San Diego, California, USA
April 24, 2025
Cibus, Inc. (Nasdaq: CBUS) (the “Company”), a leading agricultural technology company that develops and licenses plant traits to seed companies, announced today that two of its disease resistance trait products under development for canola have been designated as being not regulated by the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) Biotechnology Regulatory Services (BRS).
The two trait products reviewed by USDA-APHIS were developed utilizing Cibus’ Rapid Trait Development System™ (RTDS®) technologies that enable targeted genetic changes without integrating recombinant DNA – foreign genetic material – at any stage in the crop’s development. As a result of this designation, USDA-APHIS has confirmed the plants do not meet the definition of a “regulated article” under 7 CFR Part 340, which enables Cibus to proceed with product development without restrictions associated with regulated articles in the U.S.
“We are encouraged by USDA-APHIS’ broad designation for these traits being developed using our RTDS trait platform. The U.S. has long been a leader in regulatory modernization and this designation is yet another example of how regulatory frameworks have evolved and continue to evolve to support the promise of gene-editing technologies,” said Cibus Co-Founder and Interim Chief Executive Officer, Dr. Peter Beetham. “We are especially excited about the prospect of additional modes of action for crop diseases that will help growers lower cost and improve yields as they continue to adopt increasingly more sustainable growing practices. We remain focused on working with our customers to advance products containing these valuable traits towards commercialization.”
The USDA-APHIS confirmations are consistent with current and pending regulatory environments in many jurisdictions around the world where precision gene-edited products are or will be regulated as conventional varieties. Importantly, modernized regulatory policy for these improved breeding technologies has been advancing in many regions of the world, including the European Union (EU). In March, EU member states endorsed the EU Council's (the “Council”) negotiating mandate on the regulation of plants developed by New Genomic Techniques (NGTs), including a category of NGT products derived from gene editing that could be obtained in nature or by conventional breeding and that would be regulated similarly to conventional varieties. This important advancement enabled the Council to work with the EU Parliament and the European Commission to agree the final text of the legislation prior to formal adoption.
Cibus’ Sclerotinia resistance trait in canola offers multiple modes of action to provide durable resistance and enable farmers to improve yields and lower input costs by reducing reliance on fungicides otherwise required for controlling the disease. Sclerotinia sclerotiorum (also referred to as white mold) is a fungal pathogen that causes significant disease (stem rot) in oilseed crops and most legumes, including soybean, reducing canola yields by 7-15% with yield losses per infected plant being as great as 50%. The Canola Council of Canada considers it one of the most economically significant canola disease in Canada.
Greg Gocal, Co-Founder, Executive Vice President, and Chief Scientific Officer of Cibus, noted, “New tools are critically important as climate change continues to shift the distribution and prevalence of plant diseases, such as Sclerotinia. Importantly, we expect the application of our traits will extend to other crops like soybean, expanding benefits of these traits to additional acres and geographies.”
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