USDA Designates Cibus’ Herbicide Tolerance Canola Trait HT2 as Not Regulated Under USDA’s Biotechnology Regulations
- Received USDA-APHIS 'not regulated' designation for HT2 trait in Canola
- Achieved milestone of 17 traits designated as not regulated
- Technology addresses critical weed resistance issues in major crops
- Shows continued regulatory momentum in US and international markets
- None.
Insights
USDA's non-regulated designation for Cibus' HT2 canola trait accelerates commercialization pathway, strengthening their position in herbicide tolerance market.
This regulatory milestone marks significant progress for Cibus' herbicide tolerance trait HT2 in canola. The USDA-APHIS designation as "not regulated" effectively removes a critical regulatory hurdle toward commercialization. This is Cibus' 17th trait to receive this designation, demonstrating consistent regulatory success with their RTDS® platform technology.
The HT2 trait addresses a pressing agricultural challenge - herbicide-resistant weeds that threaten crop yields. With increasing weed resistance to widely-used herbicides threatening farmer profitability, new herbicide tolerance systems are in high demand. This trait could provide canola growers with alternative weed management tools in a market where effective options are diminishing.
This approval follows the company's recent similar designation for disease resistance traits in canola, showing sequential regulatory progress across their trait pipeline. The regulatory momentum extends beyond the US market, as the company notes international progress as well, potentially expanding their addressable market.
Cibus' business model of developing and licensing traits to seed companies positions them to generate revenue without the capital-intensive aspects of seed production and distribution. As they accumulate more approved traits, their licensing potential grows proportionally. The company's focus on broad acre crops like canola and soybean targets large-scale commercial agriculture markets where weed management technologies can command significant value.
This action follows the USDA’s recent designation of Cibus’ disease resistance traits in Canola as not regulated, continuing Cibus’ product development momentum in the globally important Canola crop
SAN DIEGO, June 06, 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 its most recent trait for its herbicide tolerance trait (HT2) in Canola has been designated as “not regulated” by the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) Biotechnology Regulatory Services (BRS) as Plant Pests or Which There is Reason to Believe Are Plant Pests, as described in 7 CFR part 340.
Dr. Peter Beetham, Co-Founder and Interim Chief Executive Officer of Cibus, stated, “HT2 represents an advanced multi-crop herbicide tolerance trait within Cibus’ pipeline of productivity and agronomic traits aimed at providing growers newer and more advanced tools to improve weed management,” Peter added, “We are encouraged by our pace of development and look forward to working with our partners to deliver our next generation herbicide tolerance traits to the market. The recent regulatory determinations from USDA-APHIS reflects our continued positive momentum, not only in the United States, but in international markets as well.”
Consistent with other Cibus developed and advanced traits developed utilizing Cibus’ Rapid Trait Development System™ (RTDS®), this most recent USDA-APHIS regulatory determination, along with others recently announced, brings Cibus’ total number of traits designated as not regulated to seventeen.
Cibus’ traits benefit agriculture productivity and sustainability by enabling growers to improve their profitability and protect their yield. The HT2 trait in canola aims to offer a better and novel solution to address weeds resistant to widely-used herbicides. Broad acre crops like Canola and Soybean need weed management solutions that are more efficient and control weeds that can have a major effect on yield.
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
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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; and other important factors discussed in the "Risk Factors" section of Cibus' Annual Report on Form 10-K which was filed with the Securities and Exchange Commission (the "SEC") on March 21, 2024. 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
FAQ
What is the significance of USDA's 'not regulated' designation for Cibus' HT2 trait?
How many traits has Cibus (CBUS) received 'not regulated' designation for?
What problem does Cibus' HT2 trait in Canola address?
What technology does Cibus use to develop its traits?
How does the HT2 trait benefit farmers?
