What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2023-04-03 compared with 2022-03-31 · 248 added, 419 removed, 133 unchanged (83% of the section changed)

Wellness, Inc.

is a cutting-edge developer of cannabidiol (CBD) based medical therapeutics and wellness products.

The Company’s

clinical pipeline of prescription CBD-enhanced skin care therapeutics address indications including eczema, burns, herpes cold sores,

and skin cancer.

We are in the early stage of manufacturing, distributing, and marketing a diverse line of consumer products infused

We have a proprietary, line of products:

CaniSun, CaniSkin and CaniDermRX.

Under the CaniSun brand, we are marketing patent

pending CBD-infused sun care lotion formulas containing various sun protection factors, or SPFs.

In addition, we are exploring the use

of CBD with other prescription and/or over-the-counter, or OTC, consumer products that have potentially therapeutic and medical applications.

Specifically, we are exploring the use of such topical solutions for the treatment of eczema, dermatitis (JW-100), and actinic keratosis

(JW-_100), a non-prescription lotion/lip balm (JW-200) for the treatment of symptoms of cold sores, and a prescription product for the

treatment of burns (JW-101).

The CaniDermRX (JW-100) topical solution for the treatment of eczema dermatitis is the lead product candidate

and will be further tested in humans as an investigational cosmetic ingredient followed by clinical trials subject to the regulations

of the United States Food and Drug Administration (“FDA”) under an investigational new drug, or IND, application.

February 2021, we announced the results of our novel Cannabidiol-Aspartame combination treatment JW-100 clinical trial which has shown

it significantly Reduces ISGA Score in Eczema patients.

A double blinded placebo controlled interventional study was conducted.

were assigned to apply, at home, one of three treatments:

JW-100 (a CBD and aspartame combination topical formulation), a CBD only topical

formulation, or a placebo topical formulation.

After 14 days, the average reduction in the Investigators Static Global Assessment (ISGA)

score was calculated for each group.

Additionally, the proportion of subjects achieving (ISGA) score 0 (clear) or 1 (almost clear) with

at least 2 grade improvement from baseline was recorded for each arm of the study.

50% of subjects in the JW-100 arm achieved ISGA clear

or almost clear (1 or 2) with at least a 2-grade improvement from baseline after treatment versus 20% and 15% in the CBD-only and placebo

arms, respectively.

The percentage of subjects achieving clear or almost clear with at least a 2-grade improvement from baseline was

found to be statistically significant (p=0.028).

JW-100, a novel topical formulation containing CBD and aspartame, was shown to significantly

reduce ISGA score in atopic dermatitis patients after two weeks of use.

The combination of CBD and aspartame was more effective at reducing

ISGA scores than CBD alone.

In parallel, we plan to initiate the development of other products.

We originally anticipated developmental

studies to be completed in 2020, however, these studies were delayed due to COVID-19.

We are also actively seeking to acquire or license

products in the OTC skin care market that can be infused with CBD and marketed under our CaniSkin and CaniDermRX brand names.

be no assurances that we will acquire or enter into such partnership or licensing agreements.

November 2021, Jupiter Wellness received an official written response from a Type B pre-Investigational New Drug (IND) meeting with the

Food and Drug Administration (FDA) for JW-100, a topical drug the treatment of eczema.

The main purpose of the pre-IND meeting was

to evaluate the drug development plan for JW-100.

Jupiter Wellness believes that the written response from the FDA supports the Company’s

approach and its overall drug development strategy to enable the filing of an IND for its clinical studies on JW-100.

November 16, 2021, Jupiter Wellness announced the results of a double-blinded placebo controlled clinical trial on JW-300 showing efficacy

for the treatment of developing burns (sunburn).

endocannabinoid system, which is a body system affected by CBD, plays a pivotal role in maintaining a healthy skin through modulating

pain sensation, cell proliferation and inflammation.

Our strategy for treatment of skin indications is, therefore, to focus on the use

of CBD containing topical formulations and to explore potential combinations of CBD and other agents that may augment and act synergistically

We will explore this strategy by conducting controlled clinical trials to try to ultimately gain FDA approval for specific

November 30, 2020 the Company acquired SRM Entertainment, Limited, a Hong Kong Special Administrative Region of the People’s Republic

of China limited company (“SRM”).

SRM has relationships with and supplies the amusement park industry with exclusive products

that are often only available to consumers inside the relevant amusement park, entertainment venues and theme hotels in Orlando Florida,

Beijing China, Japan and other places throughout the worldwide theme park industry.

Organizational

Wellness, Inc.

was originally incorporated in the State of Delaware on October 24, 2018.

Our principal business address is 1061 E.

110, Jupiter, FL 33477.

Wellness, Inc.

is a cutting-edge developer of cannabidiol (CBD) based medical therapeutics and wellness products.

The Company’s

clinical pipeline of prescription CBD-enhanced skin care therapeutics address indications including eczema, burns, herpes cold sores,

and skin cancer.

We are in the early stage of manufacturing, distributing, and marketing a diverse line of consumer products infused

We have a proprietary, line of products:

CaniSun, CaniSkin and CaniDermRX.

Under the CaniSun brand, we are marketing patent

pending CBD-infused sun care lotion formulas containing various sun protection factors, or SPFs.

In addition, we are exploring the use

of CBD with other prescritption and/or over-the-counter, or OTC, consumer products that have potentially therapeutic and medical applications.

Specifically, we are exploring the use of such topical solutions for the treatment of eczema, dermatitis (JW-100), and actinic keratosis

(JW-100), a non-prescription lotion/lip balm (JW-200) for the treatment of symptoms of cold sores, and a prescription product for the

treatment of burns (JW-101).

The CaniDermRX (JW-100) topical solution for the treatment of eczema dermatitis is the lead product candidate

and will be further tested in humans as an investigational cosmetic ingredient followed by clinical trials subject to the regulations

of the United States Food and Drug Administration (“FDA”) under an investigational new drug, or IND, application.In February

2021, we announced the results of our novel Cannabidiol-Aspartame combination treatment JW-100 clinical trial which has shown it significantly

Reduces ISGA Score in Eczema patients.

A double blinded placebo controlled interventional study was conducted.

Subjects were assigned

to apply, at home, one of three treatments:

JW-100 (a CBD and aspartame combination topical formulation), a CBD only topical formulation,

or a placebo topical formulation.

After 14 days, the average reduction in the Investigators Static Global Assessment (ISGA) score was

calculated for each group.

Additionally, the proportion of subjects achieving (ISGA) score 0 (clear) or 1 (almost clear) with at least

2 grade improvement from baseline was recorded for each arm of the study.

50% of subjects in the JW-100 arm achieved ISGA clear or almost

clear (1 or 2) with at least a 2-grade improvement from baseline after treatment versus 20% and 15% in the CBD-only and placebo arms,

respectively.

The percentage of subjects achieving clear or almost clear with at least a 2-grade improvement from baseline was found

to be statistically significant (p=0.028).

JW-100, a novel topical formulation containing CBD and aspartame, was shown to significantly

reduce ISGA score in atopic dermatitis patients after two weeks of use.

The combination of CBD and aspartame was more effective at reducing

ISGA scores than CBD alone.

parallel, we plan to initiate the development of other products.

We originally anticipated developmental studies to be completed in 2020,

however, these studies were delayed due to COVID-19.

We are also actively seeking to acquire or license products in the OTC skin care

market that can be infused with CBD and marketed under our CaniSkin and CaniDermRX brand names.

There can be no assurances that we will

acquire or enter into such partnership or licensing agreements.

endocannabinoid system, which is a body system affected by CBD, plays a pivotal role in maintaining a healthy skin through modulating

pain sensation, cell proliferation and inflammation.

Our strategy for treatment of skin indications is, therefore, to focus on the use

of CBD containing topical formulations and to explore potential combinations of CBD and other agents that may augment and act synergistically

We will explore this strategy by conducting controlled clinical trials to try to ultimately gain FDA approval for specific

November 30, 2020, the Company acquired SRM Entertainment, Limited, a Hong Kong Special Administrative Region of the People’s Republic

of China limited company (“SRM”).

SRM has relationships with and supplies the amusement park industry with exclusive products

that are often only available to consumers inside the relevant amusement park, entertainment venues and theme hotels in Orlando Florida,

Beijing China, Japan and other places throughout the worldwide theme park industry.

our CaniSun Brand, we developed a patent pending CBD-infused sunscreen with broad-spectrum SPF protection.

We have completed lab testing

for CBD solubility–infusing clear, colorless, odorless, and 99.5% pure CBD isolate with three different sun care active ingredients,

homosalate, octisalate and octocrylene, which have already been approved by the FDA.

The CBD-infused sun care market is fairly nascent

in the United States;

we believe that there are currently no major competitors in the category.

We see an opportunity to become the leading

manufacturer of CBD-infused sun care products, marketing the CaniSun brand through an extensive digital and social media awareness campaign.

We announced the launch of our CaniSun sun care line of SPF 30, SPF 55 and SPF 50 face lotion on June 6, 2019.

We also sell our CBD-infused

lip balm and CBD-infused SPF 30 sunscreen spray on our website Canisun.com.

currently have additional CaniSun products in various stages of development as follows:

SPF 30 Lip Balm, Peppermint and Acai Fragrance

SPF 15 sunscreen daily lotion;

Mineral-based

sunscreen lotions (SPF 30 and 50).

of the products listed above are in the developmental stage, whereby we are finalizing the formula to be used in each product, respectively.

For CBD-infused product candidates in development, such as our CBD-infused SPF 30 Lip Balm and CBD-infused SPF 15 sunscreen lotion, we

have already identified the sun care active ingredient formula (which has already been FDA approved) to be infused with CBD.

respective formulas for each of our product candidates are created, the product candidates will undergo three months of stability testing.

Provided that the product candidates pass the stability testing, we intend to sell the products on our CaniSun website.

The formula for

our mineral-based sunscreen lotion (SPF 30 and 50) (product iii) above) includes certain minerals instead of chemicals typically used

in sunscreen lotions.

we believe that our currently offered sunscreen products comply with the FDA Final Rule for sunscreen products under 21 CFR 352 Sunscreen

products for Over-the-Counter Human Use.

Therefore, we believe that our sunscreen products fall within the FDA monograph.

have been tested for SPF Evaluation (SPF rating), Critical Wave Length (Broad Spectrum claim) and Water Resistance, each of which is

defined within the monograph and labeled accordingly.

of the testing on these products is standard testing for suncare products.

Such testing protocols are not intended to test for any effects

of adding CBD.

In addition to these tests that were conducted to support the claims on the package, each batch is also tested for appearance,

color, odor, pH, viscosity, specific gravity, analytical for the sunscreen active ingredients, and microbial content testing.

products are tested each time they are manufactured.

DCR Labs manufactures our products and has represented to us that it is compliant

with the FDA’s Current Good Manufacturing Practice, or CGMP, regulations in accordance with 21 CFR 210/211 required for Over-the-Counter

drug products.

DCR Labs has self-imposed health and safety standards to ensure compliance with the FDA’s CGMPs.

expect to continually update and expand upon our corporate website and further refine our online retail strategies on an ongoing basis.

JupiterWellness.com is our primary corporate website, which will serve as the primary source of information about us for investors and

contain press releases, clinical trial pipeline, lab reports, blog posts, and additional information about each of our brands.

We anticipate

that each brand will have its own front-facing website dedicated to retail sales and brand specific information.

For example, our line

of sun care products, CaniSun, has its own website at CaniSun.com and allows for online retail purchase of the entire product line.

we expand our brands (CaniSkin and CaniDermRX), we anticipate utilizing the same strategy and dedicating a new e-commerce website to

each brand moving forward.

We are also building a website dedicated to servicing our wholesale and larger distributor clients.

will have more information about each product and provide a central location for larger retailers to find more in-depth information about

all of our brands in one place.

plan to leverage our websites with a social media presence across multiple platforms designed to utilize product reviews to increase

brand loyalty, brand recognition and sales.

The references to our website in this prospectus are inactive textual references only.

information on our website is neither incorporated by reference into this prospectus nor intended to be used in connection with this

We also see growth potential in developing retail locations.

We intend to utilize cross-promotion marketing campaigns with

our products and product category expansion that leverages our existing distribution channels.

We have built an e-commerce platform designed

to connect us directly to consumers.

We use the platform to sell products, educate customers and build brand loyalty.

Brand and CaniDermRX Brand

are currently developing other products such as CBD-infused skin care lotion under the CaniSkin brand.

Specifically, a CBD-infused moisturizing

face serum is under development.

We must first finalize the formula to be used in the face serum, and, once approved, the product candidate

will undergo stability testing.

We intend to sell the product, provided it first passes stability testing, on our website for CaniSkin

Additionally, we are developing innovative dermatological treatments under the CaniDermRX brand that are specialized to treat

atopic dermatitis and other dermatological conditions such as burns, skin cancer and herpes cold sores, respectively.

Subject to obtaining

FDA approval, we intend for our experimental-stage product for the treatment of atopic dermatitis to compete with Dupixent, an FDA-approved

product for treating atopic dermatitis, and for our experimental-stage product for the treatment of herpes cold sores to compete with

Silvadene and Abreva, FDA-approved products for treating herpes cold sores.

These products require more extensive testing to show both

safety and efficacy.

addition, we plan to seek acquisition opportunities in the branded consumer products space, including but not limited to other OTC therapeutic

brands and skin care brands that can be developed, manufactured, marketed and distributed under our CaniSkin and CaniDermRX brand names.

filed a provisional patent number 62/884,955 on 08/09/2019 on an Aspartame/CBD combination and intend to develop products containing

a combination of CBD and Aspartame under the CaniDermRX name for the treatment of pain and inflammation.

On February 11, 2021, the US

Patent Published our US Patent Application 20210038513 and on April 5, 2021 we filed the International filing through PCT Application

PCT/US 2020/045408.

On April 6, 2021, we filed a PCT Application No.:

PCT/US2021/025947* on CBD sunscreens.

believe that our CaniDermRX product candidates have the potential to treat many skin indications such as atopic dermatitis, pruritis-itch,

non-atopic dermatitis/eczema, psoriasis, dermatomyositis, scleroderma, seborrheic dermatitis, actinic keratosis, epidermolysis bullosa

and cutaneous neoplasias.

Aspartame is a rigorously tested food ingredient.

Reviews by major governmental regulatory bodies have previously

found the ingredient safe for consumption at higher levels than we contemplate using in our CaniDermRX product candidates.

that our formulations that include Aspartame, such as topical crème, lip balm, powder and dog treats, are well-tolerated by, and

safe for, users.

We believe that infusing CBD in our products may help alleviate irritation that may be caused by applying sun care products

and may lead to reduced inflammation.

In human skin, receptors of the endocannabinoid system are found in differentiated keratinocytes,

hair follicle cells, sebaceous glands, immune cells, and sensory neurons.

Activation of cannabinoid receptor type 2, or CB2, for which

CBD is a ligand receptor in these cells has been shown to reduce pain and itch sensation, regulate keratinocyte differentiation and proliferation,

decrease hair follicle growth, and modulate the release of damage-induced keratins and inflammatory mediators to control the homeostasis

of the skin environment.

market for hemp, and for products based on extracts of hemp, is expected to grow substantially over the coming years.

It is estimated

by BDS Analytics and Arcview Market Research that the collective market for CBD sales in the U.S.

will surpass $20 billion by 2024 and

that there will be a compound annual growth rate of 49 percent by 2024 across all distribution channels.

We see great potential to grow

and generate revenues in this expanding market.

to Grand View Research, the U.S.

sun care market size was estimated at $1.95 billion in 2016.

The growing consumer awareness regarding

the ill-effects of over exposure to ultraviolet, or UV, rays on the undefended skin is expected to propel growth.

The sun care market

is a highly competitive market and product differentiation in the sun care market is low.

Given the relatively low amount of product

differentiation, we see an opportunity to carve out a unique market share with our CBD-infused sun care products.

We cannot make any

claims as to such benefits prior to performing certain testing.

We see an opportunity, although there can be no assurance that we will

be successful, to become the leading manufacturer of CBD-infused sun care products, marketing the CaniSun brand through an extensive

digital and social media awareness campaign.

We announced the launch of our CaniSun sun care line of SPF 30, SPF 50 and SPF 55 face lotion

on June 6, 2019.

We also sell our CBD-infused lip balm and CBD-infused SPF 30 sunscreen spray on our website Canisun.com.

plan to seek acquisition opportunities in the branded consumer products space, including but not limited to other non-CBD OTC therapeutic

brands and skin care brands that can be manufactured, marketed and distributed under our CaniSkin and CaniDermRX brand names.

market such products as they are currently comprised or may seek to add CBD to the product.

In the event we decide to add CBD to such

products, we intend to first conduct FDA regulated clinical trials for safety and efficacy testing.

We have no definitive agreements

in place to acquire any other entities.

also intend to sell the product online directly through our own website, and other third-party marketplaces as these sites permit.

Distribution Agreement

November 5, 2020, we entered into the Nidaria Distribution Agreement with Nidaria, Pursuant to which we purchase, market, promote, distribute

and sell Nidaria’s Safe Sea® sunscreen that provides protection against jellyfish stings.

Pursuant to the Nidaria Distribution

Agreement, the Company shall serve as Nidaria’s exclusive distributor of Safe Sea in the state of Florida.

The Nidaria Distribution

Agreement shall have a term of two (2) years, commencing December 1, 2020, and may be renewed for one (1) additional year upon the mutual

consent of us and Nidaria.

This agreement was not renewed for 2022 by mutual consent.

expect to continually update and expand upon our corporate website and further refine our online retail strategies on an ongoing basis.

Jupiterwellness.com is our primary corporate website, which will serve as the primary source of information about us for investors and

contain press releases, clinical trial pipeline, lab reports, blog posts, and additional information about each of our brands.

We anticipate

that each brand will have its own front-facing website dedicated to retail sales and brand specific information.

For example, our line

of sun care products, CaniSun, has its own website at CaniSun.com and allows for online retail purchase of the entire product line.

we expand our brands (CaniSkin and CaniDermRX), we anticipate utilizing the same strategy and dedicating a new e-commerce website to

each brand moving forward.

We are also building a website dedicated to servicing our wholesale and larger distributor clients.

will have more information about each product and provide a central location for larger retailers to find more in-depth information about

all of our brands in one place.

Wellness is committed to supporting health and wellness by developing innovative solutions to a range of conditions.

We take pride in

our research and development of over-the-counter (OTC) products and intellectual property, which aim to address some of the most prevalent

health and wellness concerns today.

Our product pipeline includes a diverse range of products, such as hair loss treatments, eczema creams,

vitiligo solutions, and sexual wellness products, that cater to different health and wellness needs.

We are dedicated to staying up-to-date

with the latest scientific research and technology, ensuring that our products are effective, safe, and meet the highest industry standards.

achieve our mission, we rely on a team of highly skilled and experienced professionals who are committed to advancing our vision of health

and wellness.

Our team includes scientists, researchers, product developers, and business experts who collaborate to create new products

and enhance existing ones.

We also partner with industry leaders and organizations to leverage the latest technologies and expand our

generate revenue through various channels, including the sales of our OTC and consumer products, as well as licensing royalties.

products are available through various retailers and e-commerce platforms, making them accessible to a broad customer base.

Additionally,

we collaborate with other companies to license our intellectual property, creating additional revenue streams and expanding our global

signed agreements to license JW-700 to Taisho, a $2.6 billion revenue company and Japan’s leading seller of minoxidil products.

Taisho plans on launching the product commercially in 2024.

In India, the Company signed an agreement with Cosmofix Technovation Pvt

Ltd and Sanpellegrino Cosmetics to license its JW-700 and Photocil products.

Additional licensing opportunities for these products are

being pursued primarily in overseas markets.

Company is advancing several formulations to address psoriasis and vitiligo (Photocil), increase the effectiveness of minoxidil to treat

hair loss (JW-700 “minoxidil booster”), women’s sexual wellness (JW-500), and jellyfish sting prevention sunscreen

(NoStingz), and atopic dermatitis/eczema (JW-110).

was launched commercially in India in Q3 2022 as a treatment for vitiligo and psoriasis.

Photocil is a topical cream that works with

natural sunlight to provide patients with safe and effective phototherapy at home by blocking harmful radiation and permitting the passage

of therapeutic UV radiation from the sun.

provides an effective barrier against the stinging mechanism of jellyfish cnidocyte preventing the delivery of venom to the victim.

like other topical sun screen products, the product is clinically proven to protect users from jellyfish, sea lice, and UVA/UVB rays.

currently being licensed abroad and developed for US launch, the product has been clinically shown to increase the enzymes needed for

minoxidil to work, sulfotransferase enzymes, by using the product topically in conjunction with topical minoxidil.

Additional studies

and formulation work are ongoing.

was born out of clinical trials designed to establish a topical treatment for the restoration of nipple sensitivity for breast augmentation

patients, in addition to patients who had undergone chemotherapy or lumpectomy surgery following a cancer diagnosis.

During early studies,

women reported not only increased sensitivity but also increased libido.

The Company plans to file for a pre-IND meeting with the US

FDA and seek Orphan Drug Designation.

An expedited 505(b)(2) regulatory pathway for development is being considered as the current formulation

contains an already approved drug.

and Development

research and development team in continually looking to develop new therapeutic products, while continually improving and enhancing our

existing products and product candidates to address customer demands and emerging trends.

Our team is currently working to further improve

the protection provided by NoStingz and develop more effective formulas for our JW-700 product.

and Marketing

primarily sell our products through third-party physical retail stores and partners who license and distribute them to other markets.

Currently, our products are licensed for distribution in over 31 countries.

The majority of our sales occur via traditional physical

retailers, including their websites.

We also sell via online retailers, such as Amazon and Walmart.

To drive loyalty, word-of-mouth marketing,

and sustainable growth, we invest in customer experience and customer relationship management.

Our marketing investments are directed

towards driving profitable growth through advertising, public relations, and brand promotion activities, including digital platforms,

sponsorships, collaborations, brand activations, and channel marketing.

Additionally, we continue to invest in our marketing and brand

development efforts by investing capital expenditures on product displays to support our channel marketing via our retail partners.

Manufacturing,

Logistics and Fulfillment

outsource the manufacturing of our products to contract manufacturers, who produce them according to our formulation specifications.

Our products are manufactured by contract manufacturers in India and the US.

The majority of our products will then be shipped to third-party

warehouses and to our corporate offices, which can either transport them to our distributors, retailers, or directly to our customers.

Our third-party warehouses are located in the US.

We use a limited number of logistics providers to deliver our products to both distributors

and retailers, which allows us to lessen order fulfillment time, cut shipping costs, and improve inventory flexibility.

Entertainment

November 30, 2020, we entered into and closed the Exchange Agreement with SRM, a Hong Kong Special Administrative Region of the People’s

4 unchanged sentences

Agreement, the Company delivered the 150,000 shares of its common stock to SRM and placed 50,000 shares in escrow (“Escrow Shares”).

Pursuant to the Exchange Agreement, the Company shall release the Escrow Shares upon SRM generating $200,000 in cash receipts and revenue

prior to January 15, 2021.

The Escrow shares have not been released as of the date hereof.

Pursuant to the Exchange Agreement, the Company

assumed all of the financial obligations of SRM, as well as its employees and offices.

As a result of the Exchange Agreement, SRM became

a wholly-owned subsidiary of the Company.

Pursuant to the Exchange Agreement, the Company released the Escrow Shares in 2021.

Pursuant to the Exchange Agreement, the Company assumed

all of the financial obligations of SRM, as well as its employees and offices.

As a result of the Exchange Agreement, SRM became a wholly-owned

subsidiary of the Company.

has relationships with and supplies the amusement park industry with exclusive products such as toys, lights, fans and other items that

8 unchanged sentences

its customers.

SRM, we additionally intend to seek to sell our sun care products in the amusement parks.

We are currently developing a line of non-CBD

infused sun care products for sale in the amusement parks.

has four full time employees.

are several companies developing cannabinoid therapeutics for a range of medical indications.

The cannabinoid therapeutic area currently

includes formulated extracts of the Cannabis plant and synthetic formulations.

These formulations include CBD and THC, or a combination

of CBD/THC as the active pharmaceutical ingredient.

Certain companies such as GW Pharmaceuticals, PLC have focused on hemp-based CBD

formulations;

while other companies such as Zynerba Pharmaceuticals Inc.

and Insys Therapeutics Inc.

have focused on synthetic CBD formulations.

CBD-based consumer product industry is highly fragmented with numerous companies, consisting of publicly- and privately-owned companies.

There are also large, well-funded companies that have indicated their intention to compete in the hemp-based product category in the

We routinely evaluate internal and external opportunities to optimize value for stockholders through new product development or

by asset acquisitions or sales, and believe we are well-positioned to capitalize in the growing CBD product category.

We face competition

from larger companies that are, or may be, in the process of offering similar products to ours.

Many of our current and potential competitors

have longer operating histories, significantly greater financial, marketing and other resources than we have or may be expected to have.

may include major pharmaceutical and biotechnology companies and public and private research institutions.

Our management cannot be certain

that we will be able to compete against current or future competitors or that competitive pressure will not seriously harm our business

These competitors may be able to react to market changes, respond more rapidly to new regulations or allocate greater resources

to the development and promotion of their products than we can.

SRM, the Company additionally intends to seek to sell its sun care products in amusement parks and related beach-adjacent properties

such as cruise lines and ocean resorts.

We are currently pursuing the sale of its jellyfish protection sun care products for sale in

these locations.

Competitive Strengths

are committed to driving continuous improvement through innovation.

Since our inception, we have made significant investments in research

and development and have acquired a substantial portfolio of intellectual property, which continues to grow each year.

Our commitment

to innovation has allowed us to create unique products that address unmet needs in the market, all backed by rigorous clinical research.

Our focus on research and development has enabled us to stay ahead of the curve and provide our customers with products that are not

only effective but also innovative.

We take pride in our patent portfolio and the continuous growth we have achieved, as it showcases

our dedication to creating new and unique solutions for our customers.

By staying committed to innovation, we are confident in our ability

to meet the ever-changing needs of the market and continue to be a leading player in the wellness industry.

Growth Strategies

elements of our growth strategy include:

To capitalize on our market opportunity, we have assembled an ambitious long-term roadmap to introduce products crafted to meet the

unique needs of each of our customers.

We plan to develop products across multiple categories, with a focus on continuously

improving the customer experience to increase sales to both new and existing customers alike.

We are highly focused on finding and growing potential customers through distribution channels such as retail stores, e-commerce

portals, and direct relationships with care providers such as dermatologists in the US, while expanding our direct-to-consumer

approach and leveraging current channel partnerships.

We intend to forge innovative, strategic partnerships with a variety of stakeholders, ranging from established industry leaders to

ambitious startups.

Our goal is not only to broaden our reach, but to maximize the potential of our existing solutions and to create

value-added opportunities across the entire partner ecosystem.

We intend to grow our brand equity by increasing brand awareness in existing geographic markets, diversifying our product offerings,

and developing our partner ecosystem.

Furthermore, we will look to expand our reach and drive higher household penetration rates in

our current markets.

Explore uncharted international markets, utilizing current licensees to tap into untested territories.

We will create tailored

strategies and resources to accommodate the unique requirements of each of these new markets, taking a proactive approach to reach

regions that have historically been difficult to breach and expand our global presence.

may include major pharmaceutical and biotechnology companies, as well as specialist consumer brands companies and public and private

research institutions.

We cannot be certain that we will be able to compete against current or future competitors, or that competitive

pressure will not seriously harm our business prospects.

These competitors may be able to react faster to market changes, respond more

rapidly to new regulations, or allocate greater resources to the development and promotion of their products than we can.

some of these competitors may make acquisitions or establish collaborative relationships among themselves to increase their ability to

rapidly gain market share.

Large pharmaceutical companies may eventually enter the market.

the rapid changes affecting the global, national, and regional economies in general and cannabis-related medical research and development

in particular, we may not be able to create and maintain a competitive advantage in the marketplace.

Time-to-market is an important factor

in our industry and our success will depend on our ability to develop innovative products that will be accepted by patients as efficient

and helpful to use.

Given the rapid changes affecting the global, national, and regional economies in general and cannabis-related

medical research and development in particular, we may not be able to create and maintain a competitive advantage in the marketplace.

Time-to-market is an important factor in our industry, and our success will depend on our ability to develop innovative products that

will be accepted by patients as efficient and helpful to use.

success will also depend on our ability to respond quickly to, among other things, changes in the economy, market conditions, and competitive

Any failure to anticipate or respond adequately to such changes could have a material effect on our financial condition, operating

Any failure to adequately anticipate or respond to such changes could have a material effect on our financial condition, operating

results, liquidity, cash flow and our operational performance.

distinguishes us in the marketplace is our clinical trials approach (double-blinded, placebo-controlled trials) that have demonstrated

the clinical efficacy of our topical products.

filed Provisional Patent (CBD Formulations and Uses Thereof:

62/884,995) on a combination of CBD and Aspartame on August 8, 2019.

The patent is to cover any products that contain a combination of CBD and Aspartame.

This initially will cover the products under the

CaniDermRX Brand.

The provisional patent application was converted into a full US patent application (No.:

16/987,941) and PCT application

(PCT/US2020/045408I) on August 9, 2020.

If issued, the patent will give patent protection until 2040.

filed Provisional Patent (CBD Sunscreen Formulations and Uses Thereof:

63/005,854) on our CBD-infused sunscreen products on August

The patent is to cover any products under our CaniSun product line that contains CBD.

The priority date starts at the time the

provisional is converted into a full patent application, which will occur on April 6, 2021.

If issued, the patent will give patent protection

filed Provisional Patent (Oroanasal CBD formulations and uses thereof (No.:

63/042,458) on June 22, 2020.

This covers the use of CBD

products for the treatment of respiratory viruses.

sets us apart in the marketplace is our clinical trials approach (double-blinded, placebo-controlled trials) that have demonstrated the

clinical efficacy of our topical products.

our intellectual property is a critical component of our business, and we take necessary measures to protect it.

We rely on a blend of

patent, trademark, copyright, and trade secret laws, as well as contractual obligations like confidentiality agreements, licenses, and

intellectual property assignment agreements to establish and defend our exclusive rights.

To control access to our proprietary information,

we enforce a policy that mandates our staff, contractors, consultants, and other third parties to sign confidentiality and proprietary

rights agreements.

Although these laws, procedures, and limitations offer some level of protection, they may not entirely shield our

intellectual property rights from being challenged, invalidated, infringed upon, or misused.

There is also no assurance that we will

succeed in any patent infringement claims made against third parties.

In addition, the laws of certain countries may not grant the same

level of protection to proprietary rights as the laws of the United States, which could limit our ability to safeguard our proprietary

technology in some jurisdictions.

are committed to producing exceptional therapeutic products for our customers, and our employees play a crucial role in realizing this

To keep advancing innovative products and remain competitive in our fast-paced and fiercely competitive market, it is essential

that we attract and retain talented and skilled employees.

To achieve this goal, we endeavor to provide a compensation and benefits package

that is competitive, cultivate a culture of inclusivity where everyone feels supported and empowered to excel, and create opportunities

for our staff to contribute to their communities and make a positive social impact..

of December 31, 2022, we had ten full-time employees, including Chief Executive Officer Brian S.

John, Chairman and Chief Scientific

Glynn Wilson, and Chief Financial Officer, Douglas McKinnon.

we do not own any real property.

We rent office space at 1061 E.

Indiantown Rd., Ste.

110, Jupiter, FL 33477 for $15,038 per month.

Company entered into the office lease effective July 1, 2021, which has a primary term of the lease of five years with one renewal option

for an additional three years.

aim to provide our stakeholders with transparent and timely information on our company’s performance.

As such, we offer free access

to our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any changes made to those reports

filed or furnished under Sections 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (the “Exchange Act”), as

amended, through our website.

We make these reports available as soon as reasonably feasible after submitting them electronically to

SEC maintains an internet site (www.sec.gov) that contains reports, proxy and information statements, and other information regarding

issuers that file electronically with the SEC.

and Development

research and development programs are generally pursued by engineers and scientists employed by us in on a full-time basis or hired as

per diem consultants or through partnerships with industry leaders in manufacturing and design and researchers and academia.

working with subcontractors in developing specific components of our technologies.

primary objective of our research and development program is to advance the development of our existing and proposed products, to enhance

1 unchanged sentence

Company incurred research and development expenses of $1,637,117 and $1,079,362 for the years ended December 31, 2022 and 2021, respectively.

July 12, 2021, we entered into a clinical trial research agreement (the “Clinical Trial Research Agreement”) with AB.

the Clinical Research Agreement, AB will design, manage and conduct a head-to-head study of JW-101 compared to EUCRISA (crisaborole ointment

2%) for the treatment of Eczema (the “Study”).

The Company will sponsor the Study and under the projected budget laid out

in the Clinical Trial Research Agreement will pay AB $1,088,010.00 for its research activities.

July 12, 2021, we entered into a clinical trial research agreement (the “Clinical Trial Research Agreement”) with Applied

Biology, Inc.

Under the Clinical Research Agreement, AB will design, manage and conduct a head-to-head study of JW-101

compared to EUCRISA (crisaborole ointment 2%) for the treatment of Eczema (the “Study”).

An interim analysis is expected.

previously reported in a Current Report on Form 8-K filed with the SEC on December 14, 2021, the Company, entered into a stock purchase

agreement (the “Original Purchase Agreement”), which was later amended and restated (the “Purchase Agreement”),

and reported in a Current Report on Form 8-K filed with the SEC on January 13, 2022 (the “January 13 th Disclosure”),

with Next Frontier Pharmaceuticals, Inc.

and reported in a Current Report on Form 8-K filed with the SEC on January 13, 2022 (the “January 13th Disclosure”), with

Next Frontier Pharmaceuticals, Inc.

(“Next Frontier Pharmaceuticals”), a Delaware corporation, and certain of its affiliates

4 unchanged sentences

pursuant to which Next Frontier Pharmaceuticals terminated the Purchase Agreement (the “Termination Date”).

In light of the

Considering the

aforementioned termination, the Company did not effectuate the Transactions, including the distribution of shares of SRM to the Company’s

2 unchanged sentences

Company to the Next Frontier Parties under those certain Secured Promissory Note, dated December 8, 2021 (the “December 2021 Note”),

and Secured Promissory Note, dated January 7, 2022 (the “January 2022 Note”), is owed and outstanding.

The December 2021

Note has a maturity date of June 8, 2022, and the January 2022 Note has a maturity date of July 7, 2022, or otherwise when due.

June 4, 2021, the Company filed a registration statement on Form S-1 (File No.

333- 258005) which was declared effective on June 21,

2021, for the sale or other disposition from time to time by the selling shareholders identified in the prospectus of up to 1,050,002

shares of Common Stock consisting of up to 525,001 Common Stock, at a $4.54 share price, which may be issued upon the conversion of convertible

promissory notes issued in May 2021, and up to 525,001 Common Stock, at a $6.00 share price, which may be issued upon the exercise of

outstanding warrants.

to a registration statement on Form S-1 (File No.

333- 258005) which was declared effective on June 21, 2021 (the “June Registration

Statement”) the Company undertook a firm commitment offering (the “Offering”) of shares of our common stock (“Common

Stock”), par value $0.001 per share.

With a combined public offering price of each share of Common Stock and Company Warrant (as

defined below) of $2.80, a total of 11,066,258 shares (the “Company Offering Shares”) and 11,607,142 warrants (the “Company

Warrants”) to purchase 11,607,142 shares were registered.

In addition a total of 540,884 shares were offered by the Company selling

As part of the compensation, the Company also issued 442,650 warrants to Aegis Capital Corp.

to purchase 442,650 shares.

January 20, 2022 the Company received a letter from Nasdaq stating that, because the Company made the Share Grants not pursuant to the

2021 Equity Plan despite them considered to be S-8 eligible, Nasdaq had determined that the Company did not comply with Listing Rule

It was brought to our attention that 180,000 shares of common stock, out of the total 1,020,000 shares of common stock to consultants

(the “Consulting Share Awards”) that were issued to three consultants, Greentree Financial (100,000 shares), Inc., L&H

(20,000 shares), and Tee 2 Green Enterprises, Ltd.

(60,000 shares), during the relevant period (the “Share Grants”),

should have been issued pursuant to the 2021 Equity Plan because the Share Grants were considered to be S-8 eligible.

As a result, the

inadvertent issuance of the Share Grants to the mentioned-above three consultants was not made in compliance with Listing Rule 5635(c).

The Company subsequently notified Nasdaq that the Board has approved the reallocation of the Share Grants to be accounted for as if they

were originally issued under the 2021 Equity Plan, and has made the corresponding change to the Company’s books and records.

since the 2021 Equity Plan has previously been exercised in full, to allow for the reallocation of the Share Grants under the 2021 Equity

Plan, on January 17, 2022, the Board determined that 100,000 options that have previously been issued under the 2021 Equity Plan to Brian

John, and 100,000 options issued to Dr.

Glynn Wilson be cancelled, a revocation to which Messrs.

John and Wilson have agreed.

the remedial measures, on January 20, 2022 , the Company was informed that the Company has regained compliance with the Rule and

that this matter is now closed.

and Secured Promissory Note, dated January 7, 2022 (the “January 2022 Note,” collectively with the December 2021 Note as

the “NFP Notes”), is owed and outstanding.

The December 2021 Note has a maturity date of June 8, 2022, and the January 2022

Note has a maturity date of July 7, 2022, or otherwise when due.

In March 2022, the Company issued a Notice of Default on the NFP Notes.

As a result, the Company has determined that the NFP Notes have been impaired and has taken an impairment charge of $10,000,000 against

the 2021 earnings and $1,000,000 against the 2022 earnings.

1937, Cannabis sativa L.

12 unchanged sentences

registered with the DEA.

believe the recent passage of the Farm Bill will allow us to expand our marketplace opportunities.

On December 20, 2018, President Donald

believe the passage of the Farm Bill will allow us to expand our marketplace opportunities.

On December 20, 2018, President Donald J.

Trump signed into law the Agriculture Improvement Act of 2018, otherwise known as the “Farm Bill”.

29 unchanged sentences

The Farm Bill details possible punishments for such violations, pathways for violators

to become compliant, and even which activities qualify as felonies under the law, such as repeated offenses.

to become compliant, and even which activities qualify as felonies under the law, such as repeat offenses.

of the goals of the Agricultural Act of 2014 was to generate and protect research into hemp.

5 unchanged sentences

is still a lot to learn about hemp and its products from commercial and market perspectives.

we believe that our sunscreen products comply with the FDA Final Rule for sunscreen products under 21 CFR 352 Sunscreen products for

Over-the-Counter Human Use.

Therefore, we believe that our sunscreen products fall within the FDA monograph and that FDA premarket approval

and testing is not required.

Our products have been tested for SPF Evaluation (SPF rating), Critical Wave Length (Broad Spectrum claim)

and Water Resistance, each of which is defined within the monograph and labeled accordingly.

products are tested each time they are manufactured.

DCR Labs manufactures our products and is compliant with the FDA’s Current

Good Manufacturing Practice (“CGMP”) regulations in accordance with 21 CFR 210/211 (required for Over-the-Counter drug products).

DCR Labs has self-imposed health and safety standards to ensure compliance with the FDA’s CGMPs.

All contracted labs used by the Company to manufacture our products are compliant

with the FDA’s Current Good Manufacturing Practice (“CGMP”) regulations in accordance with 21 CFR 210/211 (required

for Over-the-Counter drug products).

Each of the Company’s contracted Labs has self-imposed health and safety standards to ensure

compliance with the FDA’s CGMPs.

Regulation of Hemp Extracts

21 unchanged sentences

FDA has not approved cannabis, marijuana, hemp or derivatives as a safe and effective drug for any indication.

We intend to file an IND

with the FDA for our CaniDermRX products in the event the pending provisional patent on an Aspartame/CBD combination is approved.

We may in the future file

an IND with the FDA for our JW-100 product in the event the pending provisional patent on an Aspartame/CBD combination is approved.

of the date hereof, our products containing CBD derived from industrial hemp are not marketed or sold using claims that their use is

11 unchanged sentences

In this event, our industrial hemp based products containing CBD may be subject to regulation.

products contain controlled substances as defined in the Controlled Substances Act (CSA).

of our products contain controlled substances as defined in the Controlled Substances Act (CSA).

Controlled substances that are pharmaceutical

6 unchanged sentences

June 25th, 2018 the US Federal Drug Administration (FDA) approved Epidiolex.

Epidiolex is the first and only FDA-approved

prescription cannabidiol (CBD).

It is approved to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous

sclerosis complex (TSC) in patients 1 year of age and older.

Accordingly, the FDA has designated CBD as a drug and the need for all marketed

products to follow FDA guidelines for safety and efficacy.

It is not yet clear how this will affect thousands of CBD products already

on the market given the multitude of state and local regulations that cover this field.

of December 31, 2021, we had twelve full-time employees , including Chief Executive Officer Brian S.

John, Chairman and Chief Science

Glynn Wilson, Chief Financial Officer, Douglas McKinnon, Chief Operating Officer, Ryan Allison and Chief Compliance Officer,

Richard Miller.

We believe our relations with our employees to be good.

we do not own any real property.

We rent an office space at 1061 E.

Indiantown Rd., Ste.

110, Jupiter, FL 33477 for $15,038 per month.

The Company entered into the office lease effective July 1, 2021, which has a primary term of the lease of five years with one renewal

option for an additional three years..

Epidiolex is the first and only FDA-approved prescription

cannabidiol (CBD).

It is approved to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis

complex (TSC) in patients 1 year of age and older.

Accordingly, the FDA has designated CBD as a drug and the need for all marketed products

to follow FDA guidelines for safety and efficacy.

It is not yet clear how this will affect thousands of CBD products already on the market

given the multitude of state and local regulations that cover this field.

Recent Development

June 4, 2021, the Company filed a registration statement on Form S-1 (File No.

333- 258005) which was declared effective on June 21,

2021, for the sale or other disposition from time to time by the selling shareholders identified in the prospectus of up to 1,050,002

shares of Common Stock consisting of up to 525,001 Common Stock, at a $4.54 share price, which may be issued upon the conversion of convertible

promissory notes issued in May 2021, and up to 525,001 Common Stock, at a $6.00 share price, which may be issued upon the exercise of

outstanding warrants.

to a registration statement on Form S-1 (File No.

333- 258005) which was declared effective on June 21, 2021 (the “June Registration

Statement”) the Company undertook a firm commitment offering (the “Offering”) of shares of our common stock (“Common

Stock”), par value $0.001 per share.

With a combined public offering price of each share of Common Stock and Company Warrant (as

defined below) of $2.80, a total of 11,066,258 shares (the “Company Offering Shares”) and 11,607,142 warrants (the “Company

Warrants”) to purchase 11,607,142 shares were registered.

In addition a total of 540,884 shares were offered by the Company selling

As part of the compensation, the Company also issued 442,650 warrants to Aegis Capital Corp.

to purchase 442,650 shares.

January 20, 2022 the Company received a letter from Nasdaq stating that, because the Company made the Share Grants not pursuant to the

2021 Equity Plan despite them considered to be S-8 eligible, Nasdaq had determined that the Company did not comply with Listing Rule

It was brought to our attention that 180,000 shares of common stock, out of the total 1,020,000 shares of common stock to consultants

(the “Consulting Share Awards”) that were issued to three consultants, Greentree Financial (100,000 shares), Inc., L&H

(20,000 shares), and Tee 2 Green Enterprises, Ltd.

(60,000 shares), during the relevant period (the “Share Grants”),

should have been issued pursuant to the 2021 Equity Plan because the Share Grants were considered to be S-8 eligible.

As a result, the

inadvertent issuance of the Share Grants to the mentioned-above three consultants was not made in compliance with Listing Rule 5635(c).

The Company subsequently notified Nasdaq that the Board has approved the reallocation of the Share Grants to be accounted for as if they

were originally issued under the 2021 Equity Plan, and has made the corresponding change to the Company’s books and records.

since the 2021 Equity Plan has previously been exercised in full, to allow for the reallocation of the Share Grants under the 2021 Equity

Plan, on January 17, 2022, the Board determined that 100,000 options that have previously been issued under the 2021 Equity Plan to Brian

John, and 100,000 options issued to Dr.

Glynn Wilson be cancelled, a revocation to which Messrs.

John and Wilson have agreed.

the remedial measures, on January 20, 2022 , the Company was informed that the Company has regained compliance with the Rule and that

this matter is now closed.

January 19, 2023, the Company entered into a Securities Purchase Agreement (the “PIPE Agreement”) with certain purchasers,

for the issuance of 8,631,574 common stock warrants (the “PIPE Offering”) at a price of $0.125 per warrant, comprised of

two common stock warrants (the “Common Warrants,”), each to purchase up to one share of Common Stock per Common Warrant with

an exercise price of $1.00 per share , with (a) 4,315,787 Common Warrants being immediately exercisable for three years following 6 months

from the closing of the PIPE Offering, and (b) 4,315,787 Common Warrants being immediately exercisable for five years following 6 months

from the closing of the PIPE Offering.

Concurrently to the PIPE Agreement, the Company entered into ot a Securities Purchase Agreement

(the “RD Agreement”) with certain purchasers, pursuant to which on January 23, 2023, 4,315,787 shares of common stock, par

value $0.001 (the “Common Stock”), at a price of $0.70 per share were issued to the purchasers (the “RD Offering”).

The Common Stock was issued pursuant to a Registration Statement on Form S-3 filed by the Company with the Securities and Exchange Commission

(the “Commission”) on September 28, 2022 (File No.

333-267644) and declared effective on November 9, 2022.

The aggregate

gross proceeds to the Company from both the PIPE Offering and the RD Offering were approximately $4.1 million, with the purchase price

of one share, one 3-year warrant and one 5-year warrant as $0.95.

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