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Pharma Capital
Market: ASX
52-week High/Low: A$0.16 / A$0.10
Sector: Pharma & Biotech
Market Cap: A$24.02M

Regeneus Ltd (ASX:RGS) is a clinical-stage regenerative medicine company developing a portfolio of cell therapies with a focus on musculoskeletal disease, oncology and dermatology.

Regeneus Ltd

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Big picture - Why invest in Regeneus Ltd

Regeneus Ltd Snapshot

Regeneus is a Sydney based regenerative medicine company founded in August 2007 that is focused on using the regenerative capacities of adipose-derived cells to develop innovative cell therapies for humans and animals. Regenerative medicine is a rapidly growing multidisciplinary speciality that is focused on the repair or regeneration of cells, tissues and organs. The primary goal is to enhance the body's natural ability to replace tissue damaged or destroyed by injury or disease.

Regeneus has a focus on adipose tissue as it is a rich source of regenerative cells (including mesenchymal stem cells) that possess anti-inflammatory and repair and regenerative qualities. The high numbers of regenerative cells within adipose tissue - there are approximately 500 fold more MSCs from equivalent amounts of fat versus bone marrow - overcome the need to culture cells. Regeneus' proprietary cell mixture contains stem cells and adipocytes, that have been shown in a third-party pre-clinical study to perform better therapeutically than a cell mixture that did not contain adipocytes.

Regeneus was founded by experienced biotechnology innovators to take advantage of the rapid advances in cell-based regenerative medicine, and the opportunity to develop and commercialise innovative adipose-derived cell therapies to treat a range of orthopaedic and other inflammatory diseases in people and animals.

Regeneus is committed to developing its proprietary regenerative cell therapy in order to provide physicians and veterinarians with next generation tools for the treatment of and functional restoration of damaged or diseased tissues. The multi potential use of our regenerative cell products provides the basis for a cell therapy platform that is able to address a wide range of inflammatory conditions.

Regenerative Medicine

Despite its apparent infancy, cell-based regenerative medicine is not new. Stem cell based therapies in the form of bone marrow transplants have been used for over 40 years for the treatment of leukaemia. Similarly, epithelial stem cell based treatments have been widely used for many years for burns and corneal disorders.

The scope of potential cell-based therapies has expanded in recent years due to major steps forward in cell research and an increased understanding of the clinical applications of adult stem cells. One key discovery is that our bodies have a rich supply of regenerative cells, including mesenchymal stem cells (MSCs) that can be found in adipose tissue (fat). The supply of regenerative cells in adipose tissues provides a non-controversial source of adult MSCs and other regenerative cell types that can be used as a basis for developing new treatments for a range of inflammatory diseases, including orthopaedic disorders such as osteoarthritis, that arise through degenerative disease, injury and old age.

MSCs have the capacity to differentiate into specialised cell types like bone, cartilage and muscle to assist with regeneration and repair. They also have the capacity to secrete various compounds that can stimulate other cells to regenerate and repair.

Regeneus has developed intellectual property, skills and experience in the area of separation, preparation and use of adipose-derived regenerative cells for therapeutic purposes in humans and animals. These developments exist within two distinct product platforms:

- Cell-based platform, which is autologous and allogeneic;
- Secretions-based platform, which is allogeneic.

Regeneus has commercially launched an autologous cell therapy prepared in-clinic for the treatment of human musculoskeletal conditions called HiQCell® and two products for the treatment of canine and equine musculoskeletal conditions called AdiCell® and CryoShot®. AdiCell is an autologous cell therapy prepared in-clinic while CryoShot is an off-the-shelf cell therapy prepared from donor regenerative cells (allogeneic).

Regeneus has found it very effective to first introduce new therapies through the veterinary market as it represents a good market proxy and provides a good testing ground for obtaining important data and evidence for introducing similar products for the human market. The proprietary AdiCell procedure was introduced to the animal health market in 2008 for canine orthopaedic conditions and has been used by veterinarians to treat over 400 animals with successful treatment outcomes. AdiCell was extended in 2010 to equine conditions with similar successful treatment outcomes.


Cell-Based Regenerative Medicine

Stem cells are the foundation cells for every organ, tissue and cell in the body. Stem cells are undifferentiated or "blank" cells that have not yet fully specialised. Stem cells are part of the tissue repair mechanism found in all mammalian tissue types. When a stem cell divides, each new cell has the potential either to remain a stem cell or differentiate into a specific cell type with a specialised function, such as a bone, cartilage or muscle cell, a red blood cell or a neuron. These characteristics distinguish stem cells from other cell types. They also have the capacity to secrete various compounds that can stimulate other cells to regenerate and repair.

There are many different types of stem cells. These include embryonic stem cells that exist only at the earliest stage of embryonic development and can form all cell types of the body. There are various types of "adult" or "tissue-specific" stem cells that exist in a number of different adult tissues like bone marrow and adipose (fat) tissue. It is known that different types of stem cells have different potential in regard to the cell types they can become. Regeneus only uses adult stem cells.


Stem Cell Therapy

Both HiQCell and AdiCell are unique autologous (derived from the same individual's body) regenerative treatments. They are relatively simple procedures that use regenerative cells including mesenchymal stem cells taken from the patient's own adipose (fat) tissue through mini liposuction (HiQCell) or excision of adipose tissue (AdiCell). The procedure then involves the processing of the adipose tissue to prepare a cell suspension and injecting this mixture of cells which contain mesenchymal stem cells along with other cell types to help repair and regenerate the affected sites by replacing lost or damaged cells, reducing inflammation, improving the function of cells at the site and recruiting cells from other parts of the body to assist in these processes.


Adipose-Derived Cells

The potential of regenerative cell-based therapies has expanded in recent years due to major steps forward in cell research. One key discovery is that our bodies have a rich supply of regenerative cells that can be found in adipose (fat) tissue.

The supply of regenerative cells in adipose tissue provides a non-controversial source of adult stem cells that can be used as a basis for developing new treatments for a range of inflammatory diseases, including orthopaedic conditions like osteoarthritis that arise through degenerative disease, injury and old age.

Adipose tissue is filled with cells called adipocytes. Adipocytes are cells that store fat. It has recently been recognised that these adipocytes play an important cell-signalling role and secrete a range of substances that effect many parts of the body. Running throughout the adipose tissue is a network of capillaries that deliver nutrients and oxygen to the adipocytes and carry away the secretions. Hanging off the capillaries, like bunches of grapes on a vine, are large numbers of cells that are not adipocytes. These cells include mesenchymal stem cells (MSCs), which form a key part of adipose cell-based treatments.

Stem cells are present in adipose tissue in surprisingly high numbers. One gram of fat will contain up to 1,000,000 MSCs. In comparison, the same amount of bone marrow will contain less than 1,000 MSCs. The large numbers and ready availability of MSCs in adipose tissue has resulted in a number of treatments where there is no need to expand or culture the cells.

Stem cells are not the only cells that are attached to the capillaries. There are endothelial progenitor cells known to be involved in angiogenesis (increased blood supply to tissue), monocytes and macrophages that secrete anti-inflammatory cytokines, pericytes, mast cells, preadipocytes, fibroblasts, and smooth muscle cells. The HiQCell and AdiCell procedures utilise this entire mixture of cells along with adipocytes and the MSCs.

R&D and Product Development

Regeneus has an extensive R&D and product development program in place that is delivering a significant knowledge base about the therapeutic effects of adipose-derived cells and their secretions.

The R&D focus is two-fold. Firstly, to develop knowledge base on the mechanisms of the therapeutic effects of the products. The second focus is to develop successful adipose-based treatments and products for a range of applications and to patent these. The Company has been successful in achieving this across a broad range of applications that range from orthopaedic conditions, through to wound healing and treatment of skin inflammatory conditions.

R&D Partners

Regeneus has R&D Collaboration agreements with Macquarie University and the Kolling Institute of Medical Research (part of the North Sydney Local Health District). More information about these agreements is available on the Partnerships page.

Development of Cell Secretions Based Product

Recent studies indicate that the therapeutic value of MSCs is largely due to molecules secreted by the cells. These molecules include cytokines and growth factors that signal resident cells, control inflammation, recruit new cells to the site of injury and modulate the localised immune system.

Company research indicates that when secretions are applied to skin, the secretions have a localised anti-inflammatory effect, accelerates wound healing and reduces scarring. The effect of a secretions based product is short term compared to cells and the use of secretions based products may be limited to applications where repeat dosing is easy. Regeneus is working on the development of a cream that contains secretions for topical treatment of a variety of skin conditions including acne and will conducting a toxicology study for this product.

Other Initiatives

There are other R&D initiatives focused on improving and enhancing the existing human product e.g. protocol enhancements for HiQCell.

Regeneus is also working on preclinical and safety trials for an allogeneic human cell therapy based on the CryoShot technology platform, as well as other pilot studies and applications for research grants.

Last updated on 8th January 2016.

Roger Aston
Independent Chairman

Dr Roger Aston is one of the most experienced and commercially astute people in drug commercialisation in Australia. Roger brings more than 20 years experience in the pharmaceutical and healthcare industries in senior roles in the United Kingdom, Asia-Pacific and Australia. Roger has held executive, non-executive director or chairman positions on a number of boards including Peptech Limited (Arana), Cambridge Antibody Technology Limited, Clinuvel Limited, Halcygen Limited, Cambridge Drug Discovery, and pSivida Limited. He started his career at major pharmaceutical company Wellcome (now Glaxo Smith Kline) and has also worked for QinetiQ Limited. Roger also served on the federal government's IRD board sub-committee for biologicals. Roger was formerly CEO of Mayne Pharma Group Limited and currently is a director and Executive Chairman of PharmAust Limited, Chairman of Immuron Limited and Chairman of Oncosil Medical Limited.

John Martin

John Martin has served on the Board of the Company since early 2009 and has worked closely with the founders to develop and grow the business since that time. He was appointed Chairman in 2010. John has over 20 years of corporate and commercial experience including roles as CEO and director of ASX listed and private companies and executive partner of Allens. He has advised and worked with emerging technology and high growth companies for over 12 years including being a co-founder and director of biotech spin outs from Macquarie University, BTF and Proteome Systems. He is currently a principal of The Channel Group, chairman of Ai-Media and director of Eagle Eye Solutions (Asia Pacific).

Dr Graham Vesey
Executive Director

Professor Graham Vesey is a co-founder and founding CEO of Regeneus and has served on the Board since incorporation. Professor Vesey is the Chief Scientific Officer for the Company. Graham is a successful biotechnology entrepreneur, technology innovator and inventor on various patents in the biotechnology area and a highly regarded scientist. He has been the primary driver of the Company's R&D programs, product innovation and development and IP portfolio. Prior to co-founding Regeneus, Graham was a co-founder and executive director of BTF, a highly successful Sydney-based biotechnology company and was responsible for developing BTF's product and patent portfolios. In 2007, BTF was acquired by bioMerieux, a French multinational diagnostic company. Graham is an Adjunct Professor at Macquarie University and a Senior Research Fellow at the University of NSW.

Barry Sechos
Non-Executive Director

Barry Sechos is a non-executive director who has served as an alternate director since 2011 and became a full director in June 2012. He has over 25 years experience as a director, business executive and corporate lawyer. Barry is a Director of the Sherman Group (a strategic investor in the Company), a privately owned investment company. Barry is also a director of See-Saw Films, a film production and finance group and winner of the 2011 Academy Award for Best Picture, Transmission Films, a film distribution company, Customers Ltd, an ATM deployment company and Sherman Contemporary Art Foundation, a charitable cultural organisation. He previously held various positions with the Aberdeen Asset Management/EquitiLink Funds Management Group including Director of  Aberdeen Asset Management, General Counsel and Compliance Officer to Equitilink Group and EquitiLink International Management. Barry commenced his professional career as a commercial lawyer at Allen Allen & Hemsley in Sydney, Singapore and London.

Glen Richards
Non-Executive Director

Glen Richards is a non-executive director who joined the Board in April 2015. Glen established Greencross Vets in Townsville in 1994. He was a foundation director and shareholder of Petbarn Pty Ltd since 2005; a director of Lyppard Australia Ltd for four years; and the foundation director and shareholder of Shanghai PAW Veterinary Clinics, China since 2001. Glen also serves on the Board of Smartvet Pty Ltd. Glen was the foundation Managing Director of Greencross Ltd, the first public listed veterinary company in Australia, from 2007 to 2014. Greencross Ltd merged with Petbarn to create the largest consumer facing pet company in Australasia with a market cap of over $700M and employing over 2000 employees. It has an ever expanding network of veterinary businesses and large format pet stores across Australia. Glen continues as a non-executive Director. Glen has been a member of the Australian Veterinary Association since 1988, with special interest groups in Small Animals and Practice Management and a fellow of the Australian Institute of Company Directors since 2001. With a strong interest in education and training, Glen has been an Industry Fellow with the University of Queensland School of Veterinary Science since 2011 and was recently awarded alumni of the year in 2012 from James Cook University.

Last updated 8th January 2016.

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