−Removed: We were incorporated under the laws of the
−Removed: State of Nevada on June 29, 2007 as Legend Mining Inc.
−Removed: We commenced operations by issuing shares and acquiring a mineral property
−Removed: located in the Province of Saskatchewan, Canada.
−Removed: We were unable to keep the mineral claim in good standing due to lack of funding
−Removed: and our interest in the property expired.
−Removed: In September 2011, we entered into a lease for laboratory and office space in Yuba City,
−Removed: California, and since that time we have worked towards establishing our new business as an agricultural biotechnology company engaged
−Removed: in the cultivation and harvest of stevia leaf and the development of stevia products.
−Removed: On October 10, 2011, we completed a merger
−Removed: with our wholly-owned subsidiary, Stevia First Corp., whereby we changed our name from “Legend Mining Inc.”
−Removed: to “Stevia
−Removed: First Corp.”
−Removed: Also on October 10, 2011, we affected a seven (7) for one (1) forward stock split of authorized, issued and
−Removed: outstanding common stock.
−Removed: As a result, our authorized capital was increased from 75,000,000 shares of common stock with a par value
−Removed: of $0.001 to 525,000,000 shares of common stock with a par value of $0.001, and issued and outstanding shares increased from 7,350,000
−Removed: to 51,450,000.
−Removed: Our Current Business
−Removed: In February 2012, we commenced operations
−Removed: as an agricultural biotechnology company engaged in the cultivation and harvest of stevia leaf and the development of stevia products.
−Removed: Our intent is to establish a vertically-integrated enterprise that controls the process of stevia production through fermentation-based
−Removed: methods or traditional stevia leaf production, and which develops, markets, and sells stevia products.
−Removed: We hope to capitalize on
−Removed: the California Central Valley region’s agricultural infrastructure to become California’s major producer of stevia.
−Removed: We are focused on the production of stevia extract through use of fermentation technologies, the production of stevia extract in
−Removed: California through traditional farming and leaf extraction, the development of consumer stevia products such as a tabletop sweetener
−Removed: product, and more broadly at building a vertically-integrated stevia enterprise in the United States.
−Removed: We expect to develop operations in California
−Removed: that will include research and development related to stevia production through fermentation-based methods, stevia production through
−Removed: stevia farming, and stevia product formulation.
−Removed: Our business goals include:
−Removed: Developing stevia production methods using fermentation-based methods;
−Removed: Expanding the existing high-grade stevia supply chain with quality control and California stevia;
−Removed: Achieving and maintaining low cost production of stevia through process innovation and vertical integration (from seed and seedling development through to leaf processing and stevia extraction);
−Removed: Developing and cultivating stevia varieties with higher leaf yield and more content of better-tasting steviol glycosides, and developing high-quality stevia seeds;
−Removed: Developing the capacity needed to meet forecast customer demand.
−Removed: In furtherance of these business goals,
−Removed: we expect to focus on the following activities during calendar years 2012 and 2013:
−Removed: Increased staffing of our research and development facilities;
−Removed: Completion of stevia field trials in California;
−Removed: Completion of laboratory trials of stevia processing technologies, including those related to fermentation-based stevia production;
−Removed: Developing a branding and marketing campaign for our stevia products geared towards both industry and consumers;
−Removed: Pursuing state and/or federal funding, or additional research and development collaborations, in order to further develop the stevia industry in California.
−Removed: Our present operations consist of research
−Removed: and development related to stevia extract production, both through fermentation-based and traditional farm-based means, and separately
−Removed: the development of stevia consumer products.
−Removed: Our present operations as an agricultural
−Removed: biotechnology company are aimed towards using fermentation or biotechnological approaches for stevia extract production, involving
−Removed: primarily the development and procurement of yeast and other microbial strains that may be useful for this purpose, characterization
−Removed: and validation of the growth and production characteristics of these strains, and planning for eventual processing scale-up, production,
−Removed: and extraction of steviol glycosides, the sweet constituents found in nature within the stevia leaf.
−Removed: We are currently working on
−Removed: developing microbial strains that produce steviol, steviol glycosides, or other molecules that could be economically-important
−Removed: and relevant to stevia extract production.
−Removed: We expect to have results from process optimization studies related to this development
−Removed: in the first half of 2013.
−Removed: In conjunction with this business goal, we are actively pursuing internal development and management
−Removed: of intellectual property related to the production of stevia using fermentation-based or biotechnological methods.
−Removed: expect that further development, regulatory approval, and first revenues on sales of such products will occur in 2014.
−Removed: We have exclusive and worldwide rights to
−Removed: patents obtained through a license of these patents from Vineland Research and Innovations Centre (the “Vineland License”).
−Removed: The patent family includes an issued U.S.
−Removed: patent, an issued European Union patent, and an issued Canadian patent.
−Removed: These patents
−Removed: relate to microbial production of steviol and steviol glycosides.
−Removed: The Vineland License has an initial term of 10 years and may
−Removed: be renewed by us for additional two-year terms until all licensed patents have expired.
−Removed: Pursuant to the Vineland License, we agreed
−Removed: to total cash fees due and payable within the first year of $50,000, of which $25,000 were paid at signing.
−Removed: In addition to these
−Removed: cash fees, we will owe royalties of 0.5% of the sale price of products developed using the intellectual property, and in the third
−Removed: year and all subsequent years of the Vineland License the Company will owe a minimum annual royalty of $10,000.
−Removed: Prior to the launch of stevia extract produced
−Removed: using fermentation processes, we need to achieve certain operational milestones, including but not limited to process development
−Removed: and optimization, processing methods scale-up for commercial production, regulatory approvals for processing facilities, and regulatory
−Removed: approvals of final products.
−Removed: We currently estimate that completion of these milestones will not occur until 2014 and that completion
−Removed: of necessary milestones for initial commercialization of stevia extract products produced using fermentation processes would require
−Removed: approximately $1,000,000 of additional investment that would need to be obtained through additional funding by our existing stockholders
−Removed: and other qualified investors.
−Removed: We are also pursuing the production of California
−Removed: stevia extract produced using traditional industry means involving stevia crop production and leaf extraction.
−Removed: In order for commercialization
−Removed: of these products, we need to achieve additional milestones including stevia field trial production output, development and scale-up
−Removed: of leaf extraction methods, and any necessary regulatory approvals for processing facilities or products.
−Removed: We currently estimate
−Removed: that completion of these milestones will not occur until at least 2014 and that completion of necessary milestones for initial
−Removed: commercialization of California stevia extract will require approximately $500,000 of additional investment that would need to
−Removed: be obtained through additional funding by our existing stockholders and other qualified investors.
−Removed: Our field operations include the management
−Removed: of stevia plantings, currently at field sites, propagation houses, or greenhouses.
−Removed: This work directly supports our stevia field
−Removed: trials in California, which are designed to provide data about potential crop yields and growing economics that are relevant to
−Removed: California’s Central Valley and our local growers.
−Removed: We expect to obtain interim data from field trials in the first half of
−Removed: 2013, and we expect more extensive data to be available beginning in the second half of 2013.
−Removed: However, these field trials are ongoing,
−Removed: and could result in other improvements, such as better stevia plant varieties or improved cultivation practices.
−Removed: While we could
−Removed: produce California stevia leaf in 2013 that is of significant quantity to justify commercial sales and revenue generation, selling
−Removed: stevia leaf to overseas stevia extract producers may not be economically viable in the long-term, and so our California leaf supply
−Removed: will instead be used to support research and development operations.
−Removed: Specifically, our field operations provide a ready supply
−Removed: of stevia leaf that can be used for development and scale-up of steviol glycoside extraction and processing methods.
−Removed: We have initiated operations related to
−Removed: the development and launch of a stevia tabletop sweetener.
−Removed: This product is intended to be sold directly to consumers or through
−Removed: retail stores.
−Removed: Until we produce our own California stevia extract in sufficient quantities and obtain regulatory approval for this
−Removed: product, we will purchase and use stevia extracts that are commercially-available from other suppliers for use within our own branded
−Removed: tabletop sweetener products, and a similar strategy will be used with any other stevia products that we develop and launch in the
−Removed: We expect to initiate product testing and obtain product testing results in the first half of 2013, and depending on
−Removed: these results, may launch the tabletop sweetener product later in 2013.
−Removed: Assuming favorable product testing results, we expect to
−Removed: generate revenues in the second half of 2013 from the release of a tabletop sweetener product.
−Removed: As noted above, this product would
−Removed: not include our own stevia extract produced by fermentation or more conventional industry means.
−Removed: We expect additional expenses
−Removed: related to this development work to be approximately $30,000, costs for initial manufacturing runs and distribution of the product
−Removed: to be approximately $20,000, and that each of these activities would be funded internally.
−Removed: We expect our total expenditures over the
−Removed: next 12 months to be approximately $1,000,000.
−Removed: After giving effect to the funds raised in the January Private Placement
−Removed: and the funds received from the investor under the February Subscription Agreement, as of the date of this annual report we expect
−Removed: to have sufficient funds to operate our business over the next 12 months.
−Removed: However, our estimate of total expenditures could increase
−Removed: if we encounter unanticipated difficulties.
−Removed: In addition, our estimates of the amount of cash necessary to fund our business may
−Removed: prove to be wrong, and we could spend our available financial resources much faster than we currently expect.
−Removed: If we cannot raise
−Removed: the money that we need in order to continue to develop our business, we will be forced to delay, scale back or eliminate some or
−Removed: all of our proposed operations.
−Removed: If any of these were to occur, there is a substantial risk that our business would fail.
−Removed: to continue to seek funding from our stockholders and other qualified investors in order to pursue our business plan.
−Removed: have any arrangements in place for any future financing.
−Removed: Sources of additional funds may not be available on acceptable terms or
−Removed: January Subscription Agreement
−Removed: On January 31, 2012, we issued a $250,000
−Removed: convertible debenture to a single investor in the January Private Placement.
−Removed: The debenture bears interest at the rate of 6.0% per
−Removed: annum, payable semi-annually in arrears on June 30 and December 31 of each year beginning on June 30, 2012.
−Removed: The debenture is convertible
−Removed: at the holder’s option into our common stock at an initial conversion price of $0.50 per share.
−Removed: We may elect to make interest
−Removed: payments in common stock valued at the conversion price.
−Removed: The entire principal balance of the debenture is due and payable three
−Removed: years following its issuance unless earlier redeemed by us in accordance with its terms.
−Removed: We may repay the principal and interest
−Removed: owing under the debenture in common stock at maturity or upon redemption of the debenture.
−Removed: The debenture also provides for customary
−Removed: events of default which, if any of them occurs, would permit or require the principal of and accrued interest on the debenture
−Removed: to become or to be declared due and payable.
−Removed: February Subscription Agreement
−Removed: Pursuant to the terms of the February Subscription
−Removed: Agreement, the investor agreed to purchase such shares and such convertible debentures in five tranches, for proceeds to us of
−Removed: $250,000 per tranche, under the following schedule:
−Removed: (i) on March 1, 2012, 125,000 shares of common stock and a $125,000 debenture
−Removed: convertible into shares of our common stock at a conversion price of $0.65;
−Removed: (ii) on June 1, 2012, 125,000 shares of common stock
−Removed: and a $125,000 debenture convertible into shares of our common stock at a conversion price of $0.80;
−Removed: (iii) on September 1, 2012,
−Removed: 125,000 shares of common stock and a $125,000 note convertible into shares of our common stock at a conversion price of $0.95;
−Removed: (iv) on December 1, 2012, 125,000 shares of common stock and a $125,000 note convertible into shares of our common stock at a conversion
−Removed: price of $1.10;
−Removed: and (v) on March 1, 2013, 125,000 shares of common stock and a $125,000 note convertible into shares of our common
−Removed: stock at a conversion price of $1.25.
−Removed: The conversion price of the common stock underlying each of the convertible debentures is
−Removed: subject to adjustment upon a reclassification or other change in our outstanding common stock and certain distributions to all
−Removed: holders of our common stock, and the conversion prices for all tranches may be set to $1.50 in the event that funding does not
−Removed: occur pursuant to the defined schedule.
−Removed: On May 22, 2012, we received an advance payment of $850,000 from the investor under the
−Removed: February Subscription Agreement, which represented all remaining amounts owed by the investor under the February Subscription Agreement.
−Removed: After our receipt of the investor’s advance payment of $850,000, the investor has purchased common stock and convertible
−Removed: debentures under the February Subscription Agreement for total proceeds to us of $1,250,000.
−Removed: Each convertible debenture issued pursuant
−Removed: to the February Subscription Agreement bears interest at the rate of 6.0% per annum, payable semi-annually in arrears on June 30
−Removed: and December 31 of each year, and is convertible at the holder’s option into our common stock at the applicable conversion
−Removed: We may elect to make interest payments in common stock valued at the conversion price.
−Removed: The entire principal balance of each
−Removed: debenture is due and payable three years following its date of issuance unless earlier redeemed by us in accordance with its terms.
−Removed: We may repay the principal and interest owing under each of the debentures in common stock at maturity or upon redemption of the
−Removed: The debenture also provides for customary events of default which, if any of them occurs, would permit or require the
−Removed: principal of and accrued interest on the debenture to become or to be declared due and payable.
−Removed: California’s Central Valley
−Removed: Initially we intend to conduct most of our
−Removed: operations in or around Yuba City, California, which is located in California’s Central Valley.
−Removed: The Central Valley area produces
−Removed: more than $13 billion worth of food products annually and offers an ideal combination of land-base, climate and agro-industrial
−Removed: expertise and infrastructure.
−Removed: Our headquarters are currently located in Yuba City in the heart of the Central Valley.
−Removed: This location
−Removed: should provide ready access to talent from University of California, Davis, one of the leading agricultural research universities
−Removed: in the United States, and the rich talent pool of scientists, agronomists, agricultural innovators and equipment suppliers in the
−Removed: History of Stevia Production and Commercialization
−Removed: Stevia rebaudiana, popularly known as stevia,
−Removed: is a plant from the chrysanthemum family that is native to Paraguay.
−Removed: South American natives have used stevia as a sweetener in
−Removed: its raw, unprocessed form for hundreds of years.
−Removed: They call it “k’aa h’ee,”
−Removed: which means sweet leaf or honey
−Removed: The small green plant’s leaves have a taste that can be 30 times sweeter than sugar.
−Removed: Stevia is commercially produced in temperate
−Removed: regions of the world where it can be grown as a perennial crop.
−Removed: Stevia has been grown commercially in Brazil, Paraguay, Uruguay,
−Removed: parts of Central America, Thailand, China, and, in recent years, the United States.
−Removed: Most commercial stevia production now takes
−Removed: place in China, where growing conditions are favorable and labor costs support what has historically been a labor-intensive activity.
−Removed: According to an Equity Development report on PureCircle in January 2010, China then had some 32,000 hectares of stevia under cultivation,
−Removed: accounting for approximately 80% of global stevia production.
−Removed: According to PureCircle in their 2010 annual report, at mid-2010,
−Removed: total global leaf for the 2010 harvest was estimated at 70,000 to 100,000 tons.
−Removed: This was an increase of some 1,000% to 1,500% since
−Removed: Since the 1970s, stevia has been used widely
−Removed: in Japan and has achieved high market penetration.
−Removed: It was demand from Japan that led to its cultivation in China for commercial
−Removed: Prior to 2008, stevia had been sold in the United States as a supplement, primarily in the natural foods industry.
−Removed: the issuance of the U.S.
−Removed: Food and Drug Administration’s (“FDA”) first no objection letter on December 17, 2008,
−Removed: various Rebaudioside A (“Reb A”) extracts or steviol glycoside extracts, including those of 97% Reb A purity (referred
−Removed: to as “Reb A 97”), and 95% purity (referred to as “Reb A 95”), have been “generally recognized as
−Removed: (“GRAS”) and permitted for use as sweeteners for food and beverages in the United States.
−Removed: The world’s
−Removed: second largest market for high-intensity sweeteners, the European Union, adopted regulations to approve stevia extract for use
−Removed: in in November 2011.
−Removed: In the United States, the primary market
−Removed: for our potential products, 25 or more stevia products have received GRAS approval, including Reb A products and also refined mixtures
−Removed: of steviol glycosides.
−Removed: All of these products use traditional industry means for obtaining steviol glycosides, including the cultivation
−Removed: of the stevia plant and extraction of steviol glycosides from the stevia leaf.
−Removed: Of these products, none appear to involve directed
−Removed: production of steviol from lower-cost substrates using fermentation, enzymatic, or other biotechnological processes.
−Removed: Certain products
−Removed: appear to use industrial enzymes for use with leaf extraction, and three products appear to use industrial enzymes for modification
−Removed: of steviol glycoside mixtures.
−Removed: No products appear to involve the directed production of Reb A, currently the industry-leading steviol
−Removed: glycoside, from lower-cost substrates using fermentation, enzymatic, or otherwise biotechnological processes.
−Removed: Steviol Glycoside Compounds
−Removed: Stevia leaves contain nine to 12 compounds
−Removed: called steviol glycosides, which taste sweet but have no calories.
−Removed: These steviol glycosides are responsible for the sweet taste
−Removed: of the leaves of the stevia plant and are 30 times sweeter than sugar when in raw form.
−Removed: When refined, the steviol glycosides can
−Removed: reach sweetness levels 200 to 300 times greater than those of sugar, and range in sweetness from 40 to 300 times sweeter than sucrose.
−Removed: They are heat-stable, pH-stable, and do not ferment.
−Removed: They do not induce a glycemic response when ingested, making them attractive
−Removed: as natural sweeteners to diabetics and others on carbohydrate-controlled diets.
−Removed: The steviol gylocoside compound Reb A is
−Removed: the sweetest of the steviol glycosides.
−Removed: Historically, stevia was not processed to a high extract purity level, and as a result
−Removed: suffered from aftertaste or bitterness, which some have described as a licorice-like taste.
−Removed: However, isolating the glycoside Reb
−Removed: A has decreased this aftertaste.
−Removed: The GRAS notification issued by the FDA initially applied only to extracted and refined stevia
−Removed: of at least Reb A 95.
−Removed: Advanced stevia processing capabilities now enable the extraction of highly purified Reb A, at 97% and higher.
−Removed: In all or nearly all stevia extract products today, Reb A is extracted from the leaves and then purified for use in food and beverages.
−Removed: Reb A and Stevia Cultivation
−Removed: Developing a variety of stevia leaf with
−Removed: significantly higher Reb A content would allow for larger volumes of high-grade stevia extract with lower raw material (leaf) costs.
−Removed: Furthermore, the higher the Reb A content of a raw stevia leaf, the less costly the downstream processing activities required to
−Removed: increase its purity.
−Removed: One focus of our operations will be to develop varieties of stevia with high sugar content in general, or
−Removed: high Total Stevia Glycosides (“TSG”), and in particular, high Reb A content.
−Removed: TSG and Reb A content increase as the
−Removed: plant matures, concentrating over time with sunlight.
−Removed: However, TSG declines when the plant flowers.
−Removed: Delaying flowering is key to
−Removed: allowing the plants to achieve higher Reb A content in the leaf and giving them more time to produce leaves prior to harvesting.
−Removed: The stevia plant is photoperiod sensitive,
−Removed: which means that it depends on a particular day-length to initiate flowering and other stages of development.
−Removed: Stevia’s native
−Removed: range is 15 degrees to 25 degrees latitude, and passes through distinct stages with the seasons.
−Removed: TSG concentrates with vegetative
−Removed: growth in the longer days of summer.
−Removed: Typically the plant flowers when the length of the day shortens.
−Removed: In general, any undue stress
−Removed: will initiate flowering.
−Removed: This makes latitude, time of planting, and source of propagation key factors to commercial success.
−Removed: recent years, growers have begun cultivating stevia farther from the equator to take advantage of longer summer days that promote
−Removed: higher TSG and Reb A content.
−Removed: Virtually all the commercial production today is between 15 and 45 degrees latitude.
−Removed: Yuba City, California
−Removed: is located at approximately 39 degrees latitude.
−Removed: Stevia is native to semi-humid, sub-tropical
−Removed: climates where temperatures typically range from 21°
−Removed: F to 110°
−Removed: While tolerant of mild frost, hard frosts will kill the
−Removed: roots of the plant.
−Removed: Although stevia grows well on infertile, acid soils, it can also be cultivated on more neutral soils.
−Removed: of average temperature highs and lows in Yuba City, California is 39°F to 97°F.
−Removed: From Stevia Leaf to Extract
−Removed: Stevia is commercialized as dry leaf, concentrated
−Removed: liquid, pulverized leaves or white concentrated powder.
−Removed: The liquid and the pulverized leaf have a light herbal aftertaste.
−Removed: concentrated liquid is approximately 70 times sweeter than sugar and is often added to milk, tea, coffee or chocolate.
−Removed: The pulverized
−Removed: leaf is 30 times sweeter than sugar.
−Removed: The white concentrated powder is 150 times sweeter than sugar.
−Removed: If the white concentrated powder
−Removed: is refined into Reb A, its crystals are 200 to 300 times sweeter than sugar.
−Removed: The cost of producing or acquiring dry leaf currently
−Removed: accounts for an estimated 70% of the costs involved in traditional stevia extract production.
−Removed: Stevia Extract from Fermentation-based or Biotechnological
−Removed: Production Methods
−Removed: Certain companies and research groups have
−Removed: recently investigated the potential for stevia extract to be produced through natural methods that mimic the biosynthesis of steviol
−Removed: glycosides within the stevia plant.
−Removed: In doing this, steviol glycosides can potentially be produced in yeast or plant cells using
−Removed: directed fermentation and related biotechnological methods so as to better control the blend of steviol glycosides in the final
−Removed: This could be done starting with low-cost plant materials, or crude stevia extract, and if such a process is able to scale
−Removed: effectively it could produce a superior tasting stevia extract that contains few impurities and be more economical than current
−Removed: methods that rely upon complex stevia farming and extraction methods.
−Removed: As of January 2013, three companies have
−Removed: obtained or sought GRAS approval in the United States for use of industrial enzymes as processing aids to modify crude stevia extract
−Removed: obtained from stevia leaves.
−Removed: It should be noted that such a processing aid can improve the taste of certain steviol glycosides,
−Removed: but it does not enable the production of steviol or steviol glycosides from other substrates, and it does not enable the directed
−Removed: production or purification of Reb A.
−Removed: Because there is significant inherent variability
−Removed: in farming production, fermentation-based methods may become a more reliable and scalable method of stevia production.
−Removed: be particularly true for Reb A extracts, which are typically present in very low levels within the stevia leaf, and therefore require
−Removed: a large amount of stevia leaf production to be used in extraction processes.
−Removed: In addition, due to the stevia leaf being a complex
−Removed: mixture of various compounds, many impurities still remain after extraction that may contain off-tastes.
−Removed: This necessitates the
−Removed: use of further processing and purification steps, which add to the cost of the stevia extract, and that may not be entirely successful
−Removed: or consistent in removing off-tastes within the final product.
−Removed: So, a process that eliminates or greatly reduces such impurities
−Removed: may provide a superior tasting product.
−Removed: If low-cost sugars or other low-cost plant materials are able to be converted into steviol
−Removed: glycosides at large volumes, stevia extracts may not only be better tasting but also more readily available and have lower production
−Removed: Such methods rely upon knowledge and characterization
−Removed: of the genes and enzymes that play a role in the biosynthesis of steviol glycosides within the stevia leaf.
−Removed: In 2007, Brandle, et.
−Removed: in Phytochemistry , state that it had been over 40 years since the first insights into the biosynthesis of steviol glycosides
−Removed: were published, and that only a limited understanding of the enzymes involved existed as of 1999.
−Removed: But, over the next seven years,
−Removed: all of the gene in the pathway, except one, were cloned and sequenced and many of them functionally characterized.
−Removed: The only gene
−Removed: remaining that Brandle et.
−Removed: refers to is the kaurenoic acid 13-hydroxylase, an enzyme that helps produce steviol.
−Removed: called glucosyltransferases had been characterized by Richman et.
−Removed: in Plant , and these enzymes enable the conversion
−Removed: of steviol to the sweet steviol glycoside compounds.
−Removed: The Global Sweetener Industry
−Removed: The value of the global sweetener market
−Removed: in 2009, dominated by sugar, was estimated at US$58.3 billion, as reported by Reuters.
−Removed: According to Mintel’s 2011 report
−Removed: on Stevia and Natural Sweeteners, stevia is one of the fastest-growing newcomers in the $6 billion estimated sugar substitute market.
−Removed: This includes artificial chemical sweeteners as well as naturally derived non-caloric sweeteners.
−Removed: There are two main segments of the global
−Removed: sweetener market:
−Removed: “nutritive”
−Removed: sweeteners, including sugar and high fructose corn syrup, which contain calories;
−Removed: “non-nutritive”
−Removed: sweeteners, which are low- or zero-calorie sweeteners, and include zero-calorie high intensity artificial
−Removed: sweeteners such as aspartame and sucralose, as well as naturally derived sweeteners such as stevia.
−Removed: According to Mintel, sugar
−Removed: and high fructose corn syrup comprise 80% of the sweetener market and are growing in-line with population expansion, whereas non-nutritive
−Removed: sweeteners are projected to grow at 5% a year between 2008 and 2015.
−Removed: Artificial non-nutritive sweeteners have dominated the non-nutritive
−Removed: sweetener market, but the trend is toward natural sweeteners, according to the Mintel report.
−Removed: The artificial sweetener market is
−Removed: expected to grow 5.5% annually through 2015, according to a July 2007 report by Global Industry Analysts on Artificial Sweeteners.
−Removed: Traditional Nutritive Sweeteners
−Removed: Most governments subsidize the farming of
−Removed: sugar cane or sugar beet and related refinery costs because they consider sugar to be a necessity as a nutritive sweetener.
−Removed: producing either sugar cane or sugar beet in Europe and the United States have subsidies available to them.
−Removed: Sugar subsidies pose
−Removed: a major barrier to the widespread use of other sweeteners.
−Removed: While widely used, over-consumption of sugar
−Removed: carries risks.
−Removed: A 2011 report from the USDA found that sweetener deliveries for 2010 were 131.9 pounds per capita.
−Removed: It is believed
−Removed: that the increased consumption of sugar and sweeteners has contributed to increased rates of obesity, diabetes and other health
−Removed: related issues.
−Removed: In recent years, these concerns have stimulated a demand in the market for alternatives to sugar and especially
−Removed: non-nutritive sweeteners, a trend that is occurring globally.
−Removed: Even with increased concern about the adverse
−Removed: health effects of over consumption of sugar, there is a separate concern about a looming shortfall in the world’s sugar supply.
−Removed: The price of sugar rose from about $0.10 per lb.
−Removed: to more than $0.60 per lb.
−Removed: over the last 10 years.
−Removed: And global sugar consumption
−Removed: is forecast to rise by more than 50% to nearly 260 million tons by 2030, according to Mintel and the World Health Organization.
−Removed: High Fructose Corn Syrup
−Removed: A modified form of corn syrup with an increased
−Removed: fructose level, high fructose corn syrup (“HFCS”) typically contains either 42% or 55% fructose, with the remaining
−Removed: sugars being primarily glucose and higher sugars.
−Removed: Since fructose is sweeter than glucose, the syrup’s overall sweetness can
−Removed: be increased.
−Removed: This results in a more cost-effective use over sugar in food processing.
−Removed: Since HFCS’s caloric content is equivalent
−Removed: to that of sugar, it raises the same health concerns to consumers and industry.
−Removed: In addition, the human body metabolizes fructose
−Removed: differently than it does glucose.
−Removed: Fructose does not trigger the release of appetite suppressing endorphins, leading some to hold
−Removed: the view that the high consumption of HFCS is associated with contributing to increasing rates of obesity.
−Removed: Sugar Substitutes
−Removed: Non-nutritive sweeteners, sometimes referred
−Removed: to as “artificial sweeteners”
−Removed: or “high-intensity sweeteners,”
−Removed: are generally synthesized by chemical processes
−Removed: and have a higher degree of sweetness than nutritive sweeteners.
−Removed: Non-nutritive sweeteners have low or no caloric content and do
−Removed: not include fermentable carbohydrates, preventing the creation of acids through oral bacteria that causes tooth decay.
−Removed: calorie content allows diabetic patients to enjoy the taste of regular sugar without adding calories to their diet while assisting
−Removed: in weight management to prevent heart diseases and obesity.
−Removed: Increasing diabetic patient population, surging risks of heart diseases,
−Removed: and health-conscious populace are major factors driving growth in artificial sweeteners market.
−Removed: Demand for artificial sweeteners
−Removed: is expected to be stimulated by weight reduction efforts, attempts to develop foods for diabetic patients and others who need to
−Removed: cut sugar intake, and worries over dental cavities.
−Removed: Non-nutritive sweeteners are used in variety
−Removed: of products including dairy products, bakery products, confectioneries, snacks, salad dressings, beverages as well as cosmetics
−Removed: and pharmaceuticals.
−Removed: Beverages, notably diet soft drinks, are the principal market for non-nutritive sweeteners.
−Removed: The Coca Cola
−Removed: Company and PepsiCo, for example, are major purchasers and users of aspartame, a popular high-intensity sweetener, often used in
−Removed: Growth in this market is largely affected by the ongoing trends in the end-user industry.
−Removed: The United States dominates the world non-nutritive
−Removed: sweeteners market, with Europe and Asia-Pacific trailing the U.S.
−Removed: The three principal markets collectively account for
−Removed: the vast majority of the global artificial sweeteners market and the Asia-Pacific region is projected to be the fastest growing
−Removed: regional market for artificial sweeteners, with a compound annual growth rate of more than 3.0% over the analysis period, according
−Removed: to a 2007 Global Industry Analysts report.
−Removed: The market is likely to be affected by lower prices, entry of new players, particularly
−Removed: of the players operating in developing nations, expiry of patents protection and growing concerns about the usage of artificial
−Removed: This is paving way for the increased usage of various natural non-nutritive sweeteners such as stevia.
−Removed: Produced by Tate & Lyle plc.
−Removed: brand name Splenda®, sucralose is now found in more than 4,500 products.
−Removed: Developed in the 1970s, sucralose is 600 times sweeter
−Removed: than sugar, heat stable and dissolvable in water.
−Removed: Sucralose is manufactured by chemically altering a sugar molecule and substituting
−Removed: three chlorine atoms for three hydrogen-oxygen groups.
−Removed: The use of chlorine molecules in sucralose has raised health concerns because
−Removed: they are used as the base of many pesticides.
−Removed: According to Tate & Lyle plc.
−Removed: in 2012, SPLENDA®
−Removed: has a 26% share of the high
−Removed: intensity sweetener market by value, making Tate & Lyle the largest single high intensity sweetener manufacturer in the world,
−Removed: and that by volume, SPLENDA®
−Removed: Sucralose accounts for 89% of the global sucralose market.
−Removed: One of the most widely used high-intensity
−Removed: sweeteners in the food and beverage industry, aspartame was discovered in 1967 and approved by the FDA in 1981.
−Removed: It is about 200
−Removed: times sweeter than sugar, but is not heat-stable and so is not suitable for baking or cooking.
−Removed: Aspartame is, however, found widely
−Removed: in diet colas and also in some breakfast cereals, desserts and chewing gum.
−Removed: In the United States, Aspartame is marketed under the
−Removed: brand names Equal™
−Removed: and NutraSweet™.
−Removed: Global demand for aspartame is expected to grow below the industry average due
−Removed: to rising safety concerns and competition from sucralose in food and beverage applications.
−Removed: Polyols, or sugar alcohols, are produced
−Removed: by hydrogenation or fermentation of different carbohydrates.
−Removed: A few of the more common types of polyols include maltitol, erythritol,
−Removed: sorbitol, isomalt and xylitol.
−Removed: Most polyols occur naturally in vegetables, fruits and mushrooms, and are also regularly present
−Removed: in fermented foods such as wine or soy sauces.
−Removed: Polyols are not generally considered non-nutritive sweeteners because they contain
−Removed: calories, although they do contain fewer calories than sugar.
−Removed: In addition, they are not considered high-intensity sweeteners, as
−Removed: they are no sweeter than sugar and may even be less sweet.
−Removed: They are added to foods because of their low caloric content and are
−Removed: often combined with high-intensity sweeteners.
−Removed: Excluding erythritol, the laxative effect that most polyols have can cause digestive
−Removed: They are now used mainly in sugar-free gums in low doses.
−Removed: Demand for polyols may be driven by consumers’
−Removed: perceptions regarding the benefits of natural products and the continued interest of the consumers to reduce the sugar intake for
−Removed: combating diabetics, tooth decay and obesity.
−Removed: Demand for functional carbohydrates such as palatinose, among others, is likely to
−Removed: increase, as these products satisfy the consumer’s quest for healthy, flavor and texture rich products.
−Removed: Some 300 times sweeter than sugar, saccharin
−Removed: is marketed under the brand name Sweet 'N' Low®.
−Removed: Saccharin is heat stable, has a long shelf life and remains relatively cheap
−Removed: But it has been known to have a bitter aftertaste and has been subject to controversy over possible carcinogenic side
−Removed: Canada banned saccharin in1977.
−Removed: The Market for Stevia
−Removed: Stevia represents a new category of natural,
−Removed: plant-based, zero-calorie, high-intensity sweetener.
−Removed: Stevia measures zero on the glycemic index, which is important in the diabetic
−Removed: market and benefits from growing consumer understanding of the value of a low glycemic index diet.
−Removed: In addition, the ability of
−Removed: stevia extracts to remain stable under heat permits it to be utilized in processed foods.
−Removed: Reb A is increasingly being used in food
−Removed: and beverage applications.
−Removed: Because Reb A is heat, light and pH stable, it can be used in applications where other sweeteners cannot.
−Removed: Additionally, its taste is closer to sugar than other sweeteners currently being used, which could provide Reb A with significant
−Removed: advantages in certain applications.
−Removed: Japan accounts for $200 million of the global
−Removed: stevia market due to its early adoption and high acceptance rates.
−Removed: Following the FDA’s GRAS notification for Reb A 95 in
−Removed: December 2008, the stevia market expanded rapidly, as evidenced by the 200 launches of products containing stevia extracts in 2009
−Removed: and 97 products in the first quarter of 2010, according to the market research firm Mintel.
−Removed: In total, from mid-2009 to mid-2010,
−Removed: new product launches using stevia extracts increased by 200 percent, with products launched in 35 countries - 237 new products
−Removed: in the first half of 2010 alone, according to Mintel’s Global New Product Database.
−Removed: Food consultancy Zenith International reports
−Removed: that stevia saw a 27% increase in worldwide volume sales in 2010 over 2009, taking its overall market value to $285 million in
−Removed: Stevia in 2011 was estimated to account for less than 1% of the global sweetener market, or $500 million, according to research
−Removed: firm KnowGenix.
−Removed: Market research firm Mintel estimates the global market for stevia sweeteners reached $500 million by mid-2011,
−Removed: and both Zenith and Mintel predict continued rapid growth.
−Removed: The potential market for Reb A in the U.S.
−Removed: appears to be considerable.
−Removed: In 2008, the global high intensity sweetener market was valued at approximately $1.3 billion, with the U.S.
−Removed: accounting for approximately
−Removed: 35% ($455 million).
−Removed: A May 2009 study by The Freedonia Group
−Removed: indicates that greater awareness of the relationship between diet and health will continue to support an increasing demand for
−Removed: products across all categories that offer nutritional and health benefits.
−Removed: The study valued the current United States demand for
−Removed: sweeteners at $12 billion, with alternative sweetener demand accounting for 9.5%.
−Removed: In particular, the food segment is expected to
−Removed: see a high percentage of growth in demand for alternative sweeteners in the United States.
−Removed: Some of the largest growth is expected
−Removed: to occur in beverages, however, and in particular from flavored and enhanced waters.
−Removed: Driven by a flurry of new product introductions
−Removed: and advancements, growth in traditional carbonated soft drink sales is expected to remain flat (or decline slightly) while products
−Removed: such as enhanced beverages are expected to rise.
−Removed: Stevia extracts have played a significant role in new product development in this
−Removed: Use in All-Natural Products
−Removed: Stevia benefits from what appears to be
−Removed: a widespread consumer belief that all-natural products are healthier than artificial products, particularly in the sweetener industry
−Removed: where artificial high-intensity sweeteners have been subject to consumer health risk concerns.
−Removed: A Harris Poll in 2008 found that
−Removed: three out of five Americans believe artificial sweeteners are only somewhat safe or not safe at all.
−Removed: Further, an August 2008 survey
−Removed: by IFIC Food and Health reported that 43% to 45% of Americans said they wanted to use less aspartame, sucralose and saccharin.
−Removed: Consumers are increasingly demanding healthier and more nutritious food and beverage products.
−Removed: Products with excessive levels of
−Removed: sugar and high fructose corn syrup are increasingly being shunned, as are those fortified with synthetic or artificial low-calorie
−Removed: Lower calorie products with natural ingredients are increasingly in demand.
−Removed: Growing consumer preference for all-natural
−Removed: products, together with increasing rates of obesity and diabetes, have created significant demand for an all-natural, zero-calorie
−Removed: sweetener alternative.
−Removed: Stevia presents food and beverage companies
−Removed: with the opportunity to offer consumers a healthier, natural alternative to nutritive and artificial sweeteners.
−Removed: In addition, stevia
−Removed: extracts may be used in products claiming all-natural status, which is a significant factor for many consumers.
−Removed: In 2008, all-natural
−Removed: was the most prevalent claim for new products launched.
−Removed: In fact, according to AC Nielsen, retail sales that year of all-natural
−Removed: products in the United States were valued at more than $22 billion, which represents a 10% increase from 2007 and a 37% increase
−Removed: Growth in Products Containing Stevia
−Removed: According to Mintel's August 2009 report
−Removed: “Stevia and other Natural Sweeteners,”
−Removed: more than 115 new food and beverage products containing stevia were launched
−Removed: in the United States in the first seven months of 2009 by leading global food and beverage companies such as The Coca Cola Company,
−Removed: Cargill, PepsiCo and Merisant Company.
−Removed: Recently introduced products that utilize stevia extract as a sweetener include Coca Cola
−Removed: Company's Sprite®, Vitaminwater10™
−Removed: and Odwalla®
−Removed: juices, PepsiCo's SoBe Lifewater®
−Removed: and Trop50, and Dr.
−Removed: Snapple Group's launch of All Sport Naturally Zero.
−Removed: These products joined Cargill's tabletop sweetener TRUVIA™, Merisant
−Removed: Company's tabletop sweetener PureVia™
−Removed: and ZEVIA™
−Removed: Cola, the first commercially produced cola beverage sweetened with
−Removed: Our goal is to establish ourselves as the
−Removed: first major vertically integrated North American producer of stevia and stevia products.
−Removed: In addition to competition from producers
−Removed: and distributors of sugar, high fructose corn syrup, artificial sweeteners and other natural sweeteners, our competitors include
−Removed: national and international producers and distributors of stevia products.
−Removed: Each of these competitors is larger, more established
−Removed: and has more resources than we do.
−Removed: In addition, major global companies are expected to enter the market as demand for stevia grows.
−Removed: Currently, the largest producer of stevia-based
−Removed: sweeteners is Cargill, Incorporated, an international producer and marketer of food, agricultural, financial and industrial products
−Removed: and services that produces Truvia®
−Removed: tabletop sweetener, the leading stevia tabletop sweetener in the U.S.
−Removed: In early May 2011,
−Removed: AC Nielsen reported that Truvia®, had surpassed Sweet N Low®
−Removed: to become the number two sugar substitute in the U.S., and
−Removed: is now in more than five million U.S.
−Removed: households, accounting for 14% of the U.S.
−Removed: tabletop sugar substitute market.
−Removed: competitor, PureCircle, is a Malaysian based supplier of stevia for the PureVia™
−Removed: tabletop stevia brand, which was developed
−Removed: jointly by Merisant Company and PepsiCo, Inc.
−Removed: The acknowledged global leader in stevia production, PureCircle has contracts with
−Removed: PepsiCo and Whole Earth Sweetener Co.
−Removed: to supply Reb A and an exclusive license to market Reb A 97 under the PureVia™
−Removed: PureCircle also has supplied Cargill with Reb A.
−Removed: Other significant producers and distributers
−Removed: of stevia include the following:
−Removed: Blue California is an ingredient company based in Southern California with extraction operations in China.
−Removed: Blue California offers a Reb A 97 product marketed under the brand Good & Sweet™.
−Removed: The Reb A content of this company’s sweetener is 97% or greater and has GRAS status for use of the sweetener in various foods and beverages.
−Removed: Blue California also has announced its intention to produce or extract Reb A through methods that utilize fermentation.
−Removed: Corn Products International has a long-term agreement with Morita Kagaku Kogyo Co., Ltd.
−Removed: of Japan for access to its strain of stevia.
−Removed: Morita has been growing stevia in Brazil since 2007 and marketing a high-grade Reb A product called Enliten, which has GRAS status.
−Removed: Corn Products International has not yet launched any stevia based products.
−Removed: GLG Life Tech Corp.
−Removed: offers Rebpure ™
−Removed: , a Reb A 97 product.
−Removed: GLG Life Tech has also supplied Cargill with high-grade stevia extract that has been used in Truvia®
−Removed: tabletop sweetener.
−Removed: Evolva Holding SA, a company in Switzerland, is involved in research and development related to the production of stevia through fermentation-based methods.
−Removed: The company states that it uses biosynthetic and evolutionary technologies to create and optimize compounds and their production routes.
−Removed: Their website describes that stevia research is performed at a site in Copenhagen with development activities in the USA.
−Removed: In 2011, they acquired a collaborator company named Abunda Nutrition, Inc.
−Removed: that was California-based.
−Removed: McNeil Nutritionals, LLC, the maker of Splenda, has launched Sun Crystals All-Natural Sweetener, which combines stevia with pure cane sugar.
−Removed: According to the company, the product contains five calories per packet, and one packet has the same sweetness as two teaspoons of sugar.
−Removed: Sunwin USA, L.L.C.
−Removed: and Wild Flavors filed GRAS notices in September 2009.
−Removed: One is for using Reb A as a general purpose sweetener in various food categories.
−Removed: Another is for using purified steviol glycosides with Reb A and stevioside as the principal components for use as a general-purpose sweetener in various food categories.
−Removed: Sweet Green Fields L.L.C.
−Removed: has a stevia sweetener in which Reb A accounts for 97% or more of the content, with other steviol glycosides at 3% or less.
−Removed: The FDA has indicated that it has no objections to the sweetener for use as a general purpose sweetener in foods, excluding meat and poultry products.
−Removed: Whole Earth Sweetener Co.
−Removed: has a stevia sweetener with higher than 95% Reb A, with limits for stevioside of under 2% and for steviol of under 0.005%.
−Removed: The FDA has indicated that it has no objections to the GRAS status of the sweetener for use in various foods and beverages.
−Removed: Wisdom Natural Brands has a stevia sweetener with Reb A and stevioside accounting for 86% to 90% of the steviol glycoside content.
−Removed: Other steviol glycosides, including rebaudioside C and dulcoside A, may also be present.
−Removed: The FDA has indicated that it has no objections to the GRAS status of this sweetener for use as a general purpose sweetener in foods, excluding meat and poultry products and infant formulas.
−Removed: S&W Seed Company has launched a pilot program to produce stevia leaf as the source of an all-natural, non-caloric sweetener, has performed the planting and harvest of more than 100 acres of stevia in California, and has obtained a leaf supply agreement with PureCircle.
−Removed: S&W is a leader in warm climate alfalfa seed varieties, including varieties that can thrive in poor, saline soils.
−Removed: Three companies including NOW Foods, Toyo Sugar, and Daepyung Co., Ltd.
−Removed: have filed for or received GRAS status in the United States for stevia extracts that use industrial enzymes as processing aids that affect the taste of steviol glycosides.
−Removed: Each of these companies use an enzymatic processing aid that modifies steviol glycosides obtained through stevia leaf extraction.
−Removed: This processing aid does not enable the production of steviol or steviol glycosides from other, lower-cost starting materials, and it does not enable the directed production of Reb A, although it does improve the taste of crude stevia extract mixtures.
−Removed: Government Regulation
−Removed: Regulatory Approval of Stevia in Food and Beverage Markets
−Removed: Stevia has been approved for use in food
−Removed: and beverages in multiple markets around the world.
−Removed: Such approval is granted typically by a government body for the use of a refined
−Removed: stevia extract, such as Reb A, for use in formulations of consumer products including food, beverages, and tabletop sweeteners.
−Removed: In June 2008, the Joint Expert Committee
−Removed: on Food Additives (“JECFA”), administered jointly by the United Nations’
−Removed: World Health Organization and the Food
−Removed: and Agricultural Organization, raised the acceptable daily intake level for stevia.
−Removed: Established in 1956 as an international scientific
−Removed: committee that to evaluate food additives, JEFCA is now widely recognized as the leading authority in risk assessment of food hazards.
−Removed: The committee has evaluated more than 1,500 food additives and established the main principles and guidelines of safety assessment
−Removed: for chemicals in foods.
−Removed: JECFA published its approval of stevia after a decade of study, stating that, "95% steviol glycosides
−Removed: are safe for human use in the range of four milligrams per kilogram of body weight per day".
−Removed: This doubled the average daily
−Removed: intake level previously set by JECFA from earlier studies.
−Removed: In the United States, the primary market
−Removed: for our products, 25 or more stevia products have received GRAS approval, including Reb A products and also refined mixtures of
−Removed: steviol glycosides.
−Removed: All of these products use traditional industry means for obtaining steviol glycosides, including the cultivation
−Removed: of the stevia plant and extraction of steviol glycosides from the stevia leaf.
−Removed: Of these products, none appear to involve directed
−Removed: production of steviol from lower-cost substrates using fermentation, enzymatic, or otherwise biotechnological processes.
−Removed: products appear to use industrial enzymes for use with leaf extraction, and three products appear to use industrial enzymes for
−Removed: modification of steviol glycoside mixtures.
−Removed: No products appear to involve the directed production of Reb A, currently the industry-leading
−Removed: steviol glycoside, from lower-cost substrates using fermentation, enzymatic, or otherwise biotechnological processes.
−Removed: United States
−Removed: On December 17, 2008, the FDA issued its
−Removed: first no objection letter with respect to Reb A as a general purpose sweetener.
−Removed: Reb A 97 and Reb A 95 have been “generally
−Removed: recognized as safe”
−Removed: and permitted for use as sweeteners for food and beverages in the United States.
−Removed: The ruling enabled food
−Removed: and beverage companies to use stevia products containing Reb A in their products.
−Removed: Before the FDA’s approval, stevia had only
−Removed: been permitted as a dietary supplement.
−Removed: There is now more than 10 stevia sweeteners for which there has been a GRAS notification
−Removed: sent to the FDA and the FDA responded by issuing a no objection letter.
−Removed: This response indicates the FDA has no objection to the
−Removed: company’s conclusion within the GRAS notification that the product is “generally recognized as safe”
−Removed: among qualified
−Removed: experts for use in products such as beverages, foods, and tabletop sweeteners.
−Removed: When introducing new products containing stevia
−Removed: in the United States, companies may submit such a GRAS notification letter to the FDA for their review, or alternatively they may
−Removed: privately assert GRAS status through conducting internal reviews of their manufacturing process, product purity, and safety data.
−Removed: European Union
−Removed: In July 2011, member governments of the
−Removed: European Union approved the sale of natural sweeteners derived from the stevia plant for use in certain foodstuffs.
−Removed: Commission formally adopted the regulation permitting the use of steviol glycosides as a sweetener for foods and beverages throughout
−Removed: all 27 member states of the European Union.
−Removed: The regulation was published on November 12 in the Official Journal of the European
−Removed: Union, thus becoming effective 20 days later, on December 2, 2011.
−Removed: The government of France approved Reb A
−Removed: 97 for use as an ingredient in food and beverages in September 2009.
−Removed: France’s decision marked the first approval of Reb A
−Removed: 97 in the European Union.
−Removed: Australia and New Zealand
−Removed: The Australian and New Zealand food and
−Removed: safety regulatory body approved stevia for use as an ingredient in food and beverages in 2008.
−Removed: The approval was based on research
−Removed: and data published by JECFA as well as studies conducted by the Plant Science Group at Central Queensland University and Australian
−Removed: Stevia Mills.
−Removed: Other countries where stevia extracts have
−Removed: been approved for use in food and beverages include China, Japan, Mexico, Brazil, and Paraguay.
−Removed: Other Regulations
−Removed: In addition to laws and regulations enforced
−Removed: by the FDA and those related to the sale of stevia leaf or refined stevia extract, we are also subject to regulations under the
−Removed: Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation
−Removed: and Recovery Act and other present and potential future federal, state or local laws and regulations, as our research and development
−Removed: may involve the controlled use of hazardous materials, chemicals, and compounds.
−Removed: Regulatory Approval of Stevia Products using Novel Fermentation
−Removed: or Biotechnological Methods
−Removed: Because the Company seeks to produce steviol
−Removed: glycosides using novel fermentation or biotechnological methods, these processing and production methods may be subject to additional
−Removed: regulatory approvals, as compared to stevia products that are produced using known industry methods, if the methods or substances
−Removed: used for stevia production have not received GRAS approval or if they are not otherwise exempt from premarket approval by the FDA.
−Removed: For example, if the Company develops and intends to use novel reaction substrates, production microorganisms, or processing enzymes
−Removed: that mimic the natural biosynthesis of the stevia plant, the Company may be required to obtain premarket approval and to seek GRAS
−Removed: approval through a petition process for these novel substances used as processing aids or food additives.
−Removed: Section 409(b)(2) of
−Removed: the FDA Act prescribes the statutory requirements for food additive petitions, and these requirements are discussed in further
−Removed: detail under title 21 of the Code of Federal Regulations (“CFR”), part 171.1.
−Removed: The eligibility requirements for classification
−Removed: of a substance as GRAS are described under CFR 170.30 and for GRAS affirmation petitions in CFR 170.35.
−Removed: Such additional approval
−Removed: process would involve a separate petition and review of any novel food additives or processing aids, and include a necessary determination
−Removed: by qualified experts that the substance is safe for its intended use and that sufficient information about the safety and use of
−Removed: the substance is widely known and publicly available.
−Removed: Intellectual Property
−Removed: As of March 31, 2012, we had no patents
−Removed: or trademarks.
−Removed: As of July 3, 2012, we had one full-time
−Removed: employee, our Chief Executive Officer Robert Brooke, and three part-time employees.
−Removed: We expect to increase the number of our employees
−Removed: as we increase our operations.
−Removed: Environmental Law Compliance
−Removed: Our agricultural operations will be subject
−Removed: to a broad range of evolving environmental laws and regulations.
−Removed: These laws and regulations include the Clean Air Act, the Clean
−Removed: Water Act, the Resource Conservation and Recovery Act, the Federal Insecticide, Fungicide and Rodenticide Act and the Comprehensive
−Removed: Environmental Response, Compensation and Liability Act.
−Removed: These environmental laws and regulations are intended to address concerns
−Removed: related to air quality, storm water discharge and management and disposal of agricultural chemicals relating to agricultural practices.
−Removed: We anticipate that any pesticide or agricultural chemicals used will be managed by trained individuals, certified and licensed
−Removed: through the California Department of Pesticide Regulation.
−Removed: Compliance with these laws is not expected to have a material effect
−Removed: on our capital expenditures, however we cannot be certain that in the future the cost of compliance with environmental laws and
−Removed: regulations will not be material.
−Removed: Moreover, it is possible that future developments, such as increasingly strict environmental
−Removed: laws and enforcement policies thereunder, and further restrictions on the use of agricultural chemicals, could result in increased
−Removed: compliance costs.
−Removed: Research and Development
−Removed: We began engaging in research and development
−Removed: activities related to the cultivation and harvest of stevia leaf during the fourth quarter of our fiscal year ended March 31, 2012.
−Removed: During the fiscal years ended March 31, 2011 and 2012 we did not incur any expenses that were allocated directly to these activities.
−Removed: General Information
−Removed: We maintain a website at www.steviafirst.com.
−Removed: Information contained on our website is not incorporated by reference in this annual report.
−Removed: We file reports with the
−Removed: Securities and Exchange Commission (“SEC”) and make available, free of charge, on or through our website, our annual
−Removed: reports, quarterly reports, current reports, proxy and information statements and amendments to those reports filed or furnished
−Removed: pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
+Added: otherwise provided in this Annual Report, references to the “Company,” “we,” “us”, and “our”
+Added: refer to Range Impact, Inc., a Nevada corporation formed on June 29, 2007 as Legend Mining Inc., and its consolidated subsidiaries.
+Added: October 10, 2011, we completed a merger with our wholly-owned subsidiary, Stevia First Corp., whereby we changed our name from “Legend
+Added: Mining Inc.” to “Stevia First Corp.” On July 15, 2016, our Board of Directors and shareholders approved a name change
+Added: to “Vitality Biopharma, Inc.” On October 1, 2021, we completed a merger with our wholly-owned subsidiary, Malachite Innovations,
+Added: Inc., whereby we changed our name from “Vitality Biopharma, Inc.” to “Malachite Innovations, Inc.” On December
+Added: 14, 2023, we completed a merger with our wholly-owned subsidiary, Range Impact, Inc., whereby we changed our name from “Malachite
+Added: Innovations, Inc.” to “Range Impact, Inc.”
+Added: Range Impact, Inc.
+Added: is a public company dedicated to improving the health and wellness of people and the planet through a novel and innovative approach to
+Added: impact investing.
+Added: Range owns and operates several complementary operating businesses focused on developing long-term solutions to environmental,
+Added: social, and health challenges, with a particular focus on acquiring, reclaiming and repurposing mine sites and other undervalued land
+Added: in economically disadvantaged communities throughout Appalachia.
+Added: Range takes an opportunistic approach to impact investing by leveraging
+Added: its competitive advantages and looking at solving old problems in new ways.
+Added: Range seeks to thoughtfully allocate its capital into strategic
+Added: opportunities that are expected to make a positive impact on the people-planet ecosystem and generate strong investment returns for its
+Added: shareholders.
+Added: corporate headquarters is located in Cleveland, Ohio, with additional office locations in Flatwoods, West Virginia, Fola, West Virginia
+Added: and Rocklin, California.
+Added: As of March 28, 2024, we employed 56 full-time employees.
+Added: In addition, we have, from time to time, engaged various consultants and professional service
+Added: firms to provide us with flexible and experienced resources to advance our corporate objectives in order to maintain a cost-effective overhead
+Added: We strive to instill a corporate culture of honesty, integrity and respect while advancing our mission of doing well by doing
+Added: Investing Strategy
+Added: impact investing strategy aims to improve the health and wellness of people and the planet, while also generating long-term sustainable
+Added: financial returns for our shareholders.
+Added: We believe that doing well and doing good are not mutually exclusive, and that an impact investing
+Added: strategy can balance the environmental, social and economic needs of people and the planet while also generating attractive risk-adjusted
+Added: financial returns for shareholders.
+Added: impact investing strategy provides an opportunity for our dedicated team to address pressing environmental, social and economic
+Added: challenges, such as air and water pollution, educational inequality and economic disparity, and climate change, through the
+Added: development of technology-based solutions.
+Added: By actively directing investment capital towards businesses that are working to create
+Added: positive environmental, social and economic outcomes, we believe that our impact investing strategy can contribute to
+Added: an improved people-planet ecosystem and a healthier and happier way of life.
+Added: have a particular interest in providing environmental and social solutions in economically-disadvantaged regions of the United States.
+Added: Initially, the Company is targeting the Appalachian region, which is home to communities with some of the most disadvantaged income,
+Added: education and employment demographics in the United States.
+Added: Our ambitious strategy is to allocate investment capital and build operating
+Added: businesses that provide positive environmental and social impact in the disadvantaged coal communities of Appalachia to maximize the
+Added: good we can do for people and the planet.
+Added: Business Segments
+Added: five operating business segments are:
+Added: (i) Range Reclaim, (ii) Range Water, (iii) Range Security, (iv) Range Land, and (v) Drug Development.
+Added: about our business segments should be read together with “Part II.
+Added: Management’s Discussion and Analysis of Financial
+Added: Condition and Results of Operations.”
+Added: May 2022, the Company acquired Range Environmental Resources, Inc., a West Virginia corporation (“Range Environmental”) and
+Added: Range Natural Resources, Inc., a West Virginia corporation (“Range Natural” and together with Range Environmental, the “Range
+Added: Reclamation Entities”).
+Added: The Range Reclamation Entities provide land reclamation, water restoration and environmental consulting
+Added: services to mining and non-mining customers throughout the Appalachian region with the goal of returning land to pre-mining conditions
+Added: or repurposing the land for natural, commercial, agricultural, residential or recreational use.
+Added: The Range Reclamation Entities’ water restoration
+Added: services seek to improve rivers, streams and discharges through novel and innovative treatment applications to help customers meet their
+Added: various regulatory standards and requirements.
+Added: The Range Reclamation Entities also provide environmental consulting services to customers,
+Added: typically in connection with land reclamation and water restoration projects, and, as an additional value-add service, sell water treatment
+Added: chemicals manufactured by third parties to their customers.
+Added: Range Natural also mines, directly and through subcontractors, natural resources, including coal, for customers
+Added: incidental to the reclamation and repurposing of mine sites.
+Added: Energy Information Administration (“EIA”), the United States had 551 coal mines in 2020, comprised of 370 active
+Added: mines, 141 idled or closed mines, and 40 new or activated mines.
+Added: Approximately 82% of those coal mines were located in Appalachia (which
+Added: comprises the Appalachian Mountains and is commonly known as the cultural region in the Eastern United States stretching from the southern
+Added: part of New York to the northern parts of Alabama and Georgia).
+Added: According to the EIA, there were approximately three times as many coal
+Added: mines in the United States in 2008 (compared to 2020) with approximately 89% located in Appalachia.
+Added: The precipitous decline in the number
+Added: of operating coal mines since 2008 is due to various supply, demand and regulatory factors, including a reduction in demand for coal
+Added: as a source of electricity due to the increased use of natural gas and renewable energy, an increase in coal production costs due to
+Added: inflation and the dearth of cost-effective locations remaining for mining, and a more stringent and costly regulatory environment, all
+Added: of which have resulted in an increasingly difficult market for coal producers.
+Added: 2000, coal was responsible for 1,966 billion kWh of electricity generation, representing 52% of the total electricity generation in
+Added: the United States.
+Added: In 2022, coal was responsible for only 828 billion kWh of electricity generation, representing 20% of the total
+Added: electricity generation in the United States, a decline of approximately 58%.
+Added: According to the EIA, 23% of the 200,568 megawatts of
+Added: coal-fired capacity currently operating in the United States is scheduled to retire by the end of 2029 due to the high cost of
+Added: operations, competition from natural gas and renewable energy resources, and sustainable initiatives of energy
+Added: the reclamation of closed and inactive mine sites has not kept pace with the increase in the number of closed and idled mine sites,
+Added: thus creating a substantial backlog of reclamation work that needs to be completed on former mine sites.
+Added: According to the U.S.
+Added: Office of Surfacing Mining Reclamation and Enforcement (“OSMRE”), there are approximately 50,000 high-priority abandoned
+Added: mine land locations in the United States resulting from legacy coal mining operations that failed to adequately reclaim the land and
+Added: waterways back to their natural state as required by federal regulations.
+Added: Additionally, there are tens of thousands of active mine sites in the United States that
+Added: require contemporaneous reclamation of land and waterways during the active mining process, and an estimated equally large number of
+Added: idled mine locations that also require significant land reclamation and water restoration.
+Added: the Surface Mining Control and Reclamation Act of 1977 (“SMRCA”), OSMRE was established for two basic purposes:
+Added: (i) to ensure
+Added: coal mines in the United States operate in a manner that protects citizens and the environment during mining operations and to restore
+Added: the land to beneficial use following mining, and (ii) to implement an Abandoned Mine Land (“AML”) reclamation program to
+Added: address the hazards and environmental degradation resulting from two centuries of coal mining activities that occurred before SMRCA was
+Added: passed in 1977.
+Added: The AML reclamation program is funded through fees levied against coal producers based on tons of coal produced.
+Added: September 2020, the AML reclamation fund had collected a total of $11.7 billion in coal mining fees over the life of the program, with
+Added: $9.5 billion (81%) appropriated and distributed in accordance with SMCRA, and $2.2 billion (19%) unappropriated and available for future
+Added: disbursement.
+Added: In November 2021, the Infrastructure Investment and Jobs Act was enacted, which, among other things, authorized $11.3 billion
+Added: in new funding to be appropriated for deposit into the AML reclamation fund.
+Added: The AML reclamation fund is only available
+Added: to help fund the reclamation of mines abandoned before SMCRA was enacted in 1977, and therefore, all mines abandoned after the year 1977
+Added: cannot access funding from the AML reclamation fund and must obtain funding from other sources.
+Added: While much of
+Added: the funding for this reclamation work comes from the federal government, each state in Appalachia has a Department of Environmental
+Added: Protection (“DEP”) or an equivalent agency that oversees coal mining permitting, operations, and reclamation.
+Added: rules and regulations, coal mining companies are required to develop a mining and reclamation plan that is approved by the
+Added: applicable state agency, obtain a mining permit from the state, and secure a reclamation surety bond from a qualified third-party
+Added: insurance company or provide a comparable financial guarantee.
+Added: The reclamation surety bond provides the state with financial
+Added: assurances that land reclamation and waterway restoration will be performed in accordance with the reclamation plan once mining is
+Added: complete if the coal mining company, as primary obligor, fails to perform.
+Added: Therefore, there are at least three groups who may need
+Added: land reclamation, water restoration and environmental consulting services:
+Added: (i) mining companies when permits are active and
+Added: reclamation bonds are not in default, (ii) surety bond insurers when reclamation bonds are in default, and (iii) states through
+Added: their AML reclamation funds for mine lands abandoned before 1977 and for mine lands with defaulted coal mining companies and
+Added: forfeited surety bonds on or after 1977.
+Added: the time of its acquisition in May 2022, the Range Reclamation Entities had one reclamation customer, 15 pieces of owned and
+Added: financed equipment, eight pieces of rented equipment, and 12 employees, all located and operating in West Virginia.
+Added: As of March 2024,
+Added: less than two years later, the businesses had five reclamation customers, more than 100 pieces of owned and financed equipment, and
+Added: 35 employees in West Virginia.
+Added: For the full year 2021, the Range Reclamation Entities had revenues of approximately $2.5 million.
+Added: For the full year 2023, the Range Reclamation Entities generated revenues of approximately $18.7 million, an increase of $16.2
+Added: million over a two-year period.
+Added: The Range Reclamation Entities have also made a significant investment in recruiting, retaining and
+Added: rewarding employees, including providing new benefits such as health insurance, paid time off, vacation days, 401(k) retirement plan,
+Added: and job advancement training.
+Added: The Range Reclamation Entities’ employees are their most valuable asset, and therefore we are
+Added: committed to building a best-in-class culture and financially rewarding our talented, hard-working employees so that we can maximize
+Added: the good we can do for our people and their families.
+Added: Range Reclamation Entities are planning for continued growth in their land reclamation, water restoration and consulting businesses by
+Added: expanding their market share with existing coal mining customers and reclamation bond insurers, adding new coal mining and non-coal mining
+Added: customers, and collaborating with the Company’s other operating businesses to generate incremental sales opportunities.
+Added: seek to add additional people, equipment and technologies to support our ambitious growth goals to ensure we successfully execute our
+Added: value creation plans for the Company and our shareholders.
+Added: August 2023, the Company acquired Collins Building & Contracting, Inc.
+Added: (“Collins Building”), a West Virginia-based environmental
+Added: services business focused on performing reclamation services on abandoned mine lands throughout West Virginia.
+Added: Collins Building, along
+Added: with the Range Reclamation Entities, are classified within the Range Reclaim operating business segment.
+Added: Preta, LLC, an Ohio limited liability company (“Terra Preta”), is a biochar product development and environmental solutions
+Added: business started by the Company in December 2022.
+Added: Terra Preta is developing a novel and innovative combination of biochar, proprietary
+Added: materials and structural designs intended to create several first-of-its-kind agricultural and water filtration products and solutions.
+Added: is a solid, lightweight carbon-rich material produced by the thermal decomposition of organic material (such as cellulosic feedstock,
+Added: including wood and plants) using a chemical-conversion process known as pyrolysis.
+Added: Carbonization pyrolysis is a chemical degradation
+Added: process that heats organic materials to produce carbon-rich biochar, liquid bio-oils, and syngas products.
+Added: Since organic material is
+Added: thermally decomposed without oxygen during the pyrolysis process, combustion does not occur, so the process allows for the permanent
+Added: capture of carbon in the biochar end-product and eliminates the release of climate-damaging carbon dioxide into the atmosphere.
+Added: yield of biochar during the carbonization pyrolysis process depends on several variables such as temperature, heating time and heating
+Added: Lower temperatures, longer heating times and lower heating rates typically yield more biochar and less bio-oil and syngas.
+Added: Preta has been launched to build a full-cycle, carbon-negative business that reduces greenhouse gases from the atmosphere, passively
+Added: filters contaminated water without the use of harsh chemicals, and provides a fortified, nutrient-rich soil amendment to improve the
+Added: growth of agricultural products.
+Added: gases, comprised of carbon dioxide, methane, nitrous oxide and fluorinated gases, are gases that trap heat in the atmosphere, and are
+Added: generally believed to result in warmer temperatures and climate change, including changing weather patterns, rising sea levels, and more
+Added: extreme weather events.
+Added: Carbon dioxide enters the atmosphere through, among other things, the burning of fossil fuels, solid waste and
+Added: other biomass materials, and is removed from the atmosphere when absorbed by plants during the photosynthesis process.
+Added: Terra Preta is
+Added: in discussions with a large affiliated landowner to enter into a long-term lease or purchase of at least 100 acres of former mine land
+Added: in West Virginia for the planting, growth and harvesting of crops to serve as the primary feedstock for our biochar production operations.
+Added: The newly planted crops would then act as a “carbon sink”, drawing substantial amounts of carbon dioxide from the atmosphere
+Added: into the plants through the photosynthesis process.
+Added: When the plants are harvested, biochar is produced through the carbonization pyrolysis
+Added: process and the captured carbon dioxide is permanently preserved as carbon in the biochar product for use in water treatment and agricultural
+Added: to rules adopted under the Clean Water Act of 1972 (“Clean Water Act”), the U.S.
+Added: Environmental Protection Agency (“EPA”)
+Added: has implemented various pollution control programs such as wastewater standards for industry and recommendations for pollutants in surface
+Added: The Clean Water Act prohibits any party from discharging pollutants into a water of the United States unless they have a permit
+Added: issued under the National Pollutant Discharge Elimination System (“NPDES”), which contains limits on what a party can discharge
+Added: and establishes monitoring and reporting requirements.
+Added: On mining sites, coal operators are required to sample and test their water discharges
+Added: on a regular basis to ensure compliance with the Clean Water Act and applicable NPDES permits.
+Added: Currently, most mining operators treat
+Added: non-compliant water with temporary holding ponds and expensive chemicals such as pH adjusters, coagulants and flocculants that require
+Added: constant reapplication to ensure compliance.
+Added: Terra Preta will focus on developing a proprietary, biochar-based passive treatment system
+Added: that treats non-compliant mine site discharges to ensure compliance with the Clean Water Act and NPDES permits without the need for holding
+Added: ponds or expensive chemicals.
+Added: agriculture plays a critical role in the stability, growth, and diversification of our future food supply chain and the growth of plants
+Added: intended to serve as a carbon sink to reduce greenhouse gases.
+Added: High-quality soil, a key condition for sustainable agriculture, requires
+Added: organic matter, microorganisms, nutrients, and optimal compaction.
+Added: Subsoils with a sufficient number of air-filled pores have little
+Added: restriction to drainage and aeration, and typically are able to decompose and cycle organic matter and nutrients more efficiently.
+Added: Alternatively,
+Added: soil with poor aeration leads to the build-up of carbon dioxide, reduces the ability of plants to absorb water and nutrients, and leads
+Added: to increased plant stress and root disease.
+Added: To help address the ill effects of soil compaction, Terra Preta is developing a proprietary,
+Added: fortified biochar soil amendment that provides unique soil structuring characteristics that will allow plants to grow strong roots that
+Added: optimize the absorption of water and nutrients, thereby reducing root stress and disease.
+Added: December 2022, Terra Preta filed trademarks for biochar goods and services related to agricultural and water treatment applications, and in March 2023, filed provisional patents related to novel and innovative agricultural and water treatment solutions and designs.
+Added: Additionally, in March 2023, Terra Preta purchased two pyrolysis ovens that each produce one ton of biochar per day to advance our research
+Added: and development activities.
+Added: We are currently evaluating the purchase of a large continuous-process pyrolysis oven to increase
+Added: the scale of our biochar production to commercial levels.
+Added: Security Resources, LLC, an Ohio limited liability company (“Range Security”), is an environmental security services business
+Added: started by the Company in November 2022.
+Added: Range Security is focused on providing eco-friendly, technology-driven security services to
+Added: active and former mine sites, with a particular focus on locations transitioning from coal mining to next generation industries.
+Added: Security is intended to serve as a complementary business to the Range Reclamation Entities.
+Added: sites in the Appalachian region frequently comprise thousands of acres of natural habitat with valuable infrastructure and operating
+Added: assets disbursed across large tracts of land.
+Added: However, many of these mine sites lack adequate broadband access or cellular service, and
+Added: therefore traditional technology-based security solutions are not available.
+Added: Also, due to the large land areas and often challenging
+Added: access roads and mountainous terrain, consistent visual confirmation of the safety and security of high value assets is problematic,
+Added: and unnecessary amounts of carbon dioxide are emitted from heavy-duty trucks used to perform frequent visual security checks.
+Added: due to the remoteness and lack of technological options, most security services in the market fail to provide an independent verification
+Added: of the security status of a mine site and confirmation of visual security checks, resulting in a customer’s uncertainty regarding
+Added: the actual security services being provided.
+Added: assets commonly found on mine sites requiring high-levels of security services include office buildings, coal operation facilities
+Added: such as preparation plants and loadout facilities, power stations and electrical lines, vehicles and heavy equipment, supplies and
+Added: chemicals, and spare parts and components.
+Added: These high-value assets are frequently the target of theft since all or parts of these
+Added: assets can be easily removed from the mine site and sold for cash.
+Added: Unfortunately, the actual damage to the operation resulting from
+Added: this type of destructive theft is frequently many times the market value of the stolen item, primarily due to the losses resulting
+Added: from the down-time of operations, the cost of repairs and replacement components, and the long-term damage to critical
+Added: infrastructure that could be repurposed and used to attract next generation industries once mining is complete.
+Added: March 2023, Range Security was engaged by its first customer for environmental security services covering a 13,000-acre coal mine site
+Added: in West Virginia.
+Added: Range Security currently employs 17 security professionals, and is focusing its recruitment efforts on military veterans,
+Added: police officers, and other professionals with security experience.
+Added: Range Security has purchased two fuel-efficient utility task vehicles
+Added: for ground surveillance and a thermal-imaging drone for aerial surveillance, all of which use significantly less fuel and electricity
+Added: to operate than traditional security vehicles and provide a much broader coverage range with a substantially lower carbon footprint.
+Added: Range Security is also in the process of establishing satellite-based wireless service to support video surveillance and enable a mobile
+Added: technology solution used by our security professionals to provide real-time evidence of visual security checks.
+Added: Range Security plans
+Added: to expand its security service business onto additional mine sites, with a particular focus on locations with valuable infrastructure
+Added: being repurposed into non-coal multi-use complexes with attractive job growth prospects and next generation industry opportunities.
+Added: Land, LLC, an Ohio limited liability company (“Range Land”), is a land acquisition company started by the Company in
+Added: Range Land is focused on acquiring former mine lands with the goal of reclaiming and repurposing the sites for
+Added: non-fossil fuel uses, including commercial, industrial, residential and recreational developments.
+Added: Range Land is specifically
+Added: interested in acquiring land to be used for renewable energy facilities, innovative agricultural installations, and projects focused
+Added: on improving the quality and condition of our air, land and waterways.
+Added: to industry estimates, Appalachia contains approximately one million acres of abandoned, idled and non-performing mine sites that
+Added: are burdened with significant land reclamation and water restoration obligations.
+Added: Many of these troubled mine sites are subject to
+Added: mining permits and associated reclamation bonds, which as a result, prevents the land from being repurposed for non-mining uses
+Added: until the land has been reclaimed and the permits and bonds have been released by the applicable state’s environmental
+Added: protection department.
+Added: Water quality is a particularly challenging issue since a permit can only be released if the site has at
+Added: least 12-months of compliant water samples without active chemical treatment, which heightens the need for water restoration
+Added: solutions to help transition former mine land to economically viable non-mining uses.
+Added: Company, through its several operating businesses, has assembled the internal resources and capabilities to reclaim land, restore waterways,
+Added: install innovative water treatment solutions, and secure the mine site to protect the significant historical investment in infrastructure.
+Added: In addition to these in-house capabilities, the Company and its operating businesses also possess deep knowledge and expertise about
+Added: the permit and bond release process, which is a critical step necessary to unlock the underlying value of former mine land for non-fossil
+Added: Range Land is actively evaluating several mine sites in Appalachia to acquire, reclaim and repurpose in order to improve
+Added: the land and create non-fossil fuel economic development opportunities for disadvantaged local coal communities.
+Added: September 2023, Range Land, through its wholly-owned subsidiary CLV Azurite Land, LLC, an Ohio limited liability company (“CLV
+Added: Azurite”), acquired over 1,900 acres of surface interest at an idled mine complex in West Virginia.
+Added: CLV Azurite is in active discussions with the holder of the permits and bonds associated with the acquired land to ensure that the acquired
+Added: surface acreage can be repurposed for alternative non-fossil fuel uses.
+Added: Concurrently, CLV Azurite is in active discussions with two experienced
+Added: and well-capitalized solar developers to convert the former mine land into a large solar energy facility on a majority of the
+Added: acquired surface acreage, as well as additional acreage for commercial, industrial, recreational and residential development.
+Added: solar arrangements, CLV Azurite would be the landlord and the solar developer-operator would be the tenant required to pay CLV Azurite
+Added: a negotiated lease payment on a per acre basis.
+Added: Biosciences, Inc., a Nevada corporation (“Graphium”), is a cannabinoid-based drug development company tracing its history
+Added: of technological innovation and drug advancement back to October 2011 through two predecessor entities, Stevia First Corp.
+Added: Biopharma, Inc.
+Added: In October 2021, the Company formed Graphium as a wholly-owned subsidiary and transferred all of its drug development
+Added: assets to this newly-formed entity.
+Added: is advancing a broad portfolio of glycosylated cannabinoid prodrugs that have been developed to unlock the rebalancing effects of the
+Added: endocannabinoid system to address numerous chronic conditions with inadequate pharmaceutical options.
+Added: Graphium’s leading drug candidate,
+Added: VBX-100, is a glycosylated tetrahydrocannabinol (“THC”) cannabinoid that targets inflammatory conditions of the gastrointestinal
+Added: tract but without unwanted psychoactive or intoxicating side effects.
+Added: Cannabinoids,
+Added: including THC and cannabidiol (“CBD”), have well-known therapeutic benefits through their interaction with the human endocannabinoid
+Added: system, which serves a regulating and rebalancing function in the body.
+Added: For decades, patients have used cannabinoids to activate the
+Added: endocannabinoid system to provide relief for numerous chronic and debilitating ailments, including inflammation, pain, anxiety, depression,
+Added: However, THC, a commonly-used cannabinoid with significant therapeutic benefit, is psychoactive and intoxicating, and therefore
+Added: its use has many practical, and in some cases legal, limitations.
+Added: Nevertheless, many patients with chronic health conditions, including
+Added: gastrointestinal inflammation, continue to use cannabinoids because current pharmaceutical offerings do not provide adequate therapeutic
+Added: relief or result in unwanted side effects.
+Added: novel scientific discovery was the development of a proprietary enzymatic bioprocessing technology that adds one or more glucose molecules
+Added: to a cannabinoid, resulting in our proprietary glycosylated cannabinoid compounds.
+Added: Our glycosylated cannabinoids act as prodrugs that
+Added: achieve targeted delivery of the bioactive cannabinoids within the body once they are activated.
+Added: Prodrugs are compounds that, after administration,
+Added: are metabolized into a pharmacologically active drug and are often designed to improve drug properties and reduce known or expected toxicities
+Added: and adverse side effects.
+Added: The advantages of our glycosylated cannabinoid prodrugs may include:
+Added: (i) administration in a convenient oral
+Added: formulation, (ii) targeted delivery with release in the colon or large intestine, (iii) improved stability with limited degradation or
+Added: drug metabolism, and (iv) delayed release enabling longer-lasting effects and fewer administrations by patients.
+Added: have learned through our animal studies that glucose bound to cannabinoid molecules are inactive and poorly absorbed from the intestines,
+Added: allowing the combined molecule to reach the large intestine where glycoside hydrolase enzymes cleave the glucose and the cannabinoid
+Added: is released in a targeted and restricted manner.
+Added: Further, we have learned through our animal studies that a targeted release of THC,
+Added: which could be provided in very low doses to achieve physiologically beneficial results, serves as an anti-inflammatory agent in the
+Added: lower gastrointestinal tract and minimizes the amount of THC absorbed into the blood stream.
+Added: Therefore, we anticipate our glycosylated
+Added: cannabinoid prodrug will provide the anti-inflammatory benefits of low-dose THC while avoiding the psychoactive and intoxicating properties
+Added: that hinder the broader pharmaceutical use of THC.
+Added: Initially, we are targeting the $20 billion inflammatory bowel disease (“IBD”)
+Added: market in the United States, which is composed of patients suffering from ulcerative colitis and Crohn’s disease, both chronic
+Added: and debilitating conditions with no cure.
+Added: We also believe our glycosylated cannabinoids could also be used to treat other indications,
+Added: including, among others, irritable bowel syndrome (“IBS”), anxiety, depression, autism and cancer.
+Added: using our proprietary enzymatic bioprocessing technologies, our research team has developed a novel family of over 100 glycosylated cannabinoid
+Added: These glycosylated cannabinoids have unique commercial applications and patentable compositions of matter, which are separate
+Added: and distinct from ordinary cannabinoids.
+Added: Currently, our intellectual property is comprised of the following patents:
+Added: (i) Cannabinoid
+Added: Glycoside Prodrugs and Methods of Synthesis:
+Added: Patent filed in 2016 and granted in 2021 for the invention of novel glycosylated cannabinoids
+Added: and methods of targeted delivery for the treatment of gastrointestinal disorders, including IBD and IBS, (ii) Antimicrobial Compositions
+Added: Comprising Cannabinoids and Methods of Using the Same:
+Added: Patent filed in 2018 and granted in 2021 for the use of cannabinoids as antibiotics
+Added: for the treatment of Clostridioides difficile , (iii) Novel Cannabinoid Glycosides and Uses Thereof:
+Added: Patent filed in 2020 and in
+Added: prosecution for additional novel cannabinoid glycosides and includes research data supporting the improved characteristics and commercial
+Added: production strategies for these new molecules, and (iv) Continuous Enzymatic Perfusion Reactor System:
+Added: Patent filed in 2021 and in prosecution
+Added: for our improved reactor system for the efficient enzymatic glycosylation of hydrophobic small molecules, including cannabinoids.
+Added: believe our intellectual property portfolio of glycosylated cannabinoids possess significant value and, as a result, we have allocated
+Added: substantial resources to ensure that our U.S.
+Added: and international patents are properly filed and successfully prosecuted.
+Added: As our research
+Added: efforts involving glycosylated cannabinoids continue to progress, we plan to file additional patents to further expand our growing family
+Added: of intellectual property assets and create long-term value for our shareholders.
+Added: research team has performed 23 animal studies to test the safety, efficacy and dosing levels of our glycosylated cannabinoids, which
+Added: have provided us with favorable scientific data and the opportunity to further refine our drug development plan.
+Added: We have performed two
+Added: industry standard colitis disease mouse models:
+Added: (i) TNBS model in 2017 and 2018 that generated favorable colitis prevention data, and
+Added: (ii) DSS model in 2021 that generated favorable colitis treatment data.
+Added: In 2021, we received a letter from the Food and Drug Administration’s
+Added: (“FDA”) Office of Orphan Products Development stating that we have been granted Orphan Drug Designation for our glycosylated
+Added: cannabinoid VBX-100 for the treatment of pediatric ulcerative colitis.
+Added: An Orphan Drug Designation provides several benefits, including
+Added: fee waivers, tax credits, fast tracking of regulatory processes, and seven years of market exclusivity.
+Added: to our development of pharmaceutical products, we are subject to extensive regulation by the FDA and other federal, state, and local
+Added: Also, since we are researching and developing cannabinoid-based products, we are subject to regulation by the U.S.
+Added: Drug Enforcement
+Added: Administration (“DEA”).
+Added: Our research and development activities focus on cannabinoids, particularly THC and CBD derived from
+Added: the cannabis plant, which the DEA has classified as Schedule I substances.
+Added: Schedule I substances are defined as drugs with no currently
+Added: accepted medical use and a high potential for abuse.
+Added: In May 2019, the DEA informed us that it had determined that they consider our VBX-100
+Added: prodrug a Schedule I substance.
+Added: As a result, any developing, testing, manufacturing, or clinical studies involving our VBX-100 prodrug,
+Added: and by inference potentially all of our THC-glycoside molecules, are required to be properly licensed by the DEA and adhere to strict
+Added: diversion control standards.
+Added: are working closely with a third-party contract research organization to develop a detailed drug development plan to advance our leading
+Added: drug candidate, VBX-100, through Phase II clinical trials by the end of 2027, subject to receipt of sufficient funding, which is currently
+Added: estimated to be approximately $16.0 million.
+Added: We have engaged an investment banker to assist with an initial capital raise of $4.0 million
+Added: and are targeting a closing of that initial capital raise in 2Q 2024, with the remaining $12.0 million to be raised in 2025 once key
+Added: drug development milestones are achieved.
+Added: Company is focused on a large and growing marketplace for impact investing initiatives, and therefore, is anticipated to face competition
+Added: from a variety of operating businesses and investment funds who are developing similar business plans and operating strategies to satisfy
+Added: the increasing demands of these types of investments in the marketplace.
+Added: In many cases, these competitors are larger and better capitalized
+Added: operating businesses and investment funds.
+Added: Company competes on the basis of a number of factors, including our geographic focus on Appalachia, access to mission-driven
+Added: energy-transition capital, access to impact investing opportunities, strategic relationships with reclamation bond insurance
+Added: companies, recruitment and retention of key personnel, market share with key customers, and supply relationships with critical
+Added: Our ability to continue to compete effectively in our businesses will depend upon our ability to attract new employees and
+Added: retain and motivate our existing employees.
+Added: 2023, the Company engaged Foundation Software, LLC (“Foundation Software”) as its new accounting software provider and converted all of the Company’s accounting
+Added: system operations from QuickBooks to Foundation Software during the second quarter of 2023.
+Added: Cleveland, Ohio in 1985, Foundation Software is specifically designed for service companies, particularly those in the construction,
+Added: contracting and reclamation industries.
+Added: Foundation Software offers the Company several enhanced features critical to the successful
+Added: execution of its shareholder value creation plan, including (i) general ledger accounting, including accounts payable, accounts
+Added: receivable, inventory and customer billing, (ii) equipment tracking on job sites, maintenance, utilization and depreciation, (iii)
+Added: employee tracking on job sites, time and materials, utilization, and billing, (iv) job costing and profitability reporting segmented
+Added: by customers, job types and location, and (v) numerous real-time management dashboard and key performance indicator reports that
+Added: will allow management to closely monitor financial and operational performance and quickly react to business opportunities and
+Added: Furthermore, Foundation Software will allow the Company to quickly scale operations and efficiently and cost-effectively
+Added: support the anticipated growth of each business, thereby preventing our accounting and management systems from becoming a limiting
+Added: factor to our growth initiatives.
+Added: maintain a corporate website at:
+Added: www.rangeimpact.com.
+Added: Information contained on our website is not incorporated by reference in this Annual
+Added: We file reports with the Securities and Exchange Commission (“SEC”) and make available free-of-charge through our
+Added: website our annual reports, quarterly reports, current reports, proxy and information statements and amendments to those reports filed
+Added: or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
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.