REG-4basebio Plc: 4basebio Receives GMP Licence for its UK DNA Manufacturing Facility

4BasebioAnnouncement

02/04/2025 07:04

2 April 2025

   
     


4basebio PLC

("4basebio" or the "Company")

4basebio Receives GMP Licence for its UK DNA Manufacturing Facility

Cambridge, UK, 2 April 2025 – 4basebio PLC (AIM: 4BB), an innovation-led
provider of novel synthetic DNA products and a non-viral, thermostable nucleic
acid delivery platform, today announced that it has received Good
Manufacturing Practice (GMP) certification from the UK’s Medicines and
Healthcare Products Regulatory Agency (MHRA) for its UK DNA manufacturing
facility.

The GMP certification (MIA) granted by the MHRA authorises 4basebio to
manufacture and supply both Investigational Medicinal Product (IMP) Drug
Substance (Active Pharmaceutical Ingredient; API) and Critical Starting
Biological Medicinal materials used in Advanced Therapy Medicinal Products
(ATMPs) from its state-of-the-art manufacturing facility in Cambridge.

The grant of the GMP certification marks a significant achievement for the
Company, proving its ability to produce high-quality, advanced synthetic DNA
that meets regulatory standards for clinical applications. The certification
both strengthens the Company’s position in the field of advanced
therapeutics and progresses the Company towards future product
commercialisation and patient care for a range of advanced therapies.

Heikki Lanckriet, CEO of 4basebio, commented, “Achieving GMP certification
is a critical milestone for 4basebio, validates our ability to supply
synthetic DNA for clinical applications and underscores the hard work and
innovation of our team and sets the stage for the next phase of growth for the
Company.”

This announcement contains inside information for the purposes of Article 7 of
EU Regulation 596/2014 as amended by regulation 11 of the market abuse
(amendment) (EU Exit) regulations 2019/310.

For further enquiries, please contact:

 4basebio PLC Dr. Heikki Lanckriet, CEO                                                              +44 (0)1223 967 943  
 Nominated Adviser        Cairn Financial Advisers LLP Jo Tuner / Sandy Jamieson / Ed Downes         +44 (0)20 7213 0880  
 Joint Broker RBC Capital Markets Rupert Walford / Max Avison / Kathryn Deegan                       +44 (0)20 7653 4000  
 Joint Broker Cavendish Capital Markets Limited Geoff Nash / Nigel Birks                             +44 (0)20 7220 0500  

Notes to Editors

About 4basebio

4basebio (AIM: 4BB) is an innovation driven life biotechnology company focused
on accelerating the development of advanced therapy medicinal products (ATMPs)
through its high-performance synthetic DNA products and non-viral, cell
targeting nucleic acid delivery platform. The Company’s objective is to
become a market leader in the manufacture and supply of high-quality synthetic
DNA products for research, therapeutic and pharmacological use as well as
development of target specific non-viral vectors for the efficient delivery of
payloads in patients.

Forward-looking statements

This announcement may contain certain statements about the future outlook for
4basebio.  Although the directors believe their expectations are based on
reasonable assumptions, any statements about future outlook may be influenced
by factors that could cause actual outcomes and results to be materially
different.



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