22nd Century and KeyGene achieve breakthrough in hemp/cannabis plant transformation

New Capabilities Allow 22nd Century to Accelerate Revenue Streams and Create Higher Value Commercial Lines

22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and improving health and wellness through modern plant science, announced today, together with its global plant research partner KeyGene, a breakthrough in its 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, chief executive officer of 22nd Century Group.

“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.”

Said JP Tamburrino, Vice President or Research and Development at 22nd Century Group, “This new transformation methodology leading to functional protein expression in hemp/cannabis is a key enabling technology that greatly enhances our ability to directly and quickly modify specific target genes. This unique know-how adds another important tool to our established modern plant science capabilities that also includes an extensive library of hemp and cannabis germplasm, a genome database, marker-assisted, rapid-cycle molecular breeding and mutagenesis, all supported by KeyGene’s world-class bioinformatics and genome sequencing capabilities utilizing machine learning and AI. Together, these tools, which are typically only used by the largest plant science companies such as Bayer/Monsanto, Corteva and Syngenta, are being used by 22nd Century to create new, proprietary hemp/cannabis plants tailored to differentiate the content of specific major and minor cannabinoids, terpenoids or eliminate unwanted metabolites to create new commercial lines tailored to the preferences and needs of end users, often at a fraction of the time and cost of traditional breeding methods.”

22nd Century has previously demonstrated its ability to generate new, tailored hemp/cannabis lines through broad-based techniques such as molecular breeding and mutagenesis, which necessitate the creation of hundreds or thousands of plants that are then genetically sequenced to identify those with the desired genetic traits. 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. These capabilities and IP provide 22nd Century a huge competitive advantage in the field.

Plant transformation is a means of inserting highly targeted DNA controlling desirable traits from one organism, typically another plant, into the genome of a high-value target crop. Using plant transformation in this way can improve commercially critical traits in hemp/cannabis such as cannabinoid content, yield, flavor and aroma, physical characteristics of the plant, disease resistance, stress tolerance, and nutrient production. 22nd Century’s long-standing partnerships have built an extensive genomic database to identify the markers for targeted traits and the genes that affect them, and the latest breakthrough enables the specific modulation of those traits as compared to existing methodologies that rely on large populations of modified plants to secure the desired trait.

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.

Gene modification is used extensively with other crops, such as rice, soybeans, and corn, and has led to a number of important commercial developments within those plant lines.

With control of the most comprehensive and innovative upstream cannabinoid value chain in the hemp/cannabis industry, 22nd Century is unlocking commercial success for large-scale cultivation and extraction as the hemp/cannabis industry scales with the continued success of global legalization and commercialization efforts.

22nd Century completed harvest of its first two disruptive hemp/cannabis plant lines in the fourth quarter of 2021, with additional new plant lines coming through the development pipeline for 2022 and 2023 that will expand revenue generation opportunities for years to come and creating a long growth runway.