Canada Added to a Growing List of Countries Regulating Cibus’ Gene Editing Technologies Similar to Conventional Breeding

Rhea-AI Summary

Cibus (Nasdaq: CBUS), a leader in agricultural biotechnology, commends the Canadian Food Inspection Agency (CFIA) for updating its feed guidelines to regulate plants developed using gene editing, similar to conventional breeding. The guideline revision is part of a global trend, including the UK and EU, recognizing gene editing technologies like Cibus' RTDS® as safe and equivalent to traditional breeding methods. Cibus' RTDS platform aims to enhance global food productivity and sustainability. These guidelines are important for innovation and investment in Canada's agri-food sector, particularly for crops like canola. Cibus is progressing towards commercializing its Pod Shatter Reduction trait in canola, promising yield protection for Canadian farmers.

Positive

• CFIA guidelines provide regulatory clarity for gene-edited plants.
• Regulations endorse Cibus' RTDS technology as safe as conventional breeding.
• Canada joins a list of countries supporting gene editing, potentially boosting global acceptance.
• Cibus' RTDS platform offers opportunities to improve food productivity and sustainability.
• New guidelines may attract continued innovation and investment in Canada's agri-food industry.
• Cibus is advancing commercialization of its Pod Shatter Reduction trait in canola.

Negative

• Press release does not mention any immediate financial gains or profits.
• No details provided on potential regulatory hurdles or delays in other key markets.
• Does not address any potential risks or challenges in commercializing the RTDS technology.
• Lack of concrete timelines for commercialization of the Pod Shatter Reduction trait.

Cibus Applauds the Canadian Food Inspection Agency’s (CFIA) New Guidelines for Plants Developed Using Gene Editing

SAN DIEGO, May 15, 2024 (GLOBE NEWSWIRE) -- Cibus, Inc. (Nasdaq: CBUS) (the "Company"), a leading agricultural biotechnology company that uses proprietary gene editing technologies to develop plant traits (or specific genetic characteristics) in seeds, applauds the Canadian Food Inspection Agency (CFIA), Animal Feed Division’s publication of its updated feed guidelines clarifying requirements for new plant varieties developed using applications of gene editing. The guidelines confirm that CFIA intends to follow a product, rather than process-based, approach to regulation and adds Canada to a growing list of countries that have endorsed policies that will regulate Cibus' Rapid Trait Development System™ (RTDS^®) gene editing technologies similar to conventional breeding.

“Canada is an important and respected voice in the global landscape of plant biotechnology regulation. This development continues the positive global momentum with more and more governments regulating products from gene editing like those developed through conventional breeding techniques. We are encouraged to see jurisdictions like Canada, the United Kingdom, European Union and others put forward guidelines and legislation that recognize technological advancements like RTDS as equivalent to conventional breeding in terms of safety. Innovations like Cibus’ RTDS platform provide an incredible opportunity to enhance the productivity and sustainability of the global food system,” said Norm Sissons, Cibus Senior Vice President, Seeds & Traits.

With the latest guidelines from CFIA, Canada continues to demonstrate its global leadership in the implementation of pragmatic, science-based policy for the regulation of plants developed using gene editing. Along with previously published guidelines from Health Canada and the CFIA Plant Biosafety Office (PBO), the regulatory approach outlined by the CFIA Animal Feed Division provides much-needed clarity to the agri-food industry and will enable continued innovation and investment in the Canadian market and beyond.

For instance, canola is one of the crop platforms enabled by RTDS making Canada a key cultivation region for Cibus Powered™ traits. Along with its commercial partners, Cibus is moving towards the commercialization of its Pod Shatter Reduction trait in canola which is poised to provide durable yield protection for Canadian growers.

About the Cibus Trait Machine™ process and Rapid Trait Development System™

A key element of Cibus' technology breakthrough is its high-throughput breeding process (referred to as the "Trait Machine™" process). The Trait Machine process is a crop specific application of Cibus' patented Rapid Trait Development System™ (RTDS^®). The proprietary technologies in RTDS integrate crop specific cell biology platforms with a series of gene editing technologies to enable a system of end-to-end crop specific precision breeding. It is the core technology platform for Cibus' Trait Machine process: the first standardized end-to-end semi-automated crop specific gene editing system that directly edits a seed company's elite germplasm. Each Trait Machine process requires a crop specific cell biology platform that enables Cibus to edit a single cell from a customer's elite germplasm and grow that edited cell into a plant with the Cibus edits. Cibus has a Trait Machine process developed for canola and rice and has already begun transferring their elite germplasm with Cibus edits back to customers.

The traits from Cibus' RTDS-based high-throughput breeding system are indistinguishable from traits developed using conventional breeding or from nature. RTDS does not integrate any foreign DNA or transgenes. Under the European Commission's current proposals, it is expected that products from Cibus' RTDS gene editing platform such as its Pod Shatter Reduction trait and Sclerotinia resistance traits for Canola and Winter Oilseed Rape would be considered 'Conventional-like'.

Cibus believes that RTDS and the Trait Machine process represent the technological breakthrough in plant breeding that is the ultimate promise of plant gene editing: "high- throughput gene editing systems operating as an extension of seed company breeding programs." In 2024, the Trait Machine process was cited by Fast Company Magazine as one of the most innovative products in 2024.

Because the Trait Machine process is intended to be integrated into seed companies' breeding operations, the customer relationship between Cibus and seed companies with which it engages is a collaborative relationship in which seed companies transfer elite germplasm to have a specific validated trait placed in the seed company's elite germplasm and expectation of delivery back to the seed company of their elite germplasm with the Cibus edit toward commercial development. Accordingly, Cibus refers to seed company "customers" in its disclosure once such a customer relationship has been initiated.

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' focus is productivity traits for farmers for the major global row crops with large acreage such as canola, corn, rice, soybean, and wheat. Cibus is a technology leader in high throughput gene editing technology that enables Cibus to develop and commercialize plant traits at a fraction of the time and cost of conventional breeding. Cibus has developed a pipeline of five productivity traits including important traits for Pod Shatter Reduction, Sclerotinia (disease) resistance, and weed management. Its initial traits for Pod Shatter Reduction and weed management are in commercial development with leading seed companies such as Nuseed Americas Inc. in Canola as well as Nutrien Ltd. and Interoc S.A. in Rice in the United States and Latin America. Its other pipeline traits including Sclerotinia resistance are in advanced greenhouse and field trials stages.

CIBUS CONTACTS:

INVESTOR RELATIONS
Karen Troeber
ktroeber@cibus.com
858-450-2636
Jeff Sonnek – ICR
jeff.sonnek@icrinc.com

MEDIA RELATIONS
Colin Sanford
colin@bioscribe.com
203-918-4347

FAQ

What are the new CFIA guidelines for gene editing?

The new CFIA guidelines regulate gene-edited plants similar to conventional breeding, providing clarity for the agri-food industry.

What is Cibus' RTDS technology?

Cibus' RTDS (Rapid Trait Development System) is a gene editing technology used to develop specific plant traits.

How does the CFIA guideline impact Cibus' technology?

The CFIA guidelines endorse RTDS technology as safe and equivalent to conventional breeding, potentially boosting global acceptance.

Which crops are affected by Cibus' RTDS technology in Canada?

Canola is a key crop affected, with Cibus developing a Pod Shatter Reduction trait to enhance yield protection.

What is the significance of Canada regulating gene editing like conventional breeding?

It aligns Canada with global trends, potentially encouraging innovation and investment in the agri-food sector.