Calyxt's high fiber wheat deemed non-regulated by USDA

Calyxt, Inc. (NASDAQ:CLXT), a consumer-centric, food- and agriculture-focused company, today announced that the Company's high fiber wheat product has been declared a non-regulated article under the “Am I Regulated?” process by Biotechnology Regulatory Services of the Animal and Plant Health Inspection Service (APHIS), an agency of the United States Department of Agriculture (USDA). This is Calyxt's first consumer-centric wheat product and second wheat product (following Calyxt's powdery mildew resistant wheat, which received non-regulated status by the USDA in February 2016), and seventh product overall, to be given this designation.

“Receiving this additional USDA letter for Calyxt's high fiber wheat is an important next step in bringing to market food crops and plant based ingredients with the healthier characteristics for consumers and food companies” said Federico Tripodi, Calyxt CEO. “As fiber is essential for healthy digestion, there has been a strong demand in the market for great tasting high fiber products due to their potential to not only decrease the risk of food-related chronic diseases like coronary heart disease and diabetes but also lower cholesterol as well as control weight gain. Most adults only consume about half of the recommended amount of fiber in their diet, and a single serving of Calyxt's high fiber flour may provide the recommended daily requirement.”

Calyxt's high fiber wheat was developed using the Company's proprietary gene-editing technology, TALEN®, and does not contain any foreign DNA. With this USDA confirmation, Calyxt will now continue its trait validation in small- and large-scale field trials and food application development. According to industry sources, the wheat market in North America was estimated at 98 million tons in 2017, with approximately 43 percent used for human consumption in the U.S. While traditional white flour is losing ground, premium products including demand for fiber is estimated to grow at a compound annual growth rate of 11.6% globally.

“Once commercialized, Calyxt's high fiber wheat flour can be used by food manufacturers to produce premium bakery and pasta products that consumers regularly enjoy, like bread and macaroni, all the while allowing them to potentially reach their daily fiber requirement without changing existing food preferences,” added Manoj Sahoo, Calyxt CCO. “On top of that, Calyxt's high fiber wheat flour will have up to three times more dietary fiber than standard white flour, with enormous potential to disrupt the multi-billion-dollar industry at large.”

Calyxt's high fiber wheat is currently in Phase 1 of the development process and on track for commercialization as early as 2020/2021. This product is now part of a total of seven Calyxt products that have been deemed non-regulated by the USDA, including powdery mildew resistant wheat, high oleic soybean, high oleic / low linolenic soybean, improved quality alfalfa, cold storable potato and reduced browning potato.