— FDA Accepts Conclusion That Trait Protein Is Safe for Humans and Animals —
DAVIS, Calif. (July 19, 2017) – Arcadia Biosciences, Inc. (Nasdaq: RKDA), an agricultural technology company that develops and commercializes plant traits and products that improve farm economics and benefit the environment and human health, announced that the U.S. Food and Drug Administration (FDA) has accepted an Early Food Safety Evaluation (EFSE) for the company’s water use efficiency (WUE) trait. The EFSE is now applicable to all plant species that feature this trait.
The EFSE concluded that the functional protein for the WUE trait, isopentenyl transferase (IPT), is safe for humans and animals and would not raise food safety concerns if present in the food supply. This approval is an assurance of safety for WUE crops currently under development and being tested in the field and will expedite the regulatory approvals for this trait. Greenhouse and field trials of the WUE trait have been completed in agronomic crops such as rice, wheat, cotton, peanuts and alfalfa, and Arcadia is currently working with collaborators in rice, potato, sugarcane, cotton and multiple tree species.
The irregular availability of suitable water is a leading cause of reduced crop yield globally. Harvest loss due to drought in the United States, as reported to the USDA Risk Management Agency, averaged $4.1 billion per year from 2012 through 2016. Arcadia’s WUE trait was developed to help farmers withstand the varying environmental effects of climate change while expanding the range of usable acreage for crop production. In multiple years of field trials, Arcadia’s WUE trait has demonstrated improved crop yields under conditions of episodic water stress and has been shown to help crops recover from severe drought conditions.
“The FDA’s completion of its evaluation of Arcadia’s WUE trait allows us to expedite the development of our drought tolerance portfolio,” said Raj Ketkar, president and CEO of Arcadia Biosciences. “This approval reflects Arcadia’s strong regulatory capabilities and our commitment to helping growers reduce the negative impact of water stress and improve on-farm economics.”
The African Agricultural Technology Foundation (AATF) supported the EFSE study through funds from USAID’s “Feed the Future” initiative. The data provided in support of the EFSE are consistent with international regulatory requirements for genetically modified crops and will provide Arcadia and its global partners with the basis for future regulatory submittals.
Arcadia’s WUE trait technology was jointly discovered by researchers at the University of California, Davis and Technion—Israel Institute of Technology. Arcadia holds an exclusive, global license to the technology, with sublicense rights, for use in all crops.
About Arcadia Biosciences, Inc. Based in Davis, Calif., Arcadia Biosciences (Nasdaq: RKDA) develops agricultural products that create added value for farmers while benefitting the environment and enhancing human health. Arcadia’s agronomic performance traits, including Nitrogen Use Efficiency, Water Use Efficiency, Salinity Tolerance, Heat Tolerance and Herbicide Tolerance, are all aimed at making agricultural production more economically efficient and environmentally sound. Arcadia’s nutrition traits and products are aimed at creating healthier ingredients and whole foods with lower production costs. For more information, visit www.arcadiabio.com.
Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to Arcadia’s WUE trait and the regulatory process for such trait. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: Arcadia’s and its partners’ ability to develop commercial products incorporating its traits, including the WUE trait, and complete the regulatory review process for such products; Arcadia’s compliance with laws and regulations that impact the company’s business, and changes to such laws and regulations; Arcadia’s future capital requirements and ability to satisfy its capital needs; and the other risks set forth in Arcadia’s filings with the Securities and Exchange Commission from time to time, including the risks set forth in Arcadia’s Annual Report on Form 10-K for the year ended December 31, 2016 and other filings. These forward-looking statements speak only as of the date hereof, and Arcadia Biosciences, Inc. disclaims any obligation to update these forward-looking statements.