 2024, offset by a decrease
in rent receivable of approximately $132,000 driven by our collection efforts, and the non-cash items adjustment, primarily consisting
of depreciation of approximately $133,000, stock-based compensation and service expense of approximately $255,000, loss from equity method
investment of approximately $670,000 which was mainly attributable to the amortization of
identifiable intangible assets acquired from Lab Services MSO acquisition of approximately $500,000 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, and amortization of debt issuance costs and debt discount of approximately $1,115,000.
Net
cash flow used in operating activities for the nine months ended September 30, 2023 was $5,708,402, which primarily reflected our consolidated
net loss of approximately $7,152,000, and the changes in operating assets and liabilities, primarily consisting of a decrease in accrued
liabilities and other payables of approximately $140,000 due to payments made to vendors in the nine months ended September 30, 2023,
and the non-cash items adjustment, primarily consisting of income from equity method investment of approximately $351,000 resulting from
our purchase of a 40% equity interest in Lab Services MSO in February 2023, and change in fair market value of derivative liability of
approximately $129,000, offset by depreciation of approximately $167,000, stock-based compensation and service expense of approximately
$1,056,000, impairment of equity method investment of approximately $464,000, and amortization of debt issuance costs and debt discount
of approximately $291,000.
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 nine months ended September 30, 2024, as compared to $22,171 for the nine
months ended September 30, 2023. During the nine months ended September 30, 2024, we paid $100,000 for the acquisition of a 40% interest
in Lab Services MSO. During the nine months ended September 30, 2023, we made payment for purchase of property and equipment of approximately
$22,000.
Net
cash flow provided by financing activities was $4,726,942 for the nine months ended September 30, 2024, as compared to $4,091,323 for
the nine months ended September 30, 2023. During the nine months ended September 30, 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 $2,022,000, and net proceeds from equity offering of approximately $2,719,000 (net of cash paid for commission and other
offering costs of approximately $138,000), offset by repayments made for convertible debt of $3,100,000. During the nine months ended
September 30, 2023, we received proceeds from related party borrowings of $850,000, and net proceeds from issuance of convertible debt
and warrants of approximately $1,690,000 (net of original issue discount of $100,000 and cash paid for convertible note issuance costs
of approximately $211,000), 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).
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.
40
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 bears interest at a rate of 5% and provides
for maturity on drawn loans 36 months after funding. As of September 30, 2024, we had used approximately $6.8 million of the Line of
Credit and had approximately $13.2 million remaining available under the Line of Credit.
ATM
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. We and our subsidiaries also entered into security agreements in connection with issuance of the March 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 March 2024 Convertible Note.
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.
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 cash available under the Line of Credit 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 nine months ended
September 30, 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 have a material effect on us. For the three months ended September 30, 2024
and 2023, we had an unrealized foreign currency translation gain of approximately $3,000 and an unrealized foreign currency translation
loss of approximately $9,000, respectively, because of changes in the exchange rate. For the nine months ended September 30, 2024 and
2023, we had an unrealized foreign currency translation gain of approximately $3,000 and an unrealized foreign currency translation loss
of approximately $16,000, respectively, because of changes in the exchange rate.
Inflation
The
effect of inflation on our revenues and operating results was not significant for the three and nine months ended September 30, 2024
and 2023.
41
ITEM
3. 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.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.