What changed in this filing

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Item 1. Business

2024-04-01 compared with 2023-03-31 · 268 added, 243 removed, 630 unchanged (45% of the section changed)

ITEM 1 – BUSINESS

We are a platform for acquiring, developing, researching, patenting, marketing, and distributing plant-based nutraceuticals.

We are a platform for acquiring, developing, patenting, marketing, and distributing plant-based nutraceuticals.

Our proprietary and patented products target select high-growth categories within the multibillion-dollar nutraceuticals market, such as heart, brain and immune health.

Nutraceuticals are generally considered to be substances that beyond their nutritional value can be used to achieve a benefit for an existing physiological condition or provide protection against potential ailments.

Our current principal geographic markets are customers in the United States looking for nutraceutical products focused on their own heart and brain health and immune support.

Our products have not been evaluated by the U.S.

Food and Drug Administration (“FDA”) or any similar regulatory body for safety and efficacy.

The primary philosophy behind nutraceuticals is the focus on prevention and the body’s ability to use natural rather than artificially derived substances to treat disease or dysfunction — or as the Greek physician and father of modern medicine Hippocrates famously espoused, “Let food be your Medicine.”

Today, the role of nutraceuticals in human health and wellbeing has become one of the most active and important areas of scientific investigation, with the latest findings presenting wide-ranging implications for consumers, health care providers, regulators, nutritional supplement producers and distributors.

Our mission is to lead and support this investigation and use our findings to acquire or create products with health and performance benefits that have mass consumer appeal.

Our mission is to acquire or create products with health and performance benefits that have mass consumer appeal.

Guided by this mission, our first two acquisitions (in 2019 and 2020, respectively) formed our current operating subsidiaries, Bergamet NA, LLC (“Bergamet”), which offers nutraceutical heart and immune health products, and Ultimate Brain Nutrients, LLC (“UBN”), which offers nutraceutical products for brain health.

Through published research, our Bergamet products have been shown to support heart health, support immune response, and address metabolic syndrome.

Our UBN brain health formulations have been in development for more than 20 years, over which time it has gained research support.

On January 13, 2023, we entered into a definitive agreement to acquire nutraceutical manufacturer, Hyperion, L.L.C.

(“Hyperion”), and its digital marketing affiliate, Online Publishing & Marketing, LLC (“OPM”), both based in Lexington, Virginia.

We intend to use a portion of the proceeds from this Offering to fund this acquisition.

See “Use of Proceeds.”

Hyperion products have been formulated to support brain, memory, vision, sinus and digestive health, as well as healthy sleep and aging.

OPM provides online advertising and marketing for Hyperion as well as other companies in the health and wellness space.

The closing of these two acquisitions is expected to occur following the completion of and using the proceeds from this Offering.

We anticipate the acquisition of Hyperion and OPM to be transformative to our business, significantly strengthening our manufacturing, marketing and distribution capabilities, expanding our nutraceutical product portfolio, adding positive cash flow, and significantly increasing our annualized gross revenues.

We also expect that the greater financial and operational strength afforded by these two acquisitions to better enable us to make future strategic complementary acquisitions, including some of which we have identified and are currently evaluating.

Based on published research from third-party sources, we believe our Bergamet products have been shown to support heart health, support immune response, and address metabolic syndrome.

Our UBN brain health formulations have been in development for more than 20 years, over which time its effects have been supported by third-party research studies.

The overall nutraceutical market is growing at a 7.8% compounded annual growth rate (“CAGR”) and is expected to reach $441 billion by 2026, according to ReportLinker.

Driving this growth are multiple factors, including changing lifestyles, growing consumer desire to move away from expensive prescription medicine and undesirable side effects, aging population and increased life expectancy.

Our current principal geographic markets are customers in the United States looking for nutraceutical products focused on their own heart and brain health and immune support.

A growing self-care trend is also driving strong demand for nutraceuticals.

Given increasingly hectic lifestyles, and the lack of time for preparing and consuming the required nutrients through a regular diet, the desire to replenish or augment essential nutrients with nutraceuticals is also increasing.

Our BergaMet all-natural Citrus Bergamot SuperFruit TM formulations address an expanding global heart health ingredients market that is projected to grow at a 4.6% CAGR to reach $55.3 billion by 2027, according to ResearchAndMarkets.

This growth is largely being driven by concerns about cardiovascular disease, which remains the leading cause of premature death globally according to the World Health Organization.

Our UBN products tap the fast-growing market for brain health, which is growing at a 9.4% CAGR to reach $15.7 billion by 2030, according to Grandview Research .

This market is being driven in part by the rise in the aging adult population in North America and Europe, with consumers increasingly using brain health supplements to prevent or treat mental conditions such as memory loss or dementia, or to improve mental cognition, energy and focus.

Our UBN RELIEF product for migraine suffers also address a huge market opportunity, with an estimated 39 million people suffering from migraine headaches in the U.S.

and 1 billion worldwide, according to the American Migraine Foundation.

Our Competitive Strengths

We compete with other manufacturers, distributors and marketers of vitamins, minerals, herbs, and other nutritional supplements both within and outside the U.S.

The nutritional supplement industry is highly competitive, and we expect the level of competition to remain high over the near term.

We believe the following our are competitive strengths:

High Gross Margins .

We have high gross margin categories, with our gross margin ranging from 60% to 80%, depending on product and market channel.

Nutraceutical Delivery System .

Through our exclusive U.S.

and Canada licensing and manufacturing agreement with Gelteq Pty Ltd.

(“Gelteq”), a third party global leader in ingestible gel technology, we believe we are able to offer a gel-pack delivery system that our competition in North America cannot provide.

Gelteq provides a customizable platform for supplement delivery, in that each gel formulation is tailored to solve a particular problem and deliver a specific outcome.

Higher BPF Content.

As the leading North American provider of the world’s highest strength Citrus Bergamot SuperFruit, our heart and immune products have specific advantages.

For example, our BergaMet PRO+ product has 47% Bergamot Polyphenolic Fraction Gold (“ BPF Gold”) potency as compared to our closest competitor at only 38% BPF.

BPF is an extract derived from the fruit’s juice, peel, and pulp, is comprised of five polyphenols (Naringin, Neohesperidin, Brutieridin, Melitidin, and Neoeriocitrin), and its potency is determined by the concentration of these five polyphenols achieved during the extraction process.

The potency of BPF is widely compared by Bergamot users in making their purchase decisions because a higher potency may lead to greater benefits, and is generally considered more desirable in the marketplace.

Backed by published research from third-parties, our citrus bergamot has been shown to support heart health, support immune response, and address metabolic syndrome.

Our Competitive Challenges

We compete with other manufacturers, distributors and marketers of vitamins, minerals, herbs, and other nutritional supplements both within and outside the U.S.

The nutritional supplement industry is highly competitive, and we expect the level of competition to remain high.

Our ability to scale our business and grow our revenue depends on our ability to maintain the value and reputation of our brands in the face of this competition.

The nutritional supplement industry is highly fragmented and competition for the sale of nutritional supplements comes from many sources.

Such products are sold primarily through retailers (drug store chains, supermarkets, and mass market discount retailers), health and natural food stores, and direct sales channels (network marketing and internet sales).

The nutritional supplement industry is highly competitive, and we expect the level of competition to remain high over the near term.

We do not believe it is possible to accurately estimate the total number or size of our competitors.

The nutritional supplement industry has undergone some consolidation in the recent past and we expect that trend may continue in the near term.

We have a limited operating history in our current business, we are not profitable, and we do not expect to be profitable in the near future.

There is no assurance our future operations will result in revenues sufficient to obtain or sustain profitability.

We face intense competition from competitors that are larger, more established and that possess greater resources than we do, and if we are unable to compete effectively, we may be unable to gain sufficient market share to sustain profitability.

If our competitor’s market nutritional supplement products that are less expensive, safer or otherwise more appealing than our current and potential products, or that reach the market before our current and potential products, we may not achieve operational or financial success.

The market may choose to continue utilizing existing products for any number of reasons, including familiarity with or pricing of these existing products.

The failure of any of our products to compete with products marketed by our competitors would impair our ability to generate revenue, which would have a material adverse effect on our future business, financial condition, results of operations, and cash flows.

Our competitors may:

· develop and market products that are less expensive, safer, or otherwise more appealing than our products;

· commercialize competing products before we or our partners can launch our products;

· initiate or withstand substantial price competition more successfully than we can.

Our Financial Condition and Ability to Continue as a Going Concern

Our net loss from inception to December 31, 2023 was $18,399,673, and we had only very limited cash resources at December 31, 2023 of $19,441.

Our financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

Our auditor’s report reflects that our ability to continue as a going concern is dependent upon our ability to raise additional capital from the sale of common stock and, ultimately, the achievement of significant operating revenues.

If we are unable to continue as a going concern, our business will fail and stockholders will lose their investment in our company.

Even after competition of this offering, we will be required to seek additional capital to fund future growth and expansion.

No assurance can be given that such financing will be available or, if available, that it will be on commercially favorable terms.

Moreover, financing will likely be dilutive to our stockholders.

Future Anticipated Growth Drivers

New Sales Channels and Product Launches

In order to drive continued sales growth and leverage our growing customer base, we are planning to expand our product portfolio to include supplements that support gut health (the balance between helpful and harmful bacteria and yeast in the digestive system) as well as introduce more products in gel-pack format.

Our gut health products are ready to be manufactured but have not yet been introduced to the market.

We plan to further expand our sales channels as well as our portfolio of natural formulations for heart and brain health and other indications.

Strategic Acquisitions

The market for nutraceutical products is highly fragmented, which create many acquisition opportunities.

As part of our primary mission, we will continue to evaluate potential acquisition opportunities that could expand our product portfolio and benefit from our marketing strength and multi-channel distribution.

On the Healthy Extracts holding company level, our employees are comprised of our company’s two officers, each of which is a full-time employee.

Our BergaMet subsidiary has two full-time employees.

Our UBN subsidiary currently does not have its own employees since it uses outside contract help on an as-needed basis, with management provided by our officers.

We anticipate all of our employees will continue to work for us for the foreseeable future.

We plan to hire appropriate personnel on an as-needed basis and utilize the services of independent contractors as needed.

Corporate History

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The shares of common stock issued in the acquisition were equal to approximately 42.5% of our outstanding common stock immediately following the closing.

On January 13, 2023, we entered into an Acquisition Agreement for the acquisition of Hyperion, L.L.C.

and Online Publishing & Marketing, LLC, both Virginia limited liabilities companies, by merging them into our newly-formed wholly-owned subsidiaries, Green Valley Natural Solutions, LLC (“Green Valley”) and Online Publishing & Marketing, LLC (“OPM”), both Nevada limited liability companies.

The closing of the acquisition will take place following the completion of and using the proceeds from an offering.

Corporate Information

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Our websites are www.healthyextractsinc.com, www.bergametna.com, and www.tryubn.com.

Information contained on our websites is not incorporated into, and does not constitute any part of, this prospectus.

Information contained on our websites is not incorporated into, and does not constitute any part of, this annual report.

Recent Developments

Reverse Stock Split

On September 23, 2022, our majority shareholder approved by written consent, declared it advisable and in our best interest, to amend our Articles of Incorporation to effect a reverse split of our outstanding Common Stock within a range of 1-for-25 to 1-for-150, the exact ratio and timing to be determined by our board of directors (“Board”) no later than June 30, 2023.

On September 23, 2022, our Board of Directors approved the same stock split range.

We intend for the Board to determine the exact amount of and effect such reverse stock split in connection with the Offering and our intended listing of our Common Stock on the Nasdaq Capital Market (“Nasdaq”), however we cannot guarantee that The Nasdaq Stock Market LLC will approve our initial listing application for our Common Stock upon such reverse stock split.

2023 Pending Acquisitions

On January 13, 2023, we entered into an Acquisition Agreement for the acquisition of Hyperion, L.L.C.

The closing of the acquisition will take place following the satisfaction of material closing conditions set forth below, including a capital raise of at least $4,000,000 and the commencement of trading, or approval for the commencement of trading, of our common stock on the Nasdaq Capital Market.

The total purchase price for the acquisitions will be $1,750,000 in cash, $1,300,000 in the form of secured promissory notes, and $1,250,000 worth of our common stock (based on a 30% premium to the price paid per share of common stock in the above-referenced capital raise, but in no event more than ninety percent (90%) of the volume weighted average price for our common stock for the ninety (90) trading days up to and including the trading day immediately before the day the price is finally determined for securities sold in the capital raise).

The combination of the businesses is expected to significantly increase our current annualized gross revenues.

Revenues for Hyperion and OPM were over $10 million for the year ended December 31, 2022.

Hyperion is also expected to strengthen our manufacturing and distribution capabilities, as well as expand our product portfolio with 15 proprietary nutraceutical formulations sold under the brand, Green Valley Natural Solutions.

These products are formulated to support brain, memory, vision, sinus and digestive health, as well as healthy sleep and aging.

Green Valley Natural Solutions products are manufactured and shipped direct-to-consumer from specially temperature-controlled warehouses leased in Shenandoah Valley, Virginia.

These facilities would add an East Coast presence to our existing warehouse and shipping facilities in Nevada, with this expected to lower customer shipping costs and order delivery times.

Hyperion’s relationships with high-quality contract manufacturers are also expected to lower our manufacturing costs, as well as improve supply chain efficiencies and economies of scale.

Online Publishing & Marketing specializes in creating digital and affiliate marketing content for Hyperion and will enhance our overall marketing strategy and audience reach.

They also bring a large email distribution list of hundreds of thousands of potential customers with a new affiliate marketing channel.

OPM also produces engaging digital content such as educational videos and newsletters.

Online Publishing and Marketing (OPM) creates and promotes original content in the health and wellness space.

Rather than relying on pharmaceutical and specialized medicine, OPM's content is produced by certified health and wellness professionals who focus on holistic and traditional approaches.

The content is a combination of online and offline books, videos, podcasts, DVDs and newsletters that are distributed through email, public websites, secure websites and physical mail delivery.

The primary marketing method is to advertise the content to a house file that OPM has developed over the years through opt-in marketing and newsletter subscriptions.

The house file is actively managed to ensure online people who positively opt-in and engage with OPM emails are marketed.

The secondary method of marketing OPM content is through affiliate partnerships with other online content producers who share OPM content with their positively managed opt-in only house files.

This reciprocal email marketing approach eliminates any actual or perceived unwanted emails.

The planned acquisition of Hyperion and OPM is expected to add approximately 14 employees, who would continue to work out of the existing facilities in Lexington, Virginia.

We expect these two synergistic and accretive acquisitions to accelerate and support our growth and expand our market reach.

Our natural heart and brain health formulations are perfect for cross selling or private labeling with Green Valley products, such as their stem cell restore formulation that are sold across various marketing channels.

Likewise, Green Valley sales would benefit from our established marketing channels, which includes subscription-based direct-to-consumer, national grocery stores, and a strong presence on Amazon.

On a pro forma basis upon the closing of the acquisitions, we would generate over $12 million in annualized gross revenue, including significant recurring revenue being generated by subscriptions.

The anticipated positive cash flow would fund future revenue growth from new product introductions and market expansion, as well as other potential strategic acquisitions.

The completion of the acquisitions is subject to the following material closing conditions, and there can be no assurance that the transactions will be completed as described:

· we will have entered into a new lease agreement for at least a twelve-month period at the current Hyperion and OPM locations;

· a key employee of Hyperion and OPM will have entered into a consulting agreement with us;

· our independent auditor will have completed an audit of the financial statements of Hyperion and OPM;

· we will have closed on one or more rounds of financing for an aggregate amount of no less than $4,000,000, of which at least $250,000 will be from selling parties to the transaction;

· we will have commenced trading, or been approved to commence trading, on either the Nasdaq or the NYSE American Exchange.

We are a platform for acquiring, developing, researching, patenting, marketing, and distributing plant-based nutraceuticals.

Our products have not been evaluated by the U.S.

Food and Drug Administration (FDA) or any similar regulatory body for safety and efficacy.

On August 21, 2023, our majority shareholders approved by written consent, declared it advisable and in our best interest, to amend our Articles of Incorporation to (a) effect a reverse split of our outstanding Common Stock within a range of 1-for-25 to 1-for-150, the exact ratio and timing to be determined by our board of directors (“Board”) no later than December 31, 2023, and (b) reduce our authorized common stock to fifty million (50,000,000) shares.

On August 22, 2023, our Board of Directors approved the same stock split range and decrease in authorized common stock.

On December 29, 2023, we effectuated a 1-for-120 reverse split of our common stock and decreased our authorized common stock to fifty million (50,000,000) shares.

Unless specifically provided otherwise herein, all share numbers and prices in this Annual Report reflect the effectiveness of the 1-for-120 reverse stock split of our Common Stock.

Summary of Risk Factors

There are a number of risks related to our business and our common stock that you should consider.

You should carefully consider all the information presented in the section titled “Risk Factors” in this Annual Report.

Some of the principal risks related to our business include the following:

• We rely on a single supplier relationship for licensing and manufacturing, and the termination of that agreement could have material effect on the cost of our products and the manufacturing of our finished goods.

• We have a limited operating history in our current business, we are not profitable, and we do not expect to be profitable in the near future.

There is no assurance our future operations will result in revenues sufficient to obtain or sustain profitability.

If we cannot generate sufficient revenues to operate profitably, we may suspend or cease operations.

• We answered a warning letter from the FDA in November 2022 regarding one of our products.

• Our success is linked to the size and growth rate of the vitamins, minerals and supplements market and an adverse change in the size or growth rate of that market could have a material adverse effect on us;

• Our success depends on our ability to maintain the value and reputation of our brands;

• We may fail to attract, acquire or retain customers at our current or anticipated future growth rate, or may fail to do so in a cost-effective manner, which would adversely affect our business, financial condition and results of operations;

• If we are unable to anticipate customer preferences and successfully develop new and innovative products in a timely manner or effectively manage the introduction of new or enhanced products, then our business may be adversely affected;

• We are highly dependent upon consumers’ perception of the safety, quality, and efficacy of our products as well as similar products distributed by other companies in our industry, and adverse publicity and negative public perception regarding particular ingredients or products or our industry in general could limit our ability to increase revenue and grow our business;

• We face intense competition from competitors that are larger, more established and that possess greater resources than we do, and if we are unable to compete effectively, we may be unable to gain sufficient market share to sustain profitability;

• Because we depend on outside suppliers with whom we do not have long-term agreements for raw materials, we may be unable to obtain adequate supplies of raw materials for our products at favorable prices or at all, which could result in product shortages and back orders for our products, with a resulting loss of sales and profitability;

• A disruption in the service, a significant increase in the cost of our primary delivery and shipping services for our products or a significant disruption at shipping ports could adversely affect our business;

• We will require additional financing in the future, and we can provide no assurance that such funding will be available on terms that are acceptable to us, or at all.

• One of our shareholders and his adult children will continue to own a significant percentage of our Common Stock and will maintain the ability to substantially influence all matters submitted to stockholders for approval.

• We are dependent upon our lenders for financing to execute our business strategy and meet our liquidity needs, and the lack of adequate financing could negatively impact our business;

• We and our suppliers are subject to numerous laws and regulations that apply to the manufacturing and sale of nutritional supplements, and compliance with these laws and regulations, as they currently exist or as modified in the future, may increase our costs, limit or eliminate our ability to sell certain products, subject us or our suppliers to the risk of enforcement action, or otherwise adversely affect our business, results of operations and financial condition;

• Our success is dependent on the accuracy, reliability, and proper use of sophisticated and dependable information processing systems and management information technology and any interruption in these systems could have a material adverse effect on our business, financial condition and results of operations.

These and other risks are more fully described in the section titled “Risk Factors” in this Annual Report.

If any of these risks actually occurs, our business, financial condition, results of operations, cash flows and prospects could be materially and adversely affected.

As a result, you could lose all or part of your investment in our common stock.

As used in this annual report, the term “success” generally means (unless the specific context requires otherwise) our ability to establish and grow our brand, scale our manufacturing, marketing and sales activities, integrate acquired products or internally develop new products, grow our revenues and, ultimately, establish cash flow positive and profitable operations.

We are a platform for acquiring, developing, patenting, marketing, and distributing plant-based nutraceuticals.

Our proprietary and patented products target select high-growth categories within the multibillion-dollar nutraceuticals market, such as heart, brain and immune health.

Our current principal geographic markets are customers in the United States looking for nutraceutical products focused on their own heart and brain health and immune support.

Our products have not been evaluated by the FDA or any similar regulatory body for safety and efficacy.

The term “nutraceutical” is derived from the combination of the words “nutrient,” which means a nourishing food component, and “pharmaceutical,” meaning a medical drug.

The term was coined in 1989 by Stephen DeFelice, founder and chairman of the Foundation for Innovation in Medicine.

Nutraceuticals are generally considered to be substances that beyond their nutritional value can be used as medicine to achieve a benefit for an existing physiological condition or provide protection against potential aliments.

Nutraceuticals may be used to improve health, delay the aging process, help prevent chronic disease, increase life expectancy, or support the structure or function of the body.

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The primary philosophy behind nutraceuticals is the focus on prevention and the body’s ability use natural rather artificially derived substances to treat disease or dysfunction — or as the Greek physician and father of modern medicine Hippocrates famously espoused, “Let food be your Medicine.”

Today, the role of nutraceuticals in human health and wellbeing has become one of the most active and important areas of scientific investigation, with the latest findings presenting wide-raging implications for consumers, health care providers, regulators, nutritional supplement producers and distributors.

Our mission is to lead and support this investigation and use our findings to acquire or create products with health and performance benefits that have mass consumer appeal.

for consumers, health care providers, regulators, nutritional supplement producers and distributors.

Our mission is to acquire or create products with health and performance benefits that have mass consumer appeal.

Guided by this mission, our first two acquisitions (in 2019 and 2020, respectively) formed our current operating subsidiaries, Bergamet, which offers nutraceutical heart and immune health products, and UBN, which offers nutraceutical products for brain health.

Through published research, our Bergamet products have been shown to support heart health, support immune response, and address metabolic syndrome.

Our UBN brain health formulations have been in development for more than 20 years, over which time it has gained support by research studies.

Based on published research from third-party sources, we believe our Bergamet products have been shown to support heart health, support immune response, and address metabolic syndrome.

Our UBN brain health formulations have been in development for more than 20 years, over which time its effects have been supported by third-party research studies.

Heart & Immune Health

Our products which are designed to promote heart and immune health have been developed by our BergaMet subsidiary.

47% BPF Bergamet products are currently the only heart health supplements distributed in North America that contain Citrus Bergamot SuperFruit .

Our products which are intended to promote heart and immune health have been developed by our BergaMet subsidiary.

Bergamot Polyphenolic Fraction Gold (“BPF”) is the active ingredient in these products, and our 47% BPF Bergamet products are currently the only heart health supplements distributed in North America that contain Citrus Bergamot SuperFruit.

This exclusive superfruit is of the bergamot orange family, a fragrant citrus fruit about the size of a common orange but with a yellow or green color similar to a lime, depending on its ripeness.

Our Citrus Bergamot SuperFruit varietal is considered a superfruit since it has been shown to have the highest quality and concentration of polyphenols and flavonoids of the citrus bergamia or bergamot orange fruit species.

BPF is comprised of five key polyphenols (Naringin, Neohesperidin, Brutieridin, Melitidin, and Neoeriocitrin).

These five polyphenols are known to increase the product’s effectiveness, and thus its existence is viewed as a positive factor in its efficacy, and our product has a polyphenolic rate of 47%.

BergaMet currently holds the exclusive rights to distribute Citrus Bergamot SuperFruit 47% Bergamot Polyphenolic Fraction Gold (“BPF”) products in the online and direct to consumer channels in the U.S.

Our Citrus Bergamot SuperFruit varietal, with its 47% BPF, has a high concentration of polyphenols and flavonoids of the citrus bergamia or bergamot orange fruit species.

BPF is comprised of five polyphenols (Naringin, Neohesperidin, Brutieridin, Melitidin, and Neoeriocitrin).

BergaMet currently holds the rights to distribute Citrus Bergamot SuperFruit 47% BPF products in the online and direct to consumer channels in the U.S.

and Canada pursuant to a supply agreement with H&AD S.r.L., an Italian limited company, which we entered into on January 1, 2019 and amended on November 1, 2021.

The supply agreement has a term of five years and is renewable for up to four additional and successive three-year terms.

We have minimum purchase obligations under the agreement, which require us to purchase at least 4,000 kilograms of BPF in 2023.

Through 2023, we have paid H&AD a total of approximately $1.2 million for BPF product.

The agreement is mutually exclusive in that (i) we cannot purchase BPF from any third-party, sell or distribute any similar product in the territory, sell the product outside the territory, or produce the product ourselves, and (ii) H&AD will not supply or sell the product to any third-party in the territory.

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Bergamot has been used for decades in the Calabrian regions for its beneficial effects in promoting overall health, particularly in support of cholesterol, cardiovascular, and metabolic health.

Our Citrus Bergamot SuperFruit formulations contain citrus bergamot extracts approved by the prestigious Academia Del Bergamotto in Reggio Calabria, Italy.

Citrus bergamot contains five antioxidant polyphenols in unusually concentrated amounts, which are believed to help protect the human body’s trillions of cells from free radical damage.

The juice and albedo of bergamot has a profile of flavanoid and glycosides, such as neoeriocitrin, neohesperidin, naringin, rutin, neodesmin, rhoifolin, and poncirin.

Naringin has been shown to be beneficial in animal models of atherosclerosis, while neoeriocitrin and rutin have been found to exhibit a strong capacity to prevent low-density lipoprotein (“LDL”) from oxidation.

Importantly, bergamot juice is rich in brutieridine and melitidine with an ability to inhibit HMG-CoA reductase, which inhibits the liver’s ability to produce LDL, resulting in reduced cholesterol levels in liver cells.

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· BergaMet CLINICAL IMMUNE

All of our BergaMet products are certified organic, vegan friendly, non-GMO and gluten-free, and produced and tested by certified U.S.

In published research, our Citrus Bergamot has been shown to support heart health, support immune response and address metabolic syndrome.

All of our BergaMet products are vegan friendly, non-GMO and gluten-free, and produced and tested by certified U.S.

facilities, all as represented to us by our supplier, H&AD.

Our HerHeart, Cholesterol Command, and Pro+ products are vegan, non-GMO, and gluten-free, as represented to us by our supplier, Norax Supplements.

In published research from third-party sources, our Citrus Bergamot has been shown to support heart health, support immune response and address metabolic syndrome.

Our Citrus Bergamot has also been shown to naturally reduce cholesterol by lowering LDL and increasing high-density lipoprotein (“HDL”).

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UBN's mission is to naturally create better lifestyles with superior health technology and products.

UBN’s KETONOMICS® proprietary formulations, which have been designed to enhance brain activity, focus, headache and cognitive behavior, provide many sales and intellectual property licensing opportunities.

UBN’s all-natural, sugar-free and caffeine-free proprietary formulations are the result of 20 years of scientific research and are positioned to provide consumer neuro-products that are natural brain solutions.

UBN’s KETONOMICS® proprietary formulations, which are intended to enhance brain activity, focus, headache and cognitive behavior, provide many sales and intellectual property licensing opportunities.

UBN’s all-natural, sugar-free and caffeine-free proprietary formulations are the result of 20 years of scientific research by third-parties and are positioned to provide consumer neuro-products that are natural brain solutions.

UBN’s KETONOMICS® supplementation has also been studied in sports physiology, with specific regard to its potential benefits for competitive performance and endurance.

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· UBN RELIEF :

designed for migraine sufferers, this proprietary, patent-pending natural formulation has been shown to provide relief from symptoms often associated with migraine headaches, while also increasing brain and cognitive activation.

intended for migraine sufferers, this proprietary, patent-pending natural formulation has been shown to provide relief from symptoms often associated with migraine headaches, while also increasing brain and cognitive activation.

This product is sold direct-to consumer on our website as singular sale or monthly subscription, as well as sold in the retail marketplace.

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It is sold direct-to-consumer on whitneyjohns.com as a singular sale or by subscription.

The gel packs are based on patented gel science developed by Gelteq, a global leader in ingestible gel technology.

The gel packs are developed by Gelteq, a global leader in ingestible gel technology.

Gelteq gels offer a super-convenient way to consume substances that have a positive impact on mental skills (sometimes referred to as “nootropics”) and other nutrients.

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Our F4T® formulation includes C8 MCT (derived from coconut extract), Nuementix (spearmint), FloraGLO, and highly concentrated medium chain triglycerides, F4T® MCT, which are derived from our patented extraction process.

F4T® MCTs have been shown to elevate the level of ketones in the brain—a major alternative energy source.

F4T® C8 MCTs have been shown to elevate the level of ketones in the brain.

“C8” refers to the eight-carbon chain that characterizes this specific fatty acid.

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It also includes a natural marigold extract that is scientifically shown to block blue light and replenish lutein, which is critical for optimum eye health.

The formulation has been in development for more than 20 years, over which time it has gained support by research studies.

The antioxidant function comes from the Neumentix that contains a combination of polyphenols from Kemin’s proprietary spearmint extract.

The complex contains rosmarinic, salvianolic, lithospermic and caftaric acids (and more) that act as antioxidants in the brain.

The formulation has been in development for more than 20 years, over which time it has gained support by third-party research studies.

The above EEG brain scan images are from a study that showed a 46% increase in brain activation after a subject consumed our active ingredients.

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There can be no assurance that our formulations will produce the same results as this study using just our active ingredients.

The brain activation that is described is measured by electroencephalographic (EEG) electrodes placed on the surface of the skull overlying the major anatomic lobes of the brain (frontal, parietal, temporal, occipital).

The brain activation described above is measured by electroencephalographic (EEG) electrodes placed on the surface of the skull overlying the major anatomic lobes of the brain (frontal, parietal, temporal, occipital).

The activation is measured in microvolts of energy and reflects brain physiological function;

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Subjects underwent EEG voltage measurement with auditory reaction time (WaviMed System) and vision and trail making testing (Senaptec Sensory Station).

Brain activation improved in 20 of the 21 intervention group subjects with voltage increases ranging from no change to 200%,

average 46% increase.

Trail making testing (“TMT”), while not using sample sizes believed to be statistically significant, is one of the most widely used tests for cognitive impairment, is believed to measure several functions, particularly cognitive flexibility, alternating attention, sequencing, visual search,

and motor speed.

Brain activation improved in 20 of the 21 intervention group subjects with voltage increases ranging from no change to 200%, average 46% increase.

This activation level correlated positively with improvements in reaction time, vision and trail making tests.

Parameter changes were statistically significant with a strong improvement trend for the auditory reaction time measures.

The tests were conducted by Dr Neil Wolkodoff in a strict prospective, randomized manner.

The tests were conducted by Dr.

Neil Wolkodoff in a strict prospective, randomized manner.

The results were double blinded with regard to intervention versus placebo group results and all data was deposited into a blind pool until completion of the trials when the results were unblinded and statistically analyzed.

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No caffeine, steroids or other stimulants were consumed by any study subjects.

In January 2022, the World Journal of Advanced Research and Reviews published the results of a clinical study which showed that taking a daily serving of UBN RELIEF for 60 days can naturally reduce or alleviate neurological discomfort.

It was also shown to improves cognitive function, sleep satisfaction and overall quality of life.

We are in the research and development phase for new products focused on Alzheimer’s disease and dementia.

We are finalizing research on additional non-FDA approved, brain health products which focus on dementia and Alzheimer’s disease.

We expect to have research completed in 2024.

We are in the development phase for new products focused on Alzheimer’s disease and dementia.

We are finalizing development of additional non-FDA approved, brain health products which focus on dementia and Alzheimer’s disease.

We expect to have our development processes completed in 2024.

Gel-Pack Exclusive Licensing and Manufacturing Agreement

In August 2021, we signed an exclusive U.S.

and Canada licensing and manufacturing agreement with Gelteq Pty Ltd, a developer of ingestible gel technology, under which we agreed to develop and manufacture an advanced oral delivery system for our plant-based heart, immune and brain health formulations.

and Canada licensing and manufacturing agreement with Gelteq, a third party developer of ingestible gel technology, under which we agreed to develop and manufacture an advanced oral delivery system for our plant-based heart, immune and brain health formulations.

The agreement has a three-year term and can be terminated by either party in the event of a breach, and contains a minimum order amount of 500,000 units of product (of which 250,000 units must have been purchased during the first 12 months).

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Our current principal markets are nutraceutical products targeting customers focused on their own heart and brain health and immune support.

Our current principal geographic markets are customers in the United States looking for nutraceutical products focused on their own heart and brain health and immune support.

A growing self-care trend is also driving strong demand for nutraceuticals.

Given increasingly hectic lifestyles, and the lack of time for preparing and consuming the required

nutrients through a regular diet, the desire to replenish or augment essential nutrients with nutraceuticals is also increasing.

Our BergaMet all-natural Citrus Bergamot SuperFruit formulations address an expanding global heart health ingredients market that is projected to grow at a 4.6% CAGR to reach $55.3 billion by 2027, according to ResearchAndMarkets.

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Our UBN products tap the fast-growing market for brain health, which is growing at a 9.4% CAGR to reach $15.7 billion by 2030, according to Grandview Research.

This market is being driven in part by

the rise in the aging adult population in North America and Europe, with consumers increasingly using brain health supplements to prevent or treat mental conditions such as memory loss or dementia, or to improve mental cognition, energy and focus.

Americans consume unhealthy energy shots and drinks every day, with this alone generating over $12.5 billion per year in industry sales.

Within this growing market, UBN is advancing its position to meet rising consumer demand for healthy options backed by research studies.

Within this growing market, UBN is advancing its position to meet rising consumer demand for healthy options backed by third-party research studies.

Our KETONOMICS® proprietary formulations have been proven to naturally elevate brain energy and function, including memory, cognition and focus.

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The new gut health product will allow us to address a large and expanding global gut health market that is growing at a 7.9% CAGR to reach nearly $72 billion by 2027, according to Fortune Business Insights.

Our gut health (the balance between helpful and harmful bacteria and yeast in the digestive system) products are in the early stages of design and development and we have not begun development of any gut health products yet, nor do we have any data that supports that our anticipated formulations will improve gut health.

Our gut health products are ready to be manufactured but have not yet been introduced to the market.

Gut health is the balance between helpful and harmful bacteria and yeast in the digestive system.

Go-to-Market Strategy

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As a key part of our multi-channel strategy, Amazon.com has been generating strong sales, particularly with its popular ‘Subscribe & Save’ option helping to further expand our recurring revenue stream.

Amazon complements our director-to-consumer channel on our BergaMet and UBN websites that offer a subscription-based option.

Amazon complements our direct-to-consumer channel on our BergaMet and UBN websites that offer a subscription-based option.

Last year our Citrus Bergamot SuperFruit formulations also became available for purchased on Walmart.com.

In the third quarter of 2022, we launched our premium Citrus Bergamot SuperFruit heart health supplement, BergaMet PRO+, on Fullscript.com, the nation’s leading care delivery platform for integrative medicine.

This made BergaMet PRO+ available to the more than 70,000 healthcare professionals and their more than 5 million patients on the Fullscript care platform.

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Some of her popularity is due to her personalized diet and fitness program, Find Your Fit with Whit , which helps individuals from all walks of life achieve their personal nutritional and fitness goals.

We entered into a Private Label Agreement with her on October 11, 2021, pursuant to which we granted her the exclusive right to private label our products in the field of female fitness.

The agreement is for three years and was subsequently verbally amended for us to pay her a flat monthly fee of $4,000 instead of the sales and volume-based

compensation model in the original agreement.

We entered into a Private Label Agreement with her on October 11, 2021, pursuant to which we granted her the exclusive right to private label our Ultimate Brain Nutrients ACTIVATE and BergaMet NA sports performance and hormone balancing products in the field of female fitness, and granted her the right of first refusal for private label rights on any new products and technology in the field.

We have also developed our gut health and ACTIVATE gel pack products with her, which are ready to manufacture but which have not been introduced to the market yet.

The agreement is for three years and was subsequently verbally amended for us to pay her a flat monthly fee of $4,000 instead of the sales and volume-based compensation model in the original agreement.

The agreement can be terminated by either party on 90 days’ written notice.

Through September 30, 2023, we have paid her a total of $38,000 under this agreement 2 .

We also granted her RSU’s for 500,000 shares of our common stock with a purchase price of $0.01 per share.

The verbal amendment will be in place until otherwise agreed between the parties.

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This means they are also vegan-friendly, non-GMO, gluten-free and organic, and made in a certified U.S.

Moreover, they are supported by our extensive catalog of published clinical research, which helps influencers like Whitney to provide their full-throated endorsement of our proprietary formulations.

Moreover, they are supported by published research from third-party sources, which helps influencers like Whitney to provide their full-throated endorsement of our proprietary formulations.

The first Whitney products have included Whitney Johns Nutrition BRAIN ACTIVATE (in powder and gel format), ACTIVE for enhanced physical performance, and WOMEN’S HORMONE SUPPORT.

These products are available from whitneyjohns.com as well as on Whitney’s Amazon.com store, with both channels offering subscription options.

update to 12/31/23

Future Growth Drivers

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We anticipate that the greater financial and operational strength afforded by the aforementioned planned acquisitions of Hyperion and OPM will better enable us to make future strategic complementary acquisitions.

Patents and Intellectual Property Rights

Intellectual Property

We have filed formulation patent applications related to general brain health as well as patents particularly focused on migraine headaches.

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“Comprising” language is utilized wherever it is allowed by the U.S.

Patent and Trademark Office (PTO) whereby the patented formulation includes but is not limited to the elements listed in the claim.

Patent and Trademark Office

(PTO) whereby the patented formulation includes but is not limited to the elements listed in the claim.

Markush groups and claims are used so that categories can include alternative ingredients from a selected group that share structural similarities or common functions.

Expiration dates for issued patents are listed and expiration for pending patents will be 17 years after the date of issuance.

Expiration dates for issued patents are listed, expiration for pending patents will be 17 years after the date of issuance, and all patents are in the United States.

Prophylaxis and Mitigation of Migraine Headaches Using Medium Chain Triglycerides, Ketone Ester, and Other Ketogenic Sources.

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pending approval .

This composition is comprised of a dietary ketone wherein this unique ingredient is designed to address migraines with disclosure of a related method of manufacture.

This composition is comprised of a dietary ketone wherein this unique ingredient is intended to address migraines with disclosure of a related method of manufacture.

The supplement manufacturing method also contains ketogenic MCT in combination with a pharmaceutical agent.

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Relates to enhancement of metabolic energy pathways to improve attention, cognition, memory, analytical and executive functions.

Formulation categories include medium chain triglycerides (MCT), polyphenol-rich

phytonutrients, brain carotenoid antioxidants, dietary vitamins and minerals and miscellaneous nutrients.

Formulation categories include medium chain triglycerides (MCT), polyphenol-rich phytonutrients, brain carotenoid antioxidants, dietary vitamins and minerals and miscellaneous nutrients.

Relates to Activate and BergaMet product lines.

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Qualified Health Claim (QHC)

We filed a QHC petition for Fuel for migraine health with the Center for Food Safety and Nutrition of the U.S.

Food and Drug Administration (FDA) in July 2019.

We filed a QHC petition for Fuel for migraine health with the Center for Food Safety and Nutrition

of the FDA in July 2019.

The preponderance of third-party scientific evidence to support the claim has been submitted.

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We are priced similarly to their product.

They sell a 38% BPF.

They sell a 38% BPF product.

Our key competitors on digital marketing and Amazon are Doublewood, Secrets, Naomi, and Jarrow.

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For example, our BergaMet PRO+ product has 47% BPF Gold potency as compared to the closest competitor at only 38% BPF.

BPF is comprised of five key polyphenols (Naringin, Neohesperidin, Brutieridin, Melitidin, and Neoeriocitrin).

These five polyphenols are known to increase the product’s effectiveness, and thus its existence is viewed as a positive factor in its efficacy.

Backed by published research, our citrus bergamot has been shown to support heart health, support immune response, and address metabolic syndrome.

It was also shown to improve cognitive function, sleep satisfaction and overall quality of life.

On the Healthy Extracts holding company level, are employees are comprised of our officers.

Our BergaMet subsidiary has two employees.

Backed by published research from third-party sources, our citrus bergamot has been shown to support heart health, support immune response, and address metabolic syndrome.

On the Healthy Extracts holding company level, our employees are comprised of our company’s two officers, each of which is a full-time employee.

Our BergaMet subsidiary has two full-time employees .

Our UBN subsidiary currently does not have its own employees since it uses outside contract help on an as-needed basis, with management provided by our officers.

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We plan to hire appropriate personnel on an as-needed basis and utilize the services of independent contractors as needed.

We anticipate that our planned acquisition of Hyperion and OPM will add approximately 14 employees, which will continue to work out of their existing facilities in Lexington, Virginia.

Governmental Controls, Approval and Licensing Requirements

Our products have not been evaluated by the U.S.

Food and Drug Administration (FDA) or any similar regulatory body for safety and efficacy.

Our products have not been evaluated by the FDA or any similar regulatory body for safety and efficacy.

Federal laws related to the advertising, distribution and sale of health supplements .

We expect that the formulation, manufacturing, packaging, labeling, advertising, distribution and sale (hereafter, “sale” or “sold” may be used to signify all of these activities) of our vitamin and nutritional supplement products will be subject to regulation by one or more federal agencies, primarily the Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”), and to a lesser extent the Consumer Product Safety Commission (“CPSC”), the United States Department of Agriculture, and the Environmental Protection Agency.

We expect that the formulation, manufacturing, packaging, labeling, advertising, distribution and sale (hereafter, “sale” or “sold” may be used to signify all of these activities) of our vitamin and nutritional supplement products will be subject to regulation by one or more federal agencies, primarily the FDA and the Federal Trade Commission (“FTC”), and to a lesser extent the Consumer Product Safety Commission (“CPSC”), the United States Department of Agriculture, and the Environmental Protection Agency.

Our activities are also regulated by various governmental agencies for the states and localities in which our products are sold, as well as by governmental agencies in certain countries outside the United States in which our products are sold.

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The FDA’s revision of nutrition labeling requirements also affects the nutrition labeling of certain dietary supplements.

Our affected manufacturers may have revised labels on

some of their dietary supplements to comply with the new requirements.

Our affected manufacturers may have revised labels on some of their dietary supplements to comply with the new requirements.

Our manufacturers review our labels prior to each product run to assure compliance.

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The law requires, among other things, that companies that manufacture or distribute nonprescription drugs or dietary supplements report serious adverse events allegedly associated with their products to the FDA and institute recordkeeping requirements for all adverse events (serious and non-serious).

There is a risk that consumers, the press and government regulators could misinterpret reported serious adverse events as evidence of causation by the ingredient or product complained of, which could

lead to additional regulations, banned ingredients or products, increased insurance costs and a potential increase in product liability litigation, among other things.

There is a risk that consumers, the press and government regulators could misinterpret reported serious adverse events as evidence of causation by the ingredient or product complained of, which could lead to additional regulations, banned ingredients or products, increased insurance costs and a potential increase in product liability litigation, among other things.

All states regulate foods and drugs under laws that generally parallel federal statutes.

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On November 14, 2022, BergaMet NA, LLC, our subsidiary, received a warning letter from the FDA regarding claims we allegedly make about our Cholesterol Command product.

Specifically, that claims on our website, Facebook page, and the webpage of a retailer claim that the products are intended for use in the cure, mitigation, treatment, or prevention of disease because they reduce cholesterol or are an anti-inflammatory.

Specifically, the warning letter related to claims on our website, Facebook page, and the webpage of a retailer claim that the products are intended for use in the cure, mitigation, treatment, or prevention of disease because they reduce cholesterol or are an anti-inflammatory.

On December 1, 2022, we responded to the warning letter notifying the FDA that we had hired a third-party to review our advertising and revise portions of our website, Facebook page, and online product listings.

This was the first warning letter we received from the FDA, and we are awaiting their response.

This was the only warning letter we received from the FDA to date, and we are awaiting their response.

There can be no assurance that the FDA will not pursue this action further.

If the FDA were to pursue this action, we may have to cease selling our Cholesterol Command product.

Any action brought by the FDA (or any ramifications of such action, including, without limitation, a required withdrawal of Cholesterol Command from the market) would have a material adverse effect on our reputation, sales efforts and results of operations.

Currently, our products are only distributed in the United States.

If we distribute products in Canada or elsewhere in the future, we will go through the appropriate approval process.

Description of Property

We do not currently own, lease or use any office space as we operate on a virtual basis.

However, we lease warehouse facilities under an operating lease that expires in 2025.

Prior to February 4, 2022, we leased a warehouse facility on a month-to-month basis.

Our rent obligations for 2023 through 2025 are as follows:

2023 - $65,335, 2024 - $69,635, and 2025 - $5,822.

Total rent for the year ended December 31, 2022 and 2023 was $63,745 and $65,335.

– RISK FACTORS.

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Any investment in our common stock is speculative and involves a high degree of risk .

You should consider carefully the risk factors related to our business described below, together with the other information and financial statements contained in this prospectus, before you decide to buy our common stock.

You should consider carefully the risk factors related to our business described below, together with the other information and financial statements contained in this annual report, before you decide to buy our common stock.

There are numerous and varied risks, known and unknown, that may prevent us from achieving our goals.

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In August 2021, we signed an exclusive U.S.

and Canada licensing and manufacturing agreement with Gelteq Pty Ltd, a developer of ingestible gel technology, under which we agreed

to develop and manufacture an advanced oral delivery system for our plant-based heart, immune and brain health formulations.

and Canada licensing and manufacturing agreement with Gelteq, a developer of ingestible gel technology, under which we agreed to develop and manufacture an advanced oral delivery system for our plant-based heart, immune and brain health formulations.

Through this agreement we secured the exclusive rights to use Gelteq’s gelification process in the U.S.

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Our net loss from inception to December 31, 2023, was ($18,399,673).

Based on our cash position of $65,651 as of December 31, 2022, we will need to raise additional capital from the sale of our stock or debt.

Based on our cash position of $19,441 as of December 31, 2023, we have a pressing need to raise additional capital from the sale of our stock or debt (including but also following this offering).

Such funding may not be available, or may be available only on terms which are not beneficial and/or acceptable to us.

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Based upon current plans, we expect to incur operating losses in future periods because we will be incurring expenses that may exceed revenues.

We cannot guarantee that we will be successful in generating sufficient revenues in the future.

We cannot guarantee that we will be successful in generating

sufficient revenues in the future.

In the event we cannot generate sufficient revenues and/or secure additional financing, we may be forced to cease operations.

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We cannot assure you that our market will continue to develop, that the public’s interest in personalized health and wellness will continue, or that our products and services will become widely adopted.

If our market does not further develop, develops more slowly than expected, or becomes saturated with competitors, or if our products

and services do not achieve market acceptance, our business, financial condition, and operating results could be adversely affected.

If our market does not further develop, develops more slowly than expected, or becomes saturated with competitors, or if our products and services do not achieve market acceptance, our business, financial condition, and operating results could be adversely affected.

We are highly dependent upon consumers’ perception of the safety and quality of our products and if we fail to maintain adequate quality standards for our products and services, or if our products become subject to regulatory investigations, our business may be adversely affected and our reputation harmed.

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These defects could result in a product recall, market withdrawal, negative publicity or other events that would result in harm to our reputation, loss of customers or revenue, health and safety issues for our customers, product liability claims, refunds, order cancellations, or lack of market acceptance of our products and services.

Any such defects, errors, or vulnerabilities would require us to take remedial action, which could require us to allocate significant research and development and customer support resources to address any such problems.

Any such defects, errors, or vulnerabilities would require us to take remedial action, which could require us to allocate significant customer support resources to address any such problems.

Further, if we make acquisitions, we may encounter difficulties in integrating acquired technologies into our services and in augmenting those technologies to meet the quality standards that are consistent with our brand and reputation.

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Any such adverse public reports or other media attention could arise even if the adverse effects associated with such products resulted from consumers’ failure to consume such products as directed and the content of such public reports and other media attention may be beyond our control.

Publicity related to nutritional supplements may also result in increased

regulatory scrutiny of our industry.

Publicity related to nutritional supplements may also result in increased regulatory scrutiny of our industry.

Adverse publicity may have a material adverse effect on our business, financial condition, results of operations and cash flows.

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Our ability to maintain and increase the number of visitors directed to our website is not entirely within our control.

Our competitors may increase their search engine optimization efforts and outbid us for placement on various sites or search terms on various search engines, resulting in their websites receiving a higher search result page ranking than ours.

result page ranking than ours.

Additionally, internet search engines could revise their methodologies in a way that would adversely affect our search result rankings.

If internet search engines modify their search algorithms in ways that are detrimental to us, if sites refuse to display any or all of our products in certain geographic markets, or if our competitors’ efforts are more successful than ours, overall growth in our customer base could slow or our customer base could decline.

Our website has experienced fluctuations in search result

rankings in the past, and we anticipate similar fluctuations in the future.

Our website has experienced fluctuations in search result rankings in the past, and we anticipate similar fluctuations in the future.

Any reduction in the number of users directed to our website through internet search engines, lead generators, or social networking sites could harm our business and operating results.

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Even if we are successful in anticipating consumer preferences, our ability to adequately react to and address them will partially depend upon our continued ability to develop and introduce innovative, high-quality product offerings.

Development of new or enhanced products and services

may require significant time and financial investment, which could result in increased costs and a reduction in our profit margins.

Development of new or enhanced products and services may require significant time and financial investment, which could result in increased costs and a reduction in our profit margins.

If we are unable to sustain pricing levels for our products, our business could be adversely affected.

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We have operations, as well as current and potential new customers, throughout the United Kingdom and most of Europe.

If economic conditions in the United Kingdom and Europe and other key markets for our platform continue to remain uncertain

or deteriorate further, it could adversely affect our customers’ ability or willingness to subscribe to our platform, delay prospective customers’ purchasing decisions, reduce the value or duration of their subscriptions or affect renewal rates, all of which could harm our operating results.

If economic conditions in the United Kingdom and Europe and other key markets for our platform continue to remain uncertain or deteriorate further, it could adversely affect our customers’ ability or willingness to subscribe to our platform, delay prospective customers’ purchasing decisions, reduce the value or duration of their subscriptions or affect renewal rates, all of which could harm our operating results.

Inflation or other changes in economic conditions that affect demand for nutritional supplements could adversely affect our revenue.

Uncertainty about current global economic conditions poses a risk as consumers and businesses may postpone spending in response to tighter credit markets, negative financial news and/or declines in income or asset values, each of which could have a material negative effect on the demand for our products.

demand for our products.

Other factors that could influence demand include conditions in the residential real estate and mortgage markets, labor and healthcare costs, access to credit, consumer confidence and other macroeconomic factors affecting consumer spending behavior.

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Further, lower than forecasted demand could also result in excess manufacturing capacity or reduced manufacturing efficiencies, which could result in lower margins.

Conversely, if we underestimate customer demand, our suppliers and manufacturers may not be able to deliver products to meet

our requirements or we may be subject to higher costs in order to secure the necessary production capacity.

Conversely, if we underestimate customer demand, our suppliers and manufacturers may not be able to deliver products to meet our requirements or we may be subject to higher costs in order to secure the necessary production capacity.

An inability to meet customer demand and delays in the delivery of our products to our customers could result in reputational harm and damaged customer relationships and have an adverse effect on our business, financial condition, and operating results.

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We acquire ingredients for a number of our products from suppliers outside of the United States.

Accordingly, the acquisition of these ingredients is subject to the risks generally associated with importing raw materials, including, among other factors, delays in shipments, changes in economic and political conditions, quality assurance, health epidemics affecting the region of such suppliers (including the COVID-19 pandemic), nonconformity to specifications or laws and regulations, tariffs, trade disputes and foreign currency fluctuations (particularly as it relates to the tariffs currently imposed on certain products originating from China).

products originating from China).

While we inspect 100% of the lots received from third party suppliers, we cannot assure you that raw materials received from suppliers or finished products from manufacturers outside of the United States will conform to all specifications, laws and regulations or our internal standards.

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Changes in shipping terms, or the inability of these third-party shippers to perform effectively, could affect our responsiveness to our users and brick-and-mortar and online retail partners.

Increases in our shipping costs may adversely affect our financial results if we are unable to pass on these higher costs to our users or brick-and-mortar and online retail partners.

Increases in our shipping costs may adversely affect our

financial results if we are unable to pass on these higher costs to our users or brick-and-mortar and online retail partners.

We will require additional financing in the future, and we can provide no assurance that such funding will be available on terms that are acceptable to us, or at all.

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The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to make capital expenditures, declare dividends, or otherwise conduct our business.

If we are unable to obtain any funding we need on a timely basis, we may be required to significantly curtail, delay or discontinue research or development of new products, the commercialization of our products or expansion into new geographies, which could materially affect our business, financial condition, and results of operations.

If we are unable to obtain any funding we need on a timely basis, we may be required to significantly curtail, delay or discontinue development of new products, the commercialization of our products or expansion into new geographies, which could materially affect our business, financial condition, and results of operations.

Our competitors may develop nutritional supplement products that are less expensive, safer or otherwise more appealing, which may diminish or eliminate the commercial success of any potential product that we may commercialize.

If our competitors’ market nutritional supplement products that are less expensive, safer or otherwise more appealing than our current and potential products, or that reach the market before our current and potential products, we may not achieve commercial success.

If our competitors (most of whom are larger and have more resources than we do) develop and bring to market nutritional supplement products that are less expensive, safer or otherwise more appealing than our current and potential products, or that reach the market before our current and potential products, we may not achieve commercial success.

The market may choose to continue utilizing existing products for any number of reasons, including familiarity with or pricing of these existing products.

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We will be required to seek additional capital to fund future growth and expansion.

No assurance can be given that such financing will be available or, if available, that it will be on commercially favorable terms.

No assurance can be given that

such financing will be available or, if available, that it will be on commercially favorable terms.

Moreover, favorable financing may be dilutive to our stockholders.

Our controlling stockholders have significant influence over us.

Our officers and directors currently own stock representing approximately 10% of our outstanding Common Stock.

However, when combined with the shares held by our controlling shareholder, Jay Decker, such persons collectively hold approximately 63% of our outstanding Common Stock.

One of our shareholders and his adult children owns a significant percentage of our Common Stock and has the ability to substantially influence all matters submitted to stockholders for approval.

One of our shareholders, Jay Decker, owns slightly less than 50% of our outstanding shares of Common Stock.

For as long as Decker retains a significant ownership of our shares of Common Stock, he will be able to substantially influence all matters submitted to our stockholders for approval, as well as our management and affairs.

For example, he will substantially influence the election of directors and approval of any merger, consolidation or sale of all or substantially all our assets.

This concentration of voting power could delay or prevent an acquisition of us on terms that other stockholders may desire or result in management that our stockholders disagree with.

In addition, Mr.

Decker’s two adult sons collectively own an additional 14% of our outstanding Common Stock.

As a result, such individuals will possess a significant influence over our affairs and may have the effect of delaying or preventing a future change in control, impeding a merger, consolidation, takeover or other business combination or discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of the company, which in turn could materially and adversely affect the market price of our common stock.

Our minority shareholders will be unable to affect the outcome of stockholder voting as long as our officers and directors retain a controlling interest.

Decker’s adult children own and will continue to own a significant portion of our outstanding Common Stock.

See “Security Ownership of Certain Beneficial Owners and Management ”.

Our current officers and directors may set salaries and perquisites in the future which we are unable to support with our current assets.

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From time to time, we may consider possible strategic transactions, including the potential acquisitions or licensing of products or technologies or acquisition of companies, and other alternatives with the goal of maximizing stockholder value.

Our pending acquisitions of Hyperion and OPM are examples of this strategy.

We may never complete a strategic transaction, and in the event that we do complete a strategic transaction, implementation of such transactions may impair stockholder value or otherwise adversely affect our business.

Any such transaction may require us to incur non-recurring or other charges and may pose significant integration challenges and/or management and business disruptions, any of which could harm our results of operation and business prospects.

Future strategic transactions we engage in may require us to incur additional charges or expenses.

Moreover, our pending and future strategic acquisitions or other transactions may pose significant integration challenges and/or management and business disruptions, and we may not receive the anticipated benefits of such transactions, any of which could harm our results of operation and business prospects.

We may not be able to gain or sustain market acceptance for our products and services.

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As of December 31, 2021, we had over $1.9 million in inventory, after writing off over $400,000 in citrus bergamot bulk extract inventory for the year.

We believe this is the only product in our inventory that has a material risk of spoilage.

We believe this is the only product in our inventory

that has a material risk of spoilage.

The amount of our inventory exceeds our revenues for the year ended December 31, 2021.

As of December 31, 2022, we had over $1.8 million in inventory, and we wrote off approximately $97,000 in inventory in 2022.

As of December 31, 2023, we had over $1.6 million in inventory.

Our inventory could spoil or be damaged, or we could never sell it, affecting the assets on our balance sheet as well as our future profitability.

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We do not anticipate any further inventory write-offs.

This pattern will continue and will require us to start to purchase more of the BPF raw material in the next 2 to 3 years.

We are subject to and affected by extensive governmental regulations.

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In addition, the adoption of new regulations, or changes in the interpretation of existing regulations, could have a material adverse effect on us.

For example, in September 1997 the United States Food and Drug Administration (the “FDA”) issued regulations governing the labeling and marketing of dietary supplement products.

For example, in September 1997 the FDA) issued regulations governing the labeling and marketing of dietary supplement products.

In addition, claims made with respect to weight management, dietary supplement, personal care or other products of ours may change the regulatory status of the products.

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In addition, the FTC has increased its scrutiny of the use of testimonials.

We received and responded to a warning letter from the FDA.

We received a warning letter from the FDA in November 2022 regarding one of our products.

On November 14, 2022, BergaMet NA, LLC, our subsidiary, received a warning letter from the FDA regarding claims we allegedly make about our Cholesterol Command product.

On December 1, 2022, we responded to the warning letter notifying the FDA that we had hired a third-party to review our advertising and

revise portions of our website, Facebook page, and online product listings.

This was the first warning letter we received from the FDA, and we are awaiting their response.

This was the only warning letter we received from the FDA to date.

There can be no assurance that the FDA will not pursue this action further.

If the FDA were to pursue this action, we may have to cease selling our Cholesterol Command product.

Any action brought by the FDA would have a material adverse effect on our sales and operations.

Economic uncertainties or downturns could materially adversely affect our business.

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Nevertheless, we cannot guarantee that claims relating to violation of such rights will not be asserted by third parties.

If any of our products or services are found to violate third-

party intellectual property rights, we may be required to expend significant funds to re-engineer or cause to be re-engineered one or more of those products or services to avoid infringement, or seek to obtain licenses from third parties to continue offering our products and services without substantial re-engineering, and such efforts may not be successful.

If any of our products or services are found to violate third-party intellectual property rights, we may be required to expend significant funds to re-engineer or cause to be re-engineered one or more of those products or services to avoid infringement, or seek to obtain licenses from third parties to continue offering our products and services without substantial re-engineering, and such efforts may not be successful.

In addition, future patents may be issued to third parties upon which our products and services may infringe.

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Currently, no material aspect of our business is protected by registered patents, copyrights or trademarks.

Insufficient funding may inhibit our ability to obtain and maintain such protection.

Insufficient funding may inhibit our ability to obtain and maintain such

Additionally, if we must resort to legal proceedings to enforce our intellectual property rights, the proceedings could be burdensome and expensive, and could involve a high degree of risk to our proprietary rights if we are unsuccessful in, or cannot afford to pursue, such proceedings.

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Unless an exception is available, the regulations require the delivery, prior to any transaction involving a penny stock, of a disclosure schedule explaining the penny stock market and the risks associated therewith.

Risks Related to our Acquisition and Integration of Hyperion, L.L.C.

Online Publishing & Marketing, LLC

We have incurred and expect to incur substantial costs related to the acquisition of Hyperion and OPM and subsequent integration efforts.

We have incurred and expect to incur a number of non-recurring costs associated with our acquisition of Hyperion and OPM.

These costs include legal, accounting, consulting and other advisory fees, closing, integration and other related costs.

In addition, upon closing of the acquisitions, we will pay to the selling parties $1.75 million in cash and execute promissory notes in the aggregate principal amount of $1.3 million.

These obligations may have a negative impact on our operating results.

After the acquisition of Hyperion and OPM, integration may be more difficult, costly, or time-consuming than expected, and we may not realize the anticipated benefits of the underlying acquisition.

The anticipated benefits of our pending acquisition of Hyperion and OPM, including product candidate diversification and revenue growth, may not be realized fully or at all or may take longer to commercialize than expected and integration may result in additional and unforeseen expenses.

An inability to realize the full extent of the anticipated benefits, as well as any delays encountered in the integration process, could have an adverse effect upon our operating results.

In addition, we and Hyperion and OPM will have operated independently prior to the completion of the acquisition.

It is possible that the now-active integration process could result in the loss of one or more key employees, including employees of Hyperion and OPM, the disruption of each company’s ongoing businesses or inconsistencies in standards, controls, procedures, and policies that adversely affect each company’s ability to maintain relationships with clients, customers, depositors, and employees or to achieve the anticipated benefits of the acquisition.

Integration efforts between the companies may also divert management attention and resources.

These integration matters could have an adverse effect on our business and operations during this transition period and for an undetermined period.

We may not have discovered certain liabilities or other matters related to Hyperion and OPM, which may adversely affect the future financial performance of the combined company.

In the course of the due diligence review that we conducted prior to the execution of the Acquisition Agreement, we may not have discovered, or may have been unable to properly quantify, certain liabilities of Hyperion and OPM or other factors that may have an adverse effect on the business, results of operations, financial condition, and cash flows of the combined company.

Our estimates and judgments related to the acquisition accounting methods used to record the purchase price allocation related to the merger may be inaccurate.

With respect to our proposed acquisition of Hyperion and OPM (and other acquisitions we may undertake in the future), our management will make significant accounting judgments and

estimates related to the application of acquisition accounting of the acquisition under GAAP, as well as the underlying valuation models.

Our business, operating results, and financial condition could be materially adversely impacted in future periods if the accounting judgments and estimates prove to be inaccurate.

We may not satisfy all of the closing conditions to complete the acquisition of Hyperion and OPM.

The completion of the acquisitions is subject to the following material closing conditions, and there can be no assurance that the transactions will be completed as described:

· we will have entered into a new lease agreement for at least a twelve-month period at the current Hyperion and OPM locations;

· a key employee of Hyperion and OPM will have entered into a consulting agreement with us;

· our independent auditor will have completed an audit of the financial statements of Hyperion and OPM;

· we will have closed on one or more rounds of financing for an aggregate amount of no less than $4,000,000, of which at least $250,000 will be from selling parties to the transaction;

· we will have commenced trading, or been approved to commence trading, on either the Nasdaq or the NYSE American Exchange.

In the event we do not complete the transactions, we will have incurred a substantial amount of fees and expenses without adding any value or benefit.

Existing stockholders will experience additional dilution from the issuance of our Common Stock to complete the Hyperion and OPM acquisitions.

If we close on the acquisitions of Hyperion and OPM, we will issue $1,250,000 worth of our common stock to the selling parties.

The number of shares will be determined at the time of the closing, based on a 30% premium to the price paid per share of common stock in this offering, but in no event more than ninety percent (90%) of the volume weighted average price for our common stock for the ninety (90) trading days up to and including the trading day immediately before the day the price is finally determined for securities sold in this offering.

The issuance of our Common Stock to close the acquisitions will have a dilutive impact on our shareholders.

As a result, our net income per share could decrease in future periods and the market price of our common stock could decline.

Risk Factors Related to Our Securities Generally

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· if the future market price of our Common Stock declines, purchasers of shares of Common Stock may be unable to resell such shares at or above the price at which they acquired them.

We cannot assure such purchasers that the market of our Common Stock will not fluctuate or decline significantly in the future, in which case investors could incur substantial losses.

We cannot assure such purchasers that the market of our Common Stock will not fluctuate or decline significantly in the future, in which case investors in this Offering could incur substantial losses.

Further, we may incur rapid and substantial increases or decreases in our Common Stock price in the foreseeable future that may not coincide in timing with the disclosure of news or developments by or affecting us.

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· investigations, proceedings, or litigation that involve or affect us;

· the occurrence of any of the other risk factors included in this registration statement of which this prospectus forms a part;

· the occurrence of any of the other risk factors included in this annual report;

· general market and economic conditions.

The Nasdaq Stock Market LLC may delist our Common Stock from trading on Nasdaq, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.

In the event that our Nasdaq initial listing application for our Common Stock is approved, should we fail to satisfy the continued listing requirements for remaining listed on Nasdaq, such as the corporate governance requirements or the minimum closing bid price requirement, The Nasdaq Stock Market LLC may take steps to delist our Common Stock.

Such a delisting would likely have a negative effect on the price of our Common Stock and would impair your ability to sell or purchase our Common Stock when you wish to do so.

In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our Common Stock to become listed again, stabilize the market price or improve the liquidity of our Common Stock, prevent our Common Stock from dropping below Nasdaq’s minimum bid price requirement or prevent future non-compliance with such listing requirements.

If we cannot maintain the listing of our Common Stock for trading on Nasdaq, we could face significant material adverse consequences, including:

· a limited availability of market quotations for our Common Stock;

· reduced liquidity for our Common Stock;

· a determination that our Common Stock is a “penny stock” which will require brokers trading in our Common Stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our Common Stock;

· a limited amount of news and analyst coverage;

· a decreased ability to issue additional Common Stock or obtain additional financing in the future.

Even if the reverse stock split of our outstanding shares of Common Stock currently achieves the requisite increase in the market price of our Common Stock for listing of our Common Stock on Nasdaq, we cannot assure you that the market price of our Common Stock will remain high enough for such reverse split to have the intended effect of complying with Nasdaq’s minimum bid price requirement.

In connection with the initial listing of our Common Stock on Nasdaq, we expect to effect a reverse stock split of our Common Stock at the ratio we believe necessary to allow us to obtain Nasdaq approval of our initial listing application to list our Common Stock on Nasdaq.

Even if such reverse stock split achieves the requisite increase in the market price of our Common Stock for listing of our common stock on Nasdaq, there can be no assurance that the market price of our Common Stock following such reverse stock split will remain at the level required for continuing compliance with such requirements.

Following the recent reverse stock split of our outstanding shares of Common Stock, we cannot assure you that the market price of our Common Stock will remain at the same level.

On December 29, 2023, we effectuated a 1-for-120 reverse stock split of our Common Stock.

There can be no assurance that the market price of our Common Stock following such reverse stock split will remain at the same level.

It is not uncommon for the market price of a company’s Common Stock to decline in the period following a reverse stock split.

If the market price of our Common Stock declines following the effectuation of such reverse stock split, the percentage decline may be greater than would occur in the absence of a reverse stock split.

In any event, other factors unrelated to the number of shares of our Common Stock outstanding, such as negative financial or operational results, could adversely affect the market price of our Common Stock and thus jeopardize our ability to meet or maintain Nasdaq’s minimum bid price requirement.

If we are unable to satisfy these requirements or standards, we would not be able to meet Nasdaq’s initial listing requirements.

We can provide no assurance that any such action taken by us would allow our Common Stock to be listed on Nasdaq, stabilize the market price or improve the liquidity of our common stock, prevent the price of our Common Stock from dropping below Nasdaq’s minimum bid price requirement, or prevent future non-compliance with Nasdaq’s listing requirements.

The anticipated reverse stock split to be effected by us may decrease the liquidity of the shares of our Common Stock.

The liquidity of the shares of our Common Stock may be affected adversely by a reverse stock split to be effected by us given the reduced number of shares of our Common Stock that will be outstanding following such reverse stock split, especially if the market price of our Common Stock does not increase as a result of such reverse stock split.

The recent reverse stock split may decrease the liquidity of the shares of our Common Stock.

The liquidity of the shares of our Common Stock may be affected adversely by our recent reverse stock split given the reduced number of shares of our Common Stock that will be outstanding following such reverse stock split, especially if the market price of our Common Stock does not increase as a result of such reverse stock split.

In addition, such reverse stock split may increase the number of stockholders who own odd lots (less than 100 shares) of our Common Stock, creating the potential for such stockholders to experience an increase in the cost of selling their shares of Common Stock and greater difficulty effecting such sales.

Following such anticipated reverse stock split, the resulting market price of our Common Stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors.

Following our recent reverse stock split, the resulting market price of our Common Stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors.

Consequently, the trading liquidity of our common stock may not improve.

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A significant portion of our total outstanding shares of Common Stock are restricted from immediate resale but may be sold into the market in the near future, which could cause the market price of our Common Stock to drop significantly, even if our business is performing well.

As a result of the initial listing of our Common Stock on Nasdaq sales of a substantial number of shares of our Common Stock in the public market could occur at any time, subject to certain restrictions described below.

Sales of a substantial number of shares of our Common Stock in the public market could occur at any time, subject to certain restrictions described below.

All of the Shares will be freely tradable without restrictions or further registration under the Securities Act, except for any shares held by our affiliates as defined in Rule 144 under the Securities Act (“Rule 144”).

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Also, we intend to register all shares of Common Stock that we may issue under our equity compensation plan on a registration statement on Form S-8.

Upon such registration, such shares can be freely sold in the public market upon issuance, subject to the terms of applicable award agreements, volume limitations applicable to affiliates and the lock-up agreements described in the “Shares Eligible for Future Sale” section of this prospectus.

If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our Common Stock, the price of our Common Stock could decline.

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If one or more of these analysts cease to cover our Common Stock, we could lose visibility in the market for our Common Stock, which in turn could cause our Common Stock price to decline.

Raising additional capital may cause dilution to our existing stockholders and restrict our operations.

We will likely seek to raise additional capital through a combination of public and private equity offerings, debt financings.

An active trading market for our Common Stock may not develop and you may not be able to resell your shares at or above the public offering price.

Prior to this Offering, there has been a limited public market for shares of our Common Stock.

An active trading market for our Common Stock may never develop or be sustained.

In the absence of an active trading market for our Common Stock, investors may not be able to sell their Common Stock at the time that they would like to sell.

An inactive market may also impair our ability to raise capital by selling shares of our Common Stock and may impair our ability to acquire other companies, products or technologies by using shares of our Common Stock as consideration.

We have broad discretion in the use of our cash, and may not use it effectively.

Our management will have broad discretion in the application of our cash, and could spend it in ways that do not improve our results of operations or enhance the value of our Common Stock.

The failure by our management to apply these funds effectively could result in financial losses that could have a material adverse effect on our business or cause the price of our Common Stock to decline.

Pending their use, we may invest our cash in a manner that does not produce income or that loses value.

Raising additional capital will likely cause dilution to our existing stockholders and restrict our operations.

We will likely seek to raise additional capital through a combination of public and private equity offerings and debt financings.

To the extent that we raise additional capital through the sale of equity or debt securities, your ownership interest will be diluted and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.

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As a smaller reporting public company, we will incur significant legal, accounting and other expenses.

In addition, the Sarbanes-Oxley Act and rules subsequently implemented by the SEC and Nasdaq have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.

Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives.

In addition, the Sarbanes-Oxley Act and rules subsequently implemented by the SEC have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.

Our management and other personnel, who do not have extensive experience in operating a public company, will need to devote a substantial

amount of time to these compliance initiatives.

Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time consuming and costly.

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

We have made forward-looking statements in this prospectus, including the sections entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” that are based on our management’s beliefs and assumptions and on information currently available to our management.

We have made forward-looking statements in this annual report, including the sections entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” that are based on our management’s beliefs and assumptions and on information currently available to our management.

Forward-looking statements include the information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities, the effects of future regulation, and the effects of competition.

Forward-looking statements include all statements that are not historical facts and can be identified by the use of forward-looking terminology such as the words “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate” or similar expressions.

These statements are only predictions and involve known and unknown risks and uncertainties, including the risks outlined under “Risk Factors” and elsewhere in this prospectus.

Forward-looking statements contained in this prospectus include, but are not limited to, statements about the following:

These statements are only predictions and involve known and unknown risks and uncertainties, including the risks outlined under “Risk Factors” and elsewhere in this annual report.

Forward-looking statements contained in this annual report include, but are not limited to, statements about the following:

· our estimates regarding the potential market opportunity for our products;

· our ability to identify and develop new product candidates;

· the anticipated benefits of our pending acquisition of Hyperion and OPM;

· our ability to identify, recruit and retain key personnel;

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· the implementation of our business model, strategic plans for our business, product candidates and technology;

· the rate and degree of market acceptance and clinical utility of our product candidates, in general;

· the rate and degree of market acceptance and utility of our products and products in development;

· our competitive position;

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· our ability to obtain additional funding;

· our expectations related to the use of proceeds from this Offering;

· our estimates regarding expenses, future revenue, capital requirements and needs for or ability to obtain additional financing;

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and global economy, particularly the continuing COVID-19 pandemic, inflation in the U.S., globally supply chain disruptions and the sanctions imposed on Russia as a result of its invasion of Ukraine has had and will have on our industry, market, business and product candidates.

Forward-looking statements are subject to a number of significant risks, uncertainties and assumptions, including those described in “Risk Factors” and elsewhere in this prospectus.

Forward-looking statements are subject to a number of significant risks, uncertainties and assumptions, including those described in “Risk Factors” and elsewhere in this annual report.

Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time.

It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make.

In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this annual report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

Given these uncertainties, you should not place undue reliance on these forward-looking statements.

Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this prospectus.

You should read this prospectus and the documents that we have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect.

Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this annual report.

You should read this annual report and the documents that we have filed as exhibits completely and with the understanding that our actual future results may be materially different from what we expect.

Although we believe that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee future results, events, levels of activity, performance or achievement.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business