The U.S. Food and Drug Administration Completes Review of Cibus’ Altered Lignin Alfalfa Developed in Partnership with S&W Seed Company for use in Livestock Feed

Rhea-AI Summary

Cibus (NASDAQ: CBUS) has successfully completed the FDA's Plant Biotechnology Consultation Program for its altered lignin alfalfa trait, developed in partnership with S&W Seed Company. The FDA confirmed it has no further questions regarding the use of this gene-edited alfalfa in food or feed applications.

The altered lignin alfalfa offers two key benefits: potential improved digestibility for livestock and greater harvest timing flexibility for farmers. S&W Seed Company plans to commercialize two initial variety offerings - a fall dormancy five variety and a fall dormancy seven variety - marking the first commercial gene-edited alfalfa varieties in the United States.

Positive

• FDA approval enables U.S. commercialization of gene-edited alfalfa trait
• Product offers improved nutrient availability for livestock
• Provides farmers with greater harvest timing flexibility
• Potential for higher value alfalfa production with same inputs
• Two commercial varieties ready for immediate market launch

Negative

• None.

Insights

Agricultural Biotechnology Expert

FDA's clearance of Cibus' altered lignin alfalfa removes regulatory hurdles for commercialization, unlocking revenue potential in the livestock feed market.

The FDA's completion of its Plant Biotechnology Consultation Program for Cibus' altered lignin alfalfa represents a significant regulatory milestone that clears the path for U.S. commercialization. This is essentially the final regulatory hurdle before the product can generate revenue for Cibus and partner S&W Seed Company.

The trait technology itself offers dual value propositions: improved nutrient availability for livestock through altered lignin profiles and greater harvest timing flexibility for farmers. These benefits directly address key pain points in alfalfa production and livestock feeding operations. Lignin, which typically reduces digestibility in forages, has been altered to potentially improve feed conversion efficiency – a critical economic factor for dairy and beef producers.

The commercial readiness appears well-advanced, with S&W already prepared to launch two specific varieties (fall dormancy five and seven) immediately. This indicates the companies have moved beyond R&D into full commercialization planning, suggesting near-term revenue potential.

This development validates Cibus' trait technology platform in a real commercial application. As one of the first gene-edited alfalfa varieties to reach commercial status, this positions Cibus as a technology leader in applying precision breeding to forage crops. The regulatory clearance also establishes a precedent for Cibus' future gene-edited crop traits moving through similar approval processes.

Completion of the U.S. Food and Drug Administration’s Plant Biotechnology Consultation Program enables U.S. commercialization of alfalfa with an altered lignin profile offering potential improved digestibility for livestock and greater harvest flexibility for farmers.

SAN DIEGO, June 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 it has completed the U.S. Food and Drug Administration’s (FDA) Plant Biotechnology Consultation Program for its altered lignin alfalfa trait with the FDA notifying Cibus that it has no further questions concerning the use of altered lignin alfalfa in food or feed.

To develop altered lignin alfalfa, Cibus (formerly Calyxt, Inc.) collaborated with S&W Seed Company to identify an alfalfa trait with an altered lignin profile providing potential increased nutrient availability for livestock. This trait also gives farmers the added benefit of greater flexibility in harvest timing. The result is a higher value alfalfa produced on the same acre with the same inputs, putting greater profitability in the hands of the farmer.

Cibus Co-Founder and Interim Chief Executive Officer, Dr. Peter Beetham noted, “We are pleased to see that the FDA has reached the same conclusion as Cibus, that altered lignin alfalfa is suitable for use in food and feed applications and look forward to supporting S&W Seed Company to make this alfalfa forage quality enhancement trait available to farmers. Cibus is committed to advancing traits that not only enable farmers to maximize the value of their acreage but deliver benefits through the value chain. This is yet another example of that commitment.”

Brent Johnson, S&W Vice President of Sales & Marketing states, “S&W Seed Company is poised to offer the first commercial gene-edited alfalfa varieties to alfalfa growers in the United States. Commercial quantities will be available in two initial variety offerings, including a fall dormancy five variety and a fall dormancy seven variety. S&W Seed is excited to add this technology to our expanding trait portfolio. Seed of these two varieties will soon be made available for purchase and planting in the United States.”

The FDA has been operating the Plant Biotechnology Consultation Program since the 1990s to cooperatively work with developers of new plant varieties to help ensure foods made from their new varieties are safe and suitable for use prior to marketing. A developer who intends to commercialize food or feed from a new plant variety may meet with the agency to identify and discuss relevant product information to address any questions the FDA may have prior to going to market. In February 2024, the FDA published guidance for industry for food and feed products derived from plants developed through the use of gene editing. More on the FDA’s guidelines can be found at the following link here.

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’ long-term focus is productivity traits for farmers for the major global row crops. Cibus is not a seed company. It is a technology company that uses proprietary high-throughput gene editing technology to develop at a fraction of the time and cost of conventional breeding and to license them to seed companies in exchange for royalties on seed sales

About S&W Seed Company
Founded in 1980, S&W is a multi-crop, middle-market agricultural company headquartered in Longmont, Colorado. S&W’s vision is to be a preferred proprietary seed company that supports the growing demand for animal proteins and healthier consumer diets. S&W is a leader in sorghum seeds with significant research and development, production and distribution capabilities. S&W also has a commercial presence in proprietary alfalfa, and through a partnership, is focused on sustainable biofuel feedstocks primarily within camelina. For more information, please visit www.swseedco.com.

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 did the FDA approve for Cibus (CBUS) regarding its altered lignin alfalfa?

The FDA completed its Plant Biotechnology Consultation Program for Cibus's altered lignin alfalfa trait, confirming no further questions about its use in food or feed applications.

What are the main benefits of Cibus's altered lignin alfalfa trait?

The trait offers two main benefits: improved nutrient availability for livestock and greater harvest timing flexibility for farmers, potentially leading to higher value production.

When will S&W Seed Company launch the gene-edited alfalfa varieties?

S&W Seed Company will soon make available two varieties for purchase and planting in the United States: a fall dormancy five variety and a fall dormancy seven variety.

How does Cibus's altered lignin alfalfa benefit farmers?

The trait enables farmers to produce higher value alfalfa on the same acre with the same inputs, offering greater harvest timing flexibility and potentially increasing profitability.

What is the FDA's Plant Biotechnology Consultation Program?

It's a program operating since the 1990s where the FDA works with developers of new plant varieties to ensure foods made from their varieties are safe and suitable for use prior to marketing.