ITEM 1 – BUSINESS
+Added: Over the last year, we have focused on increasing revenue, maintaining our margins, and generating positive cash flow from our existing operations.
+Added: In part, we have been successful in meeting these objectives and our business has remained relatively unchanged
We are a platform for acquiring, developing, patenting, marketing, and distributing plant-based nutraceuticals.
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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.
−Removed: 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 .
+Added: Our UBN products tap the fast-growing market for brain health, which is growing at a 9.4% CAGR and is expected 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.
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The nutritional supplement industry is highly competitive, and we expect the level of competition to remain high over the near term.
−Removed: We believe the following our are competitive strengths:
+Added: We believe the following are our competitive strengths:
High Gross Margins .
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and Canada licensing and manufacturing agreement with Gelteq Pty Ltd.
−Removed: (“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.
−Removed: 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.
+Added: (“GELS”), a third-party global leader in ingestible gel technology, we will offer a gel-pack delivery system in 2025 that our competition in North America cannot provide.
+Added: GELS provides a patented, 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.
−Removed: As the leading North American provider of the world’s highest strength Citrus Bergamot SuperFruit, our heart and immune products have specific advantages.
+Added: We provide the world’s highest strength Citrus Bergamot SuperFruit, and as a result 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.
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The nutritional supplement industry has undergone some consolidation in the recent past and we expect that trend may continue in the near term.
−Removed: 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.
+Added: We currently are not profitable, but with new product introductions and stable cash flow, we expect to be profitable in the future.
There is no assurance our future operations will result in revenues sufficient to obtain or sustain profitability.
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Our Financial Condition and Ability to Continue as a Going Concern
−Removed: 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.
+Added: Our net loss from inception to December 31, 2024 was $19,240,344, and we had limited cash resources at December 31, 2024 of $112,020.
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.
−Removed: 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.
+Added: 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 or other means 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.
−Removed: 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.
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New Sales Channels and Product Launches
−Removed: 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.
−Removed: Our gut health products are ready to be manufactured but have not yet been introduced to the market.
+Added: 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 CoQ10, weight management, hydration and gut health (the balance between helpful and harmful bacteria and yeast in the digestive system).
+Added: These health products are ready to be manufactured and made available in early 2025.
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
−Removed: The market for nutraceutical products is highly fragmented, which create many acquisition opportunities.
+Added: The market for nutraceutical products is highly fragmented, which creates 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.
−Removed: 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.
+Added: On the Healthy Extracts holding company level, our company’s two officers, Kevin “Duke” Pitts and Robert Madden, are each full-time.
Our BergaMet subsidiary has two full-time employees.
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As a result of the acquisition, Jay Decker became our majority shareholder.
−Removed: The shares of common stock issued in the acquisition were equal to approximately 80.1% of our outstanding common stock immediately following the closing.
+Added: The shares of common
+Added: stock issued in the acquisition were equal to approximately 80.1% of our outstanding common stock immediately following the closing.
On April 3, 2020, we acquired Ultimate Brain Nutrients, LLC, a Delaware limited liability company (“UBN”).
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Some of the principal risks related to our business include the following:
−Removed: • 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.
−Removed: • 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.
+Added: • We utilize one main vendor for manufacturing, and the termination of that agreement could have material effect on the cost of our products and the manufacturing of our finished goods;
+Added: • We currently are not profitable, but with new product introductions and stable cash flow, we expect to be profitable in the 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;
−Removed: • 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;
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• 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;
−Removed: • 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.
+Added: • One of our shareholders, Jay Decker, 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;
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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.
+Added: Over the last year, we have focused on increasing revenue, maintaining our margins, and generating positive cash flow from our existing operations.
+Added: In part, we have been successful in meeting these objectives and our business has remained relatively unchanged.
We are a platform for acquiring, developing, patenting, marketing, and distributing plant-based nutraceuticals.
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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.
−Removed: In the U.S., nutraceutical products are regulated as drugs, food ingredients and dietary supplements.
+Added: In the U.S., nutraceutical products are regulated as drugs, food ingredients and/or dietary supplements.
The term is not defined the same in all countries but is usually defined as a product isolated from foods and generally sold in medicinal forms not usually associated with food.
−Removed: 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.”
−Removed: 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
−Removed: for consumers, health care providers, regulators, nutritional supplement producers and distributors.
+Added: 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.”
+Added: 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 acquire or create products with health and performance benefits that have mass consumer appeal.
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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.
−Removed: The supply agreement has a term of five years and is renewable for up to four additional and successive three-year terms.
−Removed: Through 2023, we have paid H&AD a total of approximately $1.2 million for BPF product.
−Removed: 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.
−Removed: Each party may terminate the agreement upon a breach by the other party.
Bergamot is a rare citrus fruit native to the Calabrian region of Southern Italy.
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The juice and albedo of bergamot has a profile of flavanoid and glycosides, such as neoeriocitrin, neohesperidin, naringin, rutin, neodesmin, rhoifolin, and poncirin.
−Removed: 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
+Added: 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 SPORTSHEART
−Removed: · BergaMet CLINICAL IMMUNE
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.
−Removed: Our HerHeart, Cholesterol Command, and Pro+ products are vegan, non-GMO, and gluten-free, as represented to us by our supplier, Norax Supplements.
+Added: Our HerHeart, Cholesterol Command, and Pro+ products are vegan, non-GMO, and gluten-free, as represented to us by our supplier, Brand Internationals and Analytical Resource Laboratory (third-party independent testing).
In published research from third-party sources, our Citrus Bergamot has been shown to support heart health, support immune response and address metabolic syndrome.
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It is sold direct-to-consumer on whitneyjohns.com as a singular sale or by subscription.
−Removed: The gel packs are developed by Gelteq, a global leader in ingestible gel technology.
−Removed: 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.
+Added: The gel-packs are developed by GELS, a global leader in ingestible gel technology.
+Added: 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.
· Brain Activate - ENERGY Gel:
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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.
−Removed: The antioxidant function comes from the Neumentix that contains a combination of polyphenols from Kemin’s proprietary spearmint extract.
+Added: The antioxidant function comes from the Neumentix that contains a combination of polyphenols
+Added: from Kemin’s proprietary spearmint extract.
The complex contains rosmarinic, salvianolic, lithospermic and caftaric acids (and more) that act as antioxidants in the brain.
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Subjects underwent EEG voltage measurement with auditory reaction time (WaviMed System) and vision and trail making testing (Senaptec Sensory Station).
−Removed: 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,
−Removed: and motor speed.
+Added: 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.
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No caffeine, steroids or other stimulants were consumed by any study subjects.
−Removed: We are in the development phase for new products focused on Alzheimer’s disease and dementia.
−Removed: We are finalizing development of additional non-FDA approved, brain health products which focus on dementia and Alzheimer’s disease.
−Removed: 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.
−Removed: 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.
+Added: and Canada licensing and manufacturing agreement with GELS, 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).
−Removed: The agreement is mutually exclusive in that Gelteq is to be the exclusive manufacturer of all gel products that contain bergamot by us in the territory, and that they will not manufacture gels containing bergamot for any other company in the territory.
−Removed: Finally, we paid Gelteq a license fee of $150,000 and 5% of the total price of products purchased by us.
−Removed: Through this agreement we secured the exclusive rights to use Gelteq’s gelification process in the U.S.
+Added: The agreement is mutually exclusive in that GELS is to be the exclusive manufacturer of all gel products that contain nutritional supplements by us in the territory, and that they will not manufacture gels containing bergamot for any other company in the territory.
+Added: Through this agreement we secured the exclusive rights in the nutritional supplement area to use GELS’ gelification process in the U.S.
and Canada for the development and marketing of natural ingestible gels that contain our Citrus Bergamot or UBN ingredients.
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The liquid extract form of Bergamot is typically not preferred due to its unpleasant bitter taste.
−Removed: The proprietary ingredients used in in our UBN product line are typically available in powder form, with this requiring it be mixed with a liquid in a separate container.
+Added: The proprietary ingredients used in in our UBN product line are typically available in powder form, which requires it to be mixed with a liquid in a separate container.
This can be messy and inconvenient for today’s on-the-go lifestyles.
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We have launched two gel-pack products using our patent-protected Fuel4Thought® (F4T®) formulation with Whitney Johns, including Brain Activate - Gel (without caffeine) and Brain Activate - ENERGY Gel .
−Removed: We plan to next introduce heart and immune health gel packs that exclusively feature Citrus Bergamot SuperFruit in 2024.
+Added: We plan to introduce a hydration and weight management gel in early 2025.
The overall nutraceutical market is growing at a 7.8% CAGR and is expected to reach $441 billion by 2026, according to ReportLinker.
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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.
−Removed: This market is being driven in part by
−Removed: 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.
+Added: 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.
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Amazon complements our direct-to-consumer channel on our BergaMet and UBN websites that offer a subscription-based option.
−Removed: Last year our Citrus Bergamot SuperFruit formulations also became available for purchased on Walmart.com.
−Removed: 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
−Removed: 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.
+Added: Last year our Citrus Bergamot SuperFruit formulations also became available for purchase on Walmart.com.
+Added: We sell our products on Fullscript.com, the nation’s leading care delivery platform for integrative medicine.
+Added: This makes select BergaMet products available to the more than 70,000 healthcare professionals and their more than 5 million patients on the Fullscript care platform.
The Fullscript launch followed the entry of our natural formulations for brain health into the retail marketplace through Natural Grocers stores nationwide.
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The retailer also provides extensive free nutrition education programs that help consumers make informed nutritional health choices.
−Removed: The initial two products sold by Natural Grocers where our Ultimate Brain Nutrients (UBN) ACTIVATE and UBN RELIEF.
+Added: Our two products sold by Natural Grocers are Ultimate Brain Nutrients (UBN) ACTIVATE and UBN RELIEF.
Influencer Program
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The agreement can be terminated by either party on 90 days’ written notice.
−Removed: Through September 30, 2023, we have paid her a total of $38,000 under this agreement 2 .
−Removed: We also granted her RSU’s for 500,000 shares of our common stock with a purchase price of $0.01 per share.
−Removed: The verbal amendment will be in place until otherwise agreed between the parties.
+Added: For the year ended December 31, 2024, we paid her a total of $32,000 under this agreement.
Whitney Johns’ new product line of brain, physical performance and women’s hormone health products are based upon our proven all-natural Citrus Bergamot SuperFruit and Ultimate Brain Nutrients formulations.
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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.
−Removed: 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.
+Added: The Whitney products include 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.
−Removed: update to 12/31/23
Future Growth Drivers
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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 as well as introduce more products in gel-pack format.
−Removed: We anticipate this to include a new Whitney Johns gut health gel-pack as well as a new gel pack option for our Ultimate Brain Nutrients RELIEF.
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
−Removed: The market for nutraceutical products is highly fragmented, which create many acquisition opportunities.
+Added: The market for nutraceutical products is highly fragmented, which creates 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.
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“Comprising” language is utilized wherever it is allowed by the U.S.
−Removed: Patent and Trademark Office
−Removed: (PTO) whereby the patented formulation includes but is not limited to the elements listed in the claim.
+Added: 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.
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Contains ability to include hemp-derived cannabinoids in unique product formulations whenever allowable under federal law.
−Removed: Qualified Health Claim (QHC)
−Removed: We filed a QHC petition for Fuel for migraine health with the Center for Food Safety and Nutrition
−Removed: of the FDA in July 2019.
−Removed: The preponderance of third-party scientific evidence to support the claim has been submitted.
−Removed: The FDA acknowledged that our petition met the requirements under 21 CFR 101.70 and was submitted in the proper legal format.
−Removed: In light of increased administrative burdens from the COVID-19 pandemic, the FDA has requested extended decision delays to which we agreed.
−Removed: A final decision is now expected before the end of 2023.
A trademark owned by us that supports the entire brain health product platform is:
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We promote our products consistently with online marketing.
−Removed: Our key competitor is Ortho Molecular, who distributors through medical offices.
+Added: One key competitor is Ortho Molecular, who distributors through medical offices.
We are priced similarly to their product.
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Based upon our exclusive U.S.
−Removed: and Canadian licensing and manufacturing agreement with Gelteq, we believe we are able to offer a gel-pack delivery system that our competition in North America cannot provide.
−Removed: Gelteq is a customizable platform for supplement delivery, in that each gel formulation is tailored to solve a particular problem and deliver a specific outcome.
+Added: and Canadian licensing and manufacturing agreement for nutritional supplements with GELS, we will offer a gel-pack delivery system in 2025 that our competition in North America cannot provide.
+Added: GELS is a customizable platform for supplement delivery, in that each gel formulation is tailored to solve a particular problem and deliver a specific outcome.
As the exclusive North American provider of H&AD’s Citrus Bergamot SuperFruit, our heart and immune products have several advantages.
For example, our BergaMet PRO+ product has 47% BPF Gold potency as compared to the closest competitor at only 38% BPF.
−Removed: 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.
+Added: 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
+Added: 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-party sources, our citrus bergamot has been shown to support heart health, support immune response, and address metabolic syndrome.
−Removed: 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.
+Added: On the Healthy Extracts holding company level, our company’s two officers, Kevin “Duke” Pitts and Robert Madden, are each full-time.
Our BergaMet subsidiary has two full-time employees .
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It is uncertain whether these efforts will have a material impact on the dietary supplement market.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: This was the only warning letter we received from the FDA to date, and we are awaiting their response.
−Removed: There can be no assurance that the FDA will not pursue this action further.
−Removed: If the FDA were to pursue this action, we may have to cease selling our Cholesterol Command product.
−Removed: 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.
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We do not currently own, lease or use any office space as we operate on a virtual basis.
−Removed: However, we lease warehouse facilities under an operating lease that expires in 2025.
+Added: However, we lease warehouse facilities under an operating lease that expires in February 2025 which further got renewed till January 31, 2028.
Prior to February 4, 2022, we leased a warehouse facility on a month-to-month basis.
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In August 2021, we signed an exclusive U.S.
−Removed: 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.
−Removed: Through this agreement we secured the exclusive rights to use Gelteq’s gelification process in the U.S.
+Added: and Canada licensing and manufacturing agreement with GELS, 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.
+Added: Through this agreement we secured the exclusive rights to use GELS’s gelification process in the U.S.
and Canada for the development and marketing of natural ingestible gels that contain our Citrus Bergamot or UBN ingredients.
In the event either party terminates that agreement, our ability to obtain and manufacture our products will be interrupted, and we may not be able to find a replacement at the same cost.
−Removed: 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.
+Added: 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.
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We were incorporated on December 19, 2014, but we have changed our business focus with the acquisition of BergaMet in 2019 and UBN in 2020.
−Removed: We have not fully developed our current business operations and have not yet to generate significant revenue from such operations.
+Added: We have not fully developed our current business operations and have not yet generated significant revenue from such operations.
Our ability to continue as a going concern is dependent upon our ability to further establish and then grow our business and to obtain adequate financing in order to reach profitable levels of operations.
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Our net loss from inception to December 31, 2024, was $19,240,344.
−Removed: 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).
+Added: Based on our cash position of $112,020 as of December 31, 2024, we have a pressing need to raise additional capital from the sale of our stock or debt.
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.
−Removed: We cannot guarantee that we will be successful in generating
−Removed: sufficient revenues in the future.
+Added: 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 are highly dependent upon consumers’ perception of the safety and quality of our products as well as similar products distributed by other companies.
−Removed: Thus, the mere publication of reports asserting that such products may be harmful or adverse public reports or other media attention regarding the safety, efficacy and quality of nutritional supplements in general, or our products specifically, or associating the consumption of nutritional supplements with illness, questioning the benefits of nutritional supplements in general, or our products specifically, or claiming that such products do not perform as marketed, labeled and advertised, could have a material adverse effect on us, regardless of whether these reports are scientifically supported.
+Added: Thus, the mere
+Added: publication of reports asserting that such products may be harmful or adverse public reports or other media attention regarding the safety, efficacy and quality of nutritional supplements in general, or our products specifically, or associating the consumption of nutritional supplements with illness, questioning the benefits of nutritional supplements in general, or our products specifically, or claiming that such products do not perform as marketed, labeled and advertised, could have a material adverse effect on us, regardless of whether these reports are scientifically supported.
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.
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Our ability to maintain and increase the number of visitors directed to our website is not entirely within our control.
−Removed: 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
−Removed: result page ranking than ours.
+Added: 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.
Additionally, internet search engines could revise their methodologies in a way that would adversely affect our search result rankings.
−Removed: 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.
+Added: 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
+Added: 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.
45 unchanged sentences
Inflation or other changes in economic conditions that affect demand for nutritional supplements could adversely affect our revenue.
−Removed: 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
−Removed: demand for our products.
+Added: 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.
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.
−Removed: These and other economic factors could have a material adverse effect on demand for our products and on our financial condition and operating results.
+Added: These and other economic factors
+Added: could have a material adverse effect on demand for our products and on our financial condition and operating results.
Overall tightening of the labor market, increases in labor costs or any possible labor unrest may adversely affect our business and results of operations.
17 unchanged sentences
We acquire ingredients for a number of our products from suppliers outside of the United States.
−Removed: 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
−Removed: products originating from China).
+Added: 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).
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.
−Removed: There have in the past been quality and safety issues in our industry with certain items imported from overseas.
+Added: have in the past been quality and safety issues in our industry with certain items imported from overseas.
We may incur additional expenses and experience shipment delays due to preventative measures adopted by the U.S.
18 unchanged sentences
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.
−Removed: Increases in our shipping costs may adversely affect our
−Removed: financial results if we are unable to pass on these higher costs to our users or brick-and-mortar and online retail partners.
+Added: 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.
17 unchanged sentences
We will be required to seek additional capital to fund future growth and expansion.
−Removed: No assurance can be given that
−Removed: such financing will be available or, if available, that it will be on commercially favorable terms.
+Added: 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.
21 unchanged sentences
We have a significant amount of unsold inventory, which could affect our assets and our profitability.
−Removed: 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.
−Removed: We believe this is the only product in our inventory
−Removed: that has a material risk of spoilage.
−Removed: The amount of our inventory exceeds our revenues for the year ended December 31, 2021.
−Removed: As of December 31, 2022, we had over $1.8 million in inventory, and we wrote off approximately $97,000 in inventory in 2022.
−Removed: As of December 31, 2023, we had over $1.6 million in inventory.
+Added: As of December 31, 2023, we had over $1.6 million in inventory, and as of December 31, 2024, we had over $1.3 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.
Our build-up in inventory peaked at the end of 2020 and we have been able to continue to reduce our inventory through increased sales.
−Removed: We do not anticipate any further inventory write-offs.
+Added: We do not anticipate any inventory write-offs.
We are subject to and affected by extensive governmental regulations.
42 unchanged sentences
In the event of a claim of infringement, we may be required to obtain one or more licenses from third parties.
−Removed: There can be no assurance that we will be able to obtain such licenses at a reasonable cost, if at all.
+Added: no assurance that we will be able to obtain such licenses at a reasonable cost, if at all.
Defense of any lawsuit or failure to obtain any such license could be costly and have a material adverse effect on our business.
20 unchanged sentences
Currently, no material aspect of our business is protected by registered patents, copyrights or trademarks.
−Removed: Insufficient funding may inhibit our ability to obtain and maintain such
+Added: Insufficient funding may inhibit our ability to obtain and maintain such protection.
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.
20 unchanged sentences
· if our future market capitalization reflects trading dynamics unrelated to our financial performance or prospects, purchasers of our Common Stock could incur substantial losses as prices decline once the level of market volatility has abated;
−Removed: · 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.
−Removed: 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.
+Added: · if the future market price of our Common Stock declines, holders of shares of Common Stock may be unable to resell such shares at or above the price at which they acquired them.
+Added: We cannot assure such holders that the market of our Common Stock will not fluctuate or decline significantly in the future, in which case investors 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.
16 unchanged sentences
· general market and economic conditions.
−Removed: 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.
−Removed: On December 29, 2023, we effectuated a 1-for-120 reverse stock split of our Common Stock.
−Removed: There can be no assurance that the market price of our Common Stock following such reverse stock split will remain at the same level.
−Removed: It is not uncommon for the market price of a company’s Common Stock to decline in the period following a reverse stock split.
−Removed: 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.
−Removed: 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.
−Removed: The recent reverse stock split may decrease the liquidity of the shares of our Common Stock.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Consequently, the trading liquidity of our common stock may not improve.
−Removed: Although we believe that a higher market price of our Common Stock may help generate greater or broader investor interest, there can be no assurance that the reverse stock split will result in a share price that will attract new investors, including institutional investors.
−Removed: In addition, there can be no assurance that the market price of our Common Stock will satisfy the investing requirements of those investors.
−Removed: As a result, the trading liquidity of our Common Stock may not necessarily improve.
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.
2 unchanged sentences
These sales, or the perception in the market that holders of a large number of shares of our Common Stock intend to sell shares, could reduce the market price of our Common Stock.
−Removed: We have outstanding 2,963,906 shares of Common Stock, 597,265 of which may be resold in the public market immediately without restriction, and the rest of which may be sold pursuant to Rule 144.
+Added: We have outstanding 2,989,406 shares of Common Stock, 648,890 of which
+Added: may be resold in the public market immediately without restriction, and the rest of which may be sold pursuant to Rule 144.
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.
6 unchanged sentences
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.
−Removed: Prior to this Offering, there has been a limited public market for shares of our Common Stock.
+Added: 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.
13 unchanged sentences
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.
−Removed: Our management and other personnel, who do not have extensive experience in operating a public company, will need to devote a substantial
−Removed: amount of time to these compliance initiatives.
+Added: 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.
27 unchanged sentences
· our ability to obtain additional funding;
−Removed: · 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;
1 unchanged sentence
· the impact that general economic conditions and the uncertainty of the U.S.
−Removed: 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.
+Added: and global economy, inflation in the U.S., global supply chain disruptions, tariffs, 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 annual report.
8 unchanged sentences
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.