European Parliament Votes to Support Proposal for the Regulation of New Genomic Techniques

Rhea-AI Summary

The European Parliament has voted in favor of a new regulation for plants obtained by certain new genomic techniques, aiming to increase the sustainability and resilience of the EU food system. Cibus, Inc. (Nasdaq: CBUS) welcomes the vote and applauds the EU Parliament for supporting a science-based approach. The legislation will facilitate international trade and benefit EU growers by bringing EU policy closer to that of trading partners in North and South America, UK, India, Australia, and Japan.

Insights

Agricultural Biotechnology Expert

The European Parliament's vote to advance legislation for New Genomic Techniques (NGTs) marks a significant shift in the regulatory landscape for agricultural biotechnology within the EU. The categorization of targeted mutagenesis and cisgenesis as 'Conventional-like' means that once these NGTs are verified, they could be subject to the same regulatory standards as traditional breeding methods. This has profound implications for the speed and efficiency with which new plant varieties can be developed and brought to market.

From a biotechnological perspective, this legislation could stimulate innovation and investment in the sector, as developers of NGT products, particularly those in academia and small to mid-sized enterprises, may find a more conducive environment for bringing their products to market. The potential for creating plant varieties that are more resilient to climate change, require fewer inputs and have higher yields could not only enhance the sustainability of the EU's food system but also position the EU as a competitive player in the global agricultural market.

International Trade Analyst

The alignment of EU policy on NGTs with those of key trading partners such as North and South America, the UK, India, Australia and Japan could have significant implications for international trade. By streamlining regulations and reducing barriers to the adoption of NGT products, the EU may enhance its trade relations and market access for agricultural products. This could lead to a more harmonized global regulatory framework, which is often a major hurdle for the trade of genetically modified organisms (GMOs) and related products.

For businesses and investors, this could translate into new market opportunities and potentially lower costs related to compliance and market entry. However, it is essential to monitor how this legislation will be implemented and how international partners respond, as this will determine the actual impact on trade dynamics and the competitiveness of EU agricultural exports.

Sustainability Analyst

The proposed regulation's focus on sustainability aligns with broader global trends towards more sustainable agricultural practices. By facilitating the development and adoption of plant varieties that are climate resilient and require fewer chemical inputs, the EU is addressing both environmental concerns and the long-term viability of its food systems. This approach may also resonate with consumers who are increasingly demanding more sustainably produced food.

For stakeholders, particularly investors in the agri-food sector, this move signals a growing market for sustainable agricultural technologies. It could also drive demand for investment in research and development within this space, as companies seek to leverage the regulatory changes to gain a competitive edge. The long-term benefits could include not only economic growth but also contributions to environmental sustainability and food security.

• The European Parliament completes a landmark vote in favour of the European Commission proposal to introduce a new regulation for plants obtained by certain new genomic techniques (NGTs) and their food and feed.
• The proposal aims to increase the sustainability and resilience of the EU food system by enabling the development of improved plant varieties that are climate resilient, pest resistant, that require less fertilisers and pesticides, can secure higher yields and reduce the EUs dependency on agricultural imports.
• Following the positive vote, the parliamentary team is now ready to begin interinstitutional negotiations for a final agreement with the European Council and European Commission, aligned with the Commission’s target of adoption by July.
  

SAN DIEGO, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Cibus, Inc. (Nasdaq: CBUS), a leading agricultural technology company that develops and licenses plant traits to seed companies, welcomes the vote of the European Parliament on 7^th February in favour of new legislation for New Genomic Techniques (NGTs). Cibus applauds the EU Parliament supporting a science-based approach developed following many years of discussion and engagement with stakeholders and expert groups.

The EU Parliament met 5-8 February in Strasbourg and, following a debate on Tuesday Feb 6^th, the Parliament voted in favour of the NGT legislation the following day. Parliamentary negotiators now have a mandate to engage in 3-way discussions with the EU Council and the European Commission to agree on the final text of the legislation prior to formal adoption.

The legislation is part of a package of measures designed to ensure the sustainable use of natural resources and to strengthen the resilience of EU food systems. It describes a category of NGTs, classed as targeted mutagenesis and cisgenesis, producing modifications that could be obtained in nature or by conventional breeding. These are determined to be ‘Conventional-like’ and, once verified, would be regulated in the same way as conventional varieties.

In addition to enabling EU growers to benefit from improved varieties, the proposed regulation would also help facilitate international trade by bringing EU policy closer to that of trading partners in North and South America, UK, India, Australia, and Japan.

MEP and rapporteur Jessica Polfjärd said of the vote, “Historic step forward: the European Parliament supports my proposal for sustainable use of new genomic techniques (NGT). A game changer for sustainable agriculture and a clear signal that we embrace science and support our farmers.”

“The parliamentary vote is a significant milestone in the EU legislative process providing a welcome boost to innovators particularly in academia and small and mid-sized enterprises developing NGT products that can contribute to a sustainable EU agri-food system,” commented Tony Moran, Senior Vice President of International Development and Government Affairs at Cibus.

“This is a pivotal moment in the development of a sustainable global food supply system. The promise of gene editing is its ability to address major challenges of farming such as disease, insects and a globally changing environment with greater speed and precision with traits that are indistinguishable from conventional breeding. This vote continues a global alignment to regulate certain gene editing applications as conventional and to enable this revolution to help farmers,” stated Rory Riggs CEO of Cibus.

About the Cibus RTDS®-based High Throughput Breeding System

A key element of Cibus’ technology breakthrough is its High Throughput Breeding Process (referred to as the Trait Machine™ system). 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: 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 Trait Machine platforms 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 use any foreign DNA or transgenes. Under the European Commission 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.”

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 the major global crops such as canola, 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. Using its Trait Machine Process, Cibus has developed a pipeline of five productivity traits including important traits for pod shatter reduction, Sclerotinia resistance and weed management. Its initial traits for pod shatter reduction and weed management are developed in collaborations with leading seed companies. Its other pipeline traits including Sclerotinia resistance are in advanced greenhouse and field trial stages.

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’ strategy, future operations, prospects and plans, including the anticipated regulatory environment are forward-looking statements. 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: 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; challenges that arise in respect of Cibus’ production of high-quality plants and seeds cost effectively on a large scale; Cibus’ need for additional funding to finance its activities and challenges in obtaining additional capital on acceptable terms, or at all; 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; 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 “Risk Factors of Cibus, Inc.” filed as Exhibit 99.3 with Cibus’ Current Report on Form 8-K, which was filed with the Securities and Exchange Commission (the “SEC”) on June 1, 2023, as updated by the supplemental risk factors included in the Company's Current Reports on Form 8-K filed on October 18, 2023 and December 12, 2023, each as may be updated by any additional “Risk Factors” identified in Cibus’ subsequent reports on Forms 10-Q and 8-K filed with the SEC. 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. Cibus’ assessment of the period of time through which its financial resources will be adequate to support its operations is a forward-looking statement and involves such risks and uncertainties. Accordingly, the Company could use its available capital resources sooner than it currently expects.

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

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

FAQ

What is the purpose of the new regulation for plants obtained by certain new genomic techniques (NGTs) proposed by the European Commission?

The purpose is to increase the sustainability and resilience of the EU food system by enabling the development of improved plant varieties that are climate resilient, pest resistant, require less fertilizers and pesticides, can secure higher yields, and reduce the EU's dependency on agricultural imports.

What is the ticker symbol for Cibus, Inc.?

The ticker symbol for Cibus, Inc. is CBUS.

What is the significance of the European Parliament's vote for Cibus, Inc.?

The vote is significant as it supports a science-based approach and will facilitate international trade, benefiting EU growers and bringing EU policy closer to that of trading partners in North and South America, UK, India, Australia, and Japan.

Who is the Senior Vice President of International Development and Government Affairs at Cibus, Inc.?

Tony Moran is the Senior Vice President of International Development and Government Affairs at Cibus, Inc.

What is the CEO's statement regarding the vote by the European Parliament?

Rory Riggs, the CEO of Cibus, stated that the vote continues a global alignment to regulate certain gene editing applications as conventional and to enable this revolution to help farmers.