Braveheart Inv Regulatory News (BRH)

17 October 2023

Braveheart Investment Group plc

("Braveheart" or the "Company")

Investment update - Paraytec Limited

Braveheart Investment Group (AIM: BRH), announces an update on a company within its investment portfolio, Paraytec Limited ("Paraytec").

Paraytec develops high performance specialist detectors for the analytical and life sciences instrumentation markets. Its rapid test instrument ("CX300") is being developed for identifying cancer and pathogens, including viruses.

Paraytec has provided the Company with the following update on its work in the development of potential use cases for the CX300 by Professor Carl Smythe's team at Sheffield University:

The CX300 instrument has been successfully tested in the in the detection of Adeno-associated viruses, which are used in gene therapy. This is important because virus-like particles ("VLPs") such as adeno-associated viruses are used to encapsulate the new gene and deliver it into the body.

Paraytec has now delivered its first instrument to the Gene Therapy Innovation and Manufacturing Centre ("GTIMC") in Sheffield, for 'industrial' testing in GTIMC's research and development lab. The target is to market the CX300 for use by all gene therapy manufacturers for in-process assessment of the quality of their adeno-associated virus products during research, development and, in due course, manufacturing.

Patient safety is absolutely critical to both producers and regulators. VLPs are capsids (very small biological capsules) and are used to carry modified DNA that will perform the gene therapy into a patient's body. The aim is to use the CX300 to measure attributes of VLPs that are critical to the efficacy and safety including: (i) absolute and relative values of bound and free nucleic acid; (ii) concentrations and empty/full ratios for AAV capsids; and (iii) aggregation levels. All of these can be very harmful to patients if outside specification.

Manufacture of VLPs in a GMP setting is very expensive and takes days or weeks per batch. Product testing during production is limited because of the 'sealed' GMP environment. Current analytical methods are not well suited to testing these materials during all the stages of VLP manufacture. Hence, there is currently little opportunity for in-line feedback of product quality to allow process control changes during a production run.

As previously reported, Paraytec collaborated with the following European producers of VLPs: GSK, Medimmune and FUJIFILM Diosynth Biotechnologies, in a project called NEXUS. These partners confirmed a strong need for in-line VLP analysis and Paraytec demonstrated its expertise in the analysis of aggregation in VLPs. Paraytec will continue to enhance the CX300 instrument to detect the ratio of full/empty capsids, a critical quality attribute to be determined both during production and following purification.

Gene therapy medicine is a rapidly growing market, forecast to grow from US$3.611 billion in 2020 to US$11.769 billion by 2027 at a CAGR of 18.39%1. Leading companies making acquisitions in the gene therapy market include: Elli Lilly, Cytiva, Thermo Scientific, Novartis, Pfizer and many others.

1https://www.researchandmarkets.com/reports/5716732/global-gene-therapy-market-forecasts-from-2022?gclid=Cj0KCQjw1aOpBhCOARIsACXYv-e24eXPjMVltcDaTKSwqQACxk0J9myR5mo8FrHXaTTMFQUtu11ZOe0aAnduEALw_wcB

Paraytec has confirmed that its programme to apply the CX300 technology to a test for the rapid diagnosis of bacteraemia causing sepsis is proceeding on schedule. Paraytec's target is to demonstrate Proof of Concept of an instrument for the rapid detection of bacteria in a blood sample, before the end of the year. If bacteria are present, the CX300 is expected to report whether these bacteria are classed as Gram-positive or Gram-negative.

The Directors of Paraytec believe that such a test will greatly help clinicians identify the likely source of infection, allowing clinicians to immediately target the best antibiotic treatment, since those used to treat Gram-positive or Gram-negative bacteria are different.

Braveheart holds a 100% equity interest in Paraytec. In addition, it has provided unsecured interest free loans to Paraytec totalling £1,155,200 as at 31 March 2023.

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