About Regeneus

Regeneus is an Australian biotechnology company aiming to improve the quality of life of patients suffering from pain.

We develop regenerative medicine products that interrupt the inflammatory cascade that leads to pain in the first place. Worldwide, there are hundreds of millions of patients suffering from short-term and chronic pain. Regeneus listed on the Australian Securities Exchange (ASX) in September 2013 under the ticker code ‘RGS’.

Investment highlight

Regeneus is focused on the US$69 billion global pain market, starting with commercialising Progenza™ for osteoarthritis in Japan.

Watch the above video where new Regeneus (ASX:RGS) CEO Karolis Rosickas announces the release of the Company's Half Year Results for H1 FY21.

Latest news & insights

See below for the latest updates on the Company's activity.

Q&A with Dr. Veronica Iatarola Antas, Research Scientist and Project Lead at Regeneus

Q. Tell us about your role as a Research Scientist and Project Lead at Regeneus?

A. My role is extremely diverse and has evolved over my time at Regeneus. Initially, I was responsible for optimising our product manufacturing processes, including manufacturing products for our preclinical and clinical trials. For example, I provided the data to support preclinical studies that evaluated Progenza™ for osteoarthritis in rabbits and pain in rats.

Currently, my focus is on conducting assurance reviews of data and documentation relating to our technologies before it is transferred to prospective contract manufacturing organizations (CMOs) we may work with. For example, I am currently working on this in preparation for the manufacturing of our Progenza™ product for our Phase II clinical trials, as we seek licence and collaboration partners in the US. I also participate in R&D projects led by our Head of R&D, Dr. Charlotte Morgan and R&D Manager, Flyn McKinnirey, in addition to performing Quality Assurance and process improvement duties at Regeneus.

Q. What is your background and experience in the regenerative medicine and stem cell space? How did this lead you to Regeneus?

A. I have always been fascinated by Medical Science, especially the regenerative medicine and stem cell fields. I started my career as a Pharmacist, followed by post-graduate studies in Assisted Reproductive Technologies, Higher Education and Nutrition. My passion for research led me to complete my PhD on molecular mechanisms that regulate hematopoietic stem cell development at the University of Sydney.

During my PhD I published multiple articles on stem cells, and I also lectured in Medicine at University of Sydney. After my PhD, I worked as the Manager of the NSW Stem Cell Network where I got a glimpse of different companies and initiatives in the stem cell industry within NSW, which gave me further insight and passion for the industry. This is what led me to Regeneus.

Q. What is your focus for the next 12 months?

A. My focus for the next 12 months is to work closely and efficiently with both the Regeneus team and our CMO’s to ensure that we get Progenza™ ready for Phase II clinical trials in Japan and the US. Technology transfer between Regeneus and CMOs is well underway, together with our Good Manufacturing Practice (GMP) development, which I am helping manage. This involves applying quality processes to every manufacturing stage to ensure that the final product consistently meets specifications and safety requirements.

Once Progenza™ GMP manufacturing is concluded, Phase II clinical trials will take place. Phase II clinical trials are very important, as the data captured will allow Regeneus to move forward on our commercialisation pathway and ultimately obtain conditional market approval in Japan.

The opportunity for Progenza™ and Regeneus to deliver a truly unique and effective treatment option to patients of osteoarthritis is very promising, and over the next 12 months I am committed to ensuring these prospects turn into reality.

Q. What do you believe is next for regenerative medicine and what role do you think Regeneus can play in advancing the sector?

A. The regenerative medicine sector has made rapid progress in the past few years and there has been a dramatic increase in the number of products that are either under clinical trials or already in the market.

Regeneus has two competitive, proprietary platforms (Progenza™ and Sygenus) that target pain and inflammation, while promoting tissue repair. The disease modifying properties of these two products, due to our patented inclusion of Mesenchymal Signalling Cells (MSCs) and their bioactive molecules (‘secretome’), make them superior to most ‘traditional’ drugs, which tend to be restricted to symptomatic relief and/or are associated with serious side effects.

As Regeneus is the only regenerative medicine company to have the patents to develop this innovative science, I believe our two platforms place Regeneus at the forefront of the regenerative medicine market and I hope will see us deliver life changing therapies to patients globally.

Q. What are you most excited about for Regeneus and the impact it can make?

A. I am thrilled to be part of Regeneus at a time of rapid progress and imminent break-through achievements. Regeneus is a company that truly values innovation, research and commercialisation of novel products and technologies, and I strongly relate to these principles.

Progenza™ and Sygenus have great therapeutic potential which can positively impact the quality of life of patients suffering from osteoarthritis and other inflammatory conditions. I am most excited to see the progression of our products to clinical trials and ultimately to the market, as I have witnessed in our preclinical trials their potential to be life-changing and provide a multitude of therapeutic benefits to patients.

I am proud of the work I do at Regeneus and of the hard-working team that I am a part of. It is truly rewarding to know that one day what we do may contribute to providing pain-free life to many people worldwide.

Regeneus (ASX:RGS) May Business Update

Regeneus' (ASX:RGS) CEO Karolis Rosickas provides an update on the Company's recent announcements, including its Institutional Placement, Q3 FY21 results, and Sygenus grant from the Australian Department of Defence.

Q&A with Prof. Graham Vesey PhD, Chief Scientific Officer and Executive Director at Regeneus

Q. Tell us about your role as Chief Scientific Officer at Regeneus?

A. My role at Regeneus from the beginning has been to invent and develop Regeneus’ intellectual property (IP). With over 30 years’ experience as a scientific researcher spanning fields of regenerative medicine and microbiology, I have always been focused on developing and licencing technologies to solve problems.

When I co-founded Regeneus in 2008, we knew it was important to identify a specific area within regenerative medicine that Regeneus could own, then protect it.

I am proud to say we were one of the first companies to identify that regenerative medicine isn’t only about Mesenchymal Stem Cells, which we now refer to as Medicinal Signaling Cells (MSCs; also known as stem cells), rather it’s about the factors that MSCs secrete. Secretions or Secretome are where the real therapeutic power resides and this is what we have built our company, our technologies, and our IP around.

Over the past decade, I have been involved in building a strong portfolio of over 80 patents to protect Regeneus’ science, and our lead platform technologies Progenza™ and Sygenus, that we have developed from this.

Today, my role largely involves supporting our Head of R&D Dr. Charlotte Morgan, Director of Clinical Development and Medical Affairs Dr. Sinead Blaber and R&D Manager Flyn McKinnirey as they drive the development of Progenza™ and Sygenus, prepare our technologies for commercialisation, and manage our laboratory operations.

Q. What is your scientific background and how did this lead you to Regeneus?

A. I have been a researcher in microbiology for over 30 years and in that time founded three successful biotech companies, including BTF, Regeneus, and Biopoint.

My career began in the UK at the Centre for Applied Microbiology and Research at Porton Down where I conducted research into Legionnaires Disease. This led me to setting up and running a large commercial Legionella testing laboratory for Thames Water. I then moved to Australia in 1991 to continue my research at Macquarie University, where I developed sensitive technology for the detection of Cryptosporidium and Giardia in water. This technology was later licenced to Sydney Water.

In 1999 I founded BTF. Over eight years we developed a suite of unique microbiological products and the company became one of Australia’s fastest growing companies, winning the Deloitte FAST 50 award for outstanding revenue growth in 2005 and 2006. In 2007, BTF was acquired by French diagnostic company bioMerieux, and today, the BTF product range continues to be the fastest growing and most profitable products within the bioMerieux catalogue.

The acquisition of BTF in 2008 led me to co-found Regeneus with colleagues Ben Herbert and Mark Wilkins. We were focused on using cells from fat to treat inflammatory diseases and conditions that had – and have to this day – unmet needs to be addressed. I previously held the position of CEO of Regeneus until 2014 when I was appointed Chief Scientific Officer, and have remained a member of the Regeneus Board since the company began.

Today, alongside my work with Regeneus, I am also the co-founder of Biopoint which is developing new products for the microbiology industry.

Q. Tell us about Regeneus’ lead platform technologies Progenza™ and Sygenus.

A. Our platform technologies have immense potential to treat a range of diseases and conditions, and we are working tirelessly to develop these to provide more effective treatment options for patients globally.

Progenza™ and Sygenus are fully patented MSC-Secretome combination and Secretome-only technologies respectively.

Our lead platform technology Progenza™ contains both MSCs and their bioactive secretome for an ideal therapeutic effect that treats symptoms of pain and inflammation and also promotes tissue repair. Our second technology platform, Sygenus, utilises the bioactive secretome of MSCs only, and works as a topical treatment for pain and inflammation, as well as skin conditions, wounds, and acne.

Our current focus is on developing Progenza™ to treat knee osteoarthritis (OA). Progenza™  addresses the current gap in the knee OA market for a treatment that is more effective than Paracetamol or opioids and less invasive than joint replacement or surgery. This kind of technology is not currently available on the market, and with the strong IP protection we have built around our science, coupled with our licence and commercialisation agreement with Japanese manufacturer Kyocera Corporation, Progenza™ has the opportunity to be the first treatment of its kind for knee OA.

Q. What is unique about Progenza™ and Sygenus?

A. What’s specifically unique about our platform technologies Progenza™ and Sygenus is the science behind them, both for their therapeutic effect, but also their lifespan advantage.

Utilising MSCs and importantly, their secretions has shown to be beneficial in maintaining efficacy of the cells post-thaw from a frozen state, while MSC-only-based products have been seen to lose efficacy after freezing. Being able to freeze products without losing their therapeutic effect is essential to making treatments marketable and applicable in clinical settings, as not freezing results in a shorter lifespan for the product and logistical difficulties when it comes to distribution to end-users.

Progenza™ and Sygenus do not face the same problems, and we have protected this science with patents across our key markets, so our competitors do not have the same advantage.

Q. What do you believe is next for regenerative medicine and what role do you think Regeneus can play in advancing the sector?

A. I have been proud of the progress that Regeneus has made in developing unique technologies to treat some of the world’s most prevalent diseases in pain and inflammation, including OA, neuropathic pain, and skin wounds. Patients with these conditions are currently seeing their treatment needs left unmet, and with the work we are doing at Regeneus we hope to change that.

Of course, Regeneus’ focus has shifted over time as both the company developed and the market developed, but our understanding of the power of MSC Secretome and the importance of developing products that utilise this remains unchanged. Even the founder of MSCs, Arnold Caplan agrees, as in a recent paper he speaks about the relative higher importance of secretions compared to stem cells themselves.

I look forward to seeing Regeneus develop Progenza™ and Sygenus for a vast number of indications that provide effective, never-before-seen treatments to patients to make a positive impact on their quality of life.

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