ITEM 1A. RISK FACTORS
You should carefully consider the following
material risk factors as well as all other information set forth or referred to in this report before purchasing shares of our common
stock. Investing in our common stock involves a high degree of risk. We may not be successful in preventing the material adverse effects
that any of the following risks and uncertainties may cause. These potential risks and uncertainties may not be a complete list of the
risks and uncertainties facing us. There may be additional risks and uncertainties that we are presently unaware of, or presently consider
immaterial, that may become material in the future and have a material adverse effect on us. You could lose all or a significant portion
of your investment due to any of these risks and uncertainties.
Summary of Risk Factors
Our business is subject to numerous risks and
uncertainties that you should consider before investing in our company, as fully described below. The principal factors and uncertainties
that make investing in our company risky include, among others:
Risks Related to the Potential Merger with
YOOV
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General Operating and Business Risks
● Potential liability claims may adversely affect our business.
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Risk Factors Related to Commercialization
Activity
Risks Related to Our Securities
Risks Related to the Potential Merger with
YOOV
Failure to complete the Merger could negatively
impact the stock price and our future business and financial results.
The parties’ respective obligations to complete
the Merger are subject to the satisfaction or waiver of a number of conditions set forth in the Merger Agreement. There can be no assurance
that the conditions to completion of the Merger will be satisfied or waived or that the Merger will be completed. If the Merger is not
completed for any reason, our ongoing businesses may be materially and adversely affected and, without realizing any of the benefits of
having completed the Merger, We would be subject to a number of risks, including the following:
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In addition, we could be subject to litigation
related to any failure to complete the Merger or related to any proceeding to specifically enforce our or YOOV’s obligations under
the Merger Agreement.
If any of these risks materialize, they may materially
and adversely affect our business, financial condition, financial results and stock prices.
We and YOOV will be subject to business uncertainties
and contractual restrictions while the Merger is pending.
Uncertainty about the effect of the Merger on
employees, vendors and customers may have an adverse effect on our or YOOV and consequently on the combined company after the closing
of the Merger. These uncertainties may impair our and YOOV’s ability to retain and motivate key personnel and could cause customers
and others that deal with us and YOOV, as applicable, to defer or decline entering into contracts with us or YOOV, as applicable, or making
other decisions concerning us or YOOV, as applicable, or seek to change existing business relationships with us or YOOV, as applicable.
In addition, if key employees depart because of uncertainty about their future roles and the potential complexities of the Merger, our
and YOOV’s businesses could be harmed. Furthermore, the Merger Agreement places certain restrictions on the operation of our and
YOOV’s businesses prior to the closing of the Merger, which may delay or prevent us and YOOV from undertaking certain actions or
business opportunities that may arise prior to the consummation of the Merger.
Third parties may terminate or alter existing
contracts or relationships with us or YOOV.
Each of us and YOOV has contracts with customers,
vendors and other business partners which may require us or YOOV, as applicable, to obtain consents from these other parties in connection
with the Merger. If these consents cannot be obtained, the counterparties to these contracts and other third parties with which us and/or
YOOV currently have relationships may have the ability to terminate, reduce the scope of or otherwise materially adversely alter their
relationships with either party in anticipation of the Merger, or with the combined company following the Merger. The pursuit of such
rights may result in us and YOOV suffering a loss of potential future revenue, incurring liabilities in connection with a breach of such
agreements or losing rights that are material to their businesses. Any such disruptions could limit the combined company’s ability
to achieve the anticipated benefits of the Merger. The adverse effect of such disruptions could also be exacerbated by a delay in the
completion of the Merger or the termination of the Merger.
The Merger is subject to a number of closing
conditions and, if these conditions are not satisfied, the Merger Agreement may be terminated in accordance with its terms and the Merger
may not be completed. In addition, the parties have the right to terminate the Merger Agreement under other specified circumstances, in
which case the Merger would not be completed.
The Merger is subject to a number of closing conditions
and, if these conditions are not satisfied or waived (to the extent permitted by law), the Merger will not be completed.
These conditions include, among others: (i) the
absence of certain legal impediments, (ii) effectiveness of the registration statement on Form S-4 relating to the Merger, (iv) obtaining
approval from our stockholders to (i) approve the issuance of the shares of our common stock to be issued to YOOV shareholders in
connection with the Merger pursuant to the rules of Nasdaq and (ii) amend our certificate of incorporation to effect a reverse stock split
of our common stock to the extent we and YOOV mutually agree implementing such reverse stock split is necessary to meet Nasdaq’s
listing requirements, (v) the approval of the Merger Agreement and the Merger by YOOV shareholders and (vi) the approval of the Nasdaq
listing application and the listing of the our shares on The Nasdaq Capital Market following the Merger. In addition, each party’s
obligation to complete the Merger is subject to the accuracy of the other parties’ representations and warranties in the Merger
Agreement, the other parties’ compliance, in all material respects, with their respective covenants and agreements in the Merger
Agreement.
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The conditions to the closing of the Merger may
not be fulfilled and, accordingly, the Merger may not be completed. In addition, if the Merger is not completed by March 7, 2026, any
party may choose not to proceed with the Merger. Moreover, the parties can mutually decide to terminate the Merger Agreement at any time
prior to the consummation of the Merger, before or after receipt of the requisite approvals by our stockholders and the YOOV shareholders,
each party may elect to terminate the Merger Agreement in certain other circumstances, as set forth in the Merger Agreement. If the Merger
Agreement is terminated, we may incur substantial fees and expenses in connection with termination of such Agreement and we will not realize
the anticipated benefits of the Merger. In addition, if the Merger is not completed, we may not have sufficient capital to continue to
operate our business in the long term and may become insolvent and be required to seek the protection of the bankruptcy courts and, without
additional funding or a strategic transaction, we would likely be delisted from Nasdaq.
We or YOOV may waive one or more of the closing
conditions to the Merger without re-soliciting stockholder approval.
Each of us and YOOV has the right to waive certain
of the closing conditions to the Merger. Any such waiver may not require re-solicitation of stockholders, in which case stockholders of
us and shareholders of YOOV will not have the chance to change their votes as a result of any such waiver and we and YOOV will have the
ability to complete the Merger without seeking further stockholder approval. Any determination whether to waive any condition to the Merger,
whether stockholder approval would be re-solicited as a result of any such waiver or whether this proxy statement/prospectus would be
amended as a result of any waiver will be made us or YOOV, as applicable, at the time of such waiver based on the facts and circumstances
as they exist at that time, and any such waiver could have an adverse effect on the combined company.
Our stockholders will have a reduced ownership
and voting interest after the Merger and will exercise less influence over management.
Our stockholders, as a group have significantly
reduced ownership and voting power in the combined company compared to their current ownership and voting power in us. In particular,
upon consummation of the Merger, our stockholders, as a group, will own less than 3% of the outstanding common stock of us. In addition,
our stockholders, as a group, will be able to exercise less collective influence over the management and policies of the combined company
than they currently exercise over the management and policies of us.
The Merger Agreement limits our ability to
pursue alternatives to the Merger.
The Merger Agreement contains provisions that
make it more difficult for us to enter into alternative transactions. The Merger Agreement contains certain provisions that restrict our
ability to solicit or facilitate proposals from third parties with respect to transactions involving the financing or sale of us, or provide
non-public information to, or otherwise participate or engage in discussions or negotiations with, third parties or take certain other
actions that would reasonably be expected to lead to a third-party acquisition proposal. Further, there are only limited exceptions to
our agreement that our board of directors will not change its recommendation in favor of the adoption of the Merger Agreement. However,
at any time prior to the receipt of the requisite stockholder approval by our stockholders and the approval of the Merger Agreement and
the Merger by YOOV shareholders, in response to an unsolicited superior proposal made by a third party, Our board of directors may make
an adverse recommendation change, and terminate the Merger Agreement to enter into an alternative acquisition agreement, if it concludes
in good faith, after consultation with outside financial advisors and outside legal counsel, that the failure to take such action would
be inconsistent with the fiduciary duties of our board of directors under the circumstances and under applicable law.
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As described above, we may be required to pay
a termination fee of $1,000,000 to YOOV if the Merger is not consummated under specified circumstances as set forth in the Merger Agreement.
Upon obtaining the requisite approvals from our stockholders and YOOV shareholders, our right to terminate the Merger Agreement in response
to a Superior Proposal (as defined in the Merger Agreement) will cease.
While we believe these provisions are reasonable,
customary and not preclusive of other offers, the provisions might discourage a third party that has an interest in acquiring all or a
significant part of us from considering or proposing such an acquisition, even if such party were prepared to pay consideration with a
higher per-share value than the currently proposed merger consideration or if such party were prepared to enter into an agreement that
may be more favorable to us or our stockholders.
Our executive officers and directors may have
interests in the Merger that are different from, or in addition to, the rights of their respective stockholders.
Our executive officers negotiated the terms of
the Merger Agreement and the board of directors approved the Merger Agreement and the Merger and recommend that each stockholder vote
in favor of the proposals to be presented at the special meeting in connection with the Merger. These executive officers and directors
may have interests in the Merger that are different from, or in addition to, our stockholders. These interests include the potential continued
employment or retention as consultants of certain executive officers of us with the combined company following the Merger, the continued
service of certain of our directors as directors of the combined company following the Merger and the indemnification of our executive
officers and directors.
We, YOOV and, subsequently, the combined company
may have difficulty attracting, motivating and retaining executives and other key employees in light of the proposed Merger.
The combined company’s success after the
Merger will depend in part on each of our and YOOV’s ability to retain key executives and other employees. Uncertainty about the
effect of the Merger on our and YOOV’s employees may have an adverse effect on each company separately and consequently, the combined
company. This uncertainty may impair the combined company’s ability to attract, retain and motivate key personnel. Employee retention
may be particularly challenging during the pendency of the Merger, as our and YOOV’s employees may experience uncertainty about
their future roles in the combined business. YOOV’s common stock
Furthermore, if any of our or YOOV’s key
employees depart or are at risk of departing, including because of issues relating to the uncertainty and difficulty of integration, financial
security or a desire not to become employees of the combined business, we or YOOV, as applicable, may have to incur significant costs
in retaining such individuals or in identifying, hiring and retaining replacements for departing employees and may lose significant expertise
and talent, and the combined company’s ability to realize the anticipated benefits of the Merger may be materially and adversely
affected. No assurance can be given that the combined company will be able to attract or retain key employees to the same extent that
we or YOOV have been able to attract or retain employees in the past.
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We will incur significant transaction and Merger-related
transition costs in connection with the Merger.
We expect that we will incur significant, non-recurring
costs in connection with consummating the Merger and integrating the operations of the two companies post-Closing. We will incur significant
fees and expenses relating to financing arrangements and legal services (including any costs that would be incurred in defending against
any potential class action lawsuits and derivative lawsuits in connection with the Merger if any such proceedings are brought), accounting
and other fees and costs, associated with consummating the Merger. Some of these costs are payable regardless of whether the Merger is
completed. In addition, we may be required to pay a termination fee of $1,000,000 if the Merger Agreement is terminated under specified
circumstances described in the Merger Agreement. Though we continue to assess the magnitude of these costs, additional unanticipated costs
may be incurred in the Merger and the integration of the businesses of us and YOOV.
We may be the target of securities class action
and stockholder lawsuits which could result in substantial costs and may delay or prevent the Merger from being completed.
Securities class action lawsuits and stockholder
lawsuits are often brought against public companies that have entered into merger agreements. Even if the lawsuits are without merit,
defending against these claims can result in substantial costs and divert management time and resources. An adverse judgment could result
in monetary damages, which could have a negative impact on our liquidity and financial condition. Additionally, if a plaintiff is successful
in obtaining an injunction prohibiting completion of the Merger, then that injunction may delay or prevent the Merger from being completed,
which may adversely affect our or the combined company’s business, financial position and results of operations. As of the date
of this report, no such lawsuits have been filed in connection with the Merger and the parties cannot predict whether any will be filed.
General Operating and Business Risks
Our limited revenue makes it difficult for
us to evaluate our future business prospects and make decisions based on those estimates of our future performance.
We have limited operating revenue. Because of the uncertainties related
to our lack of significant revenue, we may be hindered in our ability to anticipate and timely adapt to increases or decreases in revenues
or expenses. If we make poor budgetary decisions as a result of unreliable historical data, we could be less profitable or incur losses,
which may result in a decline in our stock price.
Our results of operations have not resulted
in profitability and we may not be able to achieve profitability going forward.
We incurred net losses amounting to approximately $7.9 million and
$16.7 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of
approximately $87.7 million. If we incur additional significant losses, our stock price may decline, perhaps significantly. Our management
is developing plans to achieve profitability. Our business plan is speculative and unproven. There is no assurance that we will be successful
in executing our business plan or that even if we successfully implement our business plan, that we will be able to curtail our losses
now or in the future. Further, as we are a new enterprise, we expect that net losses will continue.
There is substantial doubt about our ability
to continue as a going concern, which will affect our ability to obtain future financing and may require us to curtail our operations.
Our financial statements as of December 31, 2024
were prepared under the assumption that we will continue as a going concern. The independent registered public accounting firm that audited
our 2024 financial statements, in their report, included an explanatory paragraph referring to our recurring losses since inception and
expressing management’s assessment and conclusion that there is substantial doubt in our ability to continue as a going concern.
Our financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our ability to continue
as a going concern depends on our ability to obtain additional equity or debt financing, attain further operating efficiencies, reduce
expenditures, and, ultimately, to generate revenue. We cannot assure you, however, that we will be able to achieve any of the foregoing.
See Note 2 to our Consolidated Financial Statements for further details.
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Our cash will only fund our operations for
a limited time and we will need to raise additional capital in order to support our development.
We are currently operating at a loss and expect our operating costs
will increase significantly as we continue to grow our operations. The independent registered public accounting firm that audited our
2024 financial statements, in their report, included an explanatory paragraph referring to our recurring losses since inception and expressing
management’s assessment and conclusion that there is substantial doubt in our ability to continue as a going concern. At December
31, 2024, we had cash of approximately $2.9 million. We will need to raise additional capital or generate substantial revenue in order
to support our development and commercialization efforts.
If our available cash balances are insufficient
to satisfy our liquidity requirements, including due to risks described herein, we may seek to raise additional capital through equity
offerings, debt financings, collaborations or licensing arrangements. We will need to raise additional capital, and we may also consider
raising additional capital in the future to expand our business, to pursue strategic investments, to take advantage of financing opportunities,
or for other reasons, including to:
● fund development and expansion of our operations;
● acquire, license or invest in technologies and additional laboratories;
● acquire or invest in complementary businesses or assets; and
● finance capital expenditures and general and administrative expenses.
Our present and future funding requirements will
depend on many factors, including:
● our sales and marketing and research and development activities; and
● changes in regulatory oversight applicable to our products and services.
Other than our debt facility with our
chairman, we have no arrangements or credit facilities in place as a source of funds, and there can be no assurance that we will be
able to raise sufficient additional capital on acceptable terms, or at all, and if we are not successful in raising additional
capital, we may not be able to continue as a going concern. We may seek additional capital through a combination of private and
public equity offerings, debt financings and strategic collaborations. Debt financing, if obtained, may involve agreements that
include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, that could
increase our expenses and require that our assets secure such debt. Equity financing, if obtained, could result in dilution to our
then existing stockholders and/or require such stockholders to waive certain rights and preferences. If such financing is not
available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate the development of
business opportunities and our operations and financial condition may be materially adversely affected. We can provide no assurances
that any additional sources of financing will be available to us on favorable terms, if at all. Future capital raises may dilute our
existing stockholders’ ownership and/or have other adverse effects on our operations.
If we raise additional capital by issuing equity
securities, our existing stockholders’ percentage ownership will be reduced and these stockholders may experience substantial dilution.
If we raise additional funds by issuing debt securities,
these debt securities would have rights senior to those of our common stock and the terms of the debt securities issued could impose significant
restrictions on our operations, including liens on our assets. If we raise additional funds through collaborations and licensing arrangements,
we may be required to relinquish some rights to our technologies or products, or to grant licenses on terms that are not favorable to
us.
We have significant outstanding debt obligations
and servicing these debt obligations will require a significant amount of capital, and our business may not be able to pay our substantial
debt.
As of December 31, 2024, we had approximately $8.4 million of outstanding
indebtedness. In order to service this indebtedness and any additional indebtedness we may incur in the future, we will need to generate
cash from our operating activities. Our ability to generate cash is subject, in part, to our ability to successfully execute our business
strategy, as well as general economic, financial, competitive, regulatory and other factors beyond our control. If we are unable to generate
sufficient cash to repay our debt obligations when they become due and payable, either when they mature, or in the event of a default,
we may not be able to obtain additional debt or equity financing on favorable terms, if at all, which may negatively impact our business
operations and financial condition.
If we breach any of the undertakings or default
on any of our obligations under our agreements with our lenders, our outstanding indebtedness could become immediately due and payable,
which would harm our business, financial condition and results of operations and could require us to reduce or cease operations. If our
indebtedness were to be accelerated, there can be no assurance that our assets would be sufficient to repay in full that indebtedness.
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Our business and operations may be further
impacted by epidemics, outbreaks and other public health events.
Epidemics, outbreaks or other public health events
that are outside of our control could significantly disrupt our operations and adversely affect our financial condition. The global or
national outbreak of an illness or other communicable disease, or any other public health crisis, such as COVID-19, may cause disruptions
to our business and operations, which may include (i) shortages of employees, (ii) unavailability of contractors or subcontractors, (iii)
interruption of supplies from third parties upon which we rely, (iv) recommendations of, or restrictions imposed by government and health
authorities, including quarantines, to address an outbreak and (v) restrictions that we and our contractors, subcontractors and our customers
impose, including facility shutdowns, to ensure the safety of employees.
We depend upon key personnel and need additional
personnel.
Our success depends on the continuing
services of Wenzhao Lu, our Chairman of the Board, and David Jin, Meng Li and Luisa Ingargiola, our executive officers. The loss of
Mr. Lu, Dr. Jin, Ms. Li or Ms. Ingargiola could have a material and adverse effect on our business operations. Additionally, the
success of our operations will largely depend upon our ability to successfully attract and maintain competent and qualified key
management personnel. As with any company with limited resources, there can be no guaranty that we will be able to attract such
individuals or that the presence of such individuals will necessarily translate into profitability for us. Our inability to attract
and retain key personnel may materially and adversely affect our business operations. The supply of qualified technical,
professional, managerial and other personnel, including lab medical directors and lab operations managers, is currently constrained;
competition for qualified employees, even across different industries, is intense, including as individuals leave the job market. We
may lose, or fail to attract and retain, key management personnel, or qualified skilled technical, professional or other employees.
The same is true for patient-facing staff with specialized training required to perform activities related to specimen collection.
In the future, if competition for the services of these professionals increases, we may not be able to continue to attract and
retain individuals in its markets. Changes in key management, or the ability to attract and retain qualified personnel, as a result
of increased competition for talent, wage growth, or other market factors, could lead to strategic and operational challenges and
uncertainties, distractions of management from other key initiatives, and inefficiencies and increased costs, any of which could
adversely affect our business, financial condition, results of operations, and cash flows.
Joint ventures, joint ownership arrangements
and other projects pose unique challenges and we may not be able to fully implement or realize synergies, expected returns or other anticipated
benefits associated with such projects.
We are, and may be in the future, involved in
strategic joint ventures and other joint ownership arrangements. We may not always be in complete alignment with our joint venture or
joint owner counterparties; we may have differing strategic or commercial objectives and may be outvoted by our joint venture partners
or we may disagree on governance matters with respect to the joint venture entity or the jointly owned assets. As a result, when we enter
into joint ventures or joint ownership arrangements, we may be subject to a number of risks. In some joint ventures and joint ownership
arrangements we may not be responsible for the operation of projects and will rely on our joint venture or joint owner counterparties
for such services. Joint ventures and joint ownership arrangements may also require us to expend additional internal resources that could
otherwise be directed to other projects. If we are unable to successfully execute and manage our existing and any proposed joint venture
and joint owner arrangements, it could adversely impact our financial and operating results.
We may be undertaking, or participating with various
counterparties in, a number of projects that involve forming joint ventures and acquiring laboratories that are accretive to our commercial
strategy. Many of these projects could involve numerous regulatory, environmental, commercial, economic, political and legal uncertainties
that are beyond our control, including the following:
As a result of these uncertainties, the anticipated
benefits associated with our joint ventures and joint ownership arrangements may not be achieved or could be delayed. In turn, this could
negatively impact our cash flow and our ability to make or increase cash distributions to our partners.
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We must effectively manage the growth of our
operations, or our company will suffer.
To manage our growth, we believe we must continue
to implement and improve our services and products. We may not have adequately evaluated the costs and risks associated with our planned
expansion, and our systems, procedures, and controls may not be adequate to support our operations. In addition, our management may not
be able to achieve the rapid execution necessary to successfully offer our products and services and implement our business plan on a
profitable basis. The success of our future operating activities will also depend upon our ability to expand our support system to meet
the demands of our growing business. Any failure by our management to effectively anticipate, implement, and manage changes required to
sustain our growth would have a material adverse effect on our business, financial condition, and results of operations.
Our revenue and results of operations may suffer
if we are unable to attract new tenants.
We presently derive our revenue from rental revenue
from our income-producing real estate property in New Jersey. Our growth therefore depends on our ability to attract new tenants. This
depends on our ability to understand and anticipate market and pricing trends and our tenants’ needs. Our failure to attract new
tenants could materially and adversely affect our operating results.
Potential liability claims may adversely affect
our business.
Our services, which may include recommendations
and advice to organizations regarding complex business and operational processes and regulatory and compliance issues may give rise to
liability claims by our clients or by third parties who bring claims against our clients. Healthcare organizations often are the subject
of regulatory scrutiny and litigation, and we also may become the subject of such litigation based on our advice and services. Any such
litigation, whether or not resulting in a judgment against us, may adversely affect our reputation and could have a material adverse effect
on our financial condition and results of operations. We may not have adequate insurance coverage for claims against us.
In accordance with our strategic development
policy, we may invest in companies for strategic reasons and may not realize a return on our investments.
From time to time, we may make investments in companies. These investments
may be for strategic objectives to support our key business initiatives but may also be standalone investments or acquisitions. Such investments
or acquisitions could include equity or debt instruments in private companies, many of which may not be marketable at the time of our
initial investment. These companies may range from early-stage companies that are often still defining their strategic direction to more
mature companies with established revenue streams and business models. The success of these companies may depend on product development,
market acceptance, operational efficiency, and other key business factors. The companies in which we invest may fail because they may
not be able to secure additional funding, obtain favorable investment terms for future financings, or take advantage of liquidity events
such as public offerings, mergers, and private sales. If any of these private companies fails, we could lose all or part of our investment
in that company. If we determine that impairment indicators exist and that there are other-than-temporary declines in the fair value of
the investments, we may be required to write down the investments to their fair value and recognize the related write-down as an investment
loss. For the year ended December 31, 2024, we had an impairment of goodwill acquired from Lab Services MSO acquisition of approximately
$0.3 million. In the future, we could have additional impairment charges related to investments that we may make.
Our strategic transactions involve risks, and
we may not realize the expected benefits because of numerous uncertainties and risks.
We regularly consider and may enter into strategic
transactions, including mergers, acquisitions, joint ventures, investments and other growth, market and geographic expansion strategies,
with the expectation that these transactions will result in increases in sales, cost savings, synergies, and other various benefits. Our
ability to deliver the expected benefits from any strategic transaction is subject to numerous uncertainties and risks, including our
ability to integrate personnel, labor models, financial, IT and other systems successfully; disruption of our ongoing business and distraction
of management; hiring additional management and other critical personnel; and increasing the scope, geographic diversity, and complexity
of our operations. Effective internal controls are necessary to provide reliable and accurate financial reports, and the integration of
businesses may create complexity in our financial systems and internal controls and make them more difficult to manage. Integration of
businesses into our internal control system could cause us to fail to meet our financial reporting obligations. Additionally, we may recognize
material impairments in the future, including in connection with assets we have acquired or divested in a strategic transaction or charges
to earnings associated with any strategic transaction, which may materially reduce our earnings. Our shareholders may react unfavorably
to our strategic transactions and strategic transactions may also be subject to regulatory uncertainty due to the changing enforcement
landscape. We may not realize the anticipated benefits from such transactions, we may be exposed to additional liabilities of any acquired
business or joint venture, and we may be exposed to litigation in connection with the strategic transaction. Further, we may finance these
strategic transactions by incurring additional debt, which could increase leverage or impact our ability to access capital in the future.
We face intense competition which could cause us to lose market
share.
In the healthcare markets in which we operate,
we will compete with large healthcare providers who have more significant financial resources, established market positions, long-standing
relationships, and who have more significant name recognition, technical, marketing, sales, distribution, financial and other resources
than we do. The resources available to our competitors to develop new services and products and introduce them into the marketplace exceed
the resources currently available to us. This intense competitive environment may require us to make changes in our services, products,
pricing, licensing, distribution, or marketing to develop a market position.
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If we fail to comply with our obligations in
the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business
relationships with our licensors, we could lose intellectual property rights that are important to our business.
We are party to a research agreement with the
Massachusetts Institute of Technology (“MIT”) for development of chimeric antigen receptor (CAR) technology. Although we have
halted all research and development, MIT has granted us options to non-exclusively or exclusively license MIT inventions arising under
this research agreement and we continue to maintain our joint patent applications.
Moreover, Disputes may arise regarding intellectual
property subject to a licensing agreement, including:
● the priority of invention of patented technology.
In addition, the agreements under which we currently
license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible
to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to
be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other
obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results
of operations, and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to
maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize
the affected product candidates, which could have a material adverse effect on our business, financial conditions, results of operations,
and prospects.
We may face uncertainty and difficulty in obtaining
and enforcing our patents and other proprietary rights.
There can be no assurance that any patent applications
we file or license will be approved, or that challenges will not be instituted against the validity or enforceability of any patent licensed-in
or owned by us. Our pending and future patent applications may not result in patents being issued that protect our product candidates,
in whole or in part, or which effectively prevent others from commercializing competitive product candidates. Even if our patent applications
issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing
with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar
or alternative product candidates in a non-infringing manner. The cost of litigation to uphold the validity and prevent infringement of
a patent is substantial. Furthermore, there can be no assurance that others will not independently develop substantially equivalent technologies
not covered by patents to which we have rights or obtain access to our know-how. In addition, the laws of certain countries may not adequately
protect our intellectual property. Our competitors may possess or obtain patents on products or processes that are necessary or useful
to the development, use, or manufacture of our product candidates. There can also be no assurance that our proposed technology will not
infringe upon patents or proprietary rights owned by others, with the result that others may bring infringement claims against us and
require us to license such proprietary rights, which may not be available on commercially reasonable terms, if at all. Any such litigation,
if instituted, could have a material adverse effect, potentially including monetary penalties, diversion of management resources, and
injunction against continued manufacture, use, or sale of certain products or processes.
We rely upon non-patented proprietary know-how.
There can be no assurance that we can adequately protect our rights in such non-patented proprietary know-how, or that others will not
independently develop substantially equivalent proprietary information or techniques or gain access to our proprietary know-how. Any of
the foregoing events could have a material adverse effect on us. In addition, if any of our trade secrets, know-how or other proprietary
information were to be disclosed, or misappropriated, the value of our trade secrets, know-how and other proprietary rights would be significantly
impaired and our business and competitive position would suffer.
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In September 2011, the Leahy-Smith America Invents
Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These
include provisions that affect the way patent applications will be prosecuted and may also affect patent litigation. In particular, under
the Leahy-Smith Act, the United States transitioned in March 2013 to a “first to file” system in which the first inventor
to file a patent application will be entitled to the patent. Third parties are allowed to submit prior art before the issuance of a patent
by the U.S. Patent and Trademark Office, or USPTO, and may become involved in opposition, derivation, post-grant and inter partes review,
or interference proceedings challenging our patent rights. An adverse determination in any such submission, proceeding or litigation could
reduce the scope of, or invalidate, our patent rights, which could adversely affect our competitive position.
The USPTO has developed new and untested
regulations and procedures to govern the full implementation of the Leahy-Smith Act, and many of the substantive changes to patent
law associated with the Leahy-Smith Act, and in particular, the “first-to-file” provisions, only became effective in
March 2013. The Leahy-Smith Act has also introduced procedures that may make it easier for third parties to challenge issued
patents, as well as to intervene in the prosecution of patent applications. Finally, the Leahy-Smith Act contains new statutory
provisions that still require the USPTO to issue new regulations for their implementation, and it may take the courts years to
interpret the provisions of the new statute. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the
operation of our business. The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the
prosecution of our patent applications and the enforcement or defense of our issued patents.
We may not be able to protect our intellectual
property rights throughout the world.
Filing, prosecuting and defending patents on our
product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some
countries outside the United States may be less extensive than those in the United States. In addition, the laws of some foreign countries
do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not
be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing
products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions
where we do not obtain patent protection to develop their own products and may also export infringing products to territories where we
have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products and
our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many companies have encountered significant problems
in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly
certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly
those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of
competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions,
whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business,
could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could
provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies
awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world
may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
Patent terms may be inadequate to protect our
competitive position on our product candidates for an adequate amount of time.
Patents have a limited lifespan. In the United
States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional
filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents
covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive products,
including generics or biosimilars. Given the amount of time required for the development, testing and regulatory review of new product
candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, any
patents we may obtain may not provide us with sufficient rights to exclude others from commercializing products similar or identical to
ours.
Obtaining and maintaining patent protection
depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent
agencies, and any patent protection we may obtain in the future could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity
fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental
patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. The USPTO and various
non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions
during the patent application process. There are situations in which non-compliance can result in abandonment or lapse of the patent
or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors
might be able to enter the market and this circumstance would have a material adverse effect on our business.
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It is difficult and costly to protect our proprietary
rights, and we may not be able to ensure their protection. If we fail to protect or enforce our intellectual property rights adequately
or secure rights to patents of others, the value of our intellectual property rights would diminish.
Our commercial viability will depend in part on
obtaining and maintaining patent protection and trade secret protection of our product candidates, and the methods used to manufacture
them, as well as successfully defending these patents against third-party challenges. Our ability to stop third parties from making, using,
selling, offering to sell, or importing our products is dependent upon the extent to which we obtain rights under valid and enforceable
patents or trade secrets that cover these activities.
The patent positions of pharmaceutical and biopharmaceutical
companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.
No consistent policy regarding the breadth of claims allowed in biopharmaceutical patents has emerged to date in the United States. The
biopharmaceutical patent situation outside the United States is even more uncertain. Changes in either the patent laws or in interpretations
of patent laws in the United States and other countries may diminish the value of our intellectual property. Accordingly, we cannot predict
the breadth of claims that may be allowed or enforced in the patents we own. Further, if any of our patents are deemed invalid and unenforceable,
it could impact our ability to commercialize or license our technology.
The degree of future protection for our proprietary
rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain
or keep our competitive advantage. For example:
● the patents of others may have an adverse effect on our business.
We also may rely on trade secrets to protect our
technology, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to
protect. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific
collaborators, and other advisors may unintentionally or willfully disclose our information to competitors. In addition, courts outside
the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent
knowledge, methods, and know-how.
We may be subject to claims challenging the
inventorship of patents and other intellectual property.
We or our licensors may be subject to claims
that former employees, collaborators or other third parties have an interest as an inventor or co-inventor in intellectual property
we own or license. For example, we or our licensors may have inventorship disputes arise from conflicting obligations of employees,
consultants or others who are involved in developing our product candidates. We may be subject to claims by third parties asserting
that our licensors, employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our
own intellectual property. Litigation may be necessary to defend against these and other claims challenging inventorship or our or
our licensors’ ownership of our owned or in-licensed patents, trade secrets or other intellectual property. If we or our
licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property
rights, such as exclusive ownership of, or right to use, intellectual property that is important to our product candidates. Even if
we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management
and other employees. Any of the foregoing could have a material adverse effect on our business, financial condition, results of
operations and prospects.
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If any of our trade secrets, know-how or other
proprietary information is disclosed, the value of our trade secrets, know-how and other proprietary rights would be significantly impaired
and our business and competitive position would suffer.
Our viability also depends upon the skills, knowledge
and experience of our scientific and technical personnel, and our consultants and advisors. To help protect our proprietary know-how and
our inventions for which patents may be unobtainable or difficult to obtain, we rely on trade secret protection and confidentiality agreements.
To this end, we require all of our employees, consultants, advisors and contractors to enter into agreements which prohibit unauthorized
disclosure and use of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments,
discoveries and inventions important to our business. These agreements are often limited in duration and may not provide adequate protection
for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure or the lawful development
by others of such information. There is no assurance that such agreements will be honored by such parties or enforced in whole or part
by the courts. We cannot be certain that others will not gain access to these trade secrets or that our patents will provide adequate
protection. Others may independently develop substantially equivalent proprietary information and techniques or otherwise gain access
to our trade secrets. In addition, enforcing a claim that a third party illegally obtained and is using any of our trade secrets is expensive
and time consuming, and the outcome is unpredictable. If any of our trade secrets, know-how or other proprietary information is improperly
disclosed, the value of our trade secrets, know-how and other proprietary rights would be significantly impaired and our business and
competitive position would suffer.
We may incur substantial costs as a result
of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights
to, or use of, our technology.
If we choose to go to court to stop a third party
from using the inventions claimed in our patents, that individual or company has the right to ask the court to rule that such patents
are invalid and/or should not be enforced against that third party. These lawsuits are expensive and would consume time and other resources,
even if we were successful in discontinuing the infringement of our patents. In addition, there is a risk that the court will decide that
these patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk
that, even if the validity of these patents is upheld, the court will refuse to stop the other party on the ground that such other party’s
activities do not infringe our rights to these patents. In addition, the U.S. Supreme Court has in the past invalidated tests used by
the USPTO in granting patents over the past 20 years. As a consequence, issued patents may be found to contain invalid claims according
to the newly revised standards. Some of our own patents may be subject to challenge and subsequent invalidation in a variety of post-grant
proceedings, particularly inter partes review, before the USPTO or during litigation under the revised criteria, which make it
more difficult to defend the validity of claims in already issued patents.
Furthermore, a third party may claim that we
or our manufacturing or commercialization partners are using inventions covered by the third party’s patent rights and may go
to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates. These
lawsuits are costly and could affect our results of operations and divert the attention of managerial and technical personnel. There
is a risk that a court could decide that we or our commercialization partners are infringing the third party’s patents and
order us or our partners to stop the activities covered by the patents. In addition, there is a risk that a court could order us or
our partners to pay the other party damages for having violated the other party’s patents. The biotechnology industry has
produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various
types of products, manufacturing processes or methods of use. The coverage of patents is subject to interpretation by the courts,
and the interpretation is not always uniform. If we are sued for patent infringement, we would need to demonstrate that our
products, manufacturing processes or methods of use either do not infringe the patent claims of the relevant patent and/or that the
patent claims are invalid, and we may not be able to do this. Proving invalidity, in particular, is difficult since it requires a
showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.
As some patent applications in the United States
may be maintained in secrecy until the patents are issued, because patent applications in the United States and many foreign jurisdictions
are typically not published until eighteen months after filing, and because publications in the scientific literature often lag behind
actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our issued patents or
our pending applications, or that we were the first to invent the technology. Our competitors may have filed, and may in the future file,
patent applications covering technology similar to ours. Any such patent applications may have priority over our patent applications or
patents, which could further require us to obtain rights to issued patents covering such technologies. If another party has filed a United
States patent application on inventions similar to ours, we may have to participate in an interference proceeding declared by the USPTO
to determine priority of invention in the United States. The costs of these proceedings could be substantial, and it is possible that
such efforts would be unsuccessful if, unbeknownst to us, the other party had independently arrived at the same or similar invention prior
to our own invention, resulting in a loss of our U.S. patent position with respect to such inventions.
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Some of our competitors may be able to sustain
the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any
uncertainties resulting from the initiation and continuation of any litigation or inter partes review proceedings could have a
material adverse effect on our ability to raise the funds necessary to continue our operations.
Some jurisdictions in which we operate have enacted
legislation which allows members of the public to access information under statutes similar to the U.S. Freedom of Information Act. Even
though we believe our information would be excluded from the scope of such statutes, there are no assurances that we can protect our confidential
information from being disclosed under the provisions of such laws. If any confidential or proprietary information is released to the
public, such disclosures may negatively impact our ability to protect our intellectual property rights.
Breaches or compromises of our information
security systems or our information technology systems or infrastructure could result in exposure of private information, disruption of
our business and damage to our reputation, which could harm our business, results of operation and financial condition.
We utilize information security and information
technology systems and websites that allow for the secure storage and transmission of proprietary or private information regarding our
clients, patients, employees, vendors and others, including individually identifiable health information. A security breach of our network,
hosted service providers, or vendor systems, may expose us to a risk of loss or misuse of this information, litigation and potential liability.
Hackers and data thieves are increasingly sophisticated and operate large-scale and complex automated attacks, including on companies
within the healthcare industry. Although we believe that we take appropriate measures to safeguard sensitive information within our possession,
we may not have the resources or technical sophistication to anticipate or prevent rapidly-evolving types of cyber-attacks targeted at
us, our clients, our patients, or others who have entrusted us with information. Actual or anticipated attacks may cause us to incur costs,
including costs to deploy additional personnel and protection technologies, train employees, and engage third-party experts and consultants.
We invest in industry standard security technology to protect personal information. Advances in computer capabilities, new technological
discoveries, or other developments may result in the technology used by us to protect personal information or other data being breached
or compromised. To our knowledge, we have not experienced any material breach of our cybersecurity systems. If our or our third-party
service provider systems fail to operate effectively or are damaged, destroyed, or shut down, or there are problems with transitioning
to upgraded or replacement systems, or there are security breaches in these systems, any of the aforementioned could occur as a result
of natural disasters, software or equipment failures, telecommunications failures, loss or theft of equipment, acts of terrorism, circumvention
of security systems, or other cyber-attacks, we could experience delays or decreases in revenue, and reduced efficiency of our operations.
Additionally, any of these events could lead to violations of privacy laws, loss of customers, or loss, misappropriation or corruption
of confidential information, trade secrets or data, which could expose us to potential litigation, regulatory actions, sanctions or other
statutory penalties, any or all of which could adversely affect our business, and cause us to incur significant losses and remediation
costs.
We may be exposed to liabilities under the
Foreign Corrupt Practices Act, and any determination that we violated the Foreign Corrupt Practices Act or Chinese anti-corruption law
could have a material adverse effect on our business.
We are subject to the Foreign Corrupt Practice
Act, or FCPA, and other laws that prohibit improper payments or offers of payments to foreign governments and their officials and political
parties by U.S. persons and issuers as defined by the statute, for the purpose of obtaining or retaining business. We have operations
and agreements with third parties where corruption may occur. It is our policy to implement safeguards to prevent these practices by our
employees. However, our existing safeguards and any future improvements may prove to be less than effective, and the employees, consultants,
sales agents or distributors of our company may engage in conduct for which we might be held responsible.
Violations of the FCPA or other anti-corruption
laws may result in severe criminal or civil sanctions, and we may be subject to other liabilities, which could negatively affect our business,
operating results and financial condition. In addition, the United States government may seek to hold our company liable for successor