4basebio Plc Regulatory News (4BB)

4basebio Plc - Development of GMP Manufacturing Capacity

PR Newswire

London, September 27

4basebio PLC

("4basebio", the "Company" or the “Group”)

Development of GMP manufacturing capacity

4basebio PLC (AIM: 4BB), the specialist life sciences group focused on exploiting intellectual property in the field of cell and gene therapies and DNA vaccines, is pleased to announce that it has commenced the development of its pilot clean room project for the purpose of manufacturing GMP standard DNA.

The manufacturing capacity is being developed in a dedicated 4,400 square feet facility (“the Facility”) with the installation expected to be completed before the end of 2021. The Facility will provide for seven DNA production suites which, when fully operational, will be capable of generating quantities of DNA with a value in excess of £25 million per annum (based on current market prices and depending on customer order batch sizes).

Once completed, the Facility will undergo testing and validation with a view to becoming operational during H1 2022. The Company then plans to manufacture and sell research and pre-clinical grade DNA while working towards securing GMP accreditation.

The Company will initially focus on the sale of DNA for use in AAV vectors, a common method of delivering gene therapies; and In Vitro Transcription, where DNA is the template for the manufacture of mRNA. For both products, DNA is a critical starting material.

The decision to develop the clean rooms in a dedicated facility was taken following consideration of the overall space requirements for the DNA and nanoparticle sides of the business. In order to develop the manufacturing capacity required, 4basebio UK, a subsidiary of the Company, has secured a long term lease for the Facility. 

The earmarked capital commitment for this project is about £1.5 million. Consistent with previous indications, the Company has a cash runway into 2023 and will also be able to draw on the £22m debt facility with its former parent company, if necessary.

Dr Heikki Lanckriet, CEO and CSO for 4basebio, commented: “We are very pleased to have commenced the development of this manufacturing facility, with the objective of taking the final steps in the commercialisation of our DNA technology. Alongside the clear market need for additional DNA manufacturing capacity, our synthetic DNA offers clear advantages over plasmid DNA, which we believe places 4basebio in a strong competitive position.”

Related Party Transaction

The Company has secured a lease for the Facility on standard commercial terms for a period of 15 years with break clauses at an annual cost of £50,000 per annum. Dr Lanckriet, the CEO and CSO of the Company, has a 50 percent indirect interest in the head lease of the Facility. Accordingly, the entering into the Lease by the Company is deemed to be a related party transaction (“Transaction”) pursuant to the AIM Rules for Companies. With the exception of Dr Lanckriet, the directors of the Company, having consulted with the Company's Nominated Adviser, Cairn Financial Advisers LLP, consider the terms of the Transaction to be fair and reasonable insofar as the Company’s shareholders are concerned.

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (which forms part of domestic UK law pursuant to the European Union (Withdrawal) Act 2018).

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Notes to Editors

4basebio (AIM: 4BB) is a specialist life sciences group focused on therapeutic DNA for cell and gene therapies and DNA vaccines and providing solutions for effective and safe delivery of these DNA based products to patients. It is the intention of the Company to become a market leader in the manufacture and supply of high purity, synthetic DNA for research, therapeutic and pharmacological use and develop non-viral vectors for the efficient delivery of payloads. The immediate objectives of 4bb are to validate and scale its DNA synthesis and advance its collaborations to facilitate the functional validation of its DNA based products and cell and gene delivery solutions.

Forward-looking statements

This announcement may contain certain statements about the future outlook for the 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.