Item 1A. Risk Factors
ITEM
1A. RISK FACTORS
Investing
in our securities involves a high degree of risk. You should carefully consider the risks described below, together with the other information
contained in this Annual Report on Form 10-K, including our consolidated financial statements and related notes. If any of the risks
described below occur, our business, financial condition, results of operations, cash flows, and prospects could be materially and adversely
affected. The trading price of our common stock could decline, and you could lose all or part of your investment.
Risks
Related to Our Operating History, Financial Position, and Capital Structure
We
have incurred losses and negative cash flows since inception, and we may not achieve or sustain profitability.
We
have incurred losses since inception. During the years ended December 31, 2025 and 2024, we incurred net losses of $6,124,672 and $4,751,516,
respectively. There can be no assurance that we will not continue to incur net losses in the future. Our ability to achieve profitability
depends on our ability to scale production, expand distribution, manage customer concentration, control input, labor, and logistics costs,
improve manufacturing utilization and yields, and grow gross profit at a rate sufficient to cover operating expenses and public company
costs. If we are unable to execute successfully on these objectives, we may continue to incur losses and negative cash flows, which could
materially adversely affect our business, financial condition, and results of operations.
Our
financial statements include an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.
Our
audited consolidated financial statements include an explanatory paragraph from our independent registered public accounting firm expressing
substantial doubt about our ability to continue as a going concern. This condition may adversely affect our ability to raise capital,
negotiate favorable terms with customers and suppliers, retain employees, and execute our growth strategy. If our operating performance
does not improve or we are unable to obtain additional liquidity when needed, we may be required to delay or reduce investments, scale
back operations, or pursue financing or strategic alternatives on unfavorable terms, which could materially adversely affect our business.
We
may require additional capital to fund operations and growth, and financing may not be available on acceptable terms or at all.
Our
operating model requires significant working capital to support raw material sourcing, inventory, international transit times, and customer
program requirements. We may need to raise additional capital through equity, debt, or other financings to fund operations, expand manufacturing
capacity, or support growth initiatives. Financing may not be available when needed, or may be available only on unfavorable terms, including
dilution to existing stockholders, restrictive covenants, increased leverage, or security interests in our assets. Any inability to obtain
sufficient financing could materially adversely affect our liquidity, operations, and growth prospects.
Our
current growth may not be indicative of our future growth, and our limited operating history may make it difficult to assess our future
viability.
We
expect that as our revenue increases, our revenue growth rate will decline. We also believe that growth of our revenue depends on several
factors, including our ability to:
●
expand our existing channels of
distribution;
●
develop additional channels of distribution;
●
grow our customer base;
●
effectively introduce new products;
●
increase awareness of our brand;
●
manufacture at a scale that satisfies future demand;
and
●
effectively source key raw materials.
We
may not successfully accomplish any of these objectives. We have not yet demonstrated the ability to manage rapid growth over a long
period of time or achieve profitability at scale. Consequently, any predictions regarding our future success or viability may not be
as accurate as they could be if we had a longer operating history or had previously achieved profitability.
Our
indebtedness may adversely affect our financial condition and limit our operational and financial flexibility.
Our
indebtedness and related security interests may limit our ability to incur additional debt, fund working capital needs, or pursue strategic
opportunities. If we are unable to generate sufficient cash flow to service our obligations, we may be required to refinance, raise additional
capital, or pursue other alternatives, which may not be available on favorable terms or at all.
Failure
to maintain compliance with Nasdaq listing requirements could adversely affect the liquidity and market price of our common stock.
We
have previously been subject to Nasdaq compliance matters, including monitoring related to stockholders’ equity and other continued
listing requirements. If we fail to maintain compliance with applicable listing standards, we could be subject to delisting, which could
reduce liquidity, limit access to capital markets, increase stock price volatility, and materially adversely affect the market price
of our common stock.
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The
market price of our common stock may be volatile and subject to significant fluctuations, which could result in losses for investors.
The
trading price of our common stock may fluctuate significantly due to factors including operating results, customer concentration, liquidity
constraints, financing activities, market conditions, and investor perceptions of growth-stage companies. These fluctuations may be unrelated
to our actual operating performance and could result in losses for investors.
Our
ability to access the capital markets and the issuance of additional securities could dilute existing stockholders and adversely affect
the market price of our common stock.
We
may continue to rely on the capital markets to fund operations, support growth initiatives, and strengthen our balance sheet. To raise
capital, we may issue additional shares of common stock, preferred stock, warrants, options, convertible securities, or other equity-linked
instruments. The issuance of additional securities, or the potential for such issuances, could result in substantial dilution to existing
stockholders and could adversely affect the market price of our common stock.
Our
capital structure includes outstanding warrants, stock options, and convertible notes. The exercise or conversion of these securities
could further dilute stockholders and increase the supply of shares available for sale in the public market, which could put downward
pressure on our stock price. In addition, the perception that we may issue additional equity securities in the future could adversely
affect the trading price of our common stock.
Access
to capital markets may be limited by market conditions, our operating performance, liquidity, stock price volatility, and compliance
with applicable listing requirements. If we are unable to raise capital on acceptable terms when needed, we may be required to delay
or reduce investments, curtail operations, or pursue alternative financing arrangements that may be more costly or restrictive.
Because
our common stock may have limited trading volume and analyst coverage, issuances of additional securities or significant sales of shares
by existing stockholders could result in increased price volatility and adversely affect investor confidence. If we are unable to effectively
manage our capital structure or access the capital markets on favorable terms, our business, financial condition, and growth prospects
could be materially adversely affected.
Risks
Related to Our Emerging Growth Company and Smaller Reporting Company Status
Because
we are an emerging growth company and a smaller reporting company, our disclosures may be less comprehensive than those of other public
companies.
We
are an emerging growth company (“EGC”) and a smaller reporting company (“SRC”) and take advantage of certain
reduced reporting, disclosure, and governance requirements, including exemptions from auditor attestation of internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act, reduced executive compensation disclosure, and extended transition periods
for new accounting standards. As a result, investors may find our common stock less attractive, which could result in reduced trading
activity and increased stock price volatility.
Risks
Related to Internal Controls and Financial Reporting
If
we fail to maintain effective internal control over financial reporting, our ability to produce accurate financial statements could be
impaired.
As
a public company, we are required to maintain effective internal control over financial reporting. Our operations involve complex manufacturing,
inventory, cost accounting, and cross-border transactions. As we scale our business, our systems, processes, and personnel may not keep
pace with growth. We may identify control deficiencies or material weaknesses, which could result in errors in our financial statements,
restatements, delayed reporting, or loss of investor confidence, any of which could materially adversely affect our business and stock
price.
Risks
Related to Customers, Distribution, and Market Demand
A
substantial portion of our net sales is derived from a limited number of customers.
A
significant portion of our net sales and accounts receivable is derived from a limited number of large retail customers. As a result,
our operating results, cash flows, and working capital depend on the purchasing decisions, financial condition, and payment practices
of these customers. Reductions in purchase volumes, changes in pricing or promotional terms, increased chargebacks, payment delays, or
the loss of a significant customer could materially adversely affect our net sales, margins, liquidity, and manufacturing utilization.
We
generally do not have long-term purchase commitments from customers, and demand forecasting is difficult.
Customer
purchases are typically made through purchase orders and program-based arrangements rather than long-term volume commitments. Customers
may reduce, delay, or cancel orders with limited notice, contributing to revenue volatility and increasing the difficulty of forecasting
demand, planning production, and managing inventory.
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The
consumer-packaged foods industry is highly competitive, and we may be unable to compete effectively.
We
compete with large, branded food companies, emerging snack brands, and private-label manufacturers that have significantly greater financial,
marketing, and distribution resources. Competitive pricing, promotional activity, and shifts in retailer category strategies could pressure
our margins and limit our ability to grow.
Changes
in consumer preferences or retailer category strategies could reduce demand for our products.
Consumer
tastes and retailer merchandising priorities can shift rapidly. If demand for clean-label, fruit- and vegetable-based snacks declines,
if retailers reduce shelf space, or if competing products gain preference, our net sales and operating results could be adversely affected.
Risks
Related to Manufacturing, Supply Chain, Agricultural Inputs, and Seasonality
Our
manufacturing operations are concentrated in a single facility in Peru, and any disruption could materially adversely affect our business,
results of operations, and financial condition.
All
of our production is conducted at our manufacturing facility in Pisco, Peru, which commenced operations in December 2024. As a result,
our ability to meet customer demand, maintain service levels, and generate revenue depends substantially on the continued operation of
this facility. Any disruption—including equipment failure, utilities interruptions, labor disruptions, facility damage, supply
interruptions, natural disasters, public health events, or regulatory or governmental actions—could impair production, delay shipments,
increase costs, and harm customer relationships.
Because
we do not currently have redundant manufacturing capacity, any prolonged disruption could require us to reduce or suspend production.
Replacing, repairing, or relocating production on a timely or cost-effective basis may not be feasible and could require significant
capital investment, management attention, and time. In addition, disruptions could result in inventory shortages, lost sales, penalties
or chargebacks, increased logistics costs, and reduced manufacturing utilization, which could materially adversely affect margins, cash
flows, and working capital.
We
are exposed to risks associated with operating in Peru.
Operating
in Peru exposes us to risks related to political, economic, regulatory, labor, tax, infrastructure, and currency conditions. Changes
in laws or regulations, labor disruptions, tax enforcement actions, currency controls, inflation, or political instability could increase
costs, disrupt operations, or impair our ability to repatriate cash, any of which could materially adversely affect our business.
Foreign
currency fluctuations could adversely affect our results of operations.
A
significant portion of our costs are denominated in Peruvian soles, while substantially all of our revenues are denominated in U.S. dollars.
Fluctuations in exchange rates could increase our costs, reduce margins, and adversely affect our financial results. We do not currently
hedge foreign currency risk.
If
we are unable to effectively manage growth and scale our systems and controls, our business and reporting could be adversely affected.
Scaling
a manufacturing-led, cross-border operating model places significant demands on our organizational, operational, and financial infrastructure.
If our systems, personnel, processes, and internal controls do not keep pace with growth—particularly in areas such as inventory,
cost accounting, logistics, and revenue processes—we could experience operational disruptions, increased costs, delays in reporting,
or reduced investor confidence.
Achieving
efficient manufacturing utilization and throughput is important to our margins, and failure to do so could adversely affect profitability.
Our
cost structure includes fixed and semi-fixed costs. If demand, uptime, yields, or production efficiency do not meet expectations, we
may experience margin pressure, excess inventory, inventory write-downs, or increased per-unit costs.
Agricultural
supply, environmental conditions, and commodity volatility could adversely affect our costs, production, and margins.
Our
operating scale and sourcing flexibility are more limited than those of larger competitors, which may increase our exposure to agricultural
and environmental risks. Our production depends on the availability, quality, and cost of agricultural raw materials, which are subject
to volatility driven by weather conditions, climate variability, temperature extremes, drought, flooding, crop disease, and other environmental
factors. Adverse growing conditions could reduce crop yields, affect raw material quality, disrupt harvest cycles, and increase input
costs, which could negatively affect production volumes, gross margins, and operating results.
Water
availability is also a critical factor in agricultural production and food processing. Changes in water access, drought conditions, water
use restrictions, or increased competition for water resources in regions where our raw materials are sourced or where our manufacturing
facility operates could disrupt supply, increase costs, or require operational adjustments.
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In
addition, evolving environmental; sustainability; and environmental, social and governance related expectations from regulators, customers,
and investors may increase our reporting obligations, compliance costs, and operational complexity. We may be required to provide additional
disclosures regarding environmental impact, sourcing practices, emissions, or sustainability metrics, which may require investments in
systems, processes, and data collection. Failure to meet evolving expectations could adversely affect our reputation, customer relationships,
and access to capital.
Our
products and marketing may also be subject to scrutiny related to sustainability, environmental, or product claims. Regulatory agencies,
competitors, consumer groups, or plaintiffs may challenge the accuracy or substantiation of claims related to sourcing, environmental
impact, or sustainability practices. Such challenges could result in litigation, regulatory actions, increased compliance costs, reputational
harm, or changes to our labeling or marketing practices.
If
agricultural supply conditions deteriorate, commodity price volatility persists, environmental factors worsen, or sustainability-related
requirements increase, and we are unable to effectively manage these risks, our production, margins, financial condition, and results
of operations could be materially adversely affected.
Seasonality
in harvest cycles and consumer demand may cause quarterly results to fluctuate and increase working capital requirements.
Our
operating model is influenced by harvest timing for certain raw materials and seasonal shifts in consumer demand and retailer purchasing
patterns. If we are unable to align production and inventory planning with harvest availability and customer ordering cycles—particularly
when building shelf-stable inventory for later demand—our service levels, working capital needs, and margins could be adversely
affected.
Inventory
management challenges, product shelf-life limitations, and potential obsolescence could adversely affect our margins, cash flows, and
operating results.
Our
business requires us to maintain significant levels of inventory, including raw materials, work-in-process, and finished goods, to support
customer programs, international transit times, and production planning. Although our products are shelf-stable, they have finite shelf
lives and are subject to quality, freshness, and specification requirements imposed by customers and regulators. Inaccurate demand forecasting,
changes in customer purchasing patterns, program delays, order cancellations, or shifts in retailer promotional strategies could result
in excess, slow-moving, or obsolete inventory.
Inventory
levels may also increase as a result of operational disruptions, manufacturing inefficiencies, changes in production yields, or efforts
to build inventory in advance of anticipated demand or harvest availability. Excess inventory may require markdowns, write-downs, or
disposal, which could adversely affect gross margins, operating results, and cash flows. In addition, inventory that approaches the end
of its usable shelf life may be subject to customer rejection, reduced pricing, or increased handling and logistics costs.
Our
cross-border manufacturing and distribution model further increases inventory risk due to extended production lead times, international
shipping durations, customs clearance processes, and limited ability to rapidly redeploy or rework finished goods. Once inventory is
produced and shipped, our ability to adjust volumes in response to demand changes is constrained, increasing the risk of excess or obsolete
inventory.
If
we are unable to accurately forecast demand, align production with customer requirements, or effectively manage inventory levels and
shelf life, we may experience increased inventory write-downs, reduced manufacturing utilization, margin compression, and higher working
capital requirements, any of which could materially adversely affect our business, financial condition, and results of operations.
Our
insurance coverage may be insufficient to cover all potential losses, which could materially adversely affect our business and financial
condition.
We
maintain insurance coverage for certain risks associated with our business, including property damage, business interruption, product
liability, general liability, workers’ compensation, and other customary coverages. However, our insurance policies are subject
to deductibles, coverage limits, exclusions, and other terms that may not fully cover all potential losses. In addition, certain risks,
including some types of natural disasters, cyber incidents, supply chain disruptions, regulatory actions, or catastrophic events, may
be uninsurable or economically impractical to insure.
Our
manufacturing operations are concentrated in a single facility in Peru, which increases our exposure to property damage, business interruption,
and operational disruption risks. If a significant event were to damage our facility, disrupt operations, or result in product liability
or other claims, our insurance coverage may not be sufficient to fully compensate us for the associated losses, lost revenue, remediation
costs, or liabilities. Furthermore, insurance coverage may not continue to be available on commercially reasonable terms, and premiums
may increase over time.
If
we incur losses that are not adequately covered by insurance, or if insurance becomes unavailable or prohibitively expensive, our business,
financial condition, results of operations, and cash flows could be materially adversely affected.
Tariffs
imposed on the importation of our products into the United States would increase the cost of our products and could result in decreased
demand for our products.
Our
operations and financial results may be adversely impacted by changes in trade policies, including the imposition of tariffs, import/export
restrictions, or other trade barriers. We are subject to tariffs, customs duties, and other trade-related costs. If the U.S. or other
governments impose new or increased tariffs on goods imported from Peru or other countries where we manufacture our products, it could
increase our production costs, reduce our profit margins, and lead to higher prices for consumers, potentially affecting demand for our
products. Although tariffs imposed by the Trump administration were recently struck down by U.S. Supreme Court, there can be no assurance
that other tariffs may be legally imposed in the future that will have a material adverse effect on our operations.
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International
logistics and customs processes could increase costs and disrupt service levels.
We
export products from Peru to the United States. Freight availability, fuel costs, port congestion, transit delays, and customs clearance
requirements may increase costs or delay deliveries, which could adversely affect operating results and customer relationships.
Our
reliance on a limited number of key suppliers and service providers exposes us to supply chain concentration risk that could disrupt
operations and adversely affect our business.
Our
operations rely on a limited number of key suppliers, manufacturers of specialized equipment, packaging providers, agricultural input
suppliers, logistics partners, and other service providers. In certain cases, we may depend on single-source or limited-source vendors
for critical inputs, components, or services, including materials necessary for production and distribution.
If
any of these suppliers or service providers experience financial distress, operational disruptions, capacity constraints, quality failures,
labor shortages, cybersecurity incidents, transportation delays, or other adverse events, we may be unable to obtain sufficient materials
or services on a timely or cost-effective basis. Because we may have limited bargaining power, alternative sources may not be readily
available, may require significant time and cost to qualify, or may be available only on less favorable terms, which could increase costs
and disrupt production or fulfillment.
Our
relatively limited scale may also make us more vulnerable to supplier concentration risks, including reduced leverage in pricing negotiations,
longer lead times, and greater sensitivity to vendor disruptions. If we are unable to maintain reliable supply chain relationships, manage
vendor risks, or secure alternative sources when needed, our production, margins, customer relationships, and operating results could
be materially adversely affected.
We
rely on third-party service providers for key operational functions, and disruptions or failures by these providers could materially
adversely affect our business and results of operations.
Our
operations depend on third-party logistics, transportation, information technology, and service providers, and disruptions or failures
by these providers could adversely affect our operations and financial results.
Inflation
and cost pressures could increase operating expenses and adversely affect our margins and profitability.
Our
operating results are sensitive to inflationary pressures affecting labor, transportation, raw materials, utilities, packaging, and other
operating inputs. Inflation in Peru, where our manufacturing operations are located, could increase wages, benefits, and other labor-related
costs, particularly in a competitive labor market. Labor cost increases, including wage inflation, workforce shortages, or changes in
labor regulations, could raise our cost structure and reduce operating efficiency.
We
are also exposed to fluctuations in freight and logistics costs, including ocean freight, inland transportation, fuel, and port-related
expenses. Freight inflation, shipping delays, capacity constraints, or changes in global trade dynamics could increase distribution costs
and reduce margins.
In
addition, the cost and availability of agricultural raw materials and other commodities are subject to volatility driven by weather patterns,
climate variability, supply disruptions, energy prices, and global market conditions. Increases in input costs may not be fully recoverable
through pricing actions, particularly in a competitive retail environment, which could result in margin compression.
If
inflationary pressures persist or intensify, and we are unable to effectively manage costs, improve operating efficiencies, or adjust
pricing, our gross margins, operating results, cash flows, and financial condition could be materially adversely affected.
Political,
economic, and social conditions in Peru could adversely affect our operations, costs, and financial results.
Our
manufacturing operations are located in Peru, and a significant portion of our assets, employees, and operating activities are concentrated
in that country. As a result, our business is subject to political, economic, and social risks specific to Peru that are beyond our control.
These risks include changes in government leadership or policy, political instability, civil unrest, labor strikes, changes in labor
laws or enforcement practices, tax or customs policy changes, currency controls, inflationary pressures, and disruptions to local infrastructure
or public services.
Peru
has experienced periods of political uncertainty and social unrest, which have, at times, disrupted transportation networks, ports, utilities,
and supply chains. Such events could interfere with our ability to operate our manufacturing facility, source raw materials, transport
finished goods, or export products to the United States, resulting in production delays, increased costs, or lost sales.
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Economic
conditions in Peru, including inflation, changes in interest rates, fluctuations in foreign exchange rates, or restrictions on the movement
of capital, could increase operating costs or limit our ability to repatriate cash. In addition, changes in tax laws, customs duties,
regulatory interpretations, or enforcement practices by Peruvian authorities could increase our compliance obligations, result in disputes,
or adversely affect our financial results.
If
political, economic, or social conditions in Peru deteriorate, or if we are unable to effectively manage the risks associated with operating
in a foreign jurisdiction, our business, financial condition, results of operations, and cash flows could be materially adversely affected.
Changes
in tax laws, cross-border tax matters, or adverse tax determinations in the United States or Peru could materially adversely affect our
financial condition and results of operations.
We
are subject to taxation in the United States and Peru, and our tax obligations are affected by the application and interpretation of
complex and evolving tax laws and regulations in both jurisdictions. Changes in tax laws, tax rates, regulations, or administrative practices
in either country could increase our tax liabilities, reduce our after-tax earnings, or require changes to our business structure or
operations.
Our
cross-border operations involve intercompany transactions, transfer pricing arrangements, and the allocation of income and expenses between
jurisdictions. Tax authorities in the United States or Peru may challenge our transfer pricing positions, intercompany pricing methodologies,
or the characterization of transactions, which could result in additional taxes, interest, penalties, or disputes. Such determinations
could increase our effective tax rate and adversely affect our financial results.
We
are also subject to indirect taxes, including value-added taxes, customs duties, and other transaction-based taxes in Peru, as well as
United States federal and state income taxes. Changes in the administration, enforcement, or interpretation of these taxes, including
customs valuation or import/export rules, could increase compliance costs or tax liabilities.
In
addition, we may be subject to tax examinations or audits by United States or Peruvian tax authorities. The outcomes of such audits are
uncertain and could result in assessments of additional taxes, interest, and penalties. Our ability to utilize net operating losses or
other tax attributes may also be limited by future changes in tax law, ownership changes, or our operating performance.
If
tax authorities successfully challenge our tax positions, or if tax laws or enforcement practices change in ways that increase our tax
burden, our financial condition, results of operations, and cash flows could be materially adversely affected.
Risks
Related to Food Safety, Product Liability, and Regulation
We
are subject to extensive food safety, labeling, and product regulations, and noncompliance or quality failures could result in recalls,
import holds, enforcement actions, or reputational harm.
Our
products are subject to United States and foreign food safety and labeling requirements, including regulation by the U.S. Food and Drug
Administration and the Food Safety Modernization Act as it applies to imported foods. Failure to comply with applicable requirements,
actual or alleged contamination, labeling errors, or other product quality issues could result in product recalls, market withdrawals,
import holds, fines, litigation, increased costs, and reputational harm, any of which could adversely affect our business and operating
results.
In
addition, regulatory requirements governing ingredient disclosures, product claims, certifications, and labeling—including evolving
interpretations of terms such as “natural,” “organic,” or similar claims—may change or be subject to increased
enforcement or litigation. Adverse publicity or legal challenges related to labeling or marketing claims could reduce consumer confidence,
increase compliance costs, and negatively impact demand for our products.
We
may be subject to product liability claims and recall.
Product
contamination, spoilage, or consumer injury claims could expose us to product liability litigation, even if the claims are unfounded.
Our insurance coverage may be insufficient to cover all potential liabilities, and product liability claims could materially adversely
affect our business, financial condition, and reputation.
Our
operations are subject to regulation in multiple jurisdictions, and regulatory changes or increased enforcement could increase costs
or disrupt operations.
Our
business is subject to regulation by governmental authorities in the United States and Peru, including laws related to food safety, labor,
environmental practices, tax, and customs. Changes in regulatory requirements, interpretations, or enforcement practices—particularly
those affecting imported foods or foreign manufacturing—could require operational changes, delay shipments, increase compliance
costs, or result in enforcement actions that could materially adversely affect our business and results of operations.
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Evolving
environmental, labor, and sustainability regulations may increase compliance costs and operational complexity.
We
are subject to environmental, labor, food safety, and employment laws and regulations in the jurisdictions in which we operate. These
requirements may become more stringent over time, including increased reporting, compliance, or operational obligations related to sustainability,
environmental impact, and workforce practices. Compliance with current or future regulations could increase costs, require changes to
operations, or limit our ability to source materials or operate facilities as currently structured.
Risks
Related to Licensed Technology and Intellectual Property
Our
business depends on licensed dehydration technology, and limitations, disputes, or loss of exclusivity could materially harm our business.
Our
business depends on licensed technology from EnWave Corporation, (“Enwave”), and changes to, loss of, or limitations under
this license could materially adversely affect our operations and competitive position. Our production relies on proprietary vacuum-microwave
dehydration technology licensed from EnWave. Because we do not own the underlying patents or core technology, our ability to manufacture
certain products depends on our continued rights under the license and our compliance with its terms.
Under
the license, we are required to pay ongoing royalties and satisfy contractual obligations, including certain commercial and operational
requirements, to maintain our rights and, in some cases, product or territorial exclusivity. Royalty obligations and minimum or exclusivity-related
payments may increase over time or become more burdensome under changing operating conditions. The license contains termination and default
provisions, including for non-payment, insolvency, or breach of contractual obligations. If the license were terminated or our exclusivity
rights were reduced, we could lose the ability to manufacture certain products using EnWave technology, which could materially adversely
affect our business and growth strategy.
EnWave
retains ownership and control of the underlying technology and certain rights related to the equipment and its operation, and our dependence
on a third party for core production technology exposes us to risks related to technology availability, support, and continued cooperation.
In addition, EnWave may grant licenses to other companies, including competitors, which could reduce our technological differentiation
and increase competitive pressure.
Technological
advancements or the development of alternative processing technologies could reduce the competitiveness or commercial value of the licensed
technology over time. If royalty obligations increase, exclusivity is reduced, competing licenses are granted, the technology becomes
less competitive, or the license is terminated, our business, financial condition, and results of operations could be materially adversely
affected.
We
may be unable to adequately protect our intellectual property and proprietary know-how.
Our
competitive position depends on a combination of licensed rights, patents, trademarks, and trade secrets. Third parties may challenge
patent validity, develop alternative technologies, or misappropriate proprietary know-how. Enforcement efforts may be costly and could
divert management attention.
Risks
Related to Information Systems and Cybersecurity
Disruptions
to our information technology systems or cybersecurity incidents could harm operations, financial reporting, and our business.
We
rely on information technology systems and third-party service providers to support key business functions, including production planning,
inventory management, logistics coordination, order processing, financial reporting, and communications. Cybersecurity incidents—including
ransomware attacks, malware infections, phishing, unauthorized access, denial-of-service attacks, and other cyber intrusions—could
compromise our systems or data, disrupt operations, and adversely affect our business.
A
successful ransomware or similar attack could result in the encryption or loss of critical data, operational downtime, supply chain disruptions,
delays in order fulfillment, and increased costs associated with remediation, system restoration, cybersecurity enhancements, and potential
ransom payments. Because our manufacturing, logistics, and reporting processes depend on system availability and data integrity, a cybersecurity
incident could result in partial or complete operational shutdown, delays in production or shipments, and inability to process transactions
or prepare financial information on a timely basis.
We
also depend on third-party service providers, including cloud-based platforms, logistics and supply chain partners, and other vendors
that process, store, or transmit sensitive operational and financial data. A cybersecurity breach affecting our suppliers, service providers,
or other participants in our supply chain could expose us to data loss, operational disruption, contractual liabilities, or reputational
harm, even if our own systems are not directly compromised.
Cybersecurity
incidents could also result in theft, loss, or unauthorized disclosure of confidential business information, financial data, or personal
information, which could expose us to litigation, regulatory investigations, penalties, and remediation costs. In addition, a significant
cybersecurity incident could impair our ability to maintain effective internal control over financial reporting, delay required filings
with the Securities and Exchange Commission, require public disclosure of material incidents, and harm investor confidence.
While
we maintain cybersecurity controls and business continuity measures, these protections may not be sufficient to prevent or fully mitigate
cybersecurity risks. The occurrence of a cybersecurity incident could materially adversely affect our operations, financial condition,
results of operations, and reputation.
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Risks
Related to Personnel and Business Continuity
Our
success depends on a limited number of key personnel, and we may have difficulty attracting and retaining qualified employees.
Our
business depends on executive leadership and skilled operational, technical, and commercial personnel to scale manufacturing, manage
customer relationships, maintain compliance, and satisfy public company reporting requirements. The loss of key personnel or inability
to recruit and retain qualified employees could disrupt execution and adversely affect operating results.
Our
Chief Financial Officer is not a full-time employee.
John
Dalfonsi, our Chief Financial Officer, is not a full-time employee of the Company and is simultaneously serving other interests. There
can be no assurance that we will be able to successfully manage our finance and accounting matters without a full-time Chief Financial
Officer.
Labor
availability, wage inflation, or workplace safety incidents could increase costs and disrupt operations.
Our
manufacturing operations depend on a stable workforce and safe working conditions. Labor shortages, turnover, wage inflation, or safety
incidents could reduce productivity, increase costs, and disrupt production. Changes in labor laws or enforcement practices could increase
compliance burdens and operating costs.
Risks
Related to Corporate Governance
Our
governing documents designate Nevada courts as the exclusive forum for certain stockholder actions.
Our
governing documents designate Nevada courts as the exclusive forum for certain stockholder actions, which may limit stockholders’
ability to obtain a favorable judicial forum and could discourage litigation, potentially adversely affecting stockholders’ rights.
Risks
Related to Legal Proceedings and Compliance
We
may be subject to litigation, regulatory proceedings, and other legal matters that could materially adversely affect our business, financial
condition, and results of operations.
From
time to time, we may become involved in legal proceedings, claims, and regulatory matters arising in the ordinary course of business.
These may include, among others, commercial disputes, contract claims, intellectual property matters, employment and labor claims, product
liability claims, consumer protection actions, regulatory or governmental investigations, and other proceedings.
Litigation
and regulatory matters can be costly, time-consuming, and disruptive to our operations and may divert the attention of management and
other personnel. Even when claims lack merit, the costs associated with defending or resolving such matters can be significant. Adverse
outcomes, including judgments, settlements, fines, penalties, or injunctions, could materially adversely affect our financial condition,
results of operations, cash flows, and reputation.
In
addition, legal proceedings may result in substantial damages, increased insurance premiums, loss of intellectual property rights, changes
to our business practices, or other unfavorable outcomes. We may also be subject to claims arising from customer disputes, supplier relationships,
technology licensing arrangements, or cross-border operations, including matters subject to foreign jurisdictions, which may increase
the complexity, cost, and uncertainty of such proceedings.
Our
insurance coverage may not be sufficient to cover all potential losses associated with legal claims, and some types of claims may not
be covered by insurance at all. If we are required to record significant legal expenses, damages, or settlement costs, our business,
financial condition, and results of operations could be materially adversely affected.
13
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.