European Union Notifies Trading Partners on the Proposal for the Regulation of Plants Obtained from New Genomic Techniques
December 01 2023 - 7:00AM
Cibus, Inc. (NASDAQ: CBUS), a leading agricultural technology
company that develops and licenses plant traits to seed companies,
acknowledges the European Union notification to World Trade
Organization (WTO) members on the European Commission proposal for
regulation of plants obtained from New Genomic Techniques (NGTs) on
31st October. The notification is intended to ensure any potential
trade barriers are avoided and invites comments from WTO members by
the year end.
The proposal is a result of a European Commission
study, requested by EU Member States, which concluded that EU GMO
legislation was not fit for purpose in relation to applications of
NGTs in plants. NGTs include a variety of gene editing techniques
leading to genetic changes classed as targeted mutagenesis and
cisgenesis.
The proposal, which is part of a package of EU
proposals to ensure resilient and sustainable use of the EU's
natural resources, describes a category of NGTs 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.
The proposal was adopted by the EU College of
Commissioners at their meeting on July 5, 2023, and is currently
under review in committees of the European Parliament and by
Ministers of Member States in the Council of the European
Union.
Recent disclosures forecast that Members of the
European Parliament are going to vote on the proposal during
January 2024. In addition, the recent EU notification proposes an
adoption date in July 2024 with additional implementing acts
required to be passed within 24 months in order for the new
legislation to become fully operational.
“The ambitious schedule for adoption set out in the
notification highlights significant progress within EU institutions
that will be welcomed by trading partners, many of whom have
introduced similar regulatory policy over the past eight years,”
said Tony Moran, Senior Vice President at Cibus, Inc.
About CibusCibus 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 the
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. Three crops:
canola, rice, and soybean; with Cibus’ five traits: pod shatter
reduction, herbicide tolerance (HT)1, HT2, HT3, and Sclerotinia
resistance make up the core of Cibus’ three-crop, five-trait model,
which is the central focus of its business. Its initial traits for
pod shatter reduction and weed management are developed an in
collaboration with leading seed companies. Its other pipeline
traits including Sclerotinia resistance are in advanced greenhouse
and field trial stages.
About the Cibus
RTDS®-based High Throughput Breeding
SystemA 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 customers’
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 back to customers their
elite germplasm with Cibus edits.
The traits from Cibus’ RTDS-based
high throughput breeding system are indistinguishable from traits
developed using conventional breeding or from nature. Under the
European Commission’s current proposal, if adopted, we expect that
products from Cibus’ RTDS gene editing platform
such as its pod shatter trait and Sclerotinia resistance traits for
canola and winter oilseed rape will 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.
Forward-Looking StatementsThis
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 the benefits of the Act, Cibus’
operational performance, and Cibus’ strategy, future operations,
prospects and plans, 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. There are many factors that could cause
Cibus’ actual results, level of activity, performance or
achievements to differ materially from those expressed or implied
by forward-looking statements, including factors related to: (i)
risks associated with the possible failure to realize certain
anticipated benefits of the transactions contemplated by the merger
(the “Transactions”), including with respect to future financial
and operating results; (ii) the effect of the completion of the
Transactions on Cibus’ business relationships, operating results
and business generally; (iii) the outcome of any litigation related
to the merger agreement or Transactions; (iv) competitive responses
to the Transactions and changes in expected or existing
competition; (v) challenges to Cibus’ intellectual property
protection and unexpected costs associated with defending Cibus’
intellectual property rights; (vi) increased or unanticipated time
and resources required for Cibus’ platform or trait product
development efforts; (vii) Cibus’ reliance on third parties in
connection with its development activities; (viii) Cibus’ ability
to effectively license its productivity traits and sustainable
ingredient products; (ix) the recognition of value in Cibus’
products by farmers, and the ability of farmers and processors to
work effectively with crops containing Cibus’ traits; (x) Cibus’
ability to produce high-quality plants and seeds cost effectively
on a large scale; (xi) Cibus’ need for additional funding to
finance its activities and challenges in obtaining additional
capital on acceptable terms, or at all; (xii) Cibus’ dependence on
distributions from Cibus Global, LLC to pay taxes and cover Cibus’
corporate and overhead expenses; (xiii) regulatory developments
that disfavour or impose significant burdens on gene-editing
processes or products; (xiv) Cibus’ ability to achieve commercial
success; (xv) commodity prices and other market risks facing the
agricultural sector; and (xvi) technological developments that
could render Cibus’ technologies obsolete. In addition to these
factors, other known and unknown risks and uncertainties may
adversely affect such forward-looking statements and cause Cibus’
actual results, performance or achievements to be materially
different from those expressed or implied by the forward-looking
statements. 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 RelationsKaren Troeber
ktroeber@cibus.com858-450-2636
Media RelationsColin Sanford
colin@bioscribe.com 203-918-4347
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