Tag: 22nd Century Group

22nd Century Keen to Maximize 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 Reports ‘Exciting’ First Quarter

Photo: snowing12
22nd Century Group reported net sales revenue of $6.8 million for the first quarter of 2021 compared to $7.1 million in the 2020 first quarter.
Gross profit improved by $360,000 to $647 thousand; gross profit margin improved by 540 basis points. Gross profit margin improved year-over-year for the fifth consecutive quarter.
Net loss for the first quarter of 2021 was $5 million compared to $4 million in the same quarter last year. The change in net loss was driven by investment in anticipation of a modified-risk tobacco product (MRTP) designation of 22nd Century’s VLN cigarettes.
Adjusted earnings before interest, taxes, depreciation and amortization for the first quarter of 2021 was a $4.4 million loss compared to a $3.2 million loss for the first quarter of 2020.
In a press release, the company said its financial position is strong, with cash, cash equivalents and short-term investment securities totaling $30.9 million at the end of the first quarter of 2021.
“Our 2021 is off to an exciting start as we anticipate achieving multiple key milestones that will dramatically expand our commercial opportunities in both our tobacco and hemp/cannabis franchises,” said James A. Mish, CEO of 22nd Century Group.
“I remain highly confident in our MRTP authorization. We continue to steadily increase our advocacy activities at both the federal and state levels to achieve MRTP authorization in support of this critical public health issue. In addition to our primary VLN launch strategy to go to market within 90 days of authorization, we remain willing to license our technology to every cigarette manufacturer to help them join us in our efforts to reduce the harm caused by smoking and to protect future generations from ever becoming addicted to cigarettes.”
May 6, 2021
22nd Century Installs Nicotine Equipment

Photo: Nitiphol
22nd Century Group is advancing and expanding the capabilities of the laboratory at its cigarette manufacturing facility in Mocksville, North Carolina, USA, for testing of its VLN reduced nicotine content tobacco and cigarettes. The company estimates that its cost per VLN sample will improve by more than 90 percent, and the lead time for key data will take less than a day compared to using a third-party testing service that can take weeks.
“This is an important investment and milestone for 22nd Century, as it is imperative to the launch of VLN and the future of the organization that we have the ability to rapidly conduct high-precision analysis of our own products at higher testing volumes,” says James A. Mish, CEO of 22nd Century Group, in a press note.
22nd Century now has the same lab testing equipment and capabilities as outside facilities. The company is also working toward receiving ISO/IEC 17025 accreditation, which grants international recognition of an organization’s commitment to quality, competency and reliable results. This accreditation demonstrates to customers and industry that 22nd Century has the technical competence to provide reliable and accurate test results even at the lowest nicotine levels.
Earlier this year, 22nd Century announced that it significantly expanded its tobacco growing program to support the anticipated demand for its VLN cigarettes.
May 5, 2021
22nd Century Excited About Nicotine Cuts

Photo: Tobacco Reporter archive
22nd Century Group said that it is fully prepared to partner with the U.S. Food and Drug Administration (FDA) to launch its VLN reduced nicotine content cigarette brand and license its reduced nicotine content tobacco technology to every cigarette manufacturer.
Recent media reports suggest that the Biden administration is actively considering moving forward the Advance Notice of Proposed Rulemaking (ANPRM) that will require tobacco manufacturers to reduce the amount of nicotine in all combustible cigarettes sold in the United States to be “minimally or nonaddictive.”
“A nicotine cap by the FDA has been in the works since the Obama administration,” said James A. Mish, CEO of 22nd Century Group, in a statement. “During that time, 22nd Century has consistently proven beyond any doubt with our VLN cigarettes that a cigarette that contains nicotine levels that the FDA has identified as ‘minimally or nonaddictive’ is technically feasible. Moreover, given the millions of Americans who smoke and will suffer and die from cigarette addiction, this mandate is necessary and appropriate.”
“As the only company with the ability to offer a combustible tobacco product that can meet the FDA’s mandate today, we look forward to helping with this critical public health initiative.
“Numerous independent research studies—largely funded by U.S. government agencies—have consistently confirmed the benefits of implementing a mandate on reduced nicotine content cigarettes for adult smokers.
“Once this rule is in place, we are fully prepared to provide the solution by making our VLN cigarettes available to adult smokers, and we remain willing to license our technology to every cigarette manufacturer in the industry to give them the opportunity to join us in our efforts to reduce the harm caused by smoking and to protect future generations from ever becoming addicted to cigarettes.”
We are fully prepared to provide the solution by making our VLN cigarettes available to adult smokers, and we remain willing to license our technology to every cigarette manufacturer.
James A. Mish, CEO, 22nd Century Group
The ANPRM that President Biden’s administration is considering moving forward was issued in March of 2018, and the comment period closed in June of 2018. The FDA will likely issue a notice of proposed rulemaking as the next step in the rulemaking process before a final rule is published.
Made from proprietary tobacco engineered to contain 95 percent less nicotine than conventional cigarette tobacco, 22nd Century’s RNC cigarettes are the only combustible tobacco products able to meet the nicotine levels proposed in the FDA’s ANPRM for a tobacco product standard to reduce the nicotine content of all combustible cigarettes, according to 22nd Century.
The company believes that it is in the final stages of the FDA’s application process to obtain a modified-risk tobacco product designation for its reduced nicotine content cigarettes, VLN King and VLN Menthol King. The designation will allow 22nd Century to communicate key features of the products, including the claim “95 percent less nicotine.”
April 20, 2021
Major Bonuses for 22nd Century Executives

Photo: Tobacco Reporter archive
The chief executive of 22nd Century Group received $675,000 bonus, bringing his total compensation for fiscal 2020 to $1.04 million, reports The Winston-Salem Journal, citing a regulatory filing this week.
James Mish became chief executive on June 22.
22nd Century said when Mish was hired that his starting base salary would be $450,000 annually.
President and Chief Operating Officer Michael Zercher received a 26.1 percent jump in salary to $366,451. He was promoted to president during the period before Mish was hired.
Zercher received a $366,100 bonus, stock awards valued at $447,831 and total compensation of $1.21 million, up 20.3 percent.
John Franzino was hired in June as chief financial officer and treasurer. He was paid $158,213 in salary, a $125,000 bonus and total compensation of $435,248.
22nd Century reported a $19.7 million loss for fiscal 2020 compared with a $26.5 million loss in fiscal 2019. The company derives most of its revenue from producing traditional cigarettes for third-party customers.
The company is awaiting a Food and Drug Administration decision on its modified-risk tobacco product application, which would allow it to advertise products as reduced harm or reduced risk compared with traditional cigarettes.
A specialist in low-nicotine cigarettes, 22nd Century expects to benefit greatly from an FDA plan to mandate nonaddictive nicotine levels in cigarettes.
22nd Century will hold a virtual shareholder meeting on May 20.
April 9, 2021
John Pritchard Joins FDLI Committee

Photo: Ekkasit919 | Dreamstime.com
22nd Century Group Vice President of Regulatory Science John Pritchard has joined the Food and Drug Law Institute’s (FDLI) Tobacco and Nicotine Products Committee.
The committee brings together a diverse group of stakeholders, including public health researchers, leaders of nongovernmental organizations and members of the U.S. Food and Drug Administration Center for Tobacco Products, to discuss tobacco product regulation and policy.
“We are proud that John has been invited to serve on the highly regarded FDLI Tobacco and Nicotine Product Committee and to represent 22nd Century in this forum,” said James A. Mish, CEO of 22nd Century Group, in a statement.
“Our organization is fortunate to have a number of experts on our leadership team, and it is important that we play an active role in moving the tobacco industry forward to reduce the harm caused by smoking.”
“With respiratory health front and center in everyone’s minds, there has never been a more critical time to advance effective public health policy and regulation in the area of tobacco control,” said Pritchard.
“Cigarette addiction is the leading cause of preventable death in the United States and having the opportunity for multi-stakeholder dialogue is an essential part of achieving this. I have a tremendous amount of respect for the FDLI, and I look forward to contributing my experience to the organization.”
With respiratory health front and center in everyone’s minds, there has never been a more critical time to advance effective public health policy and regulation in the area of tobacco control.
John Pritchard, vice president of regulatory science, 22nd Century Group
Pritchard started in his regulatory role at 22nd Century in 2019 and brings more than 20 years of scientific and regulatory experience in the tobacco and pharmaceutical industries as well as public health experience to the committee.
April 8, 2021
22nd Century Reports Financial Results

Photo: Firmbee from Pixabay
22nd Century Group reported a gross profit of $1.4 million in 2020—an increase of 9,413 percent over the previous year. Gross profit for the fourth quarter improved by 161.8 percent to $588,000 compared to the prior-year period. The improvement in gross margin was primarily the result of higher volume, price increases and lower labor and overhead costs driven by factory efficiencies implemented in 2020.
For the fourth quarter of 2020, operating loss was unfavorable by $696,000 compared to the prior year period. This was primarily driven by an increase in selling, general and administrative expense and was partially offset by higher gross profit and lower research and development spend related to the company’s modified-risk tobacco product (MRTP) application in 2019.
For full-year 2020, operating loss improved by $4.4 million to $19.2 million compared to the prior year, driven by the combination of higher gross profit and lower total operating expenses. The decrease in operating expenses was primarily driven by a decrease in research and development expenses related to the MRTP application in 2019, a reduction in personnel expense and an intellectual property portfolio rationalization that resulted in higher impairment in the prior year.
The company reported net sales revenue of $7.3 million in the fourth quarter of 2020, up 0.6 from the comparable 2019 quarter. For full-year 2020, net sales revenue increased 8.8 percent to $28.1 million compared to the prior year. The increase for both periods was primarily driven by higher volume and increased pricing in the company’s contract manufacturing business.
We look forward to monetizing a portion of our hemp/cannabis IP this year.

James A. Mish, CEO, 22nd Century Group
“As we look to 2021, we see tremendous commercial opportunity for our tobacco and hemp/cannabis franchises,” said James A. Mish, CEO of 22nd Century Group, in a statement. “Our focus remains on our primary mission: to reduce the harm caused by smoking. Once we secure MRTP designation, we will capitalize on our VLN brand and begin to build our tobacco franchise through licensing and partnership opportunities in the U.S. and internationally.
“We have made significant progress in our hemp/cannabis research and look forward to monetizing a portion of our hemp/cannabis IP this year. With the majority of our hemp/cannabis operational partnerships now in place, we believe we will be able to commercialize our new disruptive, commercially valuable hemp/cannabis plants in development in two years.”
March 11, 2021
22nd Century to Accelerate Commercialization of Cannabis

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 Launches Cannabis Platform

Photo: cytis from 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 Moves Headquarters

Photo: Vincent Groeneveld from Pixabay
22nd Century Group is moving its corporate headquarters to the Larkinville District in Buffalo, New York, USA.
“We have experienced tremendous positive change in our organization over the past year and this relocation will help us improve on efficiency, collaboration, and our ability to attract and retain top talent,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement. “We have deep roots in Buffalo, and we are very excited to be moving to the up-and-coming Larkinville District, Buffalo’s oldest manufacturing district, to join other organizations that are revitalizing the city’s tech and business community.”
22nd Century Group’s new Buffalo office space is in a state-of-the-art, restored manufacturing facility located at 500 Seneca Street, joining other multinational technology and professional services companies. The new headquarters will accommodate all the company’s staff from its current office location in nearby Williamsville and has significant room for expansion.
The company believes that authorization of its MRTP application by the U.S. Food and Drug Administration, along with its expected growth in the hemp/cannabis space and a soon-to-be-announced third franchise, will require an expansion of resources and space. 22nd Century Group will move to its new headquarters in March 2021.
January 28, 2021