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EPIC: RENE
Market: AIM:RENE
52-week High/Low: 220.00p / 1.95p
Sector: Pharma & Biotech
Market Cap: 26.42M
Website: www.reneuron.com
ReNeuron Group Plc (LON:RENE)

ReNeuron Group Plc

ReNeuron is a leading, clinical-stage stem cell business.  Its primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.

ReNeuron is traded in the NEX Exchange HERE

ReNeuron Group Plc

www.reneuron.com

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Big picture - Why invest in ReNeuron Group Plc


ReNeuron Group Plc Snapshot

We have used our unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered “off-the-shelf” to any eligible patient without the need for additional drug treatments. Our lead stem cell therapeutic candidate is a therapy for the treatment of patients left disabled by a stroke. We have announced positive Phase II data with this therapeutic candidate and we are pursuing plans to commence a Phase III pivotal trial in patients who are living with disability post-stroke.

Our hRPC stem cell candidate is being developed for the treatment of retinal diseases. Clinical development of this candidate in retinitis pigmentosa, a blindness-causing disease of the retina, has commenced in the US and we are expanding our hRPC programme to target a further retinal disease, cone-rod dystrophy.

We are also progressing pre-clinical development of our exosome nanomedicine platform. Exosomes are nanoparticles secreted into the culture media during the expansion of our stem cells. They contain a number of biologically active molecules such as proteins and miRNAs which have potential therapeutic benefits across a number of disease areas.

Our principal strategy is to gain clinical validation for our cell therapy programmes via well-designed clinical trials in well-regulated territories.  Ultimately, we expect to realise value for our technologies and therapeutic programmes via out-license to commercial development partners at the appropriate points in their development.  In order to achieve these objectives, we work closely with a number of key academic and industrial partners while continuing to maintain tight control over our financial resources.

ReNeuron is incorporated in and operates primarily in the UK. Our shares are traded on the London AIM market under the symbol RENE.L

Our Products & Technologies

We have used our cell expansion and screening technologies to develop “off-the-shelf” stem cell therapies for serious conditions such as stroke where the patient populations are significant and where few if any alternative treatments exist.



Using our unique and scaleable stem cell technologies, we have created a pipeline of commercially focused stem cell therapy candidates addressing significant areas of unmet medical need. These therapeutic candidates are based around two core stem cell assets, our CTX neural cell line and our human retinal progenitor cells (hRPC). Our exosome platform is yielding encouraging early pre-clinical data across a range of potential indications which are being investigated further.

CTX Cells

We have used our cell expansion and screening technologies to develop “off-the-shelf” stem cell therapies for serious conditions such as stroke where the patient populations are significant and few if any alternative treatments exist. Unlike conventional drug treatments which typically address the symptoms of disease, the potential of stem cell treatments such as ours is to address the underlying causes of the target disease. Our stem cell treatments have been shown in pre-clinical testing to stimulate natural repair mechanisms in the organs affected by the disease in question, leading to a reduction in the associated functional impairments.

Our lead CTX cell therapy candidate is a therapy for the treatment of patients left disabled by the effects of a stroke. Our second application for the CTX cells is for the treatment of critical limb ischaemia. Both treatments are currently in clinical development. The characteristics of the CTX cell line give ReNeuron some distinct technical and competitive advantages. The CTX cell line has been taken through a full manufacturing scale-up and quality-testing process. As such, it represents a standardised, clinical and commercial-grade cell therapy product capable of treating all eligible patients presenting with the diseases targeted, without the need for additional immunosuppressive drug treatments. There will be no need to re-derive and test new cell lines for subsequent clinical trials or for the market – all such cells can simply be expanded from the existing banked and tested product.

The clinical trials of our CTX stem cell therapy candidates for stroke and critical limb ischaemia utilise a cryopreserved formulation of the CTX stem cell line, designated CTXcryo. We have generated data demonstrating the equivalence of CTXcryo drug product to the original non-cryopreserved formulation. CTXcryo will provide the business with major commercial and competitive advantages in terms of the availability of a genuine off-the-shelf cell-based treatment with a competitive cost of goods and a shelf life enabling shipping to, and storage at, clinical sites on a global basis.

Pre-clinical and clinical results from our technologies and stem cell products have been published extensively in peer-reviewed scientific journals (please refer to the publications section).  We have recently announced positive data from the PISCES II Phase II clinical trial of our CTX cell therapy candidate for stroke disability.  Safety and efficacy data from this study will be presented at forthcoming stroke and rehabilitation medical conferences and published in due course.

Human retinal progenitor cells (hRPC)

Human retinal progenitor cells are cells that differentiate into components of the retina. These cells are used allogeneically, with cells from a single source being administered to multiple patients, and are grown using a patented low-oxygen cell expansion technology licensed from the Schepens Eye Research Institute at Harvard Medical School. Through our collaboration with Schepens we have developed the ability to scale up the manufacturing of the hRPCs. Using this technology, we have established a GMP-compliant hRPC cell bank to provide future drug product.

We have received regulatory approval from the US Food and Drug Administration (FDA) to commence a Phase I/II clinical trial in the US with our hRPC therapy candidate for retinitis pigmentosa (RP). This study marks the initiation of clinical trial activity in the US with our therapeutic programmes. Recruitment and treatment of the first and second dose cohort in a total of six patients has been completed.

ReNeuron is also intending to expand its clinical programme to another retinal disorder, Cone Rod Dystrophy with a Phase II trial to be run alongside the RP trial.

Exosome platform

Exosomes are nanoparticles, released by cells, and contain a number of active proteins and micro RNAs. They are believed to play a key role in cell-to-cell communication, modulate cellular immunity and promote the activation of regenerative or repair programmes in diseased or injured cells. Our CTX cells release large amounts of exosomes when grown in the laboratory enabling us to purify and characterise them.  These exosomes have been tested at differing concentrations in a range of early in vitro pre-clinical disease models with positive results. We aim to use the CTX technology and exosome platform to expand our pipeline.  We have filed a number of patents around composition, characterisation, manufacturing and therapeutic uses of the exosome platform. We are exploring the potential of our CTX cell-derived exosome platform and its role in targeting multiple indications. Data produced to date from in vivo pre-clinical studies indicate a potential therapeutic benefit in wound healing, glioma and ophthalmology.

 

Technologies

We have used our cell expansion and screening technologies to develop “off-the-shelf” stem cell therapies for serious conditions such as stroke where the patient populations are significant and where few if any alternative treatments exist.

 

We have used our unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered “off-the-shelf” to any eligible patient without the need for additional drug treatments.

ReNeuron’s stem cell products are allogeneic, enabling the treatment of many patients from the same cell bank in an off-the-shelf manner. Our programmes have been built around our unique and highly efficient stem cell expansion technologies enabling, from a single tissue sample, the growth of selected human stem cells into banks of quality-assured stem cell lines. ReNeuron has developed a product variant that can be shipped to clinical sites and stored there in a cryopreserved form. These developments will provide us with major commercial and competitive advantages in terms of the availability of a genuine off-the-shelf, low cost-of-goods cell-based treatment with a shelf life enabling shipping to, and storage at, clinical sites on a global basis.

CTX Cells

CTX is an immortalised neural cell line which has been generated using our proprietary cell expansion and cell selection technology and then taken through a full manufacturing scale-up and quality-testing process. Because CTX is derived from a single donor, there should be complete consistency between cell banks and no risk of the variability which can arise when multiple donors are needed for cell supply. All cells used in CTX-based treatments can simply be expanded from the existing banked and tested product. There will therefore be no need to re-derive and test new CTX cell lines for subsequent clinical trials or for the market.

We have developed a proprietary, cryopreserved variant of our lead CTX stem cell line enabling an extended shelf-life, (designated CTXcryo), which will be deployed in all current and future CTX-based clinical trials and for eventual in-market use.

Human retinal progenitor cells
(hRPCs)

hRPCs are cells that differentiate into components of the retina. These cells are used allogeneically and are grown using a patented low-oxygen cell expansion technology licensed from the Schepens Eye Research Institute at Harvard Medical School. Through our collaboration with Schepens we have developed the ability to scale up manufacturing of hRPCs using this technology and have established GMP-compliant hRPC cell banks to provide future drug product.

We have also developed a cryopreserved variant of our hRPCs enabling an extended shelf-life which will be deployed in all current and future clinical trials for retinal disorders and for eventual in-market use.

Exosome Platform

Cells often communicate via exosomes, nano-sized packages of information released by the cell for absorption by other cells in close proximity. These packages of information contain a variety of proteins, genetic material and other cargo which have the ability to induce functional changes in recipient cells. Under certain conditions, exosomes produced by stem cells initiate repair and regeneration. However depending on the state of the cell and its environmental stimuli, stem cells have the ability to communicate different information and induce different functional changes. We have therefore developed a technology by which a permanent stem cell line, already in clinical trials as a stem cell therapy, can be cultured under different environments to produce therapy specific agents and can be harvested at a commercially relevant scale. The ability to produce a commercially valuable therapeutic product from stem cell derived exosomes demands a standardised stem cell producer line appropriately sourced and isolated, manufactured to GMP, grown in serum-free conditions and (ideally) already having demonstrated patient safety. In the stem cell field, our CTX cell line uniquely meets all these conditions.

John Berriman BSc MSc
Chairman

John Berriman was appointed to the Board in July 2011 and became Chairman in March 2015. He is the Chairman of Autifony Therapeutics Ltd and past Chairman of Heptares Therapeutics Ltd (sold to Sosei in February 2015) and Algeta ASA (sold to Bayer AG in 2014 and previously listed on the Oslo stock exchange). He is also a non-executive director of Cytos AG (listed on the SIX Swiss exchange). Until its sale to Amgen in the spring of 2012 he was a director of Micromet Inc. (listed on NASDAQ). Previously he was a director of Abingworth Management, an international healthcare venture capital firm, where he was involved in founding, financing and serving as a director of several biotechnology companies in Europe and the USA – many of which obtained listings on public stock exchanges. Prior to that, he spent 14 years with Celltech Group plc and was a member of its Board when it listed on the London Stock Exchange in 1994. He has a degree in Chemical Engineering from the University of Cambridge and a Masters degree from the London Business School. In addition to the positions mentioned above, he has in the last five years been a non-executive director of Pronota BV.

 

Olav Hellebo
Chief Executive Officer

Olav Hellebo was appointed as Chief Executive Officer in September 2014. A highly experienced, international pharmaceutical executive he has broad commercial experience gained at both major pharmaceutical and small biotechnology companies. He has particular experience of the clinical development, out-licensing, commercialisation and marketing of new therapeutics.

Prior to ReNeuron, Olav held the role of CEO at Clavis Pharma ASA, a Norwegian, oncology focused, listed biotechnology company.  At Clavis, Olav built a multi-national leadership team, taking the company’s lead programme through Phase III clinical development as well as completing substantial fundraising and out-licensing transactions for the business.  Prior to Clavis, Olav headed up the global biologics franchise at UCB Pharma and was head of the UK commercial operations of Novartis. Olav started his pharmaceutical career in 1992 at Schering-Plough, where he held a number of senior commercial roles in Europe and the US, including leading its US commercial operations in the areas of oncology, cardiovascular and hepatitis-C, representing annual sales in excess of $2 billion.  Olav has an MBA from the IESE Business School in Spain and a Bachelor of Business Administration from Hofstra University, USA.

 

Michael Hunt

Michael Hunt BSc ACA
Chief Financial Officer

Michael Hunt joined ReNeuron in 2001. Between 2005 and 2014 he served as its CEO, leading the business through its early development to its current position as one of the global, clinical-stage leaders in the regenerative medicine field. He was appointed as Chief Financial Officer in 2014. Prior to ReNeuron, he spent six years at Biocompatibles International plc (sold to BTG plc) where he held a number of senior financial and general management positions. His early industrial career was spent at Bunzl plc. He is a founding member and co-chair of the European Section of the Alliance for Regenerative Medicine (ARM) and sits on ARM’s finance committee. He also sits on the BioIndustry Association’s Cell Therapy and Regenerative Medicine Advisory Committee and its Finance and Tax Advisory Committee. He is a past industry member of the UK Government’s Office for Life Sciences and the Department of Health’s Regenerative Medicine Expert Group. He currently sits as a member of the Cell Therapy Catapult’s Advisory Panel. He read economics at University College London and qualified as a chartered accountant with Ernst & Young.

 

Simon Cartmell

Simon Cartmell OBE
Non-executive Director

Simon Cartmell OBE was appointed to the Board in July 2011. He was, until June 2010, Chief Executive Officer of ApaTech Ltd, which he built into a world leader in orthobiologics. Its sale to Baxter International Inc was completed in March 2010. Prior to ApaTech he was Chief Executive Officer of Celltech Pharmaceuticals and a director of Celltech Group plc before which he was Chief Operating Officer of Vanguard Medica plc. His early career was spent at Glaxo plc in multiple senior UK and global commercial strategy, product development, supply chain, marketing, sales and business development roles. He is a Medical Microbiology graduate from Manchester University and an alumnus of the London Business School Sloan Fellowship Programme. He is currently Chief Executive Officer of Calon Cardio-Technologies Ltd and has non-executive or advisory roles as a Venture Partner with Imperial Innovations plc, as a non-executive director of Phase4 Ventures, as an adviser to Mercia Fund Management Ltd and as an advisor to several emerging life science and medical technology companies in the UK and internationally.

 

Dr Tim Corn MSc FFPM FRCPsych
Non-executive Director

Dr Tim Corn was appointed to the Board in June 2012. He is Chief Medical Officer at EUSA Pharma International, a division of Jazz Pharmaceuticals, and was formally Chief Medical Officer at EUSA Pharma Inc., until its acquisition by Jazz in 2012, and Chief Medical Officer at Zeneus Pharma, which was acquired by Cephalon Inc in 2006. In addition, he serves as Chair of the Board of Trustees of the Neuro Foundation, and Non- executive Director on the Board of Circassia Pharmaceuticals. Dr. Corn qualified in medicine at King’s College Hospital, London after gaining a Master’s degree in biochemistry from Imperial College. He became consultant and senior lecturer in neuropsychiatry at the Institute of Psychiatry, London and is author of more than forty scientific publications. Dr. Corn has held senior clinical and regulatory positions at GlaxoWellcome, MSD Research Laboratories, Athena Neuroscience and Elan as well as in the UK regulatory agency. He has played a key role in twenty regulatory approvals in USA and Europe for products in the fields of neurology and oncology, the most recent being the approval by FDA of the BLA for Erwinaze™. He was elected Fellow of the Faculty of Pharmaceutical Medicine in 1996 and of the Royal College of Psychiatrists in 1998.

 

Sir Chris Evens OBE

Professor Sir Chris Evans OBE
Non-executive Director

Professor Sir Chris Evans OBE was appointed to the Board in August 2013. Sir Chris is the Founder and Chairman of Excalibur Group, and is a highly successful scientist and entrepreneur, having built over 50 medical companies and created over $5 billion of value for investors with $3 billion of cash exits. He is the Founder of Chiroscience, Celsis, Biovex, Merlin, Vectura and Piramed. He has also raised $2 billion for cancer research projects. More recently, he has established Arthurian Life Sciences Ltd to provide management services to the Wales Life Sciences Investment Fund, a £100 million fund and a key part of the Welsh Government’s Life Sciences initiative.

Paul Harper

Dr Paul Harper BSc Ph.D
Non-executive Director

Dr Paul Harper was appointed to the Board in August 2005. He is a graduate of Leeds University Microbiology/Virology). He initially pursued a career in drug discovery and development with Glaxo Group Research as Head of Antimicrobial Chemotherapy, Johnson & Johnson Limited as Director of Research & Development and with Unipath plc. This was followed by work in a number of start-up companies and SMEs as Chief Executive Officer or adviser. These included, as Chief Executive Officer, preparing Cambridge Antibody Technology Ltd for flotation on the London Stock Exchange and founding Provensis Limited to develop a drug device product. Currently Chairman of Physiomics plc, Sareum Holdings plc and three other private biotechnology/devices businesses.

 

Dr Mike Owen

Dr Mike Owen Ph.D
Non-executive Director

Dr Mike Owen was appointed to the Board in December 2015. His career in biotech, the pharmaceutical industry and academia spans almost 40 years.  He was formerly Senior Vice President for Biopharmaceuticals Research at GlaxoSmithKline where he was responsible for the discovery and development of antibody drugs in multiple therapeutic areas through to successful clinical proof of concept.  He was also a Founder and Chief Scientific Officer of Kymab Ltd, an antibody-based biotech company, and for many years held a research position at the Imperial Cancer Research Fund (now CR-UK). He currently serves as a director of Zealand Pharma, Ossianix Inc, BliNK Biomedical SAS and Avacta plc and is a member of the Scientific Advisory Boards of Kymab Ltd and the CRT Pioneer Fund LP, and the investor advisory board of HS Lifesciences gmbh.  He is a Fellow of the Academy of Medical Sciences and a member of the European Molecular Biology Organisation.

The Directors (together with their families and their family trusts and pension scheme arrangements) in aggregate hold 29,171,103 ordinary shares in the Company, representing 0.92% of the Company’s current issued share capital.

36.31% of the issued share capital is not in public hands.

The Company is aware of the following significant (3% or greater) shareholdings in the Company’s ordinary shares:

Number of ordinary shares % of issued share capital
Woodford Investment Management LLP 35.48%
Wales Life Sciences Investment Fund LP 9.50%
Invesco Limited 9.25%
Aviva plc & its subsidiaries 5.70%

The above information was last updated on Tuesday, 7 February 2017

General enquiries:
[email protected]

Product and licensing enquires:
[email protected]

Press enquiries:
Mark Court or Sophie Cowles – Buchanan
+44 (0) 20 7466 5000 or email: [email protected]

Please note that ReNeuron receives a large number of enquiries from interested parties regarding its technologies, therapeutic programmes and business operations. Whilst the Company will try to answer as many queries as it can, it has limited resources with which to do so and unfortunately may not be able to respond in all cases.

ReNeuron Group plc Head Office and Laboratories

ReNeuron,
Pencoed Business Park,
Pencoed,
Bridgend,
CF35 5HY

Telephone: +44 (0) 203 819 8400

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ReNeuron Group Plc Timeline

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