Yield10 Bioscience Files Request for Regulatory Status Review with USDA-APHIS for Camelina Designed to Produce the EPA and DHA Components of Omega-3 Oil
08 Janeiro 2024 - 10:31AM
Yield10 Bioscience, Inc. (Nasdaq:YTEN) (“Yield10” or the
“Company”), an agricultural bioscience company, today announced
that the Company recently filed a request for a Regulatory Status
Review (“RSR”) with USDA-APHIS Biotechnology Regulatory Services
(“BRS”) under the Sustainable, Ecological, Consistent, Uniform,
Responsible, Efficient (“SECURE”) Rule for proprietary elite
Camelina sativa ("Camelina”) varieties designed to produce seed oil
containing both essential omega-3 fatty acids eicosapentaenoic acid
(“EPA”) and docosahexaenoic acid (“DHA”). The genetic pathway
deployed in the omega-3 Camelina DHA1 line described in the
Company’s RSR submission produces oil containing approximately 10%
EPA and 10% DHA, closely resembling the omega-3 EPA/DHA fatty acid
profile of northern hemisphere fish oil. Yield10 is making plans to
conduct field work with omega-3 (EPA+DHA) Camelina with the goal to
begin the ramp-up of seed inventory for future planting as well as
to produce omega-3 oil for use in business development activities.
"Based on the scientific work published by the Rothamsted
Institute, including salmon feeding and human clinical trials, we
believe the Camelina omega-3 technology represents an ideal
platform for the sustainable, land-based production of high value,
omega-3 oils to address the significant potential opportunity in
the global aquafeed and human nutrition markets,” said Kristi
Snell, Ph.D., Chief Science Officer of Yield10
Bioscience. “We believe Camelina-based production of
omega-3 oil containing EPA and DHA is a promising solution to
address the ongoing shortfalls in supply of omega-3 oil from fish
oil and sustainably meet the projected increase in global demand
for omega-3 oil in the years to come. We are focused on advancing
our omega-3 oil producing Camelina along the regulatory path,
building seed inventory and engaging with potential commercial
partners.”
Background on Yield10’s Omega-3 Camelina
Program
Currently, the primary source of the essential fatty acids EPA
and DHA is ocean-caught fish, where omega-3 oil produced from
anchovy harvest is the industry benchmark. Producing omega-3 fatty
acids in Camelina represents a potential way to enable a reliable
supply of high-quality omega-3 oils to meet the global demand for
EPA and DHA. In 2020, Yield10 signed an exclusive collaboration
agreement with Rothamsted to support Rothamsted’s Flagship Program
to develop omega-3 oils in Camelina. As part of the collaboration
agreement, the Company received an exclusive option to sign a
global, exclusive license agreement for the technology. Yield10
recently announced it had exercised this option and plans to
finalize the global exclusive license with Rothamsted. Yield10
prioritized development and scale-up of EPA omega-3 Camelina and
filed an RSR for approval of this line for production in the United
States with USDA-APHIS in 2023. Yield10 planted omega-3 (EPA)
Camelina at acre-scale in Chile during the fourth quarter of 2023
to begin the ramp-up of seed inventory for future planting, as well
as to produce omega-3 (EPA) oil samples for business development
activities. Following immediately behind the EPA Camelina, Yield10
is scaling up an omega-3 Camelina line to produce oil containing
both EPA and DHA fatty acids. This line has been extensively tested
by Rothamsted and published aquafeed studies have shown that the
EPA + DHA oil produced in Camelina has the potential to serve as a
drop-in replacement for fish oil. Furthermore, published human
clinical studies have shown this oil to be an effective alternative
to fish oil in the human diet.
About the SECURE Rule
The SECURE Rule was published on May 18, 2020 and represents the
first comprehensive revision of APHIS’ biotechnology regulations
since 1987. The revisions enable APHIS to regulate organisms
developed using genetic engineering for plant pest risk with
greater precision and reduces the regulatory burden for developers
of organisms that are unlikely to pose plant pest risks. Once a
specific plant developed through genetic engineering is found not
to require regulation, new varieties of the plant containing the
same genetic modification would similarly not be regulated.
Camelina plants containing omega-3 traits are subject to regulation
by the U.S. Food and Drug Administration.
About Yield10 Bioscience
Yield10 Bioscience, Inc. ("Yield10" or the "Company") is an
agricultural bioscience company that is leveraging advanced
genetics to develop the oilseed Camelina sativa ("Camelina") as a
platform crop for large-scale production of sustainable seed
products. These seed products include feedstock oils for renewable
diesel and sustainable aviation biofuels; omega-3 (EPA and DHA+EPA)
oils for pharmaceutical, nutraceutical and aquafeed applications;
and, in the future, PHA bioplastics for use as biodegradable
bioplastics. Our commercial plan is based on establishing a grain
contracting business leveraging our proprietary elite Camelina seed
varieties, focusing on the growing demand for low-carbon intensity
feedstock oil for biofuels and omega-3 oils for nutritional
applications. Yield10 is headquartered in Woburn, MA and has a
Canadian subsidiary, Yield10 Oilseeds Inc., located in Saskatoon,
Canada.
For more information about the company, please
visit www.yield10bio.com, or follow the Company on X
(formerly Twitter), Facebook and LinkedIn.
(YTEN-G)
Safe Harbor for
Forward-Looking Statements
This press release contains forward-looking statements which are
made pursuant to the safe harbor provisions of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. The forward-looking
statements in this release do not constitute guarantees of future
performance. Investors are cautioned that statements in this press
release which are not strictly historical, including, without
limitation, statements regarding the ability of omega-3 Camelina
and the technology developed to provide sustainable alternatives to
existing means of omega-3 oil production, expectations regarding
regulatory approval for commercial production of Yield10’s Camelina
product lines, the reliability, scalability and addressable market
of omega-3 oils produced from omega-3 Camelina, and collaborations
with potential strategic partners, including the planned completion
of the global commercial license under the agreement with
Rothamsted, constitute forward-looking statements.
Such forward-looking statements are subject to a number of risks
and uncertainties that could cause actual results to differ
materially from those anticipated, including, but not limited to,
the risks and uncertainties detailed in Yield10 Bioscience's
filings with the Securities and Exchange Commission. Yield10
assumes no obligation to update any forward-looking information
contained in this press release or with respect to the matters
described herein.
Contacts: Yield10 Bioscience:Lynne H. Brum,
(617) 682-4693, LBrum@yield10bio.com
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