Item 2. Management’s Discussion and Analysis
ITEM
2. 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 three and nine months ended September
30, 2021 and 2020 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 report. Our discussion includes forward-looking statements based
upon current expectations that involve risks and uncertainties, such as our plans, objectives, expectations and intentions. Actual results
and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of a number of
factors, including those set forth under the Risk Factors, Special Note Regarding Forward-Looking Statements and Business sections in
our Form 10-K as filed with the Securities and Exchange Commission on March 30, 2021. We use words such as “anticipate,”
“estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,”
“believe,” “intend,” “may,” “will,” “should,” “could,” and similar
expressions to identify forward-looking statements.
Impact
of COVID-19 on Our Operations, Financial Condition, Liquidity and Results of Operations
Although
the COVID-19 vaccines have generally been introduced to the public, the ultimate impact of the COVID-19 pandemic on our operations is
unknown and will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration
of the COVID-19 outbreak, new information which may emerge concerning the severity of the COVID-19 pandemic, a significant increase in
new and variant strains of COVID-19 cases, availability and effectiveness of COVID-19 vaccines and therapeutics, the level of acceptance
of the vaccine by the general population and any additional preventative and protective actions that governments, or us, may determine
are needed.
The
occurrence of COVID-19 pandemic had negative impact on our operations. Some of the universities and laboratories with which we collaborate
were temporarily closed. Our general development operations have continued during the COVID-19 pandemic and we have not had significant
disruption. However, we are uncertain if the COVID-19 pandemic will impact future operations at our laboratory, or our ability to collaborate
with other laboratories and universities. In addition, we are unsure if the COVID-19 pandemic will impact future clinical trials. Given
the dynamic nature of these circumstances, the duration of business disruption and reduced traffic, the related financial effect cannot
be reasonably estimated at this time but is expected to adversely impact the Company’s business for the rest of 2021.
We
have limited cash available to fund planned operations and although we have other sources of capital described below under “Liquidity
and Capital Resources,” management continues to pursue various financing alternatives to fund our operations so we can continue
as a going concern. However, the COVID-19 pandemic has created significant economic uncertainty and volatility in the credit and capital
markets. Management plans to secure the necessary financing through the issue of new equity and/or the entering into of strategic partnership
arrangements but the ultimate impact of the COVID-19 pandemic on our ability to raise additional capital is unknown and will depend on
future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the COVID-19 outbreak
and new information which may emerge concerning the severity of the COVID-19 pandemic. We may not be able to raise sufficient additional
capital and may tailor our operations based on the amount of funding we are able to raise in the future. Nevertheless, there is no assurance
that these initiatives will be successful. Further, there is no assurance that capital available to us in any future financing will be
on acceptable terms.
Overview
The
Company is a clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative,
transformative immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. The company
also provides strategic advisory and outsourcing services to facilitate and enhance its clients’ growth and development, as well
as competitiveness in healthcare and CellTech industry markets. Through its subsidiary structure with unique integration of verticals
from innovative research and development (“R&D”) to automated bioproduction and accelerated clinical development, the
Company is establishing a leading role in the fields of cellular immunotherapy (including CAR-T/NK), exosome technology (ACTEX™),
and regenerative therapeutics.
Avalon
achieves and fosters seamless integration of unique verticals to bridge and accelerate innovative research, bio-process development,
clinical programs and product commercialization. Avalon’s upstream innovative research includes:
● Development
of Avalon Clinical-grade Tissue-specific Exosome (“ACTEX™”).
25
● Novel
therapeutic and diagnostic targets development utilizing QTY-code protein design technology with Massachusetts Institute of Technology
(MIT) including using the QTY code protein design technology for development of a hemofiltration device to treat Cytokine Storm.
●
Strategic partnership with the University of Natural Resources and Life Sciences (BOKU) in Vienna, Austria to develop an S-layer based mucosal vaccine that can be administered by an intranasal or oral route against SARS-CoV-2, the novel coronavirus that causes COVID-19 disease, and other respiratory infections.
Avalon’s
midstream bio-processing and bio-production facility is located in Nanjing, China with state-of-the-art, automated GMP and QC/QA infrastructure
for standardized bio-manufacturing of clinical-grade cellular products involved in our clinical programs in immune effector cell therapy,
regenerative therapeutics, as well as bio-banking. As a result of the COVID pandemic, the operation of this facility has not been at
full capacity. However, the Company expects to slowly increase operations in the near future.
Avalon’s
downstream medical team and facility consists of top-rated affiliated hospital network and experts specialized in hematology, oncology,
cellular immunotherapy, hematopoietic stem/progenitor cell transplant, as well as regenerative therapeutics. Our major clinical programs
include:
●
AVA-001: Avalon has initiated
its first-in-human clinical trial of CD19 CAR-T candidate, AVA-001 in August 2019 at the Hebei Yanda Lu Daopei Hospital and Beijing
Lu Daopei Hospital in China (the world’s single largest CAR-T treatment network with over 600 patients being treated with CAR-T)
for the indication of relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin Lymphoma. The AVA-001 candidate (co-developed
with China Immunotech Co. Ltd) is characterized by the utilization of 4-1BB (CD137) co-stimulatory signaling pathway, conferring
a strong anti-cancer activity during pre-clinical study. It also features a shorter bio-manufacturing time which leads to the advantage
of prompt treatment to patients where timing is important related hematologic malignancies. Avalon has successfully completed the
first-in-human clinical trial of its AVA-001 anti-CD19 CAR-T cell therapy as a bridge to allogeneic bone marrow transplantation for
patients with relapsed/refractory B-cell acute lymphoblastic leukemia at the Lu Daopei Hospital (registered clinical trial number
NCT03952923) with excellent efficacy (90% complete remission rate) and minimal adverse side effects. Avalon is currently expanding
the patient recruitment for AVA-001 to include relapsed/refractory non-Hodgkin lymphoma patients.
●
ACTEX™:
Stem cell-derived Avalon Clinical-grade Tissue-specific Exosomes (ACTEX™) is one of the core technology platforms that has
been co-developed by Avalon GloboCare and Dr. Yen-Michael Hsu at University of Pittsburgh Medical Center (UPMC). The Company formed
a strategic partnership with HydroPeptide, LLC, a leading epigenetics skin care company, to engage in co-development and
commercialization of a series of clinical-grade, exosome-based cosmeceutical and orthopedic products.
●
FLASH-CAR™ / AVA-011: The Company advanced its next generation immune cell therapy using mRNA-based, non-viral FLASH-CAR™ technology co-developed with the Company’s strategic partner Arbele Limited. The adaptable FLASH-CAR™ platform can be used to create personalized cell therapy from a patient’s own cells, as well as off-the-shelf cell therapy from a universal donor. Our leading candidate, AVA-011, is currently at process development stage to generate clinical-grade cell-therapy products for subsequent clinical studies.
●
AVA-Trap™: Avalon’s AVA-Trap™ therapeutic program plans to enter animal model testing followed by expedited clinical studies with the goal of providing an effective therapeutic option to combat COVID-19 and other life-threatening conditions involving cytokine storms. The Company initiated a sponsored research and co-development project with Massachusetts Institute of Technology (MIT) led by Professor Shuguang Zhang as Principal Investigator in May 2019. 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
provide medical related consulting services in advanced areas of immunotherapy and second opinion/referral services through our wholly-owned
subsidiary Avalon (Shanghai) Healthcare Technology Co., Ltd., or Avalon Shanghai. We also own and operate rental commercial real property
in New Jersey, where we are headquartered.
26
Going
Concern
The
Company is a clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative,
transformative immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. The company
also provides strategic advisory and outsourcing services to facilitate and enhance its clients’ growth and development, as well
as competitiveness in healthcare and CellTech industry markets. Through its subsidiary structure with unique integration of verticals
from innovative research and development (“R&D”) to automated bioproduction and accelerated clinical development, the
Company is establishing a leading role in the fields of cellular immunotherapy (including CAR-T/NK), exosome technology (ACTEX™),
and regenerative therapeutics.
In
addition, the Company owns commercial real estate that houses its headquarters in Freehold, New Jersey and provides outsourced and
customized international healthcare services to the rapidly changing health care industry primarily focused in the People’s Republic
of China. These condensed 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 condensed consolidated financial statements, the Company had working capital deficit of $3,277,946 as of
September 30, 2021 and has incurred recurring net loss and generated negative cash flow from operating activities of $6,756,247 and $3,307,520
for the nine months ended September 30, 2021, respectively. The Company has a limited operating history and its continued growth is dependent
upon the continuation of providing medical consulting services to its only few clients who are related parties and generating rental
revenue from its income-producing real estate property in New Jersey; hence generating revenues, 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 revenues.
There are no assurances that the Company will be successful in its efforts to generate significant revenues, 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
occurrence of an uncontrollable event such as the COVID-19 pandemic had negatively impact on the Company’s operations. Our general
development operations have continued during the COVID-19 pandemic and we have not had significant disruption. However, we are uncertain
if the COVID-19 pandemic will impact future operations at our laboratory, or our ability to collaborate with other laboratories and universities.
In addition, we are unsure if the COVID-19 pandemic will impact future clinical trials. Given the dynamic nature of these circumstances,
the duration of business disruption and reduced traffic, the related financial effect cannot be reasonably estimated at this time but
is expected to adversely impact the Company’s business for the rest of 2021.
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 the Company be unable to continue as
a going concern.
Critical
Accounting Policies
Use
of Estimates
Our
discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements,
which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these condensed
consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities,
revenues and expenses, and related disclosure of contingent assets and liabilities. We continually evaluate our estimates, including
those related to the useful life of property and equipment and investment in real estate, assumptions used in assessing impairment of
long-term assets, valuation of deferred tax assets and the associated valuation allowances, and valuation of stock-based compensation.
We base
our estimates on historical experience and on various other assumptions that we believed to be reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent
from other sources. Any future changes to these estimates and assumptions could cause a material change to our reported amounts of revenues,
expenses, assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.
27
Revenue
Recognition
We
recognize revenue under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC
606”). The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised
goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for
those goods or services. The following five steps are applied to achieve that core principle:
●
Step 1: Identify the contract
with the customer
●
Step 2: Identify the performance
obligations in the contract
●
Step 3: Determine the transaction
price
●
Step 4: Allocate the transaction
price to the performance obligations in the contract
●
Step 5: Recognize revenue
when the company satisfies a performance obligation
In
order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in
the contract and identify each promised goods or service that is distinct. A performance obligation meets ASC 606’s definition
of a “distinct” goods or service (or bundle of goods or services) if both of the following criteria are met:
● The
customer can benefit from the goods or service either on its own or together with other resources that are readily available to the customer
(i.e., the goods or service is capable of being distinct).
● The
entity’s promise to transfer the goods or service to the customer is separately identifiable from other promises in the contract
(i.e., the promise to transfer the goods or service is distinct within the context of the contract).
If
a goods or service is not distinct, the goods or service is combined with other promised goods or services until a bundle of goods or
services is identified that is distinct.
The
transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods
or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration
promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration is included in the
transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will
not occur when the uncertainty associated with the variable consideration is subsequently resolved.
The
transaction price is allocated to each performance obligation on a relative standalone selling price basis. The transaction price allocated
to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate.
The
Company’s revenues are derived from providing medial related consulting services for its’ related parties. Revenues related
to its service offerings are recognized at a point in time when service is rendered. Any payments received in advance of the performance
of services are recorded as deferred revenue until such time as the services are performed.
We
have determined that the 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.
We
do not offer promotional payments, customer coupons, rebates or other cash redemption offers to our customers.
28
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 probably 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 report.
RESULTS
OF OPERATIONS
Comparison
of Results of Operations for the Three and Nine Months Ended September 30, 2021 and 2020
Revenues
For
the three months ended September 30, 2021, we had real property rental revenue of $355,459, as compared to $324,982 for the three months
ended September 30, 2020, an increase of $30,477, or 9.4%. For the nine months ended September 30, 2021, we had real property rental
revenue of $925,465, as compared to $923,205 for the nine months ended September 30, 2020, an increase of $2,260, or 0.2%. The increase
was primarily attributable to the increase of tenants in 2021. We expect that our revenue from real property rent will remain in its
current quarterly level with minimal increase in the near future.
For
the three and nine months ended September 30, 2021, we had medical related consulting services revenue from related party of $131,305.
For the three and nine months ended September 30, 2020, we did not have any medical related consulting services revenue since there was
no demand for our consulting service from our related parties and there was no order for our medical related consulting services from
third party in these periods. We expect that our revenue from medical related consulting services will increase in the near future.
Costs
and 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, 2021, our real property operating expenses amounted to $215,622, as compared to $135,821 for the
three months ended September 30, 2020, an increase of $79,801, or 58.8%. The increase was mainly due to an increase in repairs and maintenance
fees of approximately $16,000, an increase in janitorial supplies of approximately $3,000, an increase in utilities of approximately
$8,000, and an increase in other miscellaneous items of approximately $52,000. For the nine months ended September 30, 2021, our real
property operating expenses amounted to $637,663, as compared to $663,086 for the nine months ended September 30, 2020, a decrease of
$25,423, or 3.8%. The decrease was mainly due to a decrease in air conditioner maintenance fees of approximately $3,000, a decrease in
janitorial supplies of approximately $4,000, and a decrease in other miscellaneous items of approximately $18,000.
29
Costs
of medical related consulting services include the cost of labor and related benefits, travel expenses related to medical related consulting
services, and other overhead costs.
For
the three and nine months ended September 30, 2021, costs of medical related consulting services amounted to $102,442. There were no
comparative revenue and related costs of revenue from our medical related consulting services for the three and nine months ended September
30, 2020 since there was no demand for our consulting service from our related parties and there was no order for our medical related
consulting services from third party in these periods.
Real
Property Operating Income
Our
real property operating income for the three months ended September 30, 2021 was $139,837, representing a decrease of $49,324, or 26.1%,
as compared to $189,161 for the three months ended September 30, 2020. The decrease was mainly attributable to the increase in real property
operating expenses as described above. Our real property operating income for the nine months ended September 30, 2021 was $287,802,
representing an increase of $27,683, or 10.6%, as compared to $260,119 for the nine months ended September 30, 2020. The increase was
mainly attributable to the decrease in real property operating expenses as described above. We expect our real property operating income
will remain in its current quarterly level with minimal increase in the near future.
Gross
Profit from Medical Related Consulting Services and Gross Margin
Our
gross profit from medical related consulting services for the three and nine months ended September 30, 2021 was $28,863, with a
gross margin of 22.0%. We did not generate any gross profit from medical related consulting services in the three and nine months ended
September 30, 2020. We estimate that our gross margin from medical related consulting services segment will remain at its current level.
Other
Operating Expenses
For
the three and nine months ended September 30, 2021 and 2020, other operating expenses consisted of the following:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2021
2020
2021
2020
Professional fees
$ 1,221,952
$ 1,753,182
$ 3,960,209
$ 4,868,530
Compensation and related benefits
434,602
1,058,570
1,544,437
3,241,090
Research and development
224,072
238,432
676,053
674,935
Directors and officers liability insurance premium
101,499
78,862
263,781
194,887
Travel and entertainment
48,646
32,735
120,865
137,548
Rent and related utilities
18,487
23,015
59,775
68,292
Advertising expenses
27,833
102,472
44,156
216,317
Other general and administrative
56,580
92,451
218,228
274,097
$ 2,133,671
$ 3,379,719
$ 6,887,504
$ 9,675,696
● Professional
fees primarily consisted of accounting fees, audit fees, legal service fees, consulting fees, investor relations service charges and
other fees incurred for service related to being a public company. For the three months ended September 30, 2021, professional fees decreased
by $531,230, or 30.3%, as compared to the three months ended September 30, 2020. The decrease was primarily attributable to a decrease
in consulting fees of approximately $738,000 mainly due to the decrease in use of consulting service providers, and a decrease in investor
relations service fees of approximately $183,000 mainly due to the decrease in use of investor relations service providers, offset by
an increase in legal service fees of approximately $316,000 mainly due to increased legal service related to our potential acquisition,
and an increase in other miscellaneous items of approximately $74,000. For the nine months ended September 30, 2021, professional fees
decreased by $908,321, or 18.7%, as compared to the nine months ended September 30, 2020. The decrease was primarily attributable to
a decrease in consulting fees of approximately $1,160,000 mainly due to the decrease in use of consulting service providers, a decrease
in investor relations service fees of approximately $479,000 mainly due to the decrease in use of investor relations service providers,
and a decrease in other miscellaneous items of approximately $63,000, offset by an increase in legal service fees of approximately $613,000
mainly due to increased legal service related to our potential acquisition, and an increase in valuation fee for our potential acquisition
of $180,000. We expect that our professional fees will remain in its current quarterly level with minimal decrease in the near future.
30
● For
the three months ended September 30, 2021, compensation and related benefits decreased by $623,968, or 58.9%, as compared to the three
months ended September 30, 2020. The significant decrease was primarily attributable to a decrease in stock-based compensation of approximately
$520,000 which reflected the value of options granted and vested to our management, and a decrease in management’s compensation
and related benefits of approximately $104,000. For the nine months ended September 30, 2021, compensation and related benefits decreased
by $1,696,653, or 52.3%, as compared to the nine months ended September 30, 2020. The significant decrease was primarily attributable
to a decrease in stock-based compensation of approximately $1,614,000 which reflected the value of options granted and vested to our
management, and a decrease in management’s compensation and related benefits of approximately $83,000. We expect that our compensation
and related benefits will remain in its current quarterly level with minimal increase in the near future.
● For
the three months ended September 30, 2021, research and development expenses decreased by $14,360, or 6.0%, as compared to the three
months ended September 30, 2020. For the nine months ended September 30, 2021, research and development expenses increased by $1,118,
or 0.2%, as compared to the nine months ended September 30, 2020. We expect that our research and development expenses will remain in
its current quarterly level with minimal increase in the near future.
● For
the three months ended September 30, 2021, Directors and Officers Liability Insurance premium increased by $22,637, or 28.7%, as compared
to the three months ended September 30, 2020. For the nine months ended September 30, 2021, Directors and Officers Liability Insurance
premium increased by $68,894, or 35.4%, as compared to the nine months ended September 30, 2020. The increase was mainly due to different
insurance provider with different premium.
● For
the three months ended September 30, 2021, travel and entertainment expense increased by $15,911, or 48.6%, as compared to the three
months ended September 30, 2020. The increase was primarily due to the increased business travel activities in the third quarter of 2021.
For the nine months ended September 30, 2021, travel and entertainment expense decreased by $16,683, or 12.1%, as compared to the nine
months ended September 30, 2020. The decrease was mainly due to decreased business travel activities and decreased entertainment expenditure
resulting from COVID-19.
● For
the three months ended September 30, 2021, rent and related utilities expenses decreased by $4,528, or 19.7%, as compared to the three
months ended September 30, 2020. For the nine months ended September 30, 2021, rent and related utilities expenses decreased by $8,517,
or 12.5%, as compared to the nine months ended September 30, 2020. The decrease was mainly attributable to the decreased monthly rent
in Avalon Shanghai’s office.
● For
the three months ended September 30, 2021, advertising expenses decreased by $74,639 or 72.8% as compared to the three months ended September
30, 2020. For the nine months ended September 30, 2021, advertising expenses decreased by $172,161 or 79.6% as compared to the nine months
ended September 30, 2020. The significant decrease was primarily due to reduced advertising activities incurred as a result of stricter
control on corporation spending. We expect that our advertising expenses will increase in the near future.
● Other
general and administrative expenses mainly consisted of NASDAQ listing fee, office supplies, and other miscellaneous items. For the three
months ended September 30, 2021, other general and administrative expenses decreased by $35,871, or 38.8%, as compared to the three months
ended September 30, 2020. For the nine months ended September 30, 2021, other general and administrative expenses decreased by $55,869,
or 20.4%, as compared to the nine months ended September 30, 2020. The decrease resulted from our efforts at stricter controls on corporate
expenditure.
Loss
from Operations
As
a result of the foregoing, for the three months ended September 30, 2021, loss from operations amounted to $1,964,971, as compared to
$3,190,558 for the three months ended September 30, 2020, a decrease of $1,225,587, or 38.4%.
As
a result of the foregoing, for nine months ended September 30, 2021, loss from operations amounted to $6,570,839, as compared to $9,415,577
for the nine months ended September 30, 2020, a decrease of $2,844,738, or 30.2%.
31
Other
Income (Expense)
Other
income (expense) mainly includes interest expense and loss from equity method investment.
Other
expense, net, totaled $59,248 for the three months ended September 30, 2021, as compared to $61,401 for the three months ended September
30, 2020, a decrease of $2,153, or 3.5%, which was primarily attributable to a decrease in other miscellaneous expense of approximately
$10,000, and a decrease in loss from equity method investment of approximately $1,000, offset by an increase in interest expense of approximately
$9,000.
Other
expense, net, totaled $185,408 for the nine months ended September 30, 2021, as compared to $163,545 for the nine months ended September
30, 2020, an increase of $21,863, or 13.4%, which was primarily attributable to an increase in interest expense of approximately $15,000,
and an increase in loss from equity method investment of approximately $13,000, offset by a decrease in other miscellaneous expense of
approximately $6,000.
Income
Taxes
We
did not have any income taxes expense for the three and nine months ended September 30, 2021 and 2020 since we incurred losses in
these periods.
Net
Loss
As
a result of the factors described above, our net loss was $2,024,219 for the three months ended September 30, 2021, as compared to $3,251,959
for the three months ended September 30, 2020, a decrease of $1,227,740 or 37.8%.
As
a result of the factors described above, our net loss was $6,756,247 for the nine months ended September 30, 2021, as compared to $9,579,122
for the nine months ended September 30, 2020, a decrease of $2,822,875 or 29.5%.
Net
Loss Attributable to Avalon GloboCare Corp. Common Shareholders
The
net loss attributable to Avalon GloboCare Corp. common shareholders was $2,024,219 or $0.02 per share (basic and diluted) for the three
months ended September 30, 2021, as compared with $3,251,959, or $0.04 per share (basic and diluted) for the three months ended September
30, 2020, a change of $1,227,740 or 37.8%.
The
net loss attributable to Avalon GloboCare Corp. common shareholders was $6,756,247 or $0.08 per share (basic and diluted) for the nine
months ended September 30, 2021, as compared with $9,579,122, or $0.12 per share (basic and diluted) for the nine months ended September
30, 2020, a change of $2,822,875 or 29.5%.
Foreign
Currency Translation Adjustment
Our
reporting currency is the U.S. dollar. The functional currency of our parent company, AHS, Avalon RT 9, Genexosome, Avactis, and Exosome,
is the U.S. dollar and the functional currency of Avalon Shanghai and Beijing Genexosome is the Chinese Renminbi (“RMB”).
The financial statements of our subsidiaries whose functional currency is the RMB are translated to U.S. dollars using period end rates
of exchange for assets and liabilities, average rate of exchange for revenues, costs, and expenses and cash flows, and at historical
exchange rates 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 $1,285
and $39,698 for the three months ended September 30, 2021 and 2020, respectively. As a result of foreign currency translations, which
are a non-cash adjustment, we reported a foreign currency translation gain of $13,349 and $20,941 for the nine months ended September
30, 2021 and 2020, respectively. This non-cash gain had the effect of decreasing our reported comprehensive loss.
Comprehensive
Loss
As
a result of our foreign currency translation adjustment, we had comprehensive loss of $2,022,934 and $3,212,261 for the three months
ended September 30, 2021 and 2020, respectively. As a result of our foreign currency translation adjustment, we had comprehensive loss
of $6,742,898 and $9,558,181 for the nine months ended September 30, 2021 and 2020, respectively.
32
Liquidity
and Capital Resources
The
Company has a limited operating history and its continued growth is dependent upon the continuation of providing medical consulting services
to its only few clients who are related parties and generating rental revenue from its income-producing real estate property in New Jersey;
hence generating revenues, 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 revenues. There are no assurances that the Company will be successful in its efforts to generate
significant revenues, 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
occurrence of an uncontrollable event such as the COVID-19 pandemic is likely to negatively affect the Company’s operations. Efforts
to contain the spread of the coronavirus have intensified, including social distancing, travel bans and quarantine, and these
are likely to negatively impact our tenants, employees and consultants. These, in turn, will not only impact our operations, financial
condition and demand for our medical related consulting services but our overall ability to react timely to mitigate the impact of this
event. Given the dynamic nature of these circumstances, the duration of business disruption and reduced traffic, the related financial
effect cannot be reasonably estimated at this time but is expected to adversely impact our business for the rest of 2021.
Liquidity
is the ability of a company to generate funds to support its current and future operations, satisfy its obligations and otherwise operate
on an ongoing basis. At September 30, 2021 and December 31, 2020, we had cash balance of approximately $532,000 and $727,000, respectively.
These funds are kept in financial institutions located as follows:
Country:
September 30,
2021
December 31,
2020
United States
$ 428,984
80.6 %
$ 559,711
77.0 %
China
103,267
19.4 %
166,866
23.0 %
Total cash
$ 532,251
100.0 %
$ 726,577
100.0 %
Under
applicable PRC regulations, foreign invested enterprises, or FIEs, in China may pay dividends only out of their accumulated profits,
if any, determined in accordance with PRC accounting standards and regulations. In addition, a foreign invested enterprise in China is
required to set aside at least 10% of its after-tax profit based on PRC accounting standards each year to its general reserves until
the cumulative amount of such reserves reach 50% of its registered capital. These reserves are not distributable as cash dividends.
In
addition, a portion of our businesses and assets are denominated in RMB, which is not freely convertible into foreign currencies. All
foreign exchange transactions take place either through the People’s Bank of China or other banks authorized to buy and sell foreign
currencies at the exchange rates quoted by the People’s Bank of China. Approval of foreign currency payments by the People’s
Bank of China or other regulatory institutions requires submitting a payment application form together with suppliers’ invoices,
shipping documents and signed contracts. These currency exchange control procedures imposed by the PRC government authorities may restrict
the ability of our PRC subsidiary to transfer its net assets to the Parent Company through loans, advances or cash dividends.
The
current PRC Enterprise Income Tax (“EIT”) Law and its implementing rules generally provide that a 10% withholding tax applies
to China-sourced income derived by non-resident enterprises for PRC enterprise income tax purposes unless the jurisdiction of incorporation
of such enterprises’ shareholder has a tax treaty with China that provides for a different withholding arrangement.
33
The
following table sets forth a summary of changes in our working capital from December 31, 2020 to September 30, 2021:
September 30,
December 31,
Changes in
2021
2020
Amount
Percentage
Working capital deficit:
Total current assets
$ 1,257,931
$ 1,286,337
$ (28,406 )
(2.2 )%
Total current liabilities
4,535,877
2,592,393
1,943,484
75.0 %
Working capital deficit
$ (3,277,946 )
$ (1,306,056 )
$ (1,971,890 )
151.0 %
Our
working capital deficit increased by $1,971,890 to $3,277,946 at September 30, 2021 from $1,306,056 at December 31, 2020. The increase
in working capital deficit was primarily attributable to a decrease in cash of approximately $194,000, an increase in accrued professional
fees of approximately $994,000, mainly due to an increase in professional services providers, an increase in accrued research and development
fees of approximately $227,000, an increase in accrued payroll liability and directors’ compensation of approximately $147,000,
an increase in accrued liabilities and other payables – related parties of approximately $142,000, and an increase in note payable
– related party of $390,000, offset by an increase in prepaid professional fees of approximately $256,000.
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, 2021 Compared to the Nine Months Ended September 30, 2020
The
following summarizes the key components of our cash flows for the nine months ended September 30, 2021 and 2020:
Nine Months Ended
September 30,
2021
2020
Net cash used in operating activities
$ (3,307,520 )
$ (6,185,198 )
Net cash used in investing activities
(67,960 )
(28,594 )
Net cash provided by financing activities
3,178,336
6,841,783
Effect of exchange rate on cash
2,818
2,628
Net (decrease) increase in cash
$ (194,326 )
$ 630,619
Net
cash flow used in operating activities for the nine months ended September 30, 2021 was $3,307,520, which primarily reflected our consolidated
net loss of approximately $6,756,000, and the changes in operating assets and liabilities, primarily consisting of a decrease in operating
lease obligation of approximately $87,000, offset by an increase accrued liabilities and other payables of approximately $1,436,000,
and an increase in accrued liabilities and other payables – related parties of approximately $142,000, and the non-cash items adjustment
primarily consisting of depreciation of approximately $227,000, amortization of right-of-use asset of approximately $93,000, and stock-based
compensation and service expense of approximately $1,621,000.
Net cash flow used in operating activities for
the nine months ended September 30, 2020 was $6,185,198, which primarily reflected our consolidated net loss of approximately $9,579,000,
and the changes in operating assets and liabilities, primarily consisting of an increase in rent receivable of approximately $94,000,
an increase in prepaid expenses and other current assets of approximately $353,000, a decrease in accrued liabilities and other payables
of approximately $680,000, offset by a decrease in accounts receivable – related party of approximately $214,000, an increase in
accrued liabilities and other payables – related parties of approximately $75,000, and the non-cash items adjustment primarily consisting
of depreciation of approximately $233,000, and stock-based compensation and service expense of approximately $3,965,000.
We
expect our cash used in operating activities to increase due to the following:
● the
development and commercialization of new products;
● an
increase in professional staff and services; 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.
34
Net
cash flow used in investing activities was $67,960 for the nine months ended September 30, 2021 as compared to $28,594 for the nine
months ended September 30, 2020. During the nine months ended September 30, 2021, we made payments for purchase of property and equipment
of approximately $17,000 and for improvement of commercial real estate of approximately $10,000, and made additional investment in equity
method investment of approximately $40,000. During the nine months ended September 30, 2020, we made additional investment in equity
method investment of approximately $29,000.
Net
cash flow provided by financing activities was $3,178,336 for the nine months ended September 30, 2021 as compared to $6,841,783 for
the nine months ended September 30, 2020. During the nine months ended September 30, 2021, we received proceeds from related party borrowings
of approximately $763,000 and net proceeds from equity offering of approximately $2,415,000 (net of cash paid for commission and other
offering costs of approximately $104,000). During the nine months ended September 30, 2020, we received proceeds from related party borrowings
of $300,000 and net proceeds from equity offering of approximately $6,742,000 (net of cash paid for commission and other offering costs
of approximately $492,000), offset by repayments made for note payable – related party of $200,000.
Our
capital requirements for the next twelve months primarily relate to working capital requirements, including salaries, fees related to
third parties’ professional services, reduction of accrued liabilities, mergers, acquisitions and the development of business opportunities.
These uses of cash will depend on numerous factors including our sales and other revenues, and our ability to control costs. All funds
received have been expended in the furtherance of growing the business. 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, including ongoing research and development programs, clinical studies, as well
as commercial strategies;
●
the use of capital for
mergers, acquisitions and the development of business opportunities;
●
addition of administrative
personnel as the business grows; and
●
the cost of being a public
company.
In the third quarter of 2019, we had secured a $20
million credit facility (Line of Credit) provided by our Chairman, Wenzhao Lu. The unsecured credit facility bears interest at a rate
of 5% and provides for maturity on drawn loans 36 months after funding. The note is not convertible to equity. As of November 4, 2021,
the Company drew down an additional aggregate of $1,000,000 from the Line of Credit. As a result of these draw downs, the Company
has approximately $15.3 million remaining available under the Line of Credit. This draw down increased the total principal
amount outstanding under the Line of Credit to $4.7 million.
On
December 13, 2019, we entered into an Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies
LLC, as sales agent (“Jefferies”), pursuant to which we may offer and sell, from time to time, through Jefferies, shares
of our common stock, par value $0.0001 per share, having an aggregate offering price of up to $20.0 million. On April 6, 2020, the date
on which we filed our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, our registration statement
became subject to the offering limits set forth in General Instruction I.B.6 of Form S-3. As of April 6, 2020, the aggregate
market value of our outstanding common stock held by non-affiliates, or public float, was $39,564,237, based on 23,691,160
shares of our outstanding common stock that were held by non-affiliates on such date and a price of $1.67 per share, which
was the price at which our common stock was last sold on The Nasdaq Capital Market on February 19, 2020 (a date within 60 days of the
date hereof), calculated in accordance with General Instruction I.B.6 of Form S-3. We have not offered any securities
pursuant to General Instruction I.B.6 of Form S-3 in the 12 calendar months preceding the date of this prospectus supplement.
We filed a prospectus supplement to amend and supplement the information in our prospectus and original prospectus supplement based on
the amount of securities that we are eligible to sell under General Instruction I.B.6 of Form S-3. After giving effect
to the $13,000,000 offering limit imposed by General Instruction I.B.6 of Form S-3, we may offer and sell additional shares
of our common stock having an aggregate offering price of up to $13,000,000 from time to time through Jefferies acting as our sales agent
in accordance with the terms of the sales agreement. As of September 30, 2021, we sold a total of 5,936,044 shares of our common
stock through Jefferies with an aggregate offering price of $9,596,542 and we have approximately $5.4 million offering price remaining
available under the Sales Agreement.
35
We
estimate that based on current plans and assumptions, that our available cash will be insufficient to satisfy our cash requirements under
our present operating expectations through cash available under our Credit Line and sales of equity through our Sales Agreement. Other
than funds received from the sale of our equity and advances from our related party, and cash resource generating 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.
Contractual
Obligations and Off-Balance Sheet Arrangements
Contractual
Obligations
We
have certain fixed contractual obligations and commitments that include future estimated payments. Changes in our business needs, cancellation
provisions, and other factors may result in actual payments differing from the estimates. We cannot provide certainty regarding the timing
and amounts of payments. We have presented below a summary of the most significant assumptions used in our determination of amounts presented
in the tables, in order to assist in the review of this information within the context of our consolidated financial position, results
of operations, and cash flows. The following tables summarize our contractual obligations as of September 30, 2021, and the effect these
obligations are expected to have on our liquidity and cash flows in future periods.
Payments Due by Period
Contractual obligations:
Total
Less than
1 year
1-3 years
3-5 years
5 + years
Operating lease commitment
$ 206,032
$ 162,024
$ 44,008
$ -
$ -
Acquisition consideration
100,000
100,000
-
-
-
Borrowings from related party (principal)
4,353,189
390,000
3,963,189
-
-
Accrued interest – related party
309,484
309,484
-
-
-
Epicon equity investment obligation
812,832
270,944
541,888
-
-
AVAR joint venture commitment
10,775,603
775,603
5,000,000
5,000,000
-
Total
$ 16,557,140
$ 2,008,055
$ 9,549,085
$ 5,000,000
$ -
Off-balance
Sheet Arrangements
We
presently do not have off-balance sheet arrangements.
Foreign
Currency Exchange Rate Risk
A
portion of our operations are in China. Thus, a portion of our revenues and operating results may be impacted by exchange rate fluctuations
between RMB and US dollars. For the three months ended September 30, 2021 and 2020, we had an unrealized foreign currency translation
gain of approximately $1,000 and $40,000, respectively, because of changes in the exchange rate. For the nine months ended September
30, 2021 and 2020, we had an unrealized foreign currency translation gain of approximately $13,000 and $21,000, respectively, because
of changes in the exchange rate.
Inflation
The
effect of inflation on our revenue and operating results was not significant.
36
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.