22nd Century Group (NYSE: XXII) reported Q2 EPS of ($0.03), in-line with the analyst estimate of ($0.03). Revenue for the quarter came in at $8.4 million, versus $6.4 million reported last year.

“We remain highly confident in a positive outcome for our Modified Risk Tobacco Product (MRTP) application, and based on continued engagement and very recent feedback from the FDA, we believe that our application has completed the scientific review process and is in the documentation process,” said James A. Mish, chief executive officer of 22nd Century Group. “I recognize that the delay by the FDA in authorizing our VLN® product is incredibly frustrating for all of us. Our application will be the first and likely the only MRTP for a combustible cigarette that the FDA will ever authorize, which means this is a complex process for the Agency that they want to be sure to get right. Our reduced nicotine content (RNC) cigarettes have been used in clinical studies that are estimated to have cost over $100 million funded by several U.S. federal government agencies, including the FDA. The benefits of our RNC cigarettes have been well documented and the FDA has already confirmed that they are appropriate for the protection of public health in our positive PMTA designation. We possess the expertise to have progressed this far and have the know-how to cross the finish line using all of our available tools, partners, and advocates to balance leverage and collaboration with the FDA to continue advancing the process forward to a successful conclusion.”

Mish added, “Our record second quarter and first half net sales were a result of the investments to scale-up our tobacco contract manufacturing capabilities and confirms our ability to generate new business and operate at scale ahead of VLN® launches in the U.S. and internationally.”

Mish concluded, “In our hemp/cannabis franchise, we have secured all key partnerships needed to maximize and support what we believe is the most comprehensive and innovative upstream cannabinoid value chain in the industry, enabling the rapid development of new disruptive plant lines and genetics critical to unlocking commercial success for large-scale cultivation and extraction across this emerging industry. Along with new lines currently growing at our farm in Colorado, we also have plant lines and IP completing the initial two-year development cycle. We look forward to the monetization of these lines and our current hemp/cannabis portfolio with our first revenue from our hemp/cannabis franchise expected to commence in the second half of 2021, while we continue the rapid development of next generation, disruptive plant lines for our 2022 and 2023 revenue programs.”

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