What changed in this filing

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Item 1. Business

2025-03-31 compared with 2020-04-29 · 742 added, 159 removed, 2 unchanged (100% of the section changed)

are a consumer health care and beauty company that is in the process of building a portfolio of best-in-class consumer product

Our strategy is to grow both organically and by further acquisition.

were organized as a corporation under the laws of the State of Nevada on December 29, 2010 under the name “Oro Capital Corporation”.

On April 7, 2014, an Agreement and Plan of Merger (the “Merger Agreement”) was entered into by and among us, Synergy

Merger Sub, Inc., a Delaware corporation and our wholly owned subsidiary formed for the purpose of the transactions under the

Merger Agreement (“Merger Sub”), and Synergy Strips Corp., a Delaware corporation incorporated on January 24, 2012

(“SSC”).

The Merger Agreement provided for the merger of Merger Sub with and into SSC (the “Merger”),

with SSC surviving the merger as our wholly owned subsidiary.

On April 17, 2014, we issued a share dividend to our shareholders

in order to effect a 30-for-1 forward stock split.

The Merger was consummated on April 21, 2014.

On April 21, 2014, we changed

our fiscal year end from July 31 to December 31.

On April 28, 2014, we changed the name of the Company from “Oro Capital

Corporation”

to “Synergy Strips Corp.”

On August 5, 2015, we changed the name to “Synergy CHC Corp.”

January 1, 2019, the Company’s U.S.

Unless the context otherwise

requires, for purposes of this section, the terms “we,” “us,” “the Company” or “Synergy”

refer to Synergy CHC Corp.

We are a provider of consumer

health care, beauty, and lifestyle products.

Our current brand portfolio consists of two marquee brands, FOCUSfactor, a clinically-tested brain

health supplement (this study was performed independently and is not related to any FDA-approved IND application) that has been shown

to improve memory, concentration and focus, and Flat Tummy, a lifestyle and wellness brand that provides a suite of nutritional products

to help women achieve their nutrition and weight management goals.

Our products are sold through some of the nation’s leading club,

mass drug, and other retailers such as Costco, Amazon.com, Walmart, Walgreens, CVS, The Vitamin Shoppe, Target.com, H-E-B, Meijer, and

Additionally, we have expanded into Canada and the United Kingdom.

We built our brand portfolio through strategic acquisitions.

the FOCUSfactor brand in January 2015 for cash consideration of $6.0 million, including an earnout.

In November 2015, we

acquired our second marquee brand, Flat Tummy, for AUD $10.0 million (or approximately $7.0 million), using a mix of cash and

Our capital structure following the acquisitions of our key brands in 2015 has been highly levered, and our focus has been on paying

our debt and, as a result, we do not have the resources to grow our business.

We have grown our FOCUSfactor brand from 3 SKUs at acquisition

to over 34 SKUs, and our Flat Tummy Brand from 1 SKU to 13 SKUs.

Our growth from 2022 to the present was driven by expanded distribution

of our FOCUSfactor product line to some of our major retailers, such as Costco, CVS and Walmart, among others.

This expansion included

SKUs within our FOCUSfactor vision line as well as focus and energy Ready-to-Drink (RTD).

We intend to accelerate the

growth of both our FOCUSfactor supplements and FOCUSfactor energy RTD products.

Our asset-light business model, in which we partner

with third-party manufacturers to produce our brand offerings, allows us to scale quickly and profitably while satisfying growing

Our flagship brand, FOCUSfactor, is a brain health nutritional supplement

with over 24 years of history and a clinically-tested formula (this study was performed independently and is not related to

any FDA-approved IND application) comprised of a proprietary blend of key brain supporting ingredients along with vitamins, minerals,

and other nutrients.

We believe FOCUSfactor is the only product in its category whose entire formula has been shown to support memory,

concentration and focus.

Our FOCUSfactor brand consists of over 34 SKUs and is sold primarily through leading retailers in the United States,

including Costco, Walmart, Amazon.com, Walgreens, CVS, Meijer, and Albertson’s, in addition to selling direct to consumer through

the FOCUSfactor website.

Across three of our key partners, we have increased the number of SKUs sold through the retailer from the single

SKU available at the beginning of our relationships, which began in 2015 and 2016.

In addition, we have increased our presence in retail

locations for these key partners, resulting in a significant increase in points of distribution, being the number of SKUs multiplied by

the number of retail locations for each retailer.

We have also expanded the brand internationally into Canada (2020), the United Kingdom

(2023) and we anticipate being in Taiwan and Mexico during 2025 and in Australia and Asia in the first quarter of 2026.

FOCUSfactor has expanded into

the beverage market with its focus plus energy RTD.

According to Zion Research in January 2024, the beverage market is a large ($176 billion

in 2022) and growing (projected 8.6% CAGR covering eight years from 2022 through 2030) market with an expanding range of functional benefits

such as energy, hydration, cognition/focus, weight loss, gut health and immunity.

Examples such as Celsius and Beyond Raw offer dual-benefit products

that deliver fat burning plus energy while C4 Smart Energy and FocusAid deliver focus plus energy.

Additionally, consumers are looking

for not only refreshing drinks but health perks such as zero sugar and low-calorie drinks.

This consumer shift in preferences towards

more functional benefits can be seen in the evolution of the energy RTD category where originally competitors like Red Bull and Monster

delivered conventional energy, then the category offered more performance energy products with added vitamins and amino acids in products

such as Reign and C4 Performance to products with more natural energy characteristics and then to the dual-benefit energy products

that we see today.

FOCUSfactor is well-positioned to

capitalize on the evolving energy RTD category (U.S.

sales of $19.2 billion in 2023 and a CAGR of 6.3% from 2018 to 2023, according

to Euromonitor in December 2023) with its new focus plus energy RTD.

We believe this represents a major growth opportunity, with

our dual-benefit RTD formula offering both focus and energy behind a 24+ year brand with strong heritage and awareness in the area

of brain health.

The FOCUSfactor brand name clearly communicates the differentiation benefit of adding focus to energy.

The FOCUSfactor

formula does not have to rely as heavily on caffeine as other brands such as Celsius, Bang, Reign and C4, as its formula is a balanced

blend of vitamins, cognitive nutrients and caffeine all in a zero sugar, low calorie, great-tasting drink.

The brand also delivers

a significant value relative to many competitors.

Additionally, FOCUSfactor has long-term relationships with large retailers where

it has an established presence, which will assist in market penetration for its RTD products.

FOCUSfactor is looking to attract both existing

consumers of supplement products (typically age 50+) to RTDs as well as a younger demographic (age 18-49).

FOCUSfactor has successfully

demonstrated the ability to leverage its existing retailer relationships to expand its RTDs.

From March 2023 through August 2023, FOCUSfactor

conducted a 5-month trial of its RTD products in 44 clubs of a warehouse club retailer throughout Texas with sales ranging from $550

per club per week to $2,382 per club per week.

From April 2024 through July 2024, a second pilot was successfully completed at a major

Canadian club retailer throughout Canada with results ranging from C$378 per club per week to C$2,206 per club per week.

Our second marquee brand, Flat

Tummy, consists of a range of lifestyle and wellness products and accessories including tea, shakes, lollipops, supplements, apparel,

and exercise accessories.

We also provide a Flat Tummy mobile app, which, as of December 31, 2024, had approximately 1.9 million

unique downloads and is intended as a tool to promote the Flat Tummy lifestyle centered around general wellness and health.

Our Flat Tummy

brand consists of 13 SKUs and is sold direct to consumer through the Flat Tummy website and application, as well as through Amazon.com,

Target.com and iherb.com.

We also own six additional,

non-core brands.

These developing brands are:

● Hand MD — complete hand care brand to help

maintain clean and healthy hands while reducing the signs of aging.

● Perfekt Beauty — beauty line of products

for the eyes, lips, brows, cheeks and skin.

● Sneaky Vaunt — a lingerie brand with a line

of women’s shapewear, bralettes and panties.

● The Queen Pegasus — eyelash enhancement products

for longer, thicker, natural lashes.

● Neuragen — fast-acting topical treatments

for neuropathic (nerve) pain.

● UrgentRx — line of fast-acting, portable,

powdered over-the-counter medications.

While we may elect to promote

these brands and commercialize their products in the future, we have prioritized our key brands, FOCUSfactor and Flat Tummy, and management

is focused on the growth of these core products.

Our Competitive Strengths

We believe that we have attributes

that differentiate us from our competitors and provide us with significant competitive advantages.

Our key competitive strengths include:

Well-Positioned in Growing Categories

Driven by Favorable Consumer Trends

An increased focus on health,

beauty and wellness by consumers has served as a tailwind for our brands.

The nutritional supplement market has experienced significant

growth across a range of areas including immune health, brain health, heart health, sleep/stress, and overall nutrition and wellness as

a result of an aging population, increased obesity, pandemic concerns and a desire for more natural solutions and treatments over prescription

We believe that we are well positioned to benefit from these favorable trends.

The brain health segment is slated to grow

at 8% per year in the United States and 13% per year globally, according to Grand View Research.

We believe our focus on lifestyle

products has also benefited from the growth and prevalence of social media.

Results Backed by Independent Study for

We believe the FOCUSfactor

brand is strengthened by an independent clinical study to support the product claims for improved memory, concentration, and focus.

has been tested in a single-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate its effect on memory,

concentration, and focus in healthy adults.

The study was not a clinical trial conducted pursuant to an FDA-approved IND application,

and the FDA has not reviewed this study or evaluated these performance claims.

In this study, FOCUSfactor

was tested on its entire 52-ingredient formulation rather than testing one or two ingredients within a formulation.

FOCUSfactor was

shown to provide a 44% increase in recall memory (an increase of 6.5 words compared to 4.5 words for the placebo group) after six weeks

of use versus placebo.

This differentiates FOCUSfactor from other brain-health supplements and is a prime reason why FOCUSfactor

has been placed in premier retailers.

See ” — FOCUSfactor Study ” for additional information.

Experienced Management Team with Proven

Track Record of Value Creation

Our executive team has a combined

90 years of experience in consumer marketing and distribution and has been instrumental in acquiring and building our core brands.

Management has exercised strong financial discipline in its acquisition strategy, with a focus on acquiring brands at attractive valuations.

For example, we acquired FOCUSfactor for approximately 3x trailing EBITDA.

Management’s philosophy is to acquire promising brands

that fit within our health, beauty and lifestyle offerings, and apply our marketing and distribution strategies to develop brands to their

full potential.

We believe we are adept at identifying promising opportunities that build out and complement our core brand portfolio.

Premier Retail Partners

Our premier retail partners

include Costco, BJ’s Wholesale Club, Walmart, Amazon.com, Publix, Meijer, Albertson’s, CVS, Walgreens and others.

sell products to these partners under their standard arrangements, which do not include a term or duration as sales under each vendor

agreement are generally made on a purchase order basis.

Our partners provide a platform to expand the breadth of our current offerings

through product line extensions and new product innovation.

We continue to introduce new SKUs to our current retail partners, such as

the addition of FOCUSfactor RTDs and vision products to our membership club and other channels.

Additionally, the international footprint

of certain of our various retail partners facilitates our geographic expansion plans.

Scalable and Flexible Asset-Light Model

to Support Growth

Our focus is on brand management,

marketing, product development and distribution, and we utilize contract manufacturing partners in order to produce our various brand

The use of third-party manufacturing partners allows us to scale quickly, as we ensure that our partners have sufficient

capacity to meet our demand needs.

We also maintain multiple relationships with different contract manufacturers, ensuring diversification

of our manufacturing base and reducing the likelihood of supply bottlenecks or deficits that could potentially slow our growth.

Our Growth Strategy

We intend to drive growth and

increased profitability in our business through these key elements of our strategy:

Broaden Media Advertising Strategy

We have experienced significant

acceleration in sales growth for the FOCUSfactor brand as a result of our television advertising in prior years.

We launched a national

advertising campaign in August 2020, which aired on major news and entertainment networks such as Fox News, CNN, MSNBC, TLC, and

TNT, targeting adults 45 years of age and older.

We anticipate a coordinated expansion of our advertising strategy during 2025, as

we focus on pushing additional SKUs within our retail sales partner network to continue to build brand awareness and increase reach for

We also plan to invest in online marketing to promote all of our brands, including social media and influencer driven marketing.

We have also experienced significant growth through our increased distribution, which we continue to drive forward.

Acquire Brands which Complement Our Existing

We will continue to evaluate

acquisition opportunities that we believe fit well within our brand portfolio and create value for our stockholders, such as further retail

expansion in nutraceuticals and market expansion in health and beauty.

In spite of historical capital constraints, our opportunistic approach

to acquisitions has resulted in a successful track record of identifying promising targets that align with our overall brand strategy

in the health, beauty and lifestyle segments.

Partner with Additional Leading Retailers

to Expand the Reach of Our Products

We have established distribution

relationships with premier retail partners, including Costco, Walmart, Amazon.com, Walgreens, CVS, The Vitamin Shoppe, Target.com, H-E-B,

Meijer, and Albertson’s.

Based on the success of our products with these leading retail partners, we believe that we are well positioned

to add new retailers that will enhance our distribution footprint.

We believe we have expansion opportunities with food retailers, including

those focused on health foods.

We intend to introduce three to five new SKUs across potential retailers, which would potentially result

in the addition of approximately 50,000 points of distribution.

Diversify Our Geographic Presence through

Entry into New Markets

We seek to accelerate our sales

growth by expanding and further diversifying our geographic footprint.

Our goal is to increase our net revenues generated from new markets.

As we target new international markets, our strategy is to develop highly competitive and differentiated products that are produced in-country for

ease of entry, with support from our regulatory group and an in-country regulatory consultant to help expedite the approval process.

In the United Kingdom, where we have distribution with Costco and Holland & Barrett, we have established relationships with manufacturers

who began producing FOCUSfactor in-country in December 2021.

We currently plan to enter the Taiwan and Mexico markets during

2025 and in Australia and Asia in the first quarter of 2026, initially with FOCUSfactor, then followed by Flat Tummy.

In Mexico, we have

identified local manufacturers and will begin connecting with retailers in Mexico in 2025.

We then plan to expand our brands into Australia

(where we have TGA approval for our FOCUSfactor products) and Asian markets in 2026.

In addition, we are developing our marketing plans

in compliance with applicable laws, and are initiating retailer meetings as we seek to gain distribution across these new retail markets.

Use Innovative Strategies to Boost Consumer

We have made investments in

promoting an app for Flat Tummy and view this as a key aspect of growing our customer base and maintaining high levels of engagement.

We have also focused on developing our social media presence, in particular through Instagram, in order to foster and grow our relationship

with customers.

Our brands appeal to both specific consumer needs as well as lifestyle choices and we seek to deepen our understanding

of our customers and boost recognition of our brands through increased engagement.

Continue to Develop and Expand Our Current

Our plan is to further develop

and expand our brands by reaching a broader set of customers through advertising and product expansion.

More specifically, we look to

develop new products for our brands to satisfy the various customer segment opportunities (i.e., baby boomers, millennials, etc.) and

satisfy various consumer needs as they relate to new and improved formulations, expanded and improved product benefits, alternative delivery

formats and sizes.

As we increase the product line-up behind our brands, we leverage our current retail distribution network by expanding

our presence as well as adding incremental distribution with new retail partners.

With a broader brand presence, we believe our advertising

becomes even more efficient at driving sales velocity.

This is evidenced by our expanded

FOCUSfactor product line, including focus and energy Ready-to-Drink (RTD) and liquid shots that are marketed to a younger adult audience.

In 2023, we successfully launched an RTD pilot program in the United States through a major retailer.

Additionally, in the second

quarter of 2024, we launched three core FOCUSfactor focus and energy RTD products in Canada.

In 2025, we plan to introduce an additional

FOCUSfactor supplement for Taiwan, RTDs for the UK and focus and energy coffee for the United States.

In the first quarter of 2025,

we plan on introducing new complementary products to the Flat Tummy line-up, including new protein shakes, gut-healthy ready-to-drink beverage,

hydration powder and pre-workout powder.

Additionally, we plan to employ this strategy of expanding our brands into international

markets that include Mexico and Asia, among others.

Marketing and Sales

Our targeted, consumer-driven marketing

strategy has been key to building our brands and driving revenue growth.

We manage dedicated marketing strategies for each of our brands

in order to build deep connections with our customers.

marketing strategy for FOCUSfactor is primarily focused on increased distribution and advertising campaigns that appeal to the demographics

of our wellness focused customer base.

We also utilize in-store promotions

along with online and social media advertising to promote our FOCUSfactor brand.

We leverage the following online and social media assets

as part of our marketing strategy:

Our FOCUSfactor

website helps to educate and inform consumers on our line of products.

The website also serves as a direct-to-consumer sales channel

for most FOCUSfactor products.

social media platform is Instagram.

As of December 31, 2024, we had approximately 13,600 followers.

● FOCUSfactor — Brain Hub App:

in 2021 we launched our Brain Hub app on the Android and Apple iOS platforms to provide an additional point of engagement with customers.

The app contains a library of brain games and guided meditation sessions on topics related to mindfulness and brain health in order to

keep consumers engaged.

As of December 31, 2024, we have approximately 13,000 app downloads.

employ a primarily online and social media driven strategy for our Flat Tummy brand.

The brand is focused primarily on women.

campaigns to reach our core target segments through a mix of traditional online advertising as well as influencer-based marketing.

Our Flat Tummy website acts as a platform

for engagement with our customers.

In addition to offering a direct-to-consumer sales channel for our products, we also host a lifestyle

blog on our website with a focus on health and fitness.

Our primary social media platform is Instagram.

As of December 31, 2024, we had approximately 1.7 million followers.

Our marketing strategy for Flat Tummy seeks to leverage our

large online following to promote products from across the Flat Tummy brand.

More recently we have engaged with social media influencers

as a new strategy to promote our products.

As of December 31, 2024, we had approximately

531,000 followers.

We mainly use the platform to share promotions and to relay content and advertisements.

● Flat Tummy App:

Our Flat Tummy app had approximately

1.9 million unique downloads as of December 31, 2024, across both the Apple and Android platforms.

The app provides customized workouts,

nutrition information, and diet plans.

The app is currently free to customers;

however, we are exploring different strategies to monetize

our large user base.

FOCUSfactor Study

FOCUSfactor has been tested

in a single-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate its effect on memory, concentration,

and focus in healthy adults.

The controlled study was conducted in normal, healthy, male and female subjects between the ages of 18 and

65 who had responded to advertisements.

A total of 96 subjects were enrolled and randomized to one of the two treatment groups (FOCUSfactor

and placebo).

Subjects were compensated for their participation.

The study was sponsored by Factor Nutrition Labs, LLC, the developer

of FOCUSfactor, and was conducted in 2011 at Cognitive Research Corporation (“CRC”) in Saint Petersburg, Florida.

in consultation with CRC, was responsible for study design including selection of dose, eligibility criteria, efficacy and safety assessments,

and vitamin/nutraceutical supply.

CRC, a contract research organization, was responsible for data collection, database preparation, overall

project management, site monitoring, data management, statistical analyses, and preparation of the final study report.

The primary endpoint was sum

recall for five trials of the Rey Auditory Verbal Learning Test (RAVLT), a standardized neuropsychological test of memory.

one of the most commonly used tests of memory in psychopharmacology research.

The test was originally developed in the 1940s and has proven

useful in evaluating verbal learning and memory, including proactive inhibition, retroactive inhibition, retention, encoding versus retrieval,

and subjective organization.

The standard RAVLT begins with a subject being read a list of 15 unrelated words at the rate of one word

The examiner then asks the subject to recall as many words as possible.

This procedure is then repeated four more times with

the same list of words and the number of correct responses is summed.

This summed score was chosen as the primary outcome measure, or

endpoint, for the current study.

The study demonstrated that,

compared to placebo, FOCUSfactor improved abilities referred to as memory (i.e., short term memory), attention (e.g., focus), concentration

and working memory in healthy adults.

Following six weeks of treatment, subjects who received FOCUSfactor had a mean increase in

recall of 6.5 words compared to 4.5 words for those who received placebo (t = -4.32, df = 87, p <0.001).

The total words

recalled over the five trials following six weeks of treatment (corrected for baseline score) was 51.9 words for subjects receiving

FOCUSfactor compared to 49.7 words for subjects receiving placebo (t = -2.98, df = 87, p = 0.002).

The significant effect on

the RAVLT summed score supports the hypothesis that FOCUSfactor improves memory, attention (e.g., focus), and concentration.

FOCUSfactor was found to be very well tolerated.

We were organized as a corporation

under the laws of the State of Nevada on December 29, 2010 under the name “Oro Capital Corporation.” In April 2014,

Synergy Strips Corp., a Delaware corporation, became our wholly-owned subsidiary, and we changed our name from “Oro Capital

Corporation” to “Synergy Strips Corp.” In August 2015, we changed our name to “Synergy CHC Corp.” In

January 2019, our other U.S.

subsidiaries, Neuragen Corp., Sneaky Vaunt Corp., The Queen Pegasus Corp.

and Breakthrough

Products Inc., merged with and into the Company.

Fiscal Year Developments

2019 we focused on development and line extensions within our existing brands.

We developed product extensions and expanded into

of the Business

is sold at America’s leading retailers such as Costco, Walmart, Amazon.com, Walgreens, CVS, The Vitamin Shoppe and online

at www.focusfactor.com.

FOCUSfactor is a brain-health nutritional supplement that includes a proprietary blend of brain supporting

vitamins, minerals, antioxidants and other nutrients.

In December 2012, the United States Patent and Trademark Office issued US

Patent 8,329,227 covering FOCUSfactor’s proprietary formulation “for enhanced mental function.”

of the patent marked one of the few times a patent has been issued for a nationally branded nutritional supplement.

is clinically tested with results demonstrating improvements in focus, concentration and memory in healthy adults.

is a material product to our revenue base, representing 64% of revenue.

Flat Tummy brand consists of multiple products and accessories including tea, shakes, lollipops, supplements, apparel, a mobile

App and exercise accessories.

Flat Tummy products are sold online at www.flattummyco.com , Amazon.com, CVS and at The Vitamin

The Flat Tummy brand is a material product to our revenue base, representing 32% of revenue.

MD is the world’s first anti-aging skincare line formulated specifically for the hands.

Hand MD is sold online at www.handmd.com

and Amazon.com.

is a topical product that works directly at the site of pain as opposed to oral products.

Neuragen reduces the spontaneous firing

of damaged peripheral nerves.

By calming these nerves, Neuragen is clinically shown to reduce shooting and burning pains quickly

and without side effects.

Neuragen is sold at Walgreens and through various distribution channels.

Vaunt is a backless, strapless, stick on, push up bra.

Sneaky Vaunt is sold online at www.sneakyvaunt.com and Amazon.com.

Fuel is a line of nootropic supplements designed to enhance brain function.

Think Fuel products are sold online at www.thinkfuel.com

and Amazon.com.

and Commercialization Strategy

intend to expand on the current retail strategies and build out a strong online sales model.

and Development

currently outsource our research and development to our manufacturers, as they are experienced in the development of new products

and line extensions.

Manufacturing

currently outsource the manufacturing of our products to third parties who have the necessary equipment and technology to provide

mass quantities as required.

FOCUSfactor is manufactured by Atrium Innovations and Vit-Best Nutrition.

Flat Tummy Tea is manufactured

by Caraway Tea Company.

Neuragen is manufactured by C-Care.

Hand MD is manufactured by HealthSpecialty.

Sneaky Vaunt is manufactured

by Dongguan Jingrui.

Commercialization

are highly dependent on two retailers for the sale of our retail products:

Costco Wholesale Corporation and Sam’s West,

Inc./Walmart (a/k/a Sam’s Club), which comprise 78% of our net revenue for retail sales of our products.

to diversify our sales network and generate revenue by selling our consumer-ready products to retailers across North America,

which retailers may then sell to end consumers through retail distribution channels.

We also sell direct to wholesalers and distributors

at a reduced cost as a means to grow our revenue base quickly and to penetrate the market more effectively.

success depends in part upon our ability to protect our core technology and intellectual property.

To establish and protect our

proprietary rights, we will rely on a combination of patents, patent applications, trademarks, copyrights, trade secrets, including

know-how, license agreements, confidentiality procedures, non-disclosure agreements with third parties, employee disclosure and

invention assignment agreements, and other contractual rights.

December 2012, the United States Patent and Trademark Office issued U.S.

Patent 8,329,227 covering FOCUSfactor’s proprietary

formulation “for enhanced mental function.”

The issuance of the patent marked one of the few times a patent

has been issued for a nationally branded nutritional supplement.

The issuance of the patent for FOCUSfactor came after a 2011

clinical study report which showed that FOCUSfactor improved memory, concentration and focus in healthy adults participating in

The clinical study of FOCUSfactor was sponsored by Factor Nutrition Labs, the owner of the Focus Factor Business at

the time, and was conducted by Cognitive Research Corporation, a full-service contract research organization that specializes

in the effects of nutritional supplements and pharmaceutical products on human cognition.

The study was conducted in compliance

with all applicable country requirements for the conduct of clinical studies, including those outlined by the International Conference

on Harmonization, Consolidated Guidelines on Good Clinical Practices, and the Food and Drug Administration.

In addition to

this intellectual property, we also rely on our proprietary knowledge and ongoing technological innovation to develop a competitive

position in the market for our products.

Each of these patents, patent applications, and know-how are integral to the conduct

of our business, the loss of any of which could have a material adverse effect on our business.

and Marketing

plan to focus on selling to retailers and distributors who currently are active in the consumer product space with the aim to

expedite the penetration of market acceptance of the product.

We are currently conducting research with focus groups to find out

what the best approach for marketing efforts is and how to do so in the most cost-effective manner.

We also plan to develop an

online sales channel.

sell our products in mostly North American retail locations along with other developed countries with similar retail landscapes

to North America.

there are many competing products on the market, in all our current product categories, FOCUSfactor is the only product in its

category with both a patent and clinical study to support its claims.

FOCUSfactor’s competitors include a wide range of

products, from targeted brain-enhancement supplements to indirect competitors such as energy drinks that claim to improve concentration.

products that we sell, and those that we are developing for future sale, may be subject to U.S.

Food and Drug Administration (“FDA”)

approval for packaging compliance.

With respect to the products we currently sell, our regulatory counsel has reviewed all of

our products and we believe we are compliant with the current rules.

Since the current products sold are considered nutraceuticals,

cosmeceuticals and over the counter products, minimal regulations are placed on the product with the exception of the appropriate

labeling and warnings on the packaging.

will rely on legal and operational compliance programs, as well as local counsel, to guide our compliance with applicable laws

and regulations of the jurisdictions in which we do business.

do not anticipate, at this time, that the cost of compliance with U.S.

and foreign laws will have a material financial impact

on operations, business or financial condition.

There are, however, no guarantees that new regulatory and tariff legislation will

not have a material negative effect on our business in the future.

As of April 13,

2020, we had 36 full-time employees.

We intend to grow our employee base in response to the demands and requirements of the

We believe that the employer-employee relationships in our Company are positive.

and Breakthrough Products

Inc., merged with and into the Company.

In July 2021, we acquired Hand MD Corp.

as a wholly-owned subsidiary.

We were a public reporting

company until July 17, 2020, the date on which we filed a Form 15 to voluntarily suspend our duty to file reports under Sections

13 and 15(d) of the Exchange Act.

As a result of our public offering in October 2024, we became subject again to the information

and reporting requirements of the Exchange Act and we file periodic reports, proxy statements and other information with the SEC.

The global nutritional supplement

market is expected to grow at a compound annual growth rate (CAGR) of approximately 9.3% from 2018 to 2028 according to Inkwood Research.

One of the drivers of this growth is the increasing availability of over-the-counter products as an alternative to prescription medication.

FOCUSfactor competes in the

brain health supplement category.

The global brain health supplements market was estimated to be $8.6 billion in 2022 and is expected

to grow at a compound annual growth rate of 13.3% from 2023 to 2030, according to Grand View Research.

The industry is fragmented, with

both global and domestic competitors, which gives us an opportunity to scale and continue to take market share.

Our Flat Tummy brand competes

in the weight management and wellbeing market, which in 2022 was estimated to be a $11.3 billion global market, with forecasted growth

of 4.0% annually from 2023 to 2032, according to Business Research Insights.

Demographic trends and changing

consumer habits, including a focus on reducing obesity prevalence, have been drivers of this market.

We expect these trends will benefit

the Flat Tummy brand and allow for new and innovative products to appeal to the changing market demographics.

Research and Development

The development of new products

is comprised of two distinct steps.

First, our marketing team reviews new product opportunities by analyzing market data and consumer

trends in the market as well as products offered by our competition and then develops preliminary new product concepts which include claims/benefits,

delivery form, packaging, and pricing targets, among others.

We then work with our third-party manufacturers and leverage their research

and development to finalize our new product initiative (including formula and specifications), as these partners are experienced in product

development and formulation.

When we acquire a brand, we typically further expand the SKUs under that brand, through internal development

and with our existing partners.

Generally, we take ownership of the formulas and related intellectual property, unless the products use

a generic formulation.

Manufacturing and Related Operations

Our company collaborates with

external manufacturers, known for their reliability, to produce our diverse range of products.

We carefully select partners based on their

expertise and manufacturing capabilities, ensuring our products are of the highest quality.

The FOCUSfactor line is produced by several

respected manufacturers, such as Nutrition Formulators Inc., Vit-Best Nutrition, and ProTab Laboratories, to ensure supply continuity

and support brand growth.

For the Flat Tummy line, we work closely with manufacturers:

Caraway Tea Company to make our teas, Vit-Best Nutrition

for shakes and capsules, Global Widget for gummies, and Clever Foods for appetite suppression lollipops.

Most of our revenues are generated

through the retail channels, primarily due to our FOCUSfactor brand which is sold mainly through leading retailers.

These retailers include

club, mass, drug and other retailers such as Costco, Walmart, Amazon.com, Walgreens, Meijer, Albertson’s and CVS.

brands are also sold directly to consumers through their respective brand websites.

nutritional supplements

retail industry is a large and highly fragmented industry with few barriers to entry.

We compete against other domestic and international

manufacturers, specialty retailers, mass merchants, multi-level marketing organizations, mail-order and direct-to-consumer companies,

and e-commerce companies.

This market is highly sensitive to the introduction of new products, which may rapidly capture a significant

share of the market.

Certain of our competitors may have significantly greater financial, technical and marketing resources than we do,

and may be able to adapt to changes in consumer preferences more quickly, devote greater resources to the marketing and sale of their

products, or generate greater brand recognition.

In addition, our competitors may be more effective and efficient in introducing new products.

Although there are many competing

products on the market across our product categories, we believe that the FOCUSfactor brand is strengthened by an independent study to

support its claim of improving memory, concentration and focus.

FOCUSfactor’s competitors include a wide range of products, from

targeted brain-enhancement supplements to indirect competitors such as energy drinks that claim to improve concentration.

Tummy brand competes in well-established segments with a diverse range of competition both domestically and internationally.

Government Regulation

Domestic (United States) Overview

The processing, formulation,

safety, manufacturing, packaging, labeling, advertising and distribution of our products in the United States are subject to regulation

by several agencies, including the U.S.

Food and Drug Administration (the “FDA”), the Federal Trade Commission (the “FTC”),

the Consumer Product Safety Commission, and by various agencies and programs of the states and localities in which our products are sold.

The FDA, which exercises regulatory authority over foods, dietary supplements (a subset of the foods category), and cosmetics, is the

regulatory body for the product categories in which we participate within the U.S.

While the FDA doesn’t

mandate pre-approval or registration for dietary supplements or food products, it does stipulate that these items must adhere to

current good manufacturing practices (“cGMPs”) and be produced in FDA-registered and audited facilities.

Additionally,

the FDA exercises regulatory oversight of ingredients and labeling of these products.

All FOCUSfactor products and

Flat Tummy products are governed by the FDA regulations in 21 CFR Part 111 (dietary supplements) or 21 CFR Part 117 (foods).

Neuragen (NDC 15377-010-04) is a homeopathic product and has not been evaluated by the FDA for safety or efficacy.

The FDA is not aware

of scientific evidence to support homeopathy as effective.

UrgentRx is an over-the-counter (“OTC”) drug, which has specific

regulatory requirements, including ingredient and manufacturing requirements.

Under the OTC monograph system, selected OTC drugs are generally

recognized as safe and effective and do not require the submission and approval of a new drug application.

The FDA OTC monographs include

well-known ingredients and specific requirements for permitted indications, required warnings and precautions, allowable combinations

of ingredients and dosage levels.

Products marketed under the OTC monograph system must conform to specific quality, formula and labeling

requirements.

We do not currently sell UrgentRx.

Food and Drug Administration

Dietary Supplements and Foods

The Dietary Supplement Health

and Education Act of 1994 (“DSHEA”) amended the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”)

to establish a new framework governing the composition, safety, labeling, manufacturing and marketing of dietary supplements.

under the FD&C Act, dietary ingredients (i.e., vitamins;

herbs or other botanicals;

or dietary substances for

use by humans to supplement the diet by increasing total dietary intake;

or any concentrate, metabolite, constituent, extract or combination

of any of the above) that were marketed in the United States prior to October 15, 1994 may be used in dietary supplements without

notifying the FDA.

“New” dietary ingredients (i.e., dietary ingredients that were not marketed in the United States before

October 15, 1994) must be the subject of a new dietary ingredient notification submitted to the FDA unless the ingredient has been

“present in the food supply as an article used for food” without being “chemically altered.” A new dietary ingredient

notification must provide the FDA evidence of a “history of use or other evidence of safety” establishing that use of the

dietary ingredient “will reasonably be expected to be safe.” A new dietary ingredient notification must be submitted to the

FDA at least 75 days before the initial marketing of the new dietary ingredient.

The FDA may determine that a new dietary ingredient

notification does not provide an adequate basis to conclude that a dietary ingredient is reasonably expected to be safe.

Such a determination could

prevent the marketing of such dietary ingredient.

In 2011 and 2016, the FDA issued draft guidance setting forth recommendations for complying

with the new dietary ingredient notification requirement.

In 2024, FDA has issued another guidance finalizing New Dietary Ingredient Notification

(“NDIN”) procedures and timeframes, noting that other parts of the 2016 draft guidance will be finalized in due time.

FDA guidance is non-binding and does not establish legally enforceable responsibilities, and companies are free to use an alternative

approach if the approach satisfies the requirements of applicable laws and regulations, FDA guidance is a strong indication of the FDA’s

view on the topic discussed in the guidance, including its position on enforcement.

At this time, the NDIN draft guidance, and finalized

timelines and procedures guideline are not anticipated to have a material impact on our operations.

As a part of our product development

process, ingredients in products are vetted for compliance with FDA’s regulations for dietary supplements.

Any ingredient suspected

to fall under the NDIN classification is further vetted to confirm the ingredient is Generally Recognized As Safe (GRAS) or that the ingredient

manufacturer/distributor has submitted NDIN to the FDA.

The FDA or other agencies could

take actions against products or product ingredients that, in their determination, present an unreasonable health risk to consumers that

would make it illegal for us to sell such products.

In addition, the FDA could issue consumer warnings with respect to the products or

ingredients in such products that we sell.

Such actions or warnings could be based on information received through FD&C Act-mandated reporting

of serious adverse events.

The Bioterrorism Act, enacted

in 2002, is a U.S.

federal law aimed at bolstering the nation’s ability to prevent, prepare for, and respond to bioterrorism

and other public health emergencies.

Key provisions include mandatory registration of food facilities with the FDA, prior notification

of imported food shipments, recordkeeping requirements for food facilities, and the FDA’s authority to administratively detain food

products posing serious health risks.

This legislation enhanced food safety by facilitating better monitoring of food facilities and imports,

improving traceability and recall efforts, and strengthening the FDA’s ability to respond swiftly to potential threats to public

In June 2007, pursuant

to the authority granted by the FD&C Act as amended by DSHEA, the FDA published detailed current Good Manufacturing Practice (“cGMP”)

regulations that govern the manufacturing, packaging, labeling, and holding operations of dietary supplement manufacturers.

The cGMP regulations,

among other things, imposed significant recordkeeping requirements on manufacturers.

The cGMP requirements are in effect for all dietary

supplement manufacturers, and the FDA conducts inspections of dietary supplement manufacturers pursuant to these requirements.

of a manufacturing facility to comply with the cGMP regulations renders products manufactured in such facility “adulterated,”

and subjects such products and the manufacturer to a variety of potential FDA enforcement actions.

In addition, the Food Safety Modernization

Act (“FSMA”), which was enacted in January 2011, aimed to modernize and strengthen the food safety system by shifting

the focus from responding to foodborne illness outbreaks to preventing them.

The act granted the FDA new regulatory authority over the

way foods are grown, harvested, and processed.

It also required food facilities to implement preventive controls to identify and address

potential hazards in their operations.

FSMA represents a fundamental shift in food safety regulation, emphasizing prevention, risk-based approaches,

and enhanced collaboration throughout the food supply chain, which has increased the costs of dietary ingredients and has subjected the

suppliers of such ingredients to more rigorous inspections and enforcement.

FSMA also requires importers of food, including dietary supplements

and dietary ingredients, to conduct verification activities to ensure that the food or ingredients they import meet applicable domestic

requirements.

We take several actions to

ensure manufacturers we engage comply with the Bioterrorism Act, have implemented FSMA procedures (as applies), and are operating under

As is common in our industry, we rely on our third-party suppliers and manufacturers to have policies and procedures that

ensure that the products they manufacture and sell to us comply with all applicable regulatory and legislative requirements.

we have a set of supplier onboarding procedures that ensure that the third-party facilities are registered with the FDA and are operating

a quality system up to cGMP standards for the respective product category.

We make an intentional effort to engage manufacturers that

have additional quality certifications and third-party audits, such as food safety certifications under the Global Food Safety Initiative

(GFSI) or dietary supplement cGMP certifications audited by the National Sanitation Foundation (NSF), whenever possible.

During this onboarding

process, the supplier’s history is also researched for any recent recalls, warning letters, or import alerts related to their facility

or products manufactured by the supplier.

Additionally, each third-party manufacturer is required to enter into a quality agreement

This document specifically outlines responsibilities and cGMP/documentation expectations for each party.

In general, we also

seek representations and warranties, indemnification and/or insurance from our vendors.

However, even with adequate insurance and indemnification,

any claims of non-compliance could significantly damage our reputation and consumer confidence in our products.

In addition, the

failure of such products to comply with applicable regulatory and legislative requirements could prevent us from marketing the products

or require us to recall or remove such products from the market, which in certain cases could materially and adversely affect our business,

financial condition and results of operations.

A removal or recall could also result in negative publicity and damage to our reputation

which could reduce future demand for our products.

In such case, we may attempt to offset any losses related to recalls and removals with

reformulated or alternative products;

however, there can be no assurance that we would be able to offset all or any portion of losses

related to any future removal or recall.

The FD&C Act permits structure/function

claims to be included in labels and labeling for dietary supplements without FDA pre-market approval.

However, companies must have

substantiation that the claims are “truthful and not misleading,” and must submit a notification with the text of the claims

to the FDA no later than 30 days after marketing the dietary supplement with the claims.

Permissible structure/function claims may

describe how a particular nutrient or dietary ingredient affects the structure, function, or general well-being of the body, or characterize

the documented mechanism of action by which a nutrient or dietary ingredient acts to maintain such structure or function.

labeling of a product marketed as a dietary supplement may not expressly or implicitly represent that a dietary supplement will diagnose,

cure, mitigate, treat, or prevent a disease (i.e., a disease claim).

If the FDA determines that a particular structure/function claim

is an unacceptable disease claim that causes the product to be regulated as a drug, a conventional food claim, or an unauthorized version

of a “health claim,” or, if the FDA determines that a particular claim is not adequately supported by existing scientific

data or is false or misleading in any particular way, we would be prevented from using the claim and would have to update our product

labels and labeling accordingly.

We have an in-house regulatory team that reviews the scientific literature and develops substantiation

as part of the product development process to ensure the crafting of compliant structure-function claims and product positioning.

Our regulatory team engages in the review of web copy, e-commerce copy, and other marketing copy at the request of the brand directors

of each respective brand.

In addition, DSHEA provides

that so-called “third-party literature,” e.g., “a publication, including an article, a chapter in a book,

or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the

editors of the publication” supplements, when reprinted in its entirety, may be used “in connection with the sale of a dietary

supplement to consumers” without the literature being subject to regulation as labeling.

Such literature:

(1) must not be false

or misleading;

(2) may not “promote” a particular manufacturer or brand of dietary supplement;

(3) must present

a balanced view or is displayed or presented with other such items on the same subject matter so as to present a balanced view of the

available scientific information;

(4) if displayed in an establishment, must be physically separate from the dietary supplements;

and (5) should not have appended to it any information by sticker or any other method.

If the literature fails to satisfy each of

these requirements, we may be prevented from disseminating such literature with our products, and any continued dissemination could subject

our product to regulatory action as an illegal drug.

The FDA has broad authority

to enforce the provisions of federal law applicable to dietary supplements, including powers to issue a public warning or notice of violation

letter to a company, publicize information about illegal products, detain products intended for import, require the reporting of serious

adverse events, require a recall of illegal or unsafe products from the market, and request the Department of Justice to initiate a seizure

action, an injunction action or a criminal prosecution in United States courts.

Federal Trade Commission

The FTC exercises jurisdiction

over the advertising of all products, including foods, dietary supplements and cosmetics, and requires that all advertising to consumers

be truthful and non-misleading.

The FTC actively monitors the dietary supplement space and has instituted numerous enforcement actions

against dietary supplement companies for failure to have adequate substantiation for claims made in advertising or for the use of false

or misleading advertising claims or practices.

These enforcement actions have resulted in consent decrees and significant monetary judgments

against the companies and/or individuals involved.

Regulators require a company to convey product claims clearly and accurately and further

require marketers to maintain adequate substantiation for their claims.

More specifically, the FTC requires such substantiation to be

based upon competent and reliable scientific evidence and requires a company to have a reasonable basis for the expressed and implied

product claim before it disseminates an advertisement.

A reasonable basis is determined based on the claims made, how the claims are presented

in the context of the entire advertisement, and how the claims are qualified.

The FTC’s standard for evaluating substantiation is

designed to ensure that consumers are protected from false and/or misleading claims by requiring scientific substantiation of product

claims at the time such claims are first made.

The failure to have this substantiation violates the Federal Trade Commission Act.

Our products sold in foreign

countries are also subject to regulation under various national, local, and international laws that include provisions governing, among

other things, the formulation, manufacturing, packaging, labeling, testing, advertising, and distribution of these products within their

respective categories.

Some foreign entities categorize these products/formulations as “Medicines” or subsets of a medicinal

category instead of as “food supplements” or “dietary supplements”, based on the regionally-specific regulations

and the nature of the product.

Government regulations in foreign countries may prevent or delay the introduction, or require the reformulation,

of certain of our products.

In foreign markets, our regulatory

department works with an in-country regulatory consultant group to guide us through the regulatory process needed to launch our product

in a particular country such as Canada, the United Kingdom and Australia.

For example, Canada and Australia require a product submission

packet and approval from Health Canada (“HC”) and the Therapeutic Goods Administration (“TGA”), respectively,

for products that would be considered “Natural Health Products” (in Canada) or “Listed Medicines” (in Australia).

In the United Kingdom, on the other hand, no formal regulatory submission or pre-approval is needed for products within the food

supplement category.

Launch timing varies by country.

In the United States and United Kingdom, once a formula is established and

labeling has been approved by our regulatory and legal advisors, the product can be launched upon production.

The Australian approval

process generally takes four to eight weeks from the time the packet is submitted, while in Canada the approval process can take

from six to twelve months from submission.

In Canada, HC has oversight

over our FOCUSfactor and Flat Tummy products.

Our FOCUSfactor and Flat Tummy products are considered natural health products (“NHPs”)

by HC, and each has been issued, so they each have a natural product number (“NPN”) that was assigned by HC upon its review

and approval.

This applies to all products currently marketed or licensed in Canada, except for the FOCUSfactor energy drinks, which are

considered supplemented foods and are not subject to pre-approval.

Energy drinks are instead subject to supplemented foods regulations

and manufacturing standards.

In the United Kingdom, FOCUSfactor

products are considered food supplements that are regulated by the Food Standards Agency (“FSA”).

There is no requirement

for licensing or registering food supplement products in the United Kingdom.

Products must comply with relevant food law, which include

formulation/ingredient restrictions, specific labeling requirements, and other parameters.

Brexit has introduced significant challenges

for the sale of food supplements from the UK into the EU.

These challenges primarily stem from regulatory misalignment and new border

Previously, products could be freely traded within the EU under harmonized regulations, but now, UK-based supplements must

adhere to separate EU regulations to be sold in the European market.

This necessitates costly and time-consuming compliance efforts,

including product testing and re-labelling.

Additionally, customs procedures and tariffs introduced post-Brexit have further impeded

the flow of goods, increasing costs for businesses and potentially limiting consumer access to certain products.

Flat Tummy products are

not currently sold in the United Kingdom.

In Australia, FOCUSfactor products

are “Listed Medicines” that are regulated by the TGA and require an AUST L (Australia Listed Medicine) number.

Listed Medicines

are regulated by the TGA, and the advertising of these products is also regulated by the TGA under the Therapeutic Goods Administrative

Code (“TGAC”).

Flat Tummy products are not currently sold in Australia.

New Legislation or Regulation

Legislation may be introduced

which, if passed, would impose substantial new regulatory requirements on dietary supplements.

We cannot determine what effect additional

domestic or international governmental legislation, regulations, or administrative orders, when and if promulgated, would have on our

business in the future.

New legislation or regulations may require the reformulation or revised labeling of certain products to meet new

standards, require the recall or discontinuance of certain products not capable of reformulation, or impose additional record keeping

or submission requirements.

Moreover, emerging or future regulations might introduce additional challenges beyond those currently foreseen,

further affecting the industry landscape.

Fragmented state-level regulations

develop in the United States from time-to-time.

Once such bill, the New York Weight Loss Products Bill, effective as of April 22, 2024,

imposes stricter regulations on weight loss and athletic performance products.

Among its provisions, it requires manufacturers to implement

age verification measures for the sale of consumers in the state of New York.

Despite its passage, opposition from industry trade

groups persists, citing concerns over its impact on the dietary supplement industry.

Another noteworthy and continuously-evolving state-level regulation

is Proposition 65, which is a California initiative that governs the presence of some chemicals and associated warnings and is managed

by the California Office of Environmental Health Hazard Assessment (OEHHA).

On a federal level in the United States,

repeated legislative attempts have been made within the last several years to introduce a mandatory product listing (MPL) for the

dietary supplement industry through the FDA, which would require notification to the FDA before bringing a product to the market and for

label information to be submitted to and maintained in a central database.

While the most recent MPL attempt failed in 2022, the FDA’s

outlined budget and legislative proposals for 2025 continue to include the modernization of DSHEA regulations and the introduction of

Several trade association groups within the dietary supplement industry continue to express opposition to the current proposal,

citing a clear lack of scope and definition of what it ultimately may require.

In Canada, Health Canada is

in the process of reviewing and updating the database of ingredient and product monographs.

While this effort is considerably focused

on the clarification and harmonization of existing monographs and resources, the changing of certain ingredient monographs may have the

potential to impact formulation or labeling, if any such ingredient is included in one of our licensed products.

If this does occur, Health

Canada is expected to provide phase-in and guidance for any such changes.

Health Canada has also provided updated labeling formatting

for Natural Health Products (NHPs), with a compliance date for existing products of 2028.

Concurrently, Health Canada is in the consultation

period for an updated fee schedule for Health Canada-related activities, such as the review of product submission packets, site licensing,

and other activities relevant to maintaining operations and regulatory compliance in Canada.

These discussions are still ongoing, but

present potential additional future expenses to companies with natural health product registrations in the Canadian regions, as well as

manufacturers or importers of such products.

The benefit of this proposed pay scheme is that it may significantly reduce the number of

product submissions from other companies in the Canadian market, which may reduce competition in the Canadian market and perhaps reduce

review timelines by Health Canada for new product registrations and other such activities, therefore decreasing the time barrier to entry.

Intellectual Property

We own 23 trademarks that have

been registered with the United States Patent and Trademark Office and have filed applications to register additional trademarks.

In addition, we claim domestic trademark and service mark rights in numerous additional marks that we use.

We own a number of trademark

registrations in countries outside the United States.

Federally registered trademarks in the United States have a perpetual

life, as long as they are maintained and renewed on a timely basis and used properly as trademarks, subject to the rights of third parties

to seek cancellation of the trademarks if they claim priority or confusion of usage.

Most foreign trademark offices use similar trademark

renewal processes.

We regard our trademarks and other proprietary rights as valuable assets and believe they make a significant positive

contribution to the marketing of our products.

We protect our legal rights

concerning our trademarks by appropriate measures, which may include legal action.

We possess a portfolio of both registered and unregistered

(i.e., common law) trademarks.

In certain circumstances, we seek and obtain registrations for our trademarks, which may confer certain

advantages, and the decision to register a trademark is made on a case-by-case basis.

We have registered and intend to register certain

trademarks in certain limited jurisdictions outside the United States where our products are sold, but we may not register all or

even some of our trademarks in every country in which we conduct business or intend to conduct business.

Patent 8,329,227

covering FOCUSfactor’s proprietary formulation “for enhanced mental function.” This patent was issued by the United States

Patent and Trademark Office in December 2012 and expires in April 2025.

In addition to this intellectual

property, we also rely on our proprietary knowledge and ongoing technological innovation to develop a competitive position in the market

for our products.

Each of our patents and know-how are integral to the conduct of our business and the loss of any could have a material

adverse effect on our business.

Human Capital Management

We recognize that attracting,

motivating and retaining passionate talent at all levels is vital to continuing our success.

By improving employee retention and engagement,

we also improve our ability to support our customers and protect the long-term interests of our stakeholders and stockholders.

invest in our employees through continuously improving benefits and various health and wellness initiatives, and offer competitive compensation

packages, working to continuously improve fairness in internal compensation practices.

As of December 31, 2024, we

had 21 full-time employees.

We intend to grow our employee base in response to the demands and requirements of the business.

that the employer-employee relationships in our Company are positive.

We have no labor union contracts.

Impact of COVID-19

outbreak of COVID-19, which has been declared by the World Health Organization to be a pandemic, has spread across the globe and

is impacting worldwide economic activity.

A pandemic, including COVID-19, or other public health epidemic poses the risk that

the Company or its employees, suppliers, and other partners may be prevented from conducting business activities at full capacity

for an indefinite period of time, including due to spread of the disease within these groups or due to shutdowns that may be requested

or mandated by governmental authorities.

While it is not possible at this time to estimate the impact that COVID-19 could have

on the Company’s business, the continued spread of COVID-19 and the measures taken by the governments of countries affected

and in which the Company operates could disrupt the operation of the Company’s business.

The COVID-19 outbreak and mitigation

measures may also have an adverse impact on global economic conditions, which could have an adverse effect on the Company’s

business and financial condition, including on its potential to conduct financings on terms acceptable to the Company, if at all.

In addition, the Company may take temporary precautionary measures intended to help minimize the risk of the virus to its employees,

including temporarily requiring all employees to work remotely, and discouraging employee attendance at in-person work-related

meetings, which could negatively affect the Company’s business.

The extent to which the COVID-19 outbreak impacts the Company’s

results will depend on future developments that are highly uncertain and cannot be predicted, including new information that may

emerge concerning the severity of the virus and the actions to contain its impact.

website address is https://synergychc.com/.

We do not intend our website address to be an active link or to otherwise incorporate

by reference the contents of the website into this Report.

Securities and Exchange Commission (the “SEC”)

maintains an Internet website (http://www.sec.gov) that contains reports, proxy and information statements and other information

regarding issuers that file electronically with the SEC.

RISK FACTORS.

a “smaller reporting company,”

as defined by Item 10 of Regulation S-K, we are not required to provide this information.

UNRESOLVED STAFF COMMENTS.

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