RENE.L Regulatory News (RENE)

ReNeuron Group plc

("ReNeuron" or the "Company")

Positive data generated in exosome programme collaboration

Significantly improved delivery of functional proteins to the brain demonstrated in vivo

Exosomes have potential to transform effective drug delivery for key neurological diseases

ReNeuron Group plc (AIM: RENE), a global leader in the development of exosome therapeutics, announces positive data that provides clear pre-clinical proof-of-concept that ReNeuron's novel exosome drug delivery technology can effectively deliver therapeutic proteins to the specific region of the brain affected by several neurological diseases.

In an ongoing collaboration with scientists at the University of Salamanca, Spain, ReNeuron has sought to determine whether its stem cell-derived exosomes can deliver a therapeutic protein to the corpus striatum; a region of the brain affected by disabling neurological diseases such as stroke, Parkinson's Disease and Huntington's disease.

Major pharmaceutical companies have identified therapeutic proteins that are effective in treating a variety of neurological diseases. However, there are major issues associated with the delivery of these protein therapeutics, which include the poor stability in living organisms, given that proteins rapidly break down and do not last long in the body; as well as issues surrounding poor tissue distribution due to an inability to target specific tissues. Whilst these issues cannot be overcome by simply administering more protein, as this can have unwanted side-effects, ReNeuron believes that its proprietary exosomes have the potential to address both these issues due to their natural tissue-targeting ability and superior stability characteristics.

Studies performed in collaboration with the University of Salamanca established that exosomes administered intrathecally were capable of delivering a therapeutic protein in an animal model (in vivo) to regions of the brain at a functional activity level much greater than that seen when simply supplying the protein alone. Contrary to this, studies performed in the laboratory showed no difference in delivery between the exosomal based protein and the protein alone. This difference between the efficiency of in vivo delivery versus in vitro delivery suggests that the exosome linked proteins were able to overcome the obstacle of protein breakdown and tissue targeting in the brain that was not possible with the native protein. The in vivo results are key in showing that ReNeuron's exosome delivery technology offer a striking higher stability, more targeted delivery, and an increase in potency, therefore potentially solving the delivery issues that can be experienced with therapeutic proteins.

Dr. Stefano Pluchino, Chief Scientific Officer of ReNeuron, commented: "I am delighted to see these extremely compelling data showing that exosomes efficiently deliver therapeutic proteins to targeted brain regions associated with severe neurological diseases. These data are the foundation of one of the main corporate programmes at ReNeuron and highlight the possibility to deliver other payloads using the same principles and technology platform, providing improved tissue distribution and specificity. This exciting strategy could potentially be used to deliver single therapies or multiple therapeutics with exosomes, enabling a number of exciting next generation precision medicine approaches."

Olav Hellebø, CEO, commented: "These results are a key milestone for our exosome delivery technology, establishing clear proof of concept in vivo, which more accurately imitates conditions for the targeted delivery of key neurological therapeutics into the human brain. In 2020 we refocussed the business on our exosome platform, as well as our retinal disease programme and iPSC platform, and these results show just how significant the potential is for exosomes to become a novel means of delivering third party biological drugs to the brain and other regions of the body. This is exciting news for the major pharmaceutical and biotechnology partners that we have collaboration agreements with and underpins the commercial opportunity that our platform provides."

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About ReNeuron

ReNeuron is a global leader in cell-based therapeutics, harnessing its unique stem cell technologies to develop 'off the shelf' stem cell treatments for disease with significant unmet needs. The Company's lead cell therapy candidate is in clinical development for the blindness-causing disease, retinitis pigmentosa.

ReNeuron is also advancing its proprietary exosome technology platform as a potential delivery system for drugs that treat diseases of the central nervous system and other disorders. The Company also has the ability through its conditionally immortalised induced pluripotent stem cell (iPSC) platform to make allogeneic tissue cells of choice; in-house programmes are currently focused on treatments for blood cancers and diabetes.

ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. For further information visit www.reneuron.com