Item 1A. Risk Factors
Item 1A. Risk Factors.
An investment in our securities involves a high degree of risk. You
should carefully consider the risks and uncertainties described below, together with all of the other information contained in this Annual
Report, including our consolidated financial statements and the related notes thereto, before deciding to invest in our securities. The
risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that
we currently believe are not material, may also become important factors that adversely affect our business. If any of the following risks
actually occur, our business, financial condition, results of operations and prospects could be materially and adversely affected. In
that event, the market price of our Common Stock could decline, and you could lose part or all of your investment.
RISKS RELATED TO OUR FINANCIAL CONDITION AND CAPITAL STRUCTURE
Our financial statements have been prepared
on a going-concern basis and our continued operations are in doubt.
The uncertainty about our ability to continue in operation
is based on our continuing losses from operation, limited revenue and limited working capital, among other things which existed as of
year-end December 31, 2025 and December 31, 2025. As of December 31, 2025 and December 31, 2024, the Company had net working capital of
$2,928,959 and $4,251,867, respectively, and has an accumulated deficit of $21,017,440 and $13,269,627, respectively. Included in the
accumulated deficit are net losses of $7,747,813 for the year ended December 31, 2025 and $6,245,737 for the year ended December 31, 2024.
Given all of these facts, we are dependent on obtaining funding from operations and the sale of debt or equity to continue as a going
concern. The financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities
that might be necessary should we be unable to continue as a going concern.
Our ability to continue as a going concern depends
on the success of any future offering and receipt of additional funds through debt or equity financing and our operations. In the event
we are unable to obtain such funding, we may have to delay, reduce or eliminate certain of our planned operations, including some of our
research and development and/or clinical validation studies to demonstrate aesthetic improvement, reduce overall overhead expense, or
divest assets. This in turn may have an adverse effect on our ability to realize the value of our assets. If we are unable to continue
as a going concern, you may lose all or part of your investment.
We have a history of net losses, and we may
not be able to achieve or maintain profitability in the future.
We have incurred net losses each year since our inception, and we may
not be able to achieve or maintain profitability in the future. We incurred net losses of $7,747,813 and $6,245,737 for the years ended
December 31, 2025 and 2024, respectively. Our expenses will likely increase in the future and may be more costly than we expect and may
not result in increased revenue or growth in our business. These offerings may require significant capital investments and recurring costs,
maintenance, depreciation, asset life and asset replacement costs, and if we are not able to maintain sufficient levels of utilization
of such assets or such offerings are otherwise not successful, our investments may not generate sufficient returns and our financial condition
may be adversely affected. Any failure to increase our revenue sufficiently to keep pace with our investments and other expenses could
prevent us from achieving or maintaining profitability or positive cash flow on a consistent basis. If we are unable to successfully address
these risks and challenges as we encounter them, our business, financial condition, results of operations and prospects could be adversely
affected. If we are unable to generate adequate revenue growth and manage our expenses, we may continue to incur significant losses in
the future and may not be able to achieve or maintain profitability.
Our operating cash consumption significantly
exceeds our revenue, and we may not be able to fund our operations without continued access to the capital markets.
Our current level of operating cash consumption
materially exceeds our revenue and is not sustainable without continued infusions of external capital. If we are unable to substantially
increase revenue from our operating subsidiaries, achieve returns on capital through PMGC Capital, or continue to access debt and equity
financing, we may be unable to fund our operations. There can be no assurance that we will be able to reduce our operating cash burn to
a level that can be sustained by our operating revenue within any particular timeframe, if at all.
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We will need additional capital to conduct
our operations and develop our products and businesses, and our ability to obtain the necessary funding is uncertain.
We have used, and expect to continue to use, a significant amount of
cash to finance our operations, and we need to obtain significant additional capital resources in order to develop our businesses and
products going forward. We may not be successful in maintaining our normal operating cash flow and the timing of our capital expenditures
may not result in cash flows sufficient to sustain our operations through the next twelve months. If financing is not sufficient and additional
financing is not available or available only on terms that are detrimental to our long-term survival, it could have a major adverse effect
on our ability to pursue our business strategy, clinical research and product development programs, and could ultimately affect our ability
to continue to function. The timing and degree of any future capital requirements and our ability to meet such capital requirements in
a timely manner, on favorable terms or at all will depend on many factors, including:
●
the accuracy of the assumptions underlying our estimates for capital needs;
●
the success and growth of our acquired operating subsidiaries;
●
scientific progress in our research and development programs at Northstrive Biosciences;
●
the magnitude and scope of our acquisition strategy and our ability to identify, negotiate, finance and integrate target companies;
●
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims;
●
the performance of PMGC Capital’s investment portfolio;
●
the number and type of pipeline products that we pursue; and
●
the development of major widespread events, including the possibility of a recession in the U.S. and globally, market volatility, geopolitical conflict, tariffs, trade restrictions and other events which could impact us and third parties on which we depend.
Additional financing through strategic
collaborations, public or private equity or debt financings or other financing sources may not be available on acceptable terms, or at
all. Additional equity financing could result in significant dilution to our stockholders, and any debt financings will likely involve
covenants restricting our business activities. Further, if we obtain additional funds through arrangements with collaborative partners,
these arrangements may require us to relinquish rights to some of our technologies, products or pipeline assets that we might otherwise
seek to develop and commercialize on our own. If sufficient capital is not available, we may be required to delay, reduce the scope of
or eliminate one or more of our business initiatives, research or product development programs, or planned acquisitions, any of which
could have a material adverse effect on our financial condition or business prospects.
Our existing equity purchase facility may result in substantial dilution
to our existing stockholders and may place downward pressure on the price of our Common Stock.
We have entered into an equity purchase facility with Streeterville
Capital, LLC (“Streeterville”), as disclosed in previous SEC filings, pursuant to which we may consummate one or more secured
pre-paid purchases of our Common Stock, and we have consummated multiple pre-paid purchases thereunder. Under these arrangements, the
outstanding principal and accrued interest is convertible at the option of the investor at a price that reflects a discount to the volume-weighted
average price of our Common Stock during a specified look-back period, subject to a floor price. We have issued, and expect to continue
to issue, significant numbers of shares of Common Stock in settlement of amounts outstanding under these arrangements.
The conversion mechanics for the pre-paid purchases under the equity
purchase facility, which allow conversion at a discount to market price, may create significant downward pressure on the trading price
of our Common Stock. As the stock price declines, additional shares may be required to settle the same dollar amount of debt, potentially
creating a cycle of increasing dilution and declining stock price. These dynamics could materially and adversely affect the market price
of our Common Stock, the ability of existing stockholders to sell their shares at favorable prices, and our ability to raise additional
capital on acceptable terms. The settlement and potential conversion of outstanding and future instruments under the equity line of credit
into shares of Common Stock will result in further dilution to our existing stockholders, and the magnitude of such dilution will depend
on market conditions at the time of conversion.
Our equity interests in our key subsidiaries and the assets of those subsidiaries are pledged as collateral under
our equity purchase facility with Streeterville,
and a default on our obligations pursuant to such facility could result in the loss of our operating businesses.
In connection with our equity purchase facility with Streeterville,
we entered into a Security Agreement and a Pledge Agreement, pursuant to which we pledged, as collateral, (i) 100% of the equity interests
(membership interests and stock, respectively) in our wholly-owned subsidiaries, AGA Precision Systems and Pacific Sun Packaging, and
(ii) substantially all of the assets of these subsidiaries. Streeterville holds a first-position security interest in this collateral
(subordinate only to certain permitted liens). If we default on our obligations under such agreements, Streeterville is entitled to seize
the pledged equity interests or the assets of the subsidiaries. This may result in the loss of one or more of our primary operating businesses,
which would have a material adverse effect on our financial condition and ability to continue operations.
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We have conducted multiple reverse stock
splits in a short period of time, which may adversely affect the market price of our Common Stock and investor confidence.
Since November 2024, we have completed multiple reverse stock splits
of our Common Stock. Reverse stock splits may be viewed negatively by investors and analysts as an indication of financial difficulty
or poor stock performance. There can be no assurance that the market price of our Common Stock following any reverse stock split will
remain at a level proportional to the prices prior to the reverse stock split. The repeated use of reverse stock splits may diminish investor
confidence, reduce trading liquidity, and adversely affect our ability to attract and retain investors. If we are unable to maintain compliance
with the Nasdaq listing requirements, including the minimum bid price rule, we may be required to undertake further reverse stock splits
in the future, which could result in additional negative market perception and further dilution on a per-share basis for investors who
acquired shares prior to such splits.
If we fail to generate sufficient cash flow
from our operations, we will be unable to continue to develop and commercialize our products and grow our businesses.
We expect capital outlays and operating expenditures
to increase over the next several years as we expand our operations, pursue acquisitions, and conduct research and development and manufacturing
activities. However, our present and future funding requirements will depend on many factors, including, among other things:
●
the level of research and development investment required to maintain and improve our competitive position;
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the success of product sales and service revenue at our operating subsidiaries and related collections;
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the returns on capital deployed by PMGC Capital;
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our need or decision to acquire or license complementary businesses, products or technologies;
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costs relating to the expansion of our workforce, management and operational support across multiple subsidiaries;
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competing technological and market developments; and
●
costs relating to changes in regulatory policies or laws that affect our operations.
As a result of these factors, we may need to raise
additional funds, and we cannot be certain that such funds will be available to us on acceptable terms when needed, if at all. If we cannot
raise funds on acceptable terms, we may not be able to expand our operations, develop new products, take advantage of future opportunities
or respond to competitive pressures or unanticipated business requirements.
We may need, but be unable, to obtain additional
funding on satisfactory terms, which could dilute our stockholders or impose burdensome financial restrictions on our business.
We have relied upon cash from financing activities. In the future,
we hope to rely on revenues generated from operations to fund the cash requirements of our activities. However, there can be no assurance
that we will be able to generate any significant cash from our operating activities in the future. Future financing may not be available
on a timely basis, in sufficient amounts or on terms acceptable to us, if at all. Any debt financing or other financing of securities
senior to the Common Stock will likely include financial and other covenants that will restrict our flexibility. Any failure to comply
with these covenants would have a material adverse effect on our business, prospects, financial condition and results of operations because
we could lose our existing sources of funding and impair our ability to secure new sources of funding.
We may be unable to realize the expected
value from the divestiture of our Elevai Skincare business, including earn-out payments.
In connection with the divestiture of our Elevai
Skincare business, the purchase consideration included potential earn-out payments contingent upon the buyer achieving certain revenue
milestones over specified periods following the closing. There can be no assurance that the buyer will achieve these milestones or that
we will receive any earn-out payments. If the buyer’s business underperforms, experiences operational difficulties, or ceases operations,
we may receive little or no additional consideration beyond the amounts received at closing. Additionally, shares of the buyer’s common
stock received as consideration may have limited liquidity and their value may decline.
Changes in tax laws or regulations could
adversely affect our business and financial results.
We are subject to U.S. federal, state and local
tax laws, which are complex and subject to change. Changes in tax laws, regulations, or interpretations thereof, including changes resulting
from new legislation, could increase our tax obligations, reduce the value of our deferred tax assets, or otherwise adversely affect our
financial condition and results of operations. In addition, tax authorities may disagree with our tax positions or the manner in which
we allocate income and deductions among our subsidiaries, which could result in additional tax liabilities, interest and penalties.
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RISKS RELATED TO OUR HOLDING COMPANY STRUCTURE
AND ACQUISITION STRATEGY
Our diversified holding company structure
may make our business more complex and difficult to manage.
We operate as a diversified holding company with
subsidiaries across multiple industries, including biotechnology, precision manufacturing, specialty packaging, and investment activities.
This structure increases the complexity of our operations, financial reporting, internal controls, and management oversight. Each of our
subsidiaries operates in distinct markets with unique regulatory requirements, competitive dynamics, and capital needs.
Managing multiple disparate businesses requires
broad management expertise, robust financial and operational reporting systems, and the ability to allocate capital and personnel effectively
across unrelated industries. Our management team is small, and the breadth of our operations may strain our resources. If we are unable
to effectively manage this complexity, our business, financial condition, and results of operations could be adversely affected.
Our results depend on our ability to allocate
capital effectively across our subsidiaries and investments.
Our business model relies on deploying capital
across multiple subsidiaries and investment opportunities. Our ability to generate returns depends on management’s judgment in allocating
capital among competing opportunities, including acquisitions, internal investments, strategic initiatives, and investments through PMGC
Capital.
There can be no assurance that our capital allocation
decisions will achieve desired returns. Capital deployed into underperforming subsidiaries or unsuccessful investments represents an opportunity
cost and may result in impairment charges. Misallocation of capital could materially adversely affect our financial condition and long-term
shareholder value.
We may not realize anticipated benefits
from operating as a platform of multiple businesses.
We may not achieve expected operational, strategic,
or financial benefits from managing multiple subsidiaries under a single corporate structure. Our subsidiaries may operate independently
with limited synergies, and the costs associated with maintaining a diversified platform—including corporate overhead, compliance
costs, management attention and reporting requirements—may outweigh the benefits. If the anticipated advantages of our holding company
structure do not materialize, our financial condition and results of operations could be adversely affected.
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Our growth strategy depends on acquisitions,
which involve significant risks and uncertainties.
A core element of our business strategy is to
grow through the acquisition of operating companies and assets. We have completed multiple acquisitions and intend to continue pursuing
additional acquisitions. These transactions involve numerous risks, including:
●
difficulties in identifying suitable targets at reasonable valuations;
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failure to accurately assess the value, prospects, strengths and weaknesses of acquisition candidates;
●
inability to negotiate favorable terms or obtain financing for acquisitions;
●
failure to complete transactions after expending significant time and resources on due diligence;
●
difficulties in integrating acquired businesses, operations, technologies, systems and personnel;
●
assumption of unknown or undisclosed liabilities, including potential legal, regulatory, tax, environmental or contractual obligations;
●
disruption to our existing business and diversion of management attention;
●
loss of key employees, customers or suppliers of acquired businesses;
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potential impairment of acquired goodwill and intangible assets;
●
dilution to existing stockholders from equity issued as acquisition consideration or to finance acquisitions; and
●
increased debt and associated covenants and restrictions.
Acquired businesses may not perform as expected
and may require significantly more capital than anticipated. Failure to successfully identify, execute, finance or integrate acquisitions
could materially adversely affect our business, financial condition, and results of operations.
Potential business combinations could require
significant management attention, prove difficult to integrate, and adversely affect our operating results.
Business combinations generally involve a number
of additional difficulties and risks to our business, including failure to integrate management information systems, personnel, research
and development and marketing, operations, sales and support; disruption of our ongoing business and diversion of management’s attention
from other business matters; potential loss of the acquired company’s customers; failure to further develop or integrate the acquired
company’s products or technology successfully; unanticipated costs and liabilities; and other accounting consequences.
In addition, we may not realize benefits from
any business combination we may undertake in the future. If we fail to successfully integrate such businesses, or the products and technologies
associated with such business combinations into our Company, the revenue and operating results of the combined company could be adversely
affected. Any integration process would require significant time and resources, and we may not be able to manage the process successfully.
We may not successfully evaluate, integrate or utilize the acquired technology and product lines or accurately forecast the financial
impact of a combination.
The purchase price allocations for our acquisitions
may be preliminary and subject to adjustment, which could materially affect our reported financial results.
In connection with our acquisitions, the initial
purchase price allocations may be preliminary and subject to adjustment as we finalize our valuations of identifiable assets acquired
and liabilities assumed. Adjustments to preliminary purchase price allocations during the measurement period could result in changes to
the carrying values of acquired assets and liabilities, including goodwill, intangible assets, property and equipment, and deferred tax
liabilities. Such adjustments could materially affect our consolidated balance sheet, results of operations and financial condition in
future periods.
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We have recorded goodwill on our consolidated
balance sheet that may be subject to impairment, which could adversely affect our financial results.
We have recorded goodwill arising from our acquisitions. Goodwill is
not amortized but is subject to annual impairment testing, or more frequently if events or changes in circumstances indicate that the
carrying value may not be recoverable. Factors that could trigger an impairment review include, among others, a significant decline in
expected future cash flows of an acquired business, deterioration of market conditions, loss of key customers, underperformance relative
to projected financial results, and a sustained decline in the market price of our Common Stock. If any of our reporting units fail to
achieve projected results or if market conditions deteriorate, we may be required to record a non-cash goodwill impairment charge, which
could have a material adverse effect on our reported financial results and the market price of our Common Stock.
Earn-out and contingent consideration arrangements
may result in disputes or financial obligations that adversely affect our results.
Certain of our acquisition agreements include
earn-out or contingent consideration provisions that are payable based on the achievement of specified financial milestones by the acquired
businesses. If acquired businesses achieve the applicable performance thresholds, we will be required to make additional payments that
will increase the overall cost of the acquisitions and reduce our available cash. Conversely, disagreements with sellers regarding the
measurement or achievement of earn-out targets could result in disputes, litigation or strained relationships with key personnel who remain
involved in the acquired businesses. Changes in fair value of contingent consideration are recognized in earnings and may cause volatility
in our reported results of operations.
We depend on the founders and key employees
of our acquired businesses, and their departure could adversely affect the performance of those businesses.
Our recently acquired subsidiaries have historically
been operated by their founders and small teams with deep customer relationships, specialized technical knowledge and institutional know-how.
The success of these businesses following acquisition depends in significant part on our ability to retain and motivate these individuals
during the transition period and beyond. If the former owners or other key employees of our acquired businesses depart or become disengaged,
we may experience disruptions to operations, loss of customer relationships, loss of critical technical expertise, and a decline in the
performance of these businesses, any of which could materially adversely affect our revenue and results of operations.
RISKS RELATED TO OUR OPERATING SUBSIDIARIES
Risks Related to Northstrive Biosciences Inc.
(Biotechnology)
Our biotechnology subsidiary, Northstrive Biosciences, is at an early
stage of product development, and we may not develop products that can be successfully commercialized.
Northstrive Biosciences is at an early stage of
product development. As of the date of this Annual Report, we have not commercialized any therapeutic products. Our lead asset, EL-22,
has completed a Phase 1 clinical trial in South Korea but has not yet been tested in human subjects in the United States. Our second asset,
EL-32, is in the preclinical stage. A key element of our growth strategy depends on our ability to develop and advance these product candidates
through clinical trials, obtain regulatory approvals, and ultimately commercialize products, which may take many years and may never occur.
We may not be able to successfully commercialize or synthesize any of our product candidates at a scale that is profitable. Our product
candidates may prove to have undesirable and unintended side effects or other characteristics adversely affecting their safety, efficacy
or cost effectiveness that could prevent or limit their use.
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Because our future commercial success with
respect to our Licensed Products (as defined below) depends on gaining regulatory approval, we cannot generate therapeutic revenue without
obtaining such approvals.
Our long-term success and generation of revenue
with respect to the Licensed Products will depend upon the successful development of these product candidates from our research and development
activities. Product development is very expensive and involves a high degree of risk. Only a small number of research and development
programs result in the commercialization of a product. The process for obtaining regulatory approval to market product candidates is expensive,
usually takes many years, and can vary substantially based on the type, complexity, and novelty of the product candidates involved. Our
ability to generate revenue from the Licensed Products would be adversely affected if we are delayed or unable to successfully develop
our products.
We cannot guarantee that any marketing application
for our product candidates will be approved. If we do not obtain regulatory approval of our products or we are significantly delayed or
limited in doing so, we cannot generate therapeutic revenue, and we may need to significantly curtail operations related to Northstrive
Biosciences.
(“Field” means (a) all prophylactic
and therapeutic uses in humans, including but not limited to the prevention and treatment of muscular (including, but not limited to,
Duchenne muscular dystrophy and sarcopenia), obesity, metabolic, renal, cardiovascular, psychological, psychiatric, neurologic, and endocrine
conditions in humans; and (b) all uses in animal health, including all applications as a feed additive.
“Licensed Products” means any therapeutic product or course
of treatment, in the Field comprising one or more Compound(s) including any Improvement(s) thereto. Capitalized terms in this definition
not defined herein have the meanings set forth in the License Agreement between the Company and MOA Life Plus Co., Ltd (“MOA”)
dated April 30, 2024, as amended, and as assigned to Northstrive Biosciences on February 28, 2025).
The development and acquisition of therapeutic
product candidates could expose us to significant legal and regulatory risks.
Our acquisition and development of innovative therapeutic product candidates,
specifically with our lead asset, EL-22, could expose us to significant legal and regulatory risks. The development and commercialization
of therapeutic product candidates, including EL-22, are subject to extensive regulation by the FDA and other regulatory authorities. The
regulations govern all aspects of product development, including pre-clinical studies, clinical trials, manufacturing and marketing. Any
failure to comply with the regulations might result in significant delays in product development, approval and commercialization or suspension
or termination of clinical trials. Any non-compliance could lead to enforcement actions, including warning letters, fines, injunctions
and withdrawal of marketing approvals.
The ability to proceed with human clinical trials for our product candidates
is contingent upon receiving FDA clearance of our eventual IND submission. If the FDA requires us to provide extensive additional data
to demonstrate safety and efficacy, including without limitation generating additional preclinical data, conducting further toxicology
or pharmacology studies or addressing unforeseen issues, we may face significant delays or be unable to proceed as planned. In addition,
as one of the first companies pursuing an oral myostatin formulation combined with GLP-1 receptor agonists, we may encounter heightened
regulatory scrutiny. Regulators may impose unexpected conditions, mandate more extensive trials or request additional safety and efficacy
data, all of which could increase our costs and delay timelines.
If we are unable to successfully complete
preclinical testing and clinical trials of the Licensed Products or experience significant delays in doing so, our business will be materially
harmed.
We expect to invest material efforts and financial
resources in the development of the Licensed Products. Our ability to generate product revenues from our therapeutic candidates, which
we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization
of the Licensed Products.
The commercial success of the Licensed Products
will depend on several factors, including successful completion of preclinical studies and clinical trials; receipt of marketing and pricing
approvals from regulatory authorities; obtaining and maintaining patent and trade secret protection for the Licensed Products; establishing
and maintaining manufacturing relationships with third parties or establishing our own manufacturing capability; and commercializing our
products, if and when approved, whether alone or in collaboration with others.
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If we do not achieve one or more of these factors
in a timely manner or at all, we could experience significant delays or an inability to successfully complete development of, or to successfully
commercialize, the Licensed Products, which would materially harm our business. Most pharmaceutical products that do overcome the long
odds of drug development and achieve commercialization still do not recoup their cost of capital.
The Licensed Products may cause adverse
effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market
acceptance.
Adverse events or serious adverse events that may be observed during
clinical trials of the Licensed Products could cause us, other reviewing entities, clinical trial sites or regulatory authorities to interrupt,
delay or halt such trials and could cause denial of regulatory approval. Serious or unexpected side effects caused by an approved product
could result in significant negative consequences, including regulatory withdrawal of approval, mandatory labelling changes, additional
clinical trials, removal from the marketplace, patient litigation, and reputational damage. These events could prevent us or our partners
from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing
the Licensed Products.
We license from a third party the rights to our therapeutic product
candidates and are therefore subject to the risk that we lose this license after investing substantial resources.
Under the License Agreement with MOA, MOA granted Northstrive Biosciences
an exclusive license to commercialize under certain of MOA’s patent rights concerning two Licensed Products: (i) a clinical stage
engineered probiotic expressing myostatin (EL-22) and (ii) a preclinical engineered probiotic expressing dual myostatin & activin-A
antigens (EL-32). If MOA terminates the License Agreement under the terms thereunder, including, amongst other things, if we breach our
obligations under the License Agreement, or the license expires before we can successfully commercialize a product candidate, our investment
in research, development, and commercialization efforts for such product candidate(s) would be lost. Additionally, if we or MOA fail to
adequately protect the related intellectual property rights relating to the Licensed Products, we may not realize the perceived or potential
benefits of the License Agreement.
Our products under development could be
rendered obsolete by technological or other medical advances.
Our products under development may be rendered
obsolete or uneconomical by our competitors’ products or technological advances or those advances within other markets that may better
or more inexpensively address the conditions that our products are designed to address. Biotechnology is rapidly developing and could
undergo significant change in the future. Several key companies are actively developing GLP-1 drugs for obesity and complementary treatments
to address associated conditions such as muscle wasting, and research and discoveries by other bioengineering, pharmaceutical or other
companies may render our technologies or potential products uneconomical or result in products superior to those we develop.
Since we rely on third parties to conduct,
supervise and monitor pre-clinical and clinical trials, their failure to perform satisfactorily may materially harm our business.
We rely on contract research organizations (“CROs”) and
other third parties to ensure the proper and timely conduct of our pre-clinical and clinical trials for the Licensed Products. While we
have agreements governing the activities of such CROs and other third parties, we cannot guarantee the actual performance of these CROs
and third parties. Nevertheless, we will be responsible for ensuring that each of our clinical trials is conducted in accordance with
its protocol, and that all legal, regulatory and scientific standards are met. Our reliance on CROs and other third parties does not relieve
us of our regulatory responsibilities.
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If we or our CROs fail to comply with cGCPs, which are the ethical,
scientific, and quality standards established by the FDA and the International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical
trials, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or other regulators may require us to
perform additional clinical trials before approving any marketing applications. If our CROs do not successfully carry out their contractual
duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised,
our clinical trials may be extended, delayed or terminated, and we may not obtain regulatory approval for our product candidates.
Because third parties may be developing
competitive products without our knowledge, we may later learn that competitive products are superior to the Licensed Products.
We face potential competition from companies that may be developing
competitive products that are superior to one or more of the Licensed Products. If in the future we learn of the existence of one or more
competitive products, we may be required to cease our development efforts for a product candidate, cause a partner to terminate its support
of a product candidate, or cause a potential partner to terminate discussions about a potential license. Any of these events may occur
after we have expended substantial amounts in connection with the clinical research of one or more product candidates.
Our therapeutic products may be expensive
to manufacture, and they may not be profitable if we are unable to control the costs to manufacture them.
Our therapeutic products may be significantly more expensive to manufacture
than other products currently on the market. We hope to substantially reduce manufacturing costs through process improvements, development
of new methods, increases in manufacturing scale and outsourcing to experienced manufacturers. If we are not able to make these improvements,
our profit margins may be significantly less than those of competitive products. In addition, we may not be able to charge a high enough
price for any product we develop, even if they are safe and effective, to make a profit. If we are unable to realize significant profits
from our pipeline products, our business will be materially and adversely impacted.
Risks Related to Pacific Sun Packaging, Inc.
(Specialty Packaging)
Pacific Sun Packaging operates in a competitive
industry and may face pricing pressure from larger competitors.
The packaging industry is highly competitive and
includes large multinational packaging companies as well as smaller specialized providers.
Pacific Sun Packaging competes primarily on the
basis of specialization in component-level IT hardware packaging, custom engineering capabilities, and reputation for reliability. Larger
competitors may have significantly greater financial, manufacturing, marketing and distribution resources. If competitors offer comparable
products at lower prices or invest in technologies that render our packaging solutions less competitive, Pacific Sun’s revenue and
margins could be adversely affected.
Pacific Sun Packaging’s revenue depends
on the IT hardware industry, which is subject to cyclical and secular changes.
Pacific Sun Packaging designs and supplies custom-engineered
protective packaging for IT hardware components, including CPUs, memory modules, SSDs, HDDs, and fiber-optic transceivers. Demand for
Pacific Sun’s products is driven by activity levels in the semiconductor, data center, and networking equipment supply chains. These industries
are subject to cyclical downturns, shifts in technology, and changes in end-market demand. A decline in IT hardware production, changes
in component form factors that reduce the need for specialized packaging, or a shift to packaging solutions that do not require Pacific
Sun’s products could materially and adversely affect Pacific Sun’s revenue and results of operations.
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Pacific Sun Packaging is dependent on a
limited number of suppliers for raw materials and components.
A significant portion of Pacific Sun’s inventory
purchases are concentrated among a limited number of key suppliers. Although we believe that alternative suppliers are available, a disruption
in supply from one or more of these key suppliers, or a significant increase in the cost of raw materials, could adversely affect Pacific
Sun’s ability to fulfill customer orders on a timely basis and at acceptable margins.
Risks Related to AGA Precision Systems LLC
(Precision Manufacturing)
AGA Precision Systems operates in industries
subject to stringent regulatory requirements, including International Traffic in Arms Regulations.
AGA Precision Systems operates in industries subject to export control
laws and regulations, including the ITAR. AGA is ITAR-registered and maintains AS9100 certification, reflecting the stringent quality
and regulatory requirements of its aerospace and defense customers. Compliance with these regulations is complex and costly. Any failure
to comply could result in significant penalties, loss of export privileges, reputational harm, restrictions on our ability to conduct
business with certain customers, including U.S. government and defense contractors, and potential debarment from government contracting.
Changes in export control regulations, trade restrictions, tariffs, or international sanctions could also adversely affect AGA’s
ability to conduct business and serve its customers.
Maintaining and renewing industry certifications,
including AS9100, is critical to AGA’s ability to serve its customers.
AGA Precision Systems holds AS9100 certification,
which is required or strongly preferred by many aerospace and defense customers. Loss of or failure to renew this certification, or failure
to meet evolving certification standards, could result in the loss of existing customers, inability to bid on new contracts, and reputational
damage. The certification process requires ongoing compliance with quality management standards, investment in systems and personnel,
and periodic audits. There can be no assurance that AGA will maintain its certifications at all times, and any lapse could have a material
adverse effect on AGA’s revenue and competitive position.
AGA Precision Systems has incurred, and
may continue to incur, significant repair and maintenance costs, and the condition of its equipment may require ongoing capital investment.
Following the acquisitions of AGA Precision Systems and certain assets
of Indarg Engineering, Inc., we incurred significant costs related to building maintenance, machine repair and recalibration of equipment.
These costs were necessary to optimize operations and maintain the useful lives of acquired equipment. There can be no assurance that
additional significant repair, maintenance or capital expenditure costs will not be required in the future. If the acquired equipment
requires replacement or further significant investment, our results of operations and cash flows could be adversely affected.
AGA Precision Systems has historically operated
without a formal sales and marketing function, which may limit its growth.
AGA Precision Systems has historically grown via referrals and repeat
orders without a formalized sales or marketing department. While we believe there is opportunity to augment growth via more proactive
business development, we cannot assure you that investments in sales and marketing efforts will result in meaningful revenue growth. If
we are unable to expand AGA’s customer base beyond its existing network of relationships, AGA’s growth may be limited and
its financial performance may be adversely impacted.
34
Risks Related to All Operating Subsidiaries
Our operations across multiple industries
expose us to diverse and potentially conflicting market risks.
We operate in multiple industries, including biotechnology,
aerospace and defense manufacturing, specialty packaging, and financial investments. These industries are subject to different economic
cycles, regulatory frameworks, and competitive pressures. Adverse developments in any one sector may not be offset by performance in other
segments, and the diversification of our operations may not mitigate overall risk as expected. A downturn affecting one or more of our
operating sectors could have a disproportionate impact on our consolidated results.
We may be subject to liability for workplace
safety and employment-related claims across our operating subsidiaries.
Our manufacturing subsidiaries operate facilities that involve the use of heavy machinery, hazardous materials,
and industrial processes that present inherent risks of workplace accidents and injuries. We are subject to federal, state and local occupational
safety and health laws and regulations, including those administered by the Occupational Safety and Health Administration ( “OSHA”).
Failure to comply with these requirements could result in fines, penalties, work stoppages, or litigation. In addition, employment-related
claims, including claims related to wages, benefits, discrimination, harassment, wrongful termination, or misclassification of employees
or independent contractors, could result in significant legal costs and liabilities. We rely in part on employees seconded from entities
controlled by our Chief Executive Officer and Chairman pursuant to the Company’s secondment agreements with each, and the classification
and treatment of these individuals could be subject to challenge by regulatory authorities.
Our insurance coverage may be inadequate
to protect us against all potential losses and liabilities.
We maintain insurance coverage that we believe
is customary for businesses of our size and type; however, there can be no assurance that our insurance will be sufficient to cover all
potential claims, liabilities or losses, including product liability, property damage, business interruption, cybersecurity incidents,
environmental liabilities, and professional liability. Certain types of losses may be uninsurable or may only be insurable at prohibitive
cost. If we incur losses or liabilities that exceed or are not covered by our insurance, our financial condition and results of operations
could be materially adversely affected.
A portion of our revenue may be derived
from a limited number of customers.
Certain of our subsidiaries may depend on a limited number of key customers
or contracts. The loss of one or more significant customers, a reduction in orders, or unfavorable changes in the terms of business with
these customers could materially adversely affect our revenue and operating results. Our recently acquired subsidiaries, Pacific Sun Packaging
and AGA, are in the early stages of operating under PMGC’s ownership, and customer relationships established by prior owners may
not transfer smoothly or be maintained over time.
Disruptions in supply chains or manufacturing
operations could adversely affect our business.
Our manufacturing and packaging operations depend
on the availability of raw materials, components, and third-party services. Disruptions in supply chains, including those caused by geopolitical
events, inflation, tariffs, trade restrictions, natural disasters, pandemics, labor disputes, supplier insolvency or supplier concentration,
could increase costs, delay production and impair our ability to fulfill customer orders. If we are unable to maintain adequate supply
chain resilience across our operating subsidiaries, our revenue, margins and customer relationships could be adversely affected.
35
A disruption in our operations could have
an adverse effect on our business.
Our operations, including those of our subsidiaries, third-party suppliers
and distribution partners, are subject to the risks inherent in manufacturing and distribution activities, including industrial accidents,
environmental events, strikes and other labor disputes, disruptions in information systems, product quality control, safety and licensing
requirements and other regulatory issues, as well as natural disasters, pandemics or other public health emergencies, acts of terrorism
and other external factors beyond our control. The loss of, or damage to, any of our operating facilities or those of our key suppliers
may have an adverse effect on our business, financial condition, results of operations and prospects.
To sustain our growth, we will need to increase
the size of our organization, and we may encounter difficulties managing growth across multiple subsidiaries.
If we are able to successfully grow our operating subsidiaries and
execute additional acquisitions, we may experience significant growth in the number of our employees and the scope of our operations across
disparate industries. The resulting growth will place significant demands on our financial, managerial and operational resources. We may
not be able to accurately forecast the number of employees required, the timing of their hire or the associated costs of expansion. Our
success will depend on the ability of our executive officers and senior management to implement and improve operational, information management
and financial control systems across multiple businesses and to expand, train and manage our employee base. Our inability to manage growth
effectively may cause our operating costs to grow faster than anticipated and adversely affect our results of operations.
RISKS RELATED TO OUR INVESTMENT ACTIVITIES
(PMGC CAPITAL)
PMGC
Capital LLC may be deemed an “investment company” under the Investment Company Act of 1940, which could impose significant
regulatory burdens.
PMGC Capital LLC is a multi-strategy investment firm engaged in investing,
lending and pursuing diversified investment opportunities. If we are deemed to be an investment company under the Investment Company Act
of 1940, as amended (the “1940 Act”), we would become subject to extensive regulation, which could impose significant compliance
costs and operational restrictions. Under the 1940 Act, a company may be deemed to be an investment company if more than 40% of its total
assets (exclusive of cash and U.S. government securities) consist of “investment securities.” We must ensure that we do not
exceed this threshold. If we fail to maintain our exclusion from the 1940 Act, we could be required to register as an investment company,
which would impose significant limitations on our capital structure, affiliate transactions and other aspects of our business, or we could
be required to restructure our operations or divest certain assets. Any such outcome could materially adversely affect our business, financial
condition, and operations.
PMGC Capital’s investment activities subject
us to market risk, and we may incur losses on our investment portfolio.
Through PMGC Capital, we hold investments in publicly traded equity
securities, private company stock, and convertible debentures. These investments are subject to market risk, including fluctuations in
the market prices of publicly traded securities, credit risk associated with debt instruments, and liquidity risk associated with private
company investments. We have in the past recognized, and may in the future recognize, realized and unrealized losses on our investment
portfolio. There can be no assurance that our investments will appreciate in value or that we will not incur additional losses. Poor investment
performance may adversely affect our financial results and our ability to fund operations.
36
RISKS RELATED TO REGULATORY, LEGAL AND INTELLECTUAL
PROPERTY MATTERS
We may become subject to litigation, regulatory
proceedings, or governmental investigations that could be costly and time-consuming.
From time to time, we may be subject to legal
proceedings, claims, disputes, regulatory inquiries, or governmental investigations arising in the ordinary course of business or otherwise.
Such matters may include contract disputes, employment claims, intellectual property disputes, product liability claims, stockholder litigation,
regulatory enforcement actions, or claims arising from our acquisitions or divestitures. Litigation and regulatory proceedings are inherently
uncertain, and adverse outcomes could result in significant monetary damages, injunctive relief, penalties, or restrictions on our business
activities. Even if we prevail, the costs of defending against such claims may be substantial and could divert management’s attention
from our business operations.
We are subject to anti-corruption, anti-bribery,
and similar laws, and non-compliance could expose us to significant penalties.
We are subject to the U.S. Foreign Corrupt Practices
Act, and other anti-corruption and anti-bribery laws and regulations. As we expand our operations, pursue international business relationships,
and engage third-party consultants, distributors and partners, our exposure to these laws increases. Any violation or alleged violation
could result in significant criminal and civil penalties, sanctions, and reputational harm. Our policies and procedures designed to promote
compliance with these laws may not be effective in preventing all violations by our employees, consultants, agents, or business partners.
Changes in U.S. trade policy, tariffs, and
international relations could adversely affect our supply chain and cost structure.
Our manufacturing and packaging operations depend
on materials and components that may be sourced domestically or internationally. Changes in U.S. trade policy, including the imposition
or escalation of tariffs, export controls, sanctions, or trade restrictions, could increase our costs, disrupt our supply chains, or limit
our ability to serve certain customers. AGA Precision Systems operates in the aerospace and defense sector, which is particularly sensitive
to changes in government policy, defense spending priorities, and international relations. Adverse changes in any of these areas could
materially affect our revenue and profitability.
If we fail to protect or enforce our intellectual
property, others could compete against us more directly and we may not be able to compete effectively in our market.
Our success depends in part on our ability to
protect our intellectual property rights. We rely on a combination of trademarks, trade secrets, confidential proprietary information,
domains, patent rights and other intellectual property rights to protect our intellectual property. We also rely on patent applications
licensed by us for the Licensed Products which we are contractually obligated to file, prosecute and maintain under our License Agreement
with MOA. Patent protection is limited in time, and we may be unsuccessful in developing and commercializing a product before a patent
expires and the underlying technology becomes available for commercialization by competitors, in which case our investment of substantial
time and resources towards the applicable product or product candidate could be lost without the realization of the benefits we anticipated.
37
Certain of our technology may not be subject
to protection through patents, which leaves us vulnerable to theft of our technology.
Certain parts of our know-how and technology are
not patentable or are trade secrets. To protect our proprietary position in such know-how and technology, we have entered and intend to
require all employees, consultants, advisors and collaborators to enter into confidentiality and invention ownership agreements with us.
These agreements may not provide meaningful protection for our trade secrets, know-how or other proprietary information in the event of
any unauthorized use or disclosure. In the absence of patent protection, competitors who independently develop substantially equivalent
technology may harm our business. If we cannot adequately protect or enforce our intellectual property rights, we may not be able to adequately
compete, and our business and prospects could be adversely affected.
We may not be able to protect our proprietary technology, which may
harm our ability to operate profitably.
The molecular biology and bioprocessing industries
place considerable importance on obtaining patent and trade secret protection for new technologies, products and processes. Our success
will depend, to a substantial degree, on our ability to obtain and enforce patent protection for our products, preserve any trade secrets
and operate without infringing the proprietary rights of others. We cannot assure you that we will succeed in obtaining any patents or
obtain them in a timely manner; that the use of our technology will not infringe on the proprietary rights of others; that patent applications
relating to our product candidates will result in the issuance of any patents; that we will be successful in monitoring, enforcing or
otherwise protecting our patents or other intellectual property rights; or that patents will not be issued to other parties which may
be infringed by our potential products or technologies.
Patents held by other persons may result
in infringement claims against us that are costly to defend and which may limit our ability to use disputed technologies.
A number of biotechnology and other companies,
universities and research institutions have filed patent applications or have been issued patents relating to technologies potentially
relevant to or required by our expected products. If third party patents or patent applications contain claims infringed by either our
licensed technology or other technology required to make and use our potential products and such claims are ultimately determined to be
valid, we might not be able to obtain licenses to these patents at a reasonable cost, if at all, or be able to develop or obtain alternative
technology. Patent litigation is very expensive and could consume substantial resources and create significant uncertainties.
If our trademarks and trade names are not
adequately protected, we may not be able to build name recognition in our target markets.
Our registered or unregistered trademarks or trade
names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks. We may not be able to
protect our rights in these trademarks and trade names, which we need in order to build name recognition with potential partners or customers
in our target markets. If we are unable to establish name recognition based on our trademarks and trade names, our business may be adversely
affected.
38
If we infringe or are alleged to infringe
intellectual property rights of third parties, our business could be harmed.
Our research, development and commercialization
activities may infringe or otherwise violate or be alleged to infringe or otherwise violate patents owned or controlled by other parties.
These third parties could bring claims against us that would cause us to incur substantial expenses and, if successful, could cause us
to pay substantial damages or be forced to stop or delay research, development, manufacturing or sales of the applicable product or product
candidate.
We may need to license additional intellectual
property from third parties in the future, and such licenses may not be available on commercially reasonable terms.
A third party may hold intellectual property, including patent rights,
that are important or necessary to the development of our future products. It may be necessary for us to use the patented or proprietary
technology of third parties to commercialize our prospective products, in which case we would be required to obtain a license from these
third parties. Failure to obtain such licenses on commercially reasonable terms may limit or eliminate our ability to develop or commercialize
our future product candidates, which may have a negative impact on our business and results of operations.
A recall or suspension of sale of our products,
or the discovery of serious safety issues, could have a significant negative impact on us.
The FDA and comparable agencies of other countries
regulate certain of our products. The FDA and equivalent foreign regulatory authorities have the authority to require the recall or suspension,
either temporarily or permanently, of commercialized products in the event that a product has a reasonable probability of causing a serious
adverse health risk due to adulteration or misbranding. Recalls, suspensions or other notices relating to any products that we distribute
would divert managerial and financial resources and have an adverse effect on our reputation, financial condition and operating results.
Regulations governing our products could
harm our business.
Certain of our products are or will be subject
to extensive government regulation by numerous federal, state and local government agencies and authorities. Many of these laws and regulations
involve a high level of subjectivity, are subject to interpretation, and vary significantly from market to market. These laws and regulations
can have several impacts on our business, including delays or prohibitions in introducing or selling a product in one or more markets;
limitations on the claims we can make regarding our products; and delays, expenses and potential product reformulations associated with
compliance.
Government regulations relating to marketing
and advertising may restrict, inhibit or delay our ability to sell our products.
If our products are marketed outside of their intended use, regulatory
agencies such as the FDA or the FTC may investigate our marketing practices. Government authorities may regulate advertising and product
claims regarding the benefits of our products, and enforcement actions could require us to revise our marketing materials, amend our claims
or stop selling certain products, which could harm our business.
39
We may incur product liability claims that
could harm our business, and past product liability claims relating to our previously divested Elevai Skincare products could still adversely
affect our business.
We may be subject to various product liability
claims related to the products we sell or develop. Product liability claims could increase our costs, cause negative publicity, and adversely
affect our business and financial results. Although we maintain general liability insurance, this insurance may not fully cover potential
liabilities.
In addition, even though we completed the divestiture of our Elevai
Skincare business in January 2025, we may still be subject to liability for past product claims related to those products. Prior to the
divestiture, we marketed and sold skincare products, and claims related to those products—including adverse reactions, product contamination,
or labeling inaccuracies—could result in legal action against us. We cannot assure you that the indemnification provisions in the
asset sale agreement will fully protect us from such liabilities. In connection with the divestiture, we also provided certain representations,
warranties and indemnification obligations. Claims under these provisions could arise if post-sale issues emerge, such as regulatory non-compliance,
product defects, or third-party intellectual property claims. If such claims are asserted and indemnification is required, we could incur
substantial financial obligations.
We may not have sufficient product liability
insurance, which may leave us vulnerable to future claims we will be unable to satisfy.
The development, testing, manufacturing, marketing
and sale of our products entail an inherent risk of product liability claims. We currently have a limited amount of product liability
insurance, which may not be adequate to meet potential product liability claims. Adequate insurance coverage may not be available in the
future on acceptable terms, if at all. Whether or not a product liability insurance policy is obtained or maintained in the future, any
product liability claim could harm our business or financial condition.
Our employees, independent contractors,
consultants, distributors, vendors and strategic partners may engage in misconduct or improper activities.
We are exposed to the risk that our employees,
independent contractors, consultants, distributors, vendors, strategic partners and other individuals or entities with whom we have arrangements
may engage in unethical, fraudulent or illegal activity. It is not always possible to identify and deter misconduct by these parties,
and the precautions we take to detect and prevent these activities may not be effective. If such actions are instituted against us, those
actions could result in government investigations, legal proceedings, the imposition of significant fines or other sanctions, which could
adversely affect our ability to operate our business and our results of operations.
If we, or our third-party manufacturers
fail to comply with environmental laws and regulations, we could become subject to fines or penalties.
Our research and development activities and our
third-party manufacturers’ and suppliers’ activities involve the controlled storage, use and disposal of hazardous materials and other
hazardous compounds. We and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage,
handling and disposal of these hazardous materials. We cannot eliminate the risk of contamination, which could cause an interruption of
our business operations and environmental damage resulting in costly clean-up and liabilities.
If our third-party suppliers, logistics
providers, and manufacturers do not comply with ethical business practices or applicable laws, our reputation and business could be harmed.
Our reputation and our customers’ willingness
to purchase our products and services depend in part on our suppliers’, manufacturers’, and service providers’ compliance with ethical
employment practices and all legal and regulatory requirements relating to the conduct of their businesses. We do not exercise control
over our third-party service providers and cannot guarantee their compliance with ethical and lawful business practices.
40
The divestiture of our Elevai Skincare business
could negatively impact our operations and strategic positioning.
In January 2025, we completed the divestiture
of our Elevai Skincare business as part of our strategic realignment. While this divestiture allows us to focus on our core businesses,
it may result in operational and strategic challenges, including adverse market perception, loss of diversification, and potential unforeseen
expenses or liabilities related to the transition. If we fail to manage this transition effectively, our financial condition, results
of operations and future growth prospects could be adversely affected.
RISKS RELATED TO OUR MANAGEMENT AND GOVERNANCE
Our corporate governance documents
and Nevada law may have anti-takeover effects that could discourage, delay, or prevent a change in control.
Provisions of our articles of incorporation, bylaws, and Nevada law may have the effect of discouraging, delaying,
or preventing a merger, acquisition, tender offer, or other change in control of the Company that stockholders might consider favorable,
including transactions in which stockholders might receive a premium over the then-current market price of our Common
Stock. These provisions include the authority of the Board to issue preferred stock with rights, preferences, and privileges determined
by the Board without stockholder approval, advance notice requirements for stockholder proposals and director nominations, and other provisions
of Nevada corporate law that may limit the ability of stockholders to effect a change in control. These provisions may frustrate or prevent
any attempt by stockholders to replace or remove our current management.
If we lose key personnel or are unable to
attract and retain qualified personnel, we may be unable to execute our business plan.
We have a limited number of employees. Our Chief Executive Officer
serves in a non-employee capacity pursuant to his consulting agreement with the Company. Our success depends on our continued ability
to attract, retain and motivate highly qualified management, business development, and operational personnel. Our success depends in large
part on the efforts and abilities of our Chief Executive Officer and Chief Financial Officer, Graydon Bensler, as well as other members
of our senior management. Finding replacements for key individuals could be difficult, may take an extended period of time and could significantly
impede the achievement of our business objectives.
Graydon Bensler serves
as both our Chief Executive Officer and Chief Financial Officer, which presents governance risks and limitations.
Our Chief Executive Officer, Graydon Bensler, currently also serves
as our Chief Financial Officer. While this dual role reduces costs, it concentrates significant authority and responsibility in a single
individual and may limit the segregation of duties and independent oversight over financial reporting that would be provided by separate
individuals in these roles. This concentration may increase the risk of errors or irregularities in financial reporting going undetected
and may be viewed negatively by investors, analysts and regulatory bodies. Such perception may adversely impact our financial performance
and/or business.
Significant related-party transactions with
entities controlled by our executive officers and directors may present conflicts of interest.
The Company has entered into consulting agreements and secondment agreements
with entities controlled by our Non-Employee Chief Executive Officer and our Non-Employee, Non-Executive Chairman, pursuant to which the
Company pays significant consulting fees, contracted performance bonuses, management fees, and reimbursements to such entities. Compensation
to such entities under the terms of such agreements include milestone-based bonuses, acquisition-based bonuses, and market capitalization-based
bonuses. These compensation arrangements create potential conflicts of interest between the personal financial interests of our executive
officers and directors and the interests of the Company and its stockholders. The milestone-based and acquisition-based bonus arrangements
may incentivize management to pursue transactions that trigger bonus payments, even if such transactions are not in the best long-term
interests of stockholders. Although our Audit Committee reviews and approves related-party transactions, there can be no assurance that
these transactions are or will be on terms as favorable to the Company as those that could be obtained from unaffiliated third parties.
41
We may be unable to accurately forecast
revenue and appropriately plan our expenses.
Forecasts may be particularly challenging given
our recently acquired subsidiaries, early-stage biotechnology programs, and ongoing acquisition strategy. We base our expense levels and
investment plans on our estimates of revenue and gross margin. However, we cannot be sure that historical growth rates or trends of our
acquired businesses are meaningful predictors of future performance, particularly under PMGC ownership. If our assumptions prove to be
wrong, we may spend more than anticipated or may generate lower revenue than expected, either of which could have an adverse effect on
our business, financial condition, results of operations and prospects.
We have a limited operating history at our
current scale and with our current business model, which may make it difficult to evaluate our business and future prospects.
We began commercial operations in 2020 as a skincare
development company, divested our skincare business in January 2025, and completed our first operating acquisitions in mid-2025. As a
result, we have an extremely limited history of operating as a diversified holding company and an even more limited history of generating
revenue from our current operating subsidiaries. Any evaluation of our business and prospects must be considered in light of this limited
operating history, which may not be indicative of future performance. Because of our limited operating history in our current form, we
face increased risks, uncertainties, expenses, and difficulties.
We have previously identified a material
weakness in our internal control over financial reporting, and there can be no assurance that additional material weaknesses will not
be identified in the future.
As disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, our management previously
identified a material weakness in our internal control over financial reporting. During the fiscal year ended December 31, 2025, we implemented
remediation measures, including the hiring of additional accounting and finance personnel and the implementation of standardized reconciliation
procedures and enhanced review processes. Based on management ’s
evaluation as of December 31, 2025, the Company has concluded that the previously reported material weakness has been remediated. However,
there can be no assurance that our remediation efforts will remain effective or that additional material weaknesses or significant deficiencies
will not be identified in the future, particularly as we integrate newly acquired subsidiaries into our financial reporting processes.
If we identify additional material weaknesses or significant deficiencies, we could be subject to sanctions or investigations by Nasdaq,
the SEC or other regulatory authorities, investor perceptions of our Company may suffer and cause a decline in the market price of our
Common Stock. Any failure of our internal control over financial reporting may have a material adverse effect on our stated results of
operations and harm our reputation.
The requirements of being a public company
may strain our resources, divert management’s attention and affect our results of operations.
As a public company in the United States, we face
increased legal, accounting, administrative and other costs and expenses. We are subject to the reporting requirements of the Exchange
Act and the Sarbanes-Oxley Act of 2002. Section 404 of the Sarbanes-Oxley Act requires that our management report on the effectiveness
of our internal controls structure and procedures for financial reporting. Compliance with these requirements diverts internal resources
and management attention. If we fail to maintain compliance, we could be subject to sanctions or investigations. We may need to hire additional
employees with public accounting and disclosure experience, which will increase costs. These increased costs will require us to divert
money that we could otherwise use to develop our business.
42
If we cannot maintain our Company culture
or focus on our mission as we grow, our success and competitive position may be harmed.
We believe our culture and mission have been key
contributors to our success to date. Any failure to preserve our culture or focus on our mission could negatively affect our ability to
retain and recruit personnel, which is critical to our growth. As we grow across multiple industries through acquisitions and develop
the infrastructure of a public company, we may find it difficult to maintain a cohesive corporate culture.
RISKS RELATED TO OUR DEPENDENCE ON THIRD PARTIES
We depend on our collaborators to help us
develop and test our proposed products, and our ability to develop and commercialize products may be impaired or delayed if collaborations
are unsuccessful.
Our strategy for the development, testing and
commercialization of our proposed products may require entering into collaborations with corporate partners, licensors, licensees and
others. We may then be dependent upon the subsequent success of these other parties in performing their respective responsibilities and
the continued cooperation of our partners. Our potential collaborators may not cooperate with us or perform their obligations under our
agreements with them. We cannot control the amount and timing of our collaborators’ resources that will be devoted to our research and
development activities. Should collaborators fail to conduct activities in a timely manner, or at all, expected product pipeline timelines
may be delayed. If we do not achieve milestones set forth in the agreements, or if our collaborators breach or terminate their collaborative
agreements with us, our business may be materially harmed.
Our reliance on non-employee consultants,
third-party vendors, and operational contractors may lead to delays in development of our proposed products and operation of our businesses.
We rely extensively on third parties for critical operational and strategic
functions, including through secondment agreements with entities controlled by our Chief Executive Officer and Chairman. These individuals
and entities are not our employees and may have commitments to other entities that limit their availability to us. We have limited control
over the activities of these service providers and can expect only limited amounts of their time to be dedicated to our business objectives.
If key consultants or contractors become unavailable or fail to perform satisfactorily, our operations and development activities could
be materially delayed.
Certain market opportunity data and forecasts
in this Annual Report were obtained from third-party sources and were not independently verified by us.
This Annual Report contains certain data and information that we obtained
from various government and private entity publications and reports. While we believe the data and information is reliable, we have not
independently verified them. There is no guarantee that any particular number or percentage of market participants covered by our market
opportunity estimates will purchase our products or generate any particular level of revenue for us. Even if the markets in which we compete
meet the size estimates and growth forecasts included in this Annual Report, our business may fail to grow at all or at the rate we anticipate.
43
We or our third-party vendors may experience
network or system failures, cybersecurity attacks, or other technology risks.
Our ability to operate uninterrupted depends upon
the performance of our internal network, systems and related infrastructure, and those of our third-party vendors. Our systems and those
of our third-party vendors may be vulnerable to computer viruses and other malware, physical or electronic security breaches, natural
disasters, and similar disruptions. Although we have not experienced any material security breaches, we cannot be certain that our defensive
measures will be sufficient to defend against all current and future methods of attack.
Any actual or perceived security breach may lead to loss of customer
confidence, regulatory scrutiny, compromise of intellectual property, costly litigation, fines and penalties, and reputational damage.
A security breach could occur and persist for an extended period without detection, increasing the costs and consequences of such a breach.
Our business may be negatively impacted
by cybersecurity threats and other security threats and disruptions.
Because our business relies on proprietary technology and computer
systems, we face security threats, including threats to our information technology infrastructure, attempts to gain access to our proprietary
or confidential information, and physical security threats. Cybersecurity threats are persistent, evolve quickly and include computer
viruses, attempts to access information, denial of service and other electronic security breaches. A security breach or other significant
disruption could disrupt operations, result in unauthorized access to or release of proprietary information, delay clinical studies, subject
us to claims and regulatory actions, and damage our reputation.
RISKS RELATED TO THE OWNERSHIP OF OUR SECURITIES
Our Common Stock may be affected by limited trading volume and price
fluctuations, which could adversely impact the value of our Common Stock.
Our Common Stock has experienced and is likely to experience in the
future significant price and volume fluctuations, which could adversely affect the market prices of our common stock without regard to
our operating performance. In addition, factors such as quarterly fluctuations in our financial results, changes in the overall economy
or the condition of the financial markets, announcements of acquisitions, and changes in investor sentiment could cause the market prices
of our common stock to fluctuate substantially. These fluctuations may also cause short sellers to periodically enter the market. We cannot
predict the actions of market participants and, therefore, can offer no assurances that the market for our common stock will be stable
or appreciate over time.
We have a significant number of shares
of Series B Preferred Stock outstanding with voting rights
that may dilute the voting power of Common Stock holders.
As of the date of this Annual Report, we have shares of Series B Preferred Stock outstanding that carry voting
rights. The voting power of our Series B Preferred Stock and
Common Stock is concentrated in a small group of holders, mainly in entities controlled by our Chief Executive Officer and Chairman. This
concentration of voting power may discourage potential acquirers and reduce the market price of our Common Stock. It also limits the ability
of other stockholders to influence corporate matters, including but not limited to the election of directors, changes to the Company’s
governance documents, the expansion of employee equity or option pool, any merger, consolidation, sale of all or substantially all of
our assets, and other major actions requiring stockholder approval.
Our Common Stock may be subject to significant volatility due to limited
public float and market conditions.
Our Common Stock may experience significant price volatility due to
limited trading volume, concentrated ownership, and market conditions affecting small-cap or microcap companies. This volatility may be
unrelated to our operating performance and could result in substantial losses for investors.
We may not be able to continue to satisfy
listing requirements of Nasdaq to maintain a listing of our Common Stock.
Our Common Stock is currently listed on Nasdaq and we must meet certain
financial and liquidity criteria to maintain such listing. Our Common Stock may be delisted if we fail to meet Nasdaq’s continued
listing requirements. We have previously received notices from Nasdaq regarding non-compliance with listing requirements and have utilized
reverse stock splits to regain compliance. There can be no assurance that we will maintain compliance with the Nasdaq continued listing
requirements in the future.
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If our Common Stock is delisted, it may be more difficult to buy or
sell them or to obtain accurate quotations, and the price of the shares of Common Stock may suffer a material decline. Delisting may also
impair our ability to raise capital. In addition, our Board may determine that the cost of maintaining our listing on a national securities
exchange outweighs the benefits of such listing.
Changes to Nasdaq listing requirements,
including potential minimum market capitalization requirements, could adversely affect our continued listing.
Nasdaq periodically reviews and may revise its continued listing standards,
including requirements relating to minimum bid price, stockholders’ equity, market value of listed securities, and market capitalization.
Any changes to these requirements, including potential increases in minimum market capitalization thresholds, may make it more difficult
for us to maintain compliance. If we are unable to meet applicable listing standards, our Common Stock may be subject to delisting, which
may adversely affect liquidity, market price, and our ability to raise capital.
We currently do not intend to declare dividends
on our Common Stock in the foreseeable future and, as a result, your returns on your investment may depend solely on the appreciation
of our common stock.
We currently do not expect to declare any dividends on our Common Stock
in the foreseeable future. Instead, we anticipate that all of our earnings in the foreseeable future will be used to provide working capital,
support our operations and finance the growth and development of our business. Any determination to declare or pay dividends in the future
will be at the discretion of our Board, subject to applicable laws and dependent upon a number of factors, including our earnings, capital
requirements and overall financial conditions. In addition, terms of any future debt or preferred securities may further restrict our
ability to pay dividends on our Common Stock. Accordingly, your only opportunity to achieve a return on your investment in our Common
Stock may be if the market price of our Common Stock appreciates and you sell your shares at a profit. The market price for our Common
Stock may never exceed, and may fall below, the price that you pay for such Common Stock.
An investment in our securities is speculative
and there can be no assurance of any return on any such investment.
An investment in our securities is speculative
and there can be no assurance that investors will obtain any return on their investment. Investors may be subject to substantial risks
involved in an investment in the Company, including the risk of losing their entire investment.
If securities or industry analysts do not
publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
The trading market for our Common Stock will depend in part on the
research and reports that securities or industry analysts publish about us or our business. If one or more analysts downgrade our stock
or publish inaccurate or unfavorable research about our business, our stock price would likely decline. If analysts cease coverage of
our Company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading
volume to decline.
If there is no active public market for
our Common Stock, you may be unable to sell your shares at or above your purchase price.
Although our Common Stock is listed on Nasdaq, an active trading market
for our shares may not be sustained. You may be unable to sell your shares quickly or at the market price if trading in shares of our
common stock is not active. An inactive market may also impair our ability to raise capital by selling shares and may impair our ability
to enter into strategic partnerships or acquire companies using our shares as consideration.
We may be subject to securities litigation,
which is expensive and could divert our management’s attention.
The market price of our securities may be volatile, and in the past
companies that have experienced volatility in the market price of their securities have been subject to securities class action litigation.
We may be the target of this type of litigation in the future. Securities litigation against us may result in substantial costs and divert
our management’s attention from other business concerns.
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Future issuances of our Common Stock or securities convertible into
or exercisable for our Common Stock could cause the market price of our Common Stock to decline and result in additional dilution to our
stockholders.
We may issue additional shares of Common Stock,
warrants, options, or other equity-linked securities in connection with future financings, acquisitions, equity incentive plans, or the
settlement of outstanding obligations. The issuance of additional shares of Common Stock, or securities convertible into or exercisable
for shares of Common Stock, will dilute the ownership interest of existing common stockholders and could depress the market price of
our Common Stock. Sales of substantial amounts of our Common Stock in the public market, or the perception that such sales could occur,
could also adversely affect the market price of our Common Stock.
IN ADDITION TO THE ABOVE RISKS, BUSINESSES
ARE OFTEN SUBJECT TO RISKS NOT FORESEEN OR FULLY APPRECIATED BY MANAGEMENT. IN REVIEWING THIS FILING, POTENTIAL INVESTORS SHOULD KEEP
IN MIND THAT OTHER POSSIBLE RISKS MAY ADVERSELY IMPACT OUR BUSINESS OPERATIONS AND THE VALUE OF OUR SECURITIES.