Impact Naturals Group, Inc. is a life science company focused on the development of innovative formulation technologies that increase bioavailability (i.e., absorption and effective utilization in the human body) of health-oriented substances and compounds, including dietary supplements and hemp-based CBD products.
Our plan is to maximize the value and opportunity of our technology across two models:
- (1) Product creation for direct-to-consumer sale under the Impact NaturalsTM brand
- (2) Co-creation of products with selected partners for licensing/enhanced reach and retail opportunity.
In addition, when practicable, we intend to expand our plan to add the development of prescription products for medical use in the future.
Our strategy is to bring science-based formulation technologies to the burgeoning domestic CBD markets, creating products that achieve better results through higher bioavailability and consistency. Our target market applications are health and wellness in addition to CBD therapeutics.
Our consumer products are marketed and sold direct-to-consumers through our eCommerce site. Our manufacturing partner, Highland Laboratories’ state-of-the-art facility follows all guidelines for Natural Products Good Manufacturing Practices (“GMP”), UL Certified, USDA Organic and our hemp extracts are processed, produced, and tested throughout the manufacturing process to confirm that the cannabinoid content meets strict company standards.
Impact Naturals has created a capital efficient business model that is built for growth, profitability and operating leverage resulting in significant EBITDA growth as sales increase.
We manufacture and distribute CBD capsule products, REVIVE, RESTORE and REST, and under the Impact Naturals brand, and expect to continue to add new products including topicals to our portfolio to enhance our line of CBD and plant-based dietary supplements. We also expect to develop and launch new product lines and brands to more effectively market and sell specific products.
Our products are developed using CHYLOSOMA technology which enables up to 500% improved CBD absorption over six hours and a quicker onset between 15-30 minutes. This translates into a more effective and satisfying user experience with a better value story than the current tinctures and gel-caps.
REVIVE, RESTORE and REST. Our capsule line is vegan, gluten free and lab-tested to ensure consistency and reliability.
We will leverage CHYLOSOMA technology to increase bioavailability even more so than our Gen1 products. In addition, we will enhance our Gen2 products with higher levels of minor cannabinoids to target other functional areas of need (e.g., depression and gastrointestinal inflammation).
Our Gen2 products are being developed with second generation CHYLOSOMA technology which allows our products to deliver up to 3x improved absorption relative to Gen1 CHYLOSOMA technology.9
Planned launch: 1H 2022.
Our buccal product is a flavored, muco-adhesive controlled release tablet that disintegrates in the lower cheek (~10-20 minutes) area. This product is formulated to take advantage of rapid absorption through mouth mucosa, providing quick onset, and can be targeted to consumers that do not want to swallow capsules or pills, or prefer a novel delivery method. The product is developed using CHYLOSOMA technology which allows our products to deliver up to 500% improved CBD absorption over six hours and a quick onset between 15-30 minutes.
Planned launch: 1H 2022.
Generation 1 Topical:
We are planning 2 topical formulations: muscle recovery gel and joint pain cream.
- The muscle recovery gel is formulated with a unique blend of medicinal terpenes and essential oils proven effective in pain reduction including menthol, peppermint, clove, and wintergreen to aid in recovery from various activities. Our target consumers are oral hesitant individuals and individuals that want to enhance their existing oral CBD treatment.
- The joint cream is formulated with essential oils, terpenes selected to impart an invigorating, energetic effect as well as lidocaine to aid in recovery. Our target consumers are oral hesitant individuals and individuals that want to enhance their existing oral CBD treatment.
Our “programmed release” capsules are designed for multi-stage release of various active products combined with CHYLOSOMA technology. The benefit to these capsules is that new ingredients, such as adaptogens, can be included and the therapeutic window can be increased on both sides for fast onset and longer effect – extending the efficacy and combined instant release with delayed release, and increasing the bioavailability of each component by giving each ingredient optimized delivery technology.
Planned Launch: 2H 2022
Our planned “Pharma-Ready” Oral is a high absorption liquid gel formulation technology developed through screening multiple solvents excipients to increase bioavailability. Animal studies are planned to support this new high absorption technology. Our initial application will be in capsule format.
Planned Launch: 2H 2022
Annual spending on CBD in the U.S. is expected in 2020 to reach an estimated $14.9 billion10, growing at a compounded annual growth rate of 12.2%. Per capita spending amongst consumers is estimated at $318.88.
Growth in CBD is being driven by eCommerce resulting in more brands are shifting to compete for consumers online. Brands with the highest consumer loyalty have the highest site traffic, and key marketing initiatives include online advertising, targeted email campaigns and subscription models.
Almost half (45%) of CBD consumers spend less than $50 per month while almost one-quarter (23%) have not purchased it at all.
Consumers’ reasons for using CBD varies. New Frontier Data reports four key demographic cohorts driving consumption:
- Medical (9%) – likeliest to use CBD daily, and enthusiastically engage in conversations about it.
- Pain Management (41%) – ranks as the oldest (51% being over age 55) and among the likeliest to share recommendations about CBD;
- Unwinding (33%) – tends to vary most widely in both respective motivations and applications in consuming CBD; and
- General Wellness (18%) – least likely to know, discuss or maintain positive impressions about CBD.
Consumers are increasingly turning to wellness-focused products to improve their health or protect their bodies. A key micro-trend in this wellness space is towards state-centric products. Consumers are increasingly seeking out products that offer solutions to specific needs such as relaxation (unwinding) and immunity (medical / general wellness).
Other Key Market Trends and Developments:
- Consolidation and Partnerships – The US CBD category is attracting Canadian licensed producers. Aurora acquired Reliva in mid-2020 to gain access to the market. High Tide Company acquired FabCBD and Valens acquired Green Roads in May 2021. Canopy Growth is collaborating with Martha Stewart on tinctures, gummies, softgels and pet CBD. HEXO and Molson Coors are collaborating to launch Truss CBD in the U.S. U.S. multi-state operator, Acreage Holdings and MedTerra are collaborating to bring MedTerra’s full-spectrum CBD collection to Acreage’s “The Botanist” brand.
- Innovation – More brands are incorporating minor cannabinoids (CBN and CBG) into their portfolio formulations. And functional ingredients are increasingly being added to CBD products, mainly to account for health claims and to capture wider appeal.
Plant-Based Wellness and Medicine – Plant-based wellness and medicine treatments are treating becoming increasingly popular.
Our Advantage: CHYLOSOMA technology
The challenge of formulating CBD (Cannabidiol) and other rare cannabinoids like CBG (Cannabigerol) and CBN (Cannabinol) for human benefit is making them bioavailable to the human body. Without a critical level of concentration in the blood it is debatable whether any cannabinoid can impact the endocannabinoid system enough for most people to really ‘feel’ a difference.
This was the starting point for our cannabinoid formulation research. As medical professionals and scientists, we believe consistency and reproducibility are key to creating a reliable and trustworthy wellness product. We have developed what we believe is the best approach on the market, validated by multiple studies measuring CBD concentration and speed of onset.
Most CBD products are diminished considerably when ingested––the liver can remove 80% or more of the CBD that passes through the GI tract during the first pass effect. To add further complication, all products that use plant-derived cannabinoids (as opposed to lab- created synthetics) have to contend with the fact that hemp plants are by nature variable, producing differing amounts of CBD per harvest (this is akin to how grapes and wine work––the grapes may come from the same plants year over year, but the alcohol levels and flavors of the wine can vary with each harvest).
Our unique formulation not only contains lab-verified levels of CBD and other minor cannabinoids in each precisely dosed serving, but it is designed to work with our bodies’ natural physiology to deliver significantly more CBD to all the places it can have a beneficial impact. Since we utilize molecular structures called chylomicrons in this delivery system, we called it CHYLOSOMA.
Our capsules rely on long-chain triglycerides to carry the CBD, CBG, and CBN molecules through the GI tract, where they are broken down into their essential components. When absorbed into the lining of the small intestine, these components then quickly reassembled into molecules called chylomicrons, which then pass into the intestinal lymph channels that transport the chylomicrons to the bloodstream. . This lipid transport system carries fats and fat soluble vitamins and nutrients directly to the blood, initially bypassing the liver, allowing our cannabinoids to be delivered faster and in larger quantities to the whole body and brain.
In fact, CHYLOSOMA enables our formulas to be 500% more bioavailable than CBD in medium chain triglycerides,
meaning the body can get a larger benefit from a smaller dose.
Our Strategy: Strategic Partnerships
Catalent Pharma Inc.
We are working with Catalent Pharma (NYSE:CTLT) in development of our formulations, including our flagship line of capsules being released in the second half of 2021. Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics, and consumer health products. It has built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development to patient.
With over 85 years of experience in the industry, Catalent supports its partners in introducing 200 new products and manufacturing over 70 billion doses each year. It has a vibrant community of approximately 15,000 employees, including around 2,400 scientists and technicians, supporting over 7,000 products for over 1,000 customers all around the world.
In addition to supporting our near-term domestic commercialization strategy, Catalent has facilities in Europe which will be instrumental in supporting our longer-term expansion plans.
We intend enter into negotiations with Lexaria Bioscience Corp. to secure a worldwide license of DehydraTECH, which has been demonstrated to improve the way active pharmaceutical ingredients (APIs) enter the bloodstream, promoting healthier oral ingestion methods and increasing the effectiveness, including bioavailability, of fat-soluble active molecules which results in lower dosing requirements.
DehydraTECH can be applied to several ingestible product formats:
- Foods and beverages;
- Oral suspensions; and
- Tablets and capsules.
Lexaria holds multiple licenses of DehydraTECH, which will be transferred to Impact Naturals Group under our agreement. DehydraTECH will be rebranded as CHYLOSOMA.
In the case that we are not able to acquire the worldwide license on an exclusive basis, we intend to acquire a non- exclusive license for the technology.
DehydraTECH has demonstrated the ability to increase bio-absorption of cannabinoids up to 5-10x, while reducing the time of onset from 1-2 hours to minutes.
Recent Developments Relating to CBD Application of DehydraTECH
In May, Lexaria announced significant gains in CBD absorption relative to controls using Lexaria’s latest DehydraTECH 2.0 formulations. According to test results, it recorded 2,708% more CBD into bloodstream during the study period than the representative MCT control formation, and it was 174% more effective than its previous, original DehydraTECH 2.0 formulation from 2019.
Vassili Kotlov (CEO)
Joe Fanelli (COO)
Sarah Kotlova (CMO)
Ramon Seva (CFO)
Dr. James Lowder (Chief Medical Officer)
Martin Betoni (Chief Growth Officer)
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Qualification StatementImpact Naturals Qualification Statement
Impact Naturals is a development stage business with no material historical operating expenses, and no revenues. The Company is committed to best practices in transparency and will make unaudited quarterly as well as audited annual financial statements available to its investors, when available, on request.
Below is a pro forma forecast based on management’s reasonable estimates of the Company’s future financial performance, assuming, amongst other things, that it will be successful in raising the maximum offering amount contemplated by this offering memorandum (for more information, see Risk Factors – Risks Related to this Offering).
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