USDA-APHIS Designates Additional Cibus’ Disease Resistance Trait Products as Not Regulated
Cibus (NASDAQ: CBUS) announced that the USDA-APHIS has designated two of its canola disease resistance trait products as non-regulated. These traits, developed using Cibus' Rapid Trait Development System™ (RTDS®), create targeted genetic changes without introducing foreign genetic material.
The designation allows Cibus to proceed with product development without restrictions in the U.S. The company's Sclerotinia resistance trait in canola provides multiple modes of action to combat white mold, a fungal pathogen that can reduce canola yields by 7-15%, with losses up to 50% per infected plant.
This development aligns with global regulatory modernization trends, including recent advancement in the European Union where member states endorsed regulations for New Genomic Techniques (NGTs), allowing certain gene-edited products to be regulated similarly to conventional varieties.
Cibus (NASDAQ: CBUS) ha annunciato che l’USDA-APHIS ha classificato due dei suoi prodotti con tratti di resistenza alle malattie della colza come non regolamentati. Questi tratti, sviluppati utilizzando il Rapid Trait Development System™ (RTDS®) di Cibus, generano modifiche genetiche mirate senza introdurre materiale genetico estraneo.
Questa designazione consente a Cibus di procedere con lo sviluppo del prodotto senza restrizioni negli Stati Uniti. Il tratto di resistenza alla Sclerotinia nella colza offre molteplici modalità d’azione per combattere la muffa bianca, un patogeno fungino che può ridurre la resa della colza dal 7 al 15%, con perdite fino al 50% per pianta infetta.
Questo sviluppo è in linea con le tendenze globali di modernizzazione normativa, inclusi i recenti progressi nell’Unione Europea, dove gli Stati membri hanno approvato regolamenti per le Nuove Tecniche Genomiche (NGT), permettendo a certi prodotti modificati con editing genetico di essere regolamentati in modo simile alle varietà convenzionali.
Cibus (NASDAQ: CBUS) anunció que el USDA-APHIS ha designado dos de sus productos con rasgos de resistencia a enfermedades en canola como no regulados. Estos rasgos, desarrollados mediante el Rapid Trait Development System™ (RTDS®) de Cibus, generan cambios genéticos específicos sin introducir material genético externo.
Esta designación permite a Cibus continuar con el desarrollo del producto sin restricciones en Estados Unidos. El rasgo de resistencia a la Sclerotinia en canola ofrece múltiples modos de acción para combatir el moho blanco, un patógeno fúngico que puede reducir el rendimiento de la canola entre un 7 y 15%, con pérdidas de hasta el 50% por planta infectada.
Este avance se alinea con las tendencias globales de modernización regulatoria, incluyendo el reciente progreso en la Unión Europea, donde los estados miembros aprobaron regulaciones para las Nuevas Técnicas Genómicas (NGT), permitiendo que ciertos productos editados genéticamente se regulen de manera similar a las variedades convencionales.
Cibus (NASDAQ: CBUS)는 USDA-APHIS가 자사의 카놀라 질병 저항성 형질 제품 두 가지를 비규제 대상으로 지정했다고 발표했습니다. 이 형질들은 Cibus의 Rapid Trait Development System™(RTDS®)을 사용해 개발되었으며, 외부 유전물질을 도입하지 않고 표적 유전 변화를 만듭니다.
이 지정으로 인해 Cibus는 미국 내에서 제품 개발을 제한 없이 진행할 수 있게 되었습니다. 카놀라의 Sclerotinia 저항성 형질은 흰곰팡이병이라는 균류 병원체와 싸우기 위한 다양한 작용 방식을 제공하며, 이는 카놀라 수확량을 7~15% 감소시키고 감염된 식물 당 최대 50%의 손실을 초래할 수 있습니다.
이 발전은 유럽연합을 포함한 전 세계 규제 현대화 추세와 부합하며, 유럽연합 회원국들이 신유전체기술(New Genomic Techniques, NGT)에 대한 규정을 승인하여 특정 유전자 편집 제품을 기존 품종과 유사하게 규제할 수 있도록 했습니다.
Cibus (NASDAQ : CBUS) a annoncé que l’USDA-APHIS a classé deux de ses produits de traits de résistance aux maladies du colza comme non réglementés. Ces traits, développés grâce au Rapid Trait Development System™ (RTDS®) de Cibus, induisent des modifications génétiques ciblées sans introduire de matériel génétique étranger.
Cette désignation permet à Cibus de poursuivre le développement de ses produits sans restrictions aux États-Unis. Le trait de résistance à la Sclérotinia du colza offre plusieurs modes d’action pour lutter contre la pourriture blanche, un pathogène fongique pouvant réduire les rendements de colza de 7 à 15 %, avec des pertes allant jusqu’à 50 % par plante infectée.
Cette avancée s’inscrit dans les tendances mondiales de modernisation réglementaire, notamment les récents progrès dans l’Union européenne où les États membres ont adopté des réglementations pour les Nouvelles Techniques Génomiques (NTG), permettant à certains produits issus de l’édition génomique d’être régulés de manière similaire aux variétés conventionnelles.
Cibus (NASDAQ: CBUS) gab bekannt, dass das USDA-APHIS zwei seiner krankheitsresistenten Canola-Eigenschaftsprodukte als nicht reguliert eingestuft hat. Diese Eigenschaften, entwickelt mit dem Rapid Trait Development System™ (RTDS®) von Cibus, bewirken gezielte genetische Veränderungen, ohne fremdes genetisches Material einzuführen.
Die Einstufung erlaubt Cibus, die Produktentwicklung in den USA ohne Einschränkungen fortzusetzen. Die Sclerotinia-Resistenz-Eigenschaft bei Canola bietet mehrere Wirkmechanismen zur Bekämpfung von Weißschimmel, einem Pilzpathogen, das die Canola-Erträge um 7-15 % senken kann, mit Verlusten von bis zu 50 % pro infizierter Pflanze.
Diese Entwicklung entspricht den globalen Trends zur Modernisierung der Regulierung, einschließlich der jüngsten Fortschritte in der Europäischen Union, wo die Mitgliedstaaten Regelungen für Neue Genomische Techniken (NGTs) verabschiedet haben, die bestimmte geneditierte Produkte ähnlich wie konventionelle Sorten regulieren.
- USDA-APHIS designation enables unrestricted product development in the U.S.
- Technology can be extended to multiple crops beyond canola
- Alignment with EU's regulatory modernization for gene-edited products
- Product addresses significant crop loss issue (7-15% yield reduction in canola)
- None.
Insights
USDA's non-regulated designation removes significant barriers for Cibus' canola disease traits, accelerating development in favorable global regulatory landscape.
The USDA-APHIS designation marks a significant regulatory milestone for Cibus, effectively removing critical development barriers for their canola disease resistance traits. By confirming these products don't meet the definition of "regulated articles" under 7 CFR Part 340, the company can now advance development without restrictions typically associated with transgenic crops.
This designation hinges on a crucial technical distinction: Cibus' Rapid Trait Development System (RTDS) creates targeted genetic changes without integrating recombinant DNA at any stage in development. This precision gene editing approach aligns perfectly with evolving global regulatory frameworks that increasingly distinguish these technologies from traditional GMO regulation.
The immediate practical application targets Sclerotinia (white mold), one of the most economically damaging canola diseases. The Canola Council of Canada identifies it as among the most significant threats, reducing yields by
The global regulatory context enhances this development's significance. The article notes EU regulatory modernization is progressing, with member states recently endorsing a negotiating mandate that would treat certain gene-edited products similarly to conventional varieties. This regulatory harmonization trend could substantially facilitate international commercialization pathways.
Beyond canola, Cibus indicates potential application to soybeans and other crops affected by this pathogen, potentially multiplying the commercial impact across major agricultural markets.
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
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
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
FAQ
What is the significance of USDA-APHIS' non-regulated designation for Cibus' (CBUS) canola traits?
How does Cibus' (CBUS) Sclerotinia resistance trait impact canola crop yields?
What is the market potential for Cibus' (CBUS) disease resistance traits?
How does Cibus' (CBUS) RTDS technology work in developing crop traits?
