RCS - Agronomics Limited - Onego Bio Update

AgronomicsAnnouncement

23/09/2025 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250923:nRSW3334Aa&default-theme=true

RNS Number : 3334A  Agronomics Limited  23 September 2025

 

Agronomics (https://agronomics.im/) Limited

("Agronomics" or the "Company")

Onego Bio Receives FDA "No Questions" Letter on GRAS Status of Bioalbumen®

San Diego, USA - September 23, 2025 - Onego Bio Limited ("Onego Bio"), a food
ingredient company producing egg protein through precision fermentation,
announced today that the U.S. Food and Drug Administration ("FDA") has issued
a "no questions" letter regarding the company's conclusion that its flagship
product, marketed as Bioalbumen®, is Generally Recognized As Safe ("GRAS")
under its conditions of use in a wide range of food and beverage applications.

The FDA's decision, communicated in response to GRAS Notice No. GRN 1249,
confirms that Bioalbumen®-a highly functional ovalbumin protein with an amino
acid sequence identical to that found in chicken eggs-can be used as a source
of dietary protein and, for example, as a foaming, gelling, and binding agent
in baked goods, beverages, meat analogs, confections, sauces, and more.

These conclusions from the FDA follows Onego Bio's recent announcement
(https://www.businesswire.com/news/home/20250312405040/en/Onego-Bio-Chooses-Jefferson-County-Wisconsin-for-Flagship-Egg-Protein-Manufacturing-Facility)
of plans to construct its flagship production facility in Jefferson County,
Wisconsin, where the company will scale Bioalbumen® manufacturing to meet
sustained high demand, ensuring uninterrupted supply at every level. This
milestone increases Onego's confidence in anchoring the facility for their
U.S. operations and supports its partnerships with leading food and beverage
companies seeking more secure and sustainable commodity ingredients.

Speaking about the announcement, Jim Mellon, Executive Chairman of Agronomics
said: "This milestone signals the beginning of what can be a hugely
significant industry in the USA. Achieving GRAS status can drive job creation
and economic growth at Onego Bio's facility in Wisconsin, as well as answer
the need from manufacturers for an ingredient which is not only sustainable,
but which can bolster supply chain security too.

The production of clean 'core' ingredients like Bioalbumin®, which have the
same benefits and functionality as the ingredients they replace, is becoming
increasingly more important as threats to supply chains, such as avian flu and
extreme weather, mount. We look forward to continuing our support for clean
food technologies such as Onego Bio, as these solutions show what a positive,
secure and sustainable food system looks like."

 

To date, Agronomics has invested a total of £7.1 million in Onego Bio which,
subject to audit, is currently carried at £11.2 million. This position
represents c.7.5% of Agronomics' last stated Net Asset Value as at 30th of
June 2025.

The full announcement is set out below without any material changes:

Onego Bio Receives FDA "No Questions" Letter on GRAS Status of Bioalbumen®

San Diego, USA- September 22, 2025 - Onego Bio, a food ingredient company
producing egg protein through precision fermentation, announced today that the
U.S. Food and Drug Administration (FDA) has issued a "no questions" letter
regarding the company's conclusion that its flagship product, marketed as
Bioalbumen®, is Generally Recognized As Safe (GRAS) under its conditions of
use in a wide range of food and beverage applications.

The FDA's decision, communicated in response to GRAS Notice No. GRN 1249,
confirms that Bioalbumen®-a highly functional ovalbumin protein with an amino
acid sequence identical to that found in chicken eggs-can be used as a source
of dietary protein and, for example, as a foaming, gelling, and binding agent
in baked goods, beverages, meat analogs, confections, sauces, and more.

Produced via precision fermentation with the filamentous fungus Trichoderma
reesei, Bioalbumen® delivers high-quality nutrition and matches the
functionality of traditional egg protein. It is designed to diversify egg
protein sources for food manufacturers, which represents a third of all eggs
produced for industrial use, providing a secure supply while reducing price
volatility and production disruptions. Additionally, supplementing the
industrial egg supply offers a strong defense against the increasing threat of
Avian Influenza on food security and public health across the U.S.

"This GRAS "no questions" letter from the FDA is an important milestone for
Onego Bio and the culmination of long-term scientific research." said Maija
Itkonen, CEO and Co-Founder of Onego Bio. "Bioalbumen® provides the same
high-quality nutrition and performance as conventional egg protein. Our U.S.
commercial and R&D team continues to sample and provide trial support to
an array of food customers ranging from craft bakeries to large scale food
manufacturers."

These conclusions from the FDA follows Onego Bio's recent announcement
(https://www.businesswire.com/news/home/20250312405040/en/Onego-Bio-Chooses-Jefferson-County-Wisconsin-for-Flagship-Egg-Protein-Manufacturing-Facility)
of plans to construct its flagship production facility in Jefferson County,
Wisconsin, where the company will scale Bioalbumen® manufacturing to meet
sustained high demand, ensuring uninterrupted supply at every level. This
milestone increases Onego's confidence in anchoring the facility for their
U.S. operations and supports its partnerships with leading food and beverage
companies seeking more secure and sustainable commodity ingredients.

"At Onego, integrity and transparency are at the heart of everything we do-our
business, our technology, our intellectual property, and our collaboration
with customers and partners," added Itkonen. "That's why we pursued the full
FDA GRAS review process. Based on that commitment, the FDA's conclusions now
confirm our right to commercialize and gives customers full confidence in
incorporating Bioalbumen ® as a reliable food solution."

About Onego Bio

Onego Bio is a food ingredient company on a mission to create a more resilient
food system through its product Bioalbumen(®)-the first non-animal egg
protein with an amino acid sequence identical to the natural protein. Made
through precision fermentation, Bioalbumen(®) matches the taste, nutrition,
and functionality of the main protein from traditional eggs with an
environmental impact around 90% smaller. Its unmatched versatility makes it
ideal across a wide range of applications, while providing greater cost and
supply stability for food manufacturers. Learn more at www.onego.bio
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.onego.bio%2F&esheet=54222529&newsitemid=20250312405040&lan=en-US&anchor=www.onego.bio&index=1&md5=2c3b4a5f822f2640eaad34d6f467cb31)
.

About Agronomics

Agronomics is a leading London-listed company focusing on investment
opportunities within the field of clean food. The Company has established a
portfolio of over 20 companies in this rapidly advancing sector. It seeks to
invest 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 and improve food security for the
world's expanding population. A full list of Agronomics' portfolio companies
is available at (https://agronomics.im/) https://agronomics.im/
(https://agronomics.im/) .

For further information, please contact:

 Agronomics Limited   Beaumont Cornish Limited  Canaccord Genuity Limited  Cavendish Capital Markets Limited  Peterhouse Capital Limited  33Seconds Limited
 The Company          Nomad                     Joint Broker               Joint Broker                       Joint Broker                Public Relations
 Jim Mellon           Roland Cornish            Andrew Potts               Giles Balleny                      Lucy Williams               Jack Ferris

 Denham Eke           James Biddle              Harry Pardoe               Michael Johnson                    Charles Goodfellow          Calum Warren-Piper

 +44 (0) 1624 639396  +44 (0) 207 628 3396      +44 (0) 207 523 8000       +44 (0) 207 397 8900               +44 (0) 207 469 0936        agronomics@33seconds.co

 info@agronomics.im

About Reach announcements

 

This is a Reach announcement. Reach is an investor communication service aimed
at assisting listed and unlisted (including AIM quoted) companies to
distribute media-only / non-regulatory news releases into the public domain.
Information required to be notified under the AIM Rules for Companies, Market
Abuse Regulation or other regulation would be disseminated as an RNS
regulatory announcement and not on Reach.

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAFLFLAAVIFFIE