TIDMANIC
Agronomics Limited
17 November 2022
17th November 2022
Agronomics Limited
("Agronomics" or the "Company")
First Cultivated Meat Company Receives Greenlight from Regulator
FDA in the US Ahead of Commercialisation
Agronomics (LON:ANIC), the leading listed company in cellular
agriculture, is pleased to announce cultivated meat company UPSIDE
Foods, Inc. ("UPSIDE Foods"), has received a 'No Questions' letter
from the US regulatory body the US Food and Drug Administration
("FDA"), accepting their conclusion that their cultivated chicken
is safe to eat. This is a momentous achievement for UPSIDE Foods,
and a pivotal moment for the entire cultivated meat industry. This
represents the first company to achieve a greenlight from the FDA
in the US, and a validation of the sector shifting from research
and development, towards commercialisation. We expect this to be
the first of many FDA approvals for the sale of cultivated meat in
the US.
The FDA's decision is a major milestone in the evolution of the
global cultivated meat sector and another step towards the
commercialisation of cellular agriculture. The news comes almost
two years after the Singapore Food Agency (SFA) gave regulatory
approval to Eat Just's cultivated chicken, which is now sold
through its subsidiary GOOD Meat. At full-scale commercialisation,
cellular agriculture has the capacity to make a meaningful
contribution to the world's food production sustainably. It is
projected that by 2040, cultivated meat could reach 35% of the
global meat market.
This is a timely achievement for the sector given global
concerns surrounding food security and climate change, which have
come to the forefront in recent years. There is an urgent need to
adopt new methods for food production to combat these challenges.
The Company remains confident that cell culturing technologies, and
cultivated meat produced from these processes, will play a vital
role in the coming decades.
Jim Mellon, Co-Founder and Executive Director of Agronomics
commented: -
"We are extremely pleased to see the first approval of a
cultivated meat product in the US. Not only is this a massive
market, but the FDA is considered one of the most stringent
regulatory bodies globally for food safety.
This approval is a landmark event for the field of cellular
agriculture and should give investors comfort that the path to
commercialisation is now clear. We look forward to news of further
approvals from within Agronomics' leading portfolio of
companies."
The full announcement is set out below without any material
changes.
FDA Completes First Pre-Market Consultation for Human Food Made
Using
Animal Cell Culture Technology
Before Entering the U.S. Market, the Food Must Meet Other
Federal Requirements
Constituent Update
November 16, 2022
The U.S. Food and Drug Administration (FDA) completed its first
pre-market consultation for a human food made from cultured animal
cells. We evaluated the information UPSIDE Foods submitted to the
agency and have no further questions at this time about the firm's
safety conclusion. The firm will use animal cell culture technology
to take living cells from chickens and grow the cells in a
controlled environment to make the cultured animal cell food.
The FDA's pre-market consultation with the firm included an
evaluation of the firm's production process and the cultured cell
material made by the production process, including the
establishment of cell lines and cell banks, manufacturing controls,
and all components and inputs. The voluntary pre-market
consultation is not an approval process. Instead, it means that
after our careful evaluation of the data and information shared by
the firm, we have no further questions at this time about the
firm's safety conclusion.
The FDA is committed to sharing information about our oversight
of human food made from cultured animal cells and today
released:
-- The FDA's response letter to the firm
-- The FDA's scientific memo that describes our evaluation of
the data and information provided by the firm
-- The firm's own assessment that their food is safe
In addition to meeting the FDA's requirements, including
facility registration for the cell culture portion of the process,
the firm will need a grant of inspection from the United States
Department of Agriculture Food Safety and Inspection Service
(USDA-FSIS) for the manufacturing establishment. Additionally, the
food itself requires a mark of inspection from USDA-FSIS before it
can enter the U.S. market. As this product comes closer to entering
the U.S. market, we are closely coordinating with USDA-FSIS to
ensure it is properly regulated and labeled.
The FDA is ready to work with additional firms developing
cultured animal cell food and production processes to ensure their
food is safe and lawful under the Federal Food, Drug, and Cosmetic
Act. We encourage firms to have these conversations with us often
and early in their product and process development phase, well
ahead of making any submission to us. We are already engaged in
discussions with multiple firms about various types of food made
from cultured animal cells, including food made from seafood cells
that will be overseen solely by the FDA. Our goal is to support
innovation in food technologies while always maintaining as our
priority the production of safe food. Human food made with cultured
animal cells must meet the same stringent requirements, including
safety requirements, as all other food.
For More Information:
-- Human Food Made with Cultured Animal Cells
-- Press Release: FDA Spurs Innovation for Human Food from Animal Cell Culture Technology
About Agronomics
Agronomics is a leading listed alternative proteins company with
a focus on cellular agriculture and cultivated meat. The Company
has established a portfolio of 24 companies in this rapidly
advancing sector. It seeks to secure minority stakes in companies
owning technologies with defensible intellectual property that
offer new ways of producing food and materials with a focus on
products historically derived from animals. These technologies are
driving a major disruption in agriculture, offering solutions to
improve sustainability, as well as addressing human health, animal
welfare and environmental damage. This disruption will decouple
supply chains from the environment and animals, as well as being
fundamental to feeding the world's expanding population. A full
list of Agronomics' portfolio companies is available at
https://agronomics.im/ .
About Cellular Agriculture
Cellular Agriculture is the production of agriculture products
directly from cells, as opposed to raising an animal for slaughter,
or growing crops. This encompasses cell culture to produce
cultivated meat and materials, and fermentation processes that
harness a combination of molecular biology, synthetic biology,
tissue engineering and biotechnology to massively simplify
production methods in a sustainable manner.
Over the coming decades, the source of the world's food supply
traditionally derived from conventional agriculture is going to
change dramatically. We have already witnessed the first wave of
this shift with the consumer adoption of plant-based alternative
proteins but today, we are on the cusp of an even bigger wave of
change. This is being facilitated by advances in cellular
agriculture. This change is necessary, given scientists claims that
if we maintain existing animal protein consumption patterns, then
we will not meet the Paris Agreement's goal of limiting warming to
1.5 .
AT Kearney, a global consultancy firm, projects that cultivated
meat's market share will reach 35% by 2040. This combined with the
Good Food Institute's estimate that a US $1.8 trillion investment
will be required in order to produce just 10% of the world's
protein using this technology, means that we are on the cusp of a
multi-decade flow of capital to build out manufacturing facilities.
Funding in the field of cellular agriculture is accelerating,
however still less than US$ 5 billion has been invested worldwide
since the industry's inception in 2016.
For further information please contact:
Agronomics Beaumont Canaccord Cenkos Peterhouse
Limited Cornish Genuity Securities Capital TB Cardew
Limited Limited Plc Limited
The Company Nomad Joint Joint Joint Public Relations
Broker Broker Broker
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Richard Reed Roland Andrew Giles Lucy Williams
Denham Eke Cornish Potts Balleny Charles Ed Orlebar
James Harry Rees Max Gould Goodfellow Alistair Walker
Biddle Alex Aylen Michael
(Head of Johnson
Equities)
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info@agronomics.im 3396 8000 8900 0936 agronomics@tbcardew.com
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