Tag: 22nd Century Group

22nd Century Acquires Manufacturer GVB Biopharma

Photo: cendeced
22nd Century Group has acquired GVB Biopharma. As a contract development and manufacturing organization, GVB is believed to be one of the largest providers of hemp-derived active ingredients for the pharmaceutical and consumer goods industries worldwide based on total tonnage.
GVB’s strengths complement 22nd Century’s existing upstream and downstream value chains, which includes expertise in cannabinoid receptor science with CannaMetrix, plant research and proprietary genetics through its KeyGene partnership, breeding expertise with Extractas, and cultivation capabilities at Needle Rock Farms.
GVB expects 2022 revenue of approximately $48 million, a 58 percent increase year-over-year, gross margin in excess of 44 percent and positive cash flow. Upon closing, the transaction is expected to more than double 22nd Century’s revenue, be immediately accretive to adjusted EBITDA, and generate positive cash flow from the acquired assets in the near term.
“GVB represents a transformational acquisition for 22nd Century that will enable us to rapidly grow our hemp/cannabis franchise,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.
“GVB is one of the largest CBD suppliers globally, possessing innovative, vertically integrated cannabinoid product manufacturing technologies driving industry leading scale and cost efficiency. In addition to immediately expanding our hemp/cannabis franchise capabilities, GVB represents an opportunity to double our revenue and internalize a comprehensive contract manufacturing and extraction platform which can be used to directly and exclusively monetize our differentiated and proprietary hemp/cannabis plant genetics and intellectual property. We are enthusiastic to begin working with the highly regarded and very experienced management team at GVB.”
“We are excited to combine with 22nd Century group, pairing our production and manufacturing capabilities together with the best hemp/cannabis plant science in the world,” said Phillip Swindells, chief executive officer at GVB. “Since 2017, we have built a loyal customer base and continue to add new, rapidly growing customers as demand in our industry accelerates. We sold more than five billion doses of CBD in 2021, and we look forward to further scaling our business as a part of 22nd Century’s comprehensive platform.”
GVB operates three U.S. manufacturing facilities in Oregon and Nevada, including a 30,000-square-feet hemp ingredient manufacturing facility in Central Oregon, a 40,000 square-feet white-label, finished product manufacturing facility in Las Vegas, and an industrial-scale hemp extraction facility in Prineville, Oregon.
May 16, 2022
22nd Century has Cannabis Research Breakthrough

Photo: Elroi
22nd Century Group and KeyGene say they have made a breakthrough in hemp/cannabis plant research leading to the successful transformation of the hemp/cannabis plant genome using a proprietary plant transformation and regeneration technology and clear protein expression by the introduced genes.
“I cannot emphasize enough what an enormous achievement it is for our company to have cracked the code to show proof of genome transformation in the hemp/cannabis plant. This is the holy grail in plant science and places us in a commanding leadership position in the race to secure patents and other valuable intellectual property in the emerging hemp/cannabis genetics field,” said James A. Mish, CEO of 22nd Century Group, in a statement.
“These newest plant transformation discoveries unlock additional revenue opportunities for the company and accelerate our efforts to create new hemp/cannabis plant lines with much higher commercial value at accelerated rates, lower cost and lower risk to our customers.”
The plant transformation breakthrough unlocked by 22nd Century and KeyGene enables the desired DNA sequences to be inserted directly into or created from a plant’s existing genetic material, creating a more expedient and focused methodology to achieve the desired outcome.
In addition to its transformation capability, 22nd Century Group has exclusive access to a battery of gene-editing capabilities, based on meganuclease technology, directed to seven of the key enzymes for the biosynthesis of cannabinoids plus four patent families that cover vital enzymes. Unlike other more widely available gene-editing technologies like CRISPR-CAS-9, this technology is allowed for use in cannabis.
The breakthrough gene-editing and transformation technology will allow 22nd Century Group to target specific hemp/cannabis biosynthesis pathways and expand the ability to engineer the modification of cannabinoids in plants.
February 23, 2022
Bates: Selling VLN Diverts Smokers From Better Choices

Photo: 22nd Century Group
Clive Bates
The U.S. Food and Drug Administration’s decision to allow 22^nd Century Group to market its low-nicotine cigarettes as reduced-risk products will spread confusion and divert smokers from better choices, according to Clive Bates, director of The Counterfactual.
On Dec. 23, the FDA authorized the marketing of 22nd Century Group’s VLN King and VLN Menthol King combusted, filtered cigarettes as modified risk tobacco products (MRTP). As part of the MRTP designation, 22nd Century may inform consumers that smoking VLN cigarettes will considerably reduce their exposure to nicotine.
According to Bates, the FDA decision is misguided because the cigarettes retain the tar that is responsible for smoking-related illness. “We have known for a long time that ‘people smoke for the nicotine but die from the tar,’” writes Bates on his blog.
“The only value these products have in public health terms is if smokers don’t use them because they are so unsatisfying, and switch to something with lower risk. If they do use them, they are still exposed to thousands of toxins from smoke,” writes Bates. “However, the purpose of the marketing communication is precisely to encourage people to buy these products.”
If smokers want to reduce their health risks, they are far better advised to switch to a non-combustible vaping or heated tobacco product, according to Bates.
“So for health-conscious smokers, this is a diversion from a strategy that would actually help them. Instead, the authorized claims falsely promote reduced nicotine exposure as a health benefit.”
December 30, 2021
22nd Century, Aurora and Cronos License Biosynthesis IP

Photo: contentdealer
Aurora Cannabis together with 22nd Century Group announced a three-way nonexclusive agreement to license biosynthesis intellectual property to Cronos Group, intended to assist in the advancement of research and development on the biosynthesis of cannabinoids.
“We are deeply interested in the evolution of cannabinoids, and this is a promising step toward the commercialization of cannabinoid products using biosynthesis,” said Miguel Martin, CEO of Aurora. “The long-term potential for rare cannabinoid molecules produced through biosynthesis is incredibly promising given their efficient production methods and potential therapeutic benefits and utility in health, wellness and consumer products.”
“This license combines the resources and intellectual property of all three companies in this agreement intended to facilitate the commercial success of a biosynthetic approach, which complements the disruptive plant-based advancements 22nd Century and Aurora continue to develop to bring more consistent and higher yields to the hemp and cannabis industry,” said James A. Mish, CEO of 22nd Century Group, in a statement. “We believe that the availability of both plant-based and biosynthetic cannabinoids will be important to the commercial success of our industry, and this agreement positions 22nd Century, Aurora and Cronos Group with an important role in each approach.”
“Cronos Group has successfully commercialized the first cultured cannabinoid product in Canada. Licensing this intellectual property provides us with a component of the process that could allow for increased speed and efficiency in the development and commercialization of cultured cannabinoids,” said Kurt Schmidt, president and CEO of Cronos Group.

December 15, 2021
22nd Century Group Partners for Hemp/Cannabis Breeding

Photo: Ian Miller
22nd Century Group has added strategic partnerships with expert commercial-scale plant breeders Sawatch Agriculture and Folium Botanical. The partnerships with these two northern hemisphere breeders add to the breeding capabilities that 22nd Century already has through its close partnership with Aurora Cannabis and another southern hemisphere-based breeder that will be announced shortly, providing 22nd Century year-round growing capabilities.
With decades of combined specialized alkaloid plant breeding and plant biotechnology experience, these expert breeders have proven next-generation technologies and innovations on breeding, commercial scale-up and cultivation, many of which are far beyond those of independent competitive breeders or in-house breeding in consumer product companies, according to 22nd Century Group. Under 22nd Century’s direction, proprietary plants will be developed with optimum levels of cannabinoids that meet high-quality standards when grown at commercial scale.
“We are thrilled to announce the addition of these world-class alkaloid-based plant breeding specialists to complement 22nd Century’s capabilities in our upstream value chain,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.
“Our four breeding partnerships complete our portfolio of comprehensive plant science capabilities, enabling the rapid creation and scale-up of stable, tailored, highly disruptive plant lines with predictable yields critical to the mass cultivation of hemp/cannabis, which will be absolutely necessary to meet the rapidly growing market demand for improved, stable genetics.
“We are giving growers a competitive advantage by substantially improving crop yield and optimizing the time that it takes to develop new lines to a two-year cycle, a reduction from the 7 to 10 years that would typically be necessary to create new lines using our proprietary capabilities.”
With today’s announcement of these expert breeding partnerships, 22nd Century says it has secured all key partnerships needed to maximize and support each of the segments of its cannabinoid value chain: plant profiling (CannaMetrix), plant biotechnology (KeyGene), plant breeding, commercial-scale plant cultivation and ingredient extraction/purification (Sawatch Agriculture, Folium Botanical, Aurora Cannabis, Needle Rock Farms and Panacea).
July 14, 2021
22nd Century Restructures Panacea Investment

Photo: Mitch
22nd Century Group has signed a definitive agreement to restructure its strategic investment in Panacea Life Sciences in line with the ongoing development of 22nd Century’s strategic partnership network.
Under terms of the agreement, 22nd Century’s existing $7 million note in Panacea will be exchanged for ownership of Needle Rock Farms, located in a Colorado hemp/cannabis growing location and valued at $2.2 million. The company will also receive a new $4.3 million note and $500,000 in Panacea equity. The new note is backed by a mortgage on the Panacea Life Sciences operations building located in Golden, Colorado, appraised at $10.7 million. Panacea will retain certain farm assets under its own nameplate of PANA Organic Botanicals at Needle Rock.
Also under the agreement, $7 million in Panacea Life Sciences Series B Preferred Stock held by 22nd Century will be converted into 91 million shares of Exactus as part of a business combination transaction via share exchange with Panacea under which Panacea will become publicly traded. The transaction is expected to be immediately accretive to 22nd Century.
“This exchange is an exciting leap forward for 22nd Century as we advance our upstream value chain strategy to bring highly disruptive hemp and cannabis plant lines to market. It is also highly attractive to 22nd Century on a financial basis, creating immediate value, asset-backed future value and potential future liquidity from an existing investment,” said James A. Mish, CEO of 22nd Century Group, in a statement.
“Needle Rock Farms is a world-class farming operation in a prime growing location where we already have plants in the ground toward our goal of revenue recognition from our cannabis franchise in the second half of 2021. We will also retain access to Panacea’s extraction, purification and testing equipment located in Golden, Colorado, for the benefit of our customers.”
“Rapidly growing demand means that mass cultivation is quickly becoming the critical challenge in the cannabis industry. Most existing plant lines do not exhibit the stable genetics, predictable yield or specific composition of cannabinoids required to fully unlock the value of the cannabis industry,” said Mish. “22nd Century can provide the stable, predictable plant solutions required to achieve true commercial scale and do so in as little as two years versus 7 to 10 years through traditional processes.”
July 2, 2021
22nd Century Set to Maximize Cannabis Opportunities

Photo: felix brönnimann
22nd Century Group has announced new initiatives to strengthen and maximize revenue opportunities in its hemp/cannabis franchise. Included in these developments are strategic partnerships with two plant breeders in the northern and southern hemispheres, providing the company with year-round growing capabilities, close partnership activities with Aurora Cannabis, and the establishment of a newly created Canadian subsidiary.
“The addition of breeders who specialize in alkaloid-based plant cultivation to our network of strategic partnerships provides us with the competitive edge to commercialize our second-generation IP and technologies,” said James A. Mish, CEO of 22nd Century Group, in a statement. “As cannabis regulation evolves, we believe that companies able to control the traits and consistency of the plants will command a premium price and margin in the marketplace. 22nd Century is well positioned to capitalize on the tremendous potential in the global legal cannabis space by creating hemp/cannabis plants that have stable, specific cannabinoid levels at commercial scale for various end-use markets.
“As a matter of preparedness, earlier we announced a $40 million registered direct offering through Cowen and Company,” Mish continued. “Cowen is well-known as a pioneer in the cannabis institutional markets, and with this registered direct placement, 22nd Century is now squarely positioned in the mainstream of the cannabis equity space. Proceeds from this offering will be used as needed for future strategic growth opportunities as our hemp/cannabis market activity continues to increase. With the Special Equities Group as our financial advisor on this transaction to the company, we now have ample financial flexibility for this franchise as we advance our revenue-generating initiatives later this year.”
Incorporated in April 2021, 22nd Century’s Canadian subsidiary will serve as a base for the company’s expanded activities in tobacco, hemp/cannabis and its yet-to-be announced third franchise.
22nd Century Canada will also serve as a hub for expanded reduced nicotine tobacco activities in Canada, to include a possible future launch of VLN and the potential expansion of its reduced nicotine tobacco-growing programs.
June 8, 2021
22nd Century to Speed Up Marketing of Cannabis IP

Photo: Tobacco Reporter archive
22nd Century Group has secured an exclusive agreement with CannaMetrix for the use of that company’s proprietary human cell-based testing CannaMetrix EC50Array technology. The technology will enable 22nd Century to accelerate the commercialization of new disruptive hemp/cannabis plant lines and intellectual property.
Since reporting third quarter earnings, 22nd Century has refocused its hemp/cannabis strategy to target the upstream segments of the cannabinoid value chain. In particular, the company seeks to accelerate the delivery of valuable commercial-scale plant lines and intellectual property for the life science, consumer product and pharmaceutical end-use markets.
With the addition of CannaMetrix, 22nd Century has now secured four out of the five key partnerships needed to maximize each component in the upstream segment of the cannabinoid value chain: plant profiling (CannaMetrix), plant biotechnology (KeyGene), plant cultivation (Panacea-Needle Rock Farm) and ingredient extraction/purification (Panacea). The company is also in final discussions with top-tier plant breeders that will be announced soon.
“22nd Century is extremely excited to add CannaMetrix into our secured network of value chain partners to increase the speed at which we develop and offer disruptive plant lines and intellectual property for the hemp/cannabis industry. For example, a plant line that would typically take 10 years or longer to develop can now be achieved in two years,” said James A. Mish, CEO of 22nd Century Group, in a statement.
“We are thrilled to collaborate with 22nd Century Group,” stated Harold Smith, founder and CEO of CannaMetrix. “They are the ideal partner, bringing decades-long experience in plant biotechnology with unmatched ability in developing valuable commercial plant lines. We believe that through this exclusive partnership, the development of new hemp/cannabis lines for large-scale cultivation and production will advance at a rapid pace and transform the hemp/cannabis industry.”
March 3, 2021
22nd Century and KeyGene Launch Cannabis Platform

Photo: surfwiz17 | Pixabay
22nd Century Group has developed and launched a technology platform that will enable the company and its strategic partners to quickly identify and incorporate commercially valuable traits of hemp/cannabis plants to create new, stable hemp/cannabis lines. The platform incorporates a suite of proprietary molecular tools and a large library of genomic markers and gene-trait correlations. The platform was developed in collaboration with researchers at KeyGene, a global leader in plant research involving high-value genetic traits and increased crop yields.
“This is a major breakthrough. Quickly and easily identifying the genes responsible for specific traits in a plant is a powerful tool for 22nd Century Group and the hemp/cannabis industry as a whole,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.
“That is why we are even now beginning discussions to license this platform to strategic partners to help them improve their plant breeding techniques and to optimize their hemp/cannabis cultivars. We continue to make great advancements through our partnership with KeyGene, and this newly developed molecular breeding platform has the potential to result in exponential growth for the company’s revenues and create new value opportunities for our stakeholders, including shareholders.”
“Using traditional breeding techniques, it typically takes at least eight to 10 years to develop new varieties of hemp/cannabis plants that consistently express important traits,” said Juan Sanchez Tamburrino, vice president of research and development at 22nd Century Group.
“Our new molecular breeding platform can dramatically reduce our development time for new high-value varieties of hemp/cannabis and allows 22nd Century scientists to identify plant lines that carry high levels of major therapeutic cannabinoids, such as cannabidiol, cannabichromene, and other minor therapeutic cannabinoids, like cannabidivarin and tetrahydrocannabivarin.”
Demonstrating how this technology can be used, 22nd Century and KeyGene scientists can now accelerate the selection of specific traits yielding novel cannabinoid profiles. For example, the team was able to select specific markers that predict the gender of hemp/cannabis plants with 99.6 percent accuracy.
February 10, 2021
22nd Century Gets Patent for Cannabis GMO Technology

Photo: cytis from Pixabay
22nd Century Group has been granted a new U.S. patent related to the control of cannabinoid and terpene production in plants. This new intellectual property exclusively provides 22nd Century with unique and powerful tools to alter the cannabinoid biosynthesis pathway in hemp/cannabis plants.
“We are delighted to receive this patent, which is the result of work carried out by our own scientists. This important, new technology will allow us to genetically modify hemp/cannabis plants to modulate their cannabinoid and terpene profiles in order to tailor these plants’ therapeutic qualities and enhance the consumer’s hemp/cannabis experience,” said Juan Sanchez Tamburrino, vice president of research & development at 22nd Century Group in a statement.
“Our patent application describes eight promoters, which are essentially molecular on/off switches, covering all of the major steps in the cannabinoid biosynthesis pathway. Typically, developing hemp/cannabis plants with new cannabinoid or terpene profiles could take 10 to 20 years using traditional breeding methods.
“Now, with the combined technologies and know-how of 22nd Century and KeyGene, we expect to shorten the development timeline to create new, differentiated, hemp/cannabis plant lines in just four to five years. Doing so will provide the company and its potential licensees and customers with significant competitive advantage as hemp/cannabis continues to penetrate the life science, consumer product, and pharmaceutical markets.”
“At 22nd Century Group, we take a scientific and solutions-oriented approach to advancing ground-breaking, plant-based technology. We are excited to secure this patent, and we believe that it demonstrates our unique and leading role in plant science innovation within the $100 billion global hemp/cannabis market,” said James A. Mish, chief executive officer of 22nd Century Group.
The new patent, published as U.S. Patent No. 10,787,674 B2 and entitled “Trichome specific promoters for the manipulation of cannabinoids and other compounds in glandular trichomes,” enables 22nd Century to develop and deliver new hemp/cannabis plants that are designed to produce cannabinoids more efficiently.
The company can potentially increase the yield of plants, stabilize the level of cannabinoids that are produced, and create custom cannabinoid profiles optimized for specific therapeutic uses. 22nd Century will also be able to potentially modulate the terpene levels within the plant—increasing them to deliver new strains of cannabis for the adult-use/recreational market and reducing them to remove the odor and taste for improved application in foods and beverages.
Cannabinoids, such as CBD, CBC, and CBG, are valuable compounds that hold great promise for the development of new medicines and other therapeutic applications. Cannabis sativa is the only plant species that produces significant amounts of these compounds including more than one hundred different cannabinoids in varying quantities.
In nature, cannabis plants restrict production of these potentially toxic compounds to the trichomes which are tiny hair-like stems and globes that grow on the surface of the plant. To successfully manipulate cannabinoids, the company’s new technology activates molecular promoters, “on/off switches,” specifically and only in the plant’s trichomes where the majority of cannabinoids are produced.
These regulatory sequences dynamically enhance or restrict gene expression levels, controlling the expression of genetic information that leads to the production of cannabinoids.
December 17, 2020