Designation confirms conventional regulation of Cibus traits in the U.S. as modernized regulatory policy for precision gene editing breeding technologies continues to advance globally
SAN DIEGO, April 24, 2025 (GLOBE NEWSWIRE) — 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.”
About Cibus
Cibus is a leader in gene edited productivity traits that address critical productivity and sustainability challenges for farmers such as diseases and pests which the United Nations estimates cost the global economy approximately $300 billion annually. Cibus is not a seed company. It is a technology company that uses gene editing to develop and license traits to seed companies in exchange for royalties on seed sales. Cibus’ long-term focus is productivity traits for farmers for the major global row crops with large acreage such as canola, rice, and soybean. Cibus is a technology leader in high-throughput gene editing technology that is expected to enable it to develop and commercialize plant traits at a fraction of the time and cost of conventional breeding. Cibus has developed a current pipeline of five productivity traits including important traits for weed management in rice, pod shatter reduction, and Sclerotinia (disease) resistance, which are its near-term focus.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of applicable securities laws, including The Private Securities Litigation Reform Act of 1995. All statements, other than statements of present or historical fact included herein, including statements regarding Cibus’ operational and financial performance, Cibus’ liquidity and capital resources, the implementation and execution of cost savings initiatives, Cibus’ strategy, future operations, prospects, and plans, including the anticipated receipt of commercial revenues and additional funding, are forward-looking statements. Cibus’ assessment of the period of time through which its financial resources will be adequate to support its operations is a forward-looking statement. Because this involves such risks and uncertainties, the Company could use its available capital resources sooner than it currently expects. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “intend,” “expect,” “plan,” “scheduled,” “could,” “would” and “will,” or the negative of these and similar expressions.
These forward-looking statements are based on the current expectations and assumptions of Cibus’ management about future events, which are based on currently available information. These forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and beyond the control of Cibus. Cibus’ actual results, level of activity, performance, or achievements could be materially different than those expressed, implied, or anticipated by forward-looking statements due to a variety of factors, including, but not limited to: Cibus’ need for additional near-term funding to finance its activities and challenges in obtaining additional capital on acceptable terms, or at all; changes in expected or existing competition; challenges to Cibus’ intellectual property protection and unexpected costs associated with defending intellectual property rights; increased or unanticipated time and resources required for Cibus’ platform or trait product development efforts; Cibus’ reliance on third parties in connection with its development activities; challenges associated with Cibus’ ability to effectively license its productivity traits and sustainable ingredient products; the risk that farmers do not recognize the value in germplasm containing Cibus’ traits or that farmers and processors fail to work effectively with crops containing Cibus’ traits; delays or disruptions in the Company’s platform or trait product development efforts, particularly with respect to its non-Rice and non-disease projects in light of the Company’s realigned strategic priorities; challenges that arise in respect of Cibus’ production of high-quality plants and seeds cost effectively on a large scale; Cibus’ dependence on distributions from Cibus Global, LLC to pay taxes and cover its corporate and overhead expenses; regulatory developments that disfavor or impose significant burdens on gene-editing processes or products; delays and uncertainties regarding regulatory developments in the European Union; Cibus’ ability to achieve commercial success; commodity prices and other market risks facing the agricultural sector; technological developments that could render Cibus’ technologies obsolete; changes in macroeconomic and market conditions, including inflation, supply chain constraints, and rising interest rates; dislocations in the capital markets and challenges in accessing liquidity and the impact of such liquidity challenges on Cibus’ ability to execute on its business plan; the Company’s assessment of the period of time through which its financial resources will be adequate to support operations; and other important factors discussed in the “Risk Factors” section of Cibus’ Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 20, 2025. Should one or more of these risks or uncertainties occur, or should underlying assumptions prove incorrect, actual results and plans could differ materially from those expressed in any forward-looking statements.
In addition, the forward-looking statements included in this press release represent Cibus’ views as of the date hereof. Cibus specifically disclaims any obligation to update such forward-looking statements in the future, except as required under applicable law. These forward-looking statements should not be relied upon as representing Cibus’ views as of any date subsequent to the date hereof.
CIBUS CONTACTS:
INVESTOR RELATIONS
Karen Troeber
ktroeber@cibus.com
858-450-2636
Jeff Sonnek – ICR
jeff.sonnek@icrinc.com
MEDIA RELATIONS
media@cibus.com
Colin Sanford
colin@bioscribe.com
203-918-4347
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