Yield10 Bioscience files request for Regulatory Status Review under USDA-APHIS’s SECURE Rule covering elite Camelina designed to produce the EPA component of omega-3 oil

Date:07-27-2023

Yield10 Bioscience, Inc. (Nasdaq:YTEN) (″Yield10″ or the ″Company″), an agricultural bioscience company, announced that the Company recently filed a request for a Regulatory Status Review (RSR) with USDA-APHIS Biotechnology Regulatory Services (BRS) under the SECURE Rule for proprietary elite Camelina varieties containing genes enabling the plant to produce the eicosapentaenoic acid (″EPA″) component of omega-3 oil. In spring 2023, Yield10 planted omega-3 (EPA) Camelina at acre-scale in the U.S. to begin the ramp up of seed inventory for future planting as well as to produce oil for use in business development activities.  

″We believe that Camelina represents an ideal platform for the sustainable, land-based production of high value, omega-3 oils targeting the significant market opportunity in animal feed and human nutrition,″ said Kristi Snell, Ph.D., Chief Science Officer of Yield10 Bioscience. ″This RSR filing is a key milestone for our team as we execute our strategy to develop Camelina for large-scale production of omega-3 oils. As we await the response to our RSR filing, we remain focused on conducting seed scale-up activities to generate seed inventory for regulatory activities and future grower contracts.″

Camelina containing the omega-3 EPA trait growing at acre-scale in the U.S. in spring 2023.

In late 2020, Yield10 signed a collaboration agreement with UK-based Rothamsted Research to support the development of omega-3 oils in Camelina. In addition, Yield10 signed an exclusive option to sign a global, exclusive or non-exclusive license agreement to the Rothamsted omega-3 technology. Yield10 has prioritized the deployment of the EPA component of omega-3 in Camelina as the initial oil profile for commercialization. Yield10 also plans to produce the EPA component of omega-3 co-deployed in Camelina with its advanced technology for a robust trait package including herbicide tolerance. The Company plans to follow this with the development of advanced EPA plus docosahexaenoic acid (″DHA″) producing Camelina varieties.

About the EPA component of Omega-3 oil

EPA is a polyunsaturated fat (PUFA) that is primarily supplied in the human diet by the consumption of oily fish such as salmon, anchovies, and mackerel. Fish obtain EPA through the consumption of algae. Clinical studies have shown that EPA is beneficial to humans as it lowers triglycerides and reduces low-density lipoprotein (LDL cholesterol) in the blood with beneficial cardiovascular effects. Using Camelina to produce EPA may represent a way to produce this beneficial ingredient without relying on the harvest of ocean fish. Several commercial products containing EPA fatty acids are available on the market including pharmaceuticals, nutritional supplements, and animal feed.

About the SECURE Rule

The SECURE Rule was published on May 18, 2020 and represents the first comprehensive revision of APHIS’ biotechnology regulations since 1987. The revisions enable APHIS to regulate organisms developed using genetic engineering for plant pest risk with greater precision and reduces the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. Once a specific plant developed through genetic engineering is found not to require regulation, new varieties of the plant containing the same genetic modification would similarly not be regulated. Camelina plants containing omega-3 traits are subject to regulation by the U.S. Food and Drug Administration.