Q&A with Flyn McKinnirey, R&D Manager 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’d always had a love for medical research, however found myself working in the pharmaceutical industry after university prior to joining Regeneus. After 6 years in the pharma industry, I’d decided I needed to get back to a research focused career. The timing was perfect when I saw an opening at Regeneus in 2013. Since then, I’ve worked closely in the development of all our products at Regeneus. I believe my pharma experience benefited my approach to research and assisted in our journey to commercialisation.

After many years in animal product development, my research moved to a more human product focus including a PhD on improving the functionality of Medicinal Signalling Cells (MSCs). This year I have published work on improving the functionality of donor MSCs and endeavour to add to that body of work. The research paper is available through Nature Journal here and listen here for my summary of my publication.

Q. Tell us about your role as a Research and Development Manager at Regeneus?
A. My role as Research and Development Manager at Regeneus is to oversee the day-to-day operations of our research scientists in our laboratories and provide technical guidance to our partners and contract manufacturing organisations. I work closely with our clinical partners in Japan and our Contract Manufacturing Organization (CMO) in the United States to ensure a smooth delivery of our Phase 2 Progenza™ product. I’m always researching ways we can improve our production and testing methods to ensure our Phase 2 Progenza™ product is successful.

Q. What is your focus for the next 12 months?
A. The main areas I will be focusing over the next 12 months are technical management and guidance for our Phase 2 trial and further development towards commercialisation. This includes development of key data packages for Progenza™ and our other technologies. My team’s ongoing support to our partners is crucial in ensuring we successfully develop and manufacture the best products we can for clinical efficacy. Successful clinical outcomes don’t exist without thorough research, so my team and I will always be investigating new and innovative ways to enhance successful patient outcomes.

Q. What do you believe is next for regenerative medicine and what role do you think Regeneus can play in advancing the sector?
A. At Regeneus, our patent position is extremely strong which goes hand in hand with our drive for change to improving and developing our technologies to enhance treatment for pain and osteoarthritis. I believe if there is one positive to come out of a tragedy like COVID-19 it is the widespread acceptance of genetic material in mRNA vaccines which are proven and are still being improved. This opens the door for many other cell and gene based therapies to become a therapy of choice rather than a last resort. I believe the pandemic has also increased the suitability for hospitals and clinic to store cryopreserved therapies, often a bottleneck in providing “off the shelf” technology.

A lot of research, not only from our laboratory but others, has gone into improving the functionality of cell-based products that undergo a cryopreservation step. Our novel techniques ensure excellent cell recovery and functionality, and our patent portfolio means we maintain this as our point of difference as the industry trends more toward this kind of treatment.

Q. What are you most excited about for Regeneus’ technology and as a company?
A. There’s always been a drive at Regeneus towards making a difference, to offer better treatment options for patients suffering from pain and osteoarthritis. This drive is key to the constant improvement of our technologies, our commitment to furthering our knowledge, and is why I believe in what we do.

The cell and gene space is relatively new which makes for exciting times to come. Targeted biological therapy using genetic and cellular material like Progenza™ is an exciting movement for modern medicine and I’m happy to be a contributor to improving patients’ lives.

Q&A with Dr. Cindy Shu, REDI Fellow

After being awarded the MTPConnect REDI Fellowship Grant in August 2020, Postdoctoral Research Fellow from the Kolling Institute and University of Sydney Royal North Shore Hospital, Dr. Cindy Shu is joining Regeneus for a 12-month project focused on readying Progenza™ for Phase II trials in Japan and the U.S.

A Medical Research Future Fund initiative, the grant provides financial support to Australian, international and/or multinational medical technology and pharmaceutical companies to bring the best talent in-house to work on priority research projects.

Dr. Shu is a valued researcher in the MTP sector and using her expertise in osteoarthritis (OA) pathophysiology, animal models and immune cell analysis, will assist Regeneus to evaluate the beneficial effects of Progenza™ as we progress to Phase II trials.

Read on to learn more about the work Dr. Shu will be undertaking with Regeneus over the next 12 months.

Q: As Regeneus progresses toward Phase II trials for Progenza™ in Japan and the US, what role will you play in optimizing the technology?

A: Our group at the Raymond Purves Bone and Joint Research Labs routinely uses a well-established pre-clinical model of OA to investigate changes in inflammation, pain sensitisation, and OA joint pathology. In our work with Progenza™, we are injecting the technology directly into the affected joints as you would with human patients. The resulting data will provide a strong indication of how Progenza™ works in an OA joint. Specifically, we will measure changes in the types of inflammatory cells that are present in the joint synovium, the lymph nodes associated with the OA joint, as well as the blood, so we can determine Progenza™’s effects locally and systemically, and in acute versus chronic OA conditions.

Another major outcome is measurement of pain sensitisation. OA causes chronic crippling pain which worsens over time, so we hope to determine how much Progenza™ can improve and stabilise pain sensitivity. We will of course also look at the long-term effect on the joint pathology itself, including whether and how much Progenza™ would slow down and/or prevent OA progression. With the data generated from this preclinical study we hope to provide supporting information for Progenza™ to progress to the next phases of the clinical trials and approvals.

Q: What are you most looking forward to learning over the next two years working with Regeneus?

A: Fundamental research scientists like myself are often limited to what we do with our research outcomes. Many of us entered this profession looking to contribute (“find a cure”), but we are generally not taught how to translate our research. Regeneus has devised a program to bridge this gap, which will also help me consider which path I want to follow if I should consider a transition from pure research.

Q: What do you find most exciting about Regeneus’ technology?

A: In our research at the Raymond Purves Bone and Joint Research Labs we have found that MSCs work their magic by secreting disease modifying factors into the surrounding tissue of the injection site. It’s great to see that this is the focus for Regeneus as we believe it results in a more direct and controlled method of treatment. I am looking forward to seeing how well this new technology can work and hopefully make a difference to patients’ lives in future.

Q: What is your background in the life sciences space and how did this lead you to Regeneus?

A: I have a Bachelor of Science (Biotechnology) and completed my PhD on a project driven by a biotech industry funding partner whose goal was to increase cellular productivity for pharmaceutical production. Following this, I wanted to do something more focused on discovery and medical research. This led me to join the Raymond Purves Bone and Joint Research Labs in 2008, where I investigated a range of musculoskeletal pathologies, potential therapeutics and their mechanisms of action, including mesenchymal signalling cells (MSCs). A big part of my time was spent completing industry funded projects using our preclinical model of traumatic osteoarthritis, to investigate the efficacy and response to the treatment within a living organism. I’m very fortunate to be under the mentorship and guidance of Professor Christopher Little – a collaborator of Regeneus – who has always driven his research with great vision and passion.

Watch: Regeneus (ASX:RGS) Investor Update - November 2021

Regeneus CEO Karolis Rosickas hosted a webinar and Q&A with investors on Thursday 4 November. During the session, Karolis provided an update on the Company's progress with its lead platform technology Progenza™, partnership with the Australian Department of Defence for Sygenus, and ongoing strategy, in addition to answering investor questions.

Download the presentation deck here and watch the webinar below.

Regeneus partners with ASTEM to improve efficiencies in adipose tissue donor selection

Regeneus has partnered with the Allogeneic STEM cell manufacturing Programme (ASTEM) to investigate the status of a novel genomic biomarker within their adipose donor banks. This work is being conducted at one of the partner institutes of the ASTEM Programme, the Genome Institute of Singapore, which is a leading Research Institute within the Agency for Science, Technology and Research (A*STAR).

One of the major challenges of cell therapy has been the quality of mesenchymal signalling cells (MSCs) obtained from donors, which are scaled up to produce banks of cells for administration to patients. Screening potential donors using this novel genomic biomarker will aid in identifying the best donors, thus ensuring the cell banks produced from them are of the best quality. As a result, the use of cultured MSCs for therapeutic purposes will be enhanced.

Studies conducted within the ASTEM programme showed that the status of the novel DNA biomarker glutathione S-transferase theta 1 (GSTT1) in bone marrow donor tissue correlates with future scalability and potency of MSCs produced from them. This discovery makes it possible to select the best potential donors from whom cell banks with the best quality cells can be propagated/created. This will have a significant impact on easing one of the major bottlenecks for MSC-based cell therapeutics, i.e., robust MSCs. The discovery is patent protected.

MSCs are the cells used in Regeneus’ leading technology platform Progenza™ and which produce the bioactive secretome used in its second technology platform Sygenus.

While work with the GSTT1 biomarker to determine MSC scalability and potency has only been performed in bone marrow donors to date, the collaboration between Regeneus and ASTEM will investigate the biomarker in donors of adipose tissue.

Understanding the scalability and potency potential of donor tissue before it is extracted will provide a valuable tool for Regeneus to improve the efficiency of its donor selection process, and in turn, the manufacturing of its product pipeline. Identifying the donor tissue which will produce the highest yield of potent MSCs and have the highest potential for scalability will position Regeneus to deliver the most effective treatments to patients to address their unmet medical needs.

Charlotte Morgan, Head of R&D at Regeneus, said: “Regeneus’ collaboration with ASTEM is part of our ongoing commitment to seeking research partners that assist us in building our point of difference.

“Collaborations with leading scientists in the regenerative medicine sector, such as the ASTEM team, help us build on our existing research and development capability to uncover more information about MSCs and their secretome. This activity ensures we have the intel we need to use science to our advantage when developing our products.”

Professor Simon Cool from the Institute of Molecular and Cell Biology (IMCB), who leads the ASTEM programme, said: “ASTEM is excited to collaborate with Regeneus on the expansion of its biomarker development programme. This partnership validates the importance of ASTEM in the cell therapy manufacturing ecosystem in addressing key challenges facing the industry, thus leading to better patient outcomes and anchoring Singapore’s role as a global innovation hub”.

ASTEM’s discovery of the potential of the GSTT1 novel biomarker has been recently published in Stem Cells and further validated in archival MSC samples, using third-party assays by renowned stem cell scientist Professor Moustapha Kassem from the University Hospital of Odense.

Regeneus in TechInvest

In July, Regeneus CEO Karolis Rosickas contributed an article to TechInvest Magazine – a quarterly publication for the tech and innovation sector featured in The Australian Financial Review.

In an article titled 'For a life free of pain', Karolis Rosickas explains how Regeneus is potentially one clinical trial away from generating revenue from Progenza™ in Japan. Read the article here.

Q&A with Chrys Maoudis, Research Scientist 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 had a passion to play a part in improving people’s health and this passion led me to undertaking a Bachelor’s degree of Medical Science at The University of Technology, Sydney (UTS).

It was actually Regeneus that led me into the stem cell and regenerative medicine space – not the other way around.

I started with Regeneus over seven years ago as an intern student while I underwent my Bachelor’s degree. From this internship and while I was still at university, I was hired at Regeneus as a Laboratory Technician. Once I completed my Bachelor’s degree, my role at Regeneus developed into a full time Research Scientist position. In this role I have had the opportunity to work on Research and Development (R&D) projects for both Progenza™ and Sygenus as well as working on exciting projects with external collaborators from both academia and industry partnerships.

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

A. My role as a Research Scientist is quite dynamic where my day-to-day duties can vary greatly from R&D projects to product manufacture, and from inventory and laboratory management roles to neuropathic pain preclinical trial designs.

I have been heavily involved in the Regeneus pain project after Regeneus received an ARC Linkage Grant with our collaborators from the University of New South Wales (UNSW) and the University of Adelaide. Our focus on pain under this grant has led to the generation of preclinical datasets for both our Progenza™ and Sygenus platforms. I worked closely with world leading pain expert Prof. Mark Hutchinson from the University of Adelaide and Regeneus Chief Scientific Officer Prof. Graham Vesey to plan, design, and manufacture a range of products to run in rodent models of acute and neuropathic pain. Those preclinical trials produced positive results where we saw reversal of acute and neuropathic pain.

Regeneus also recently received a Department of Defence (DoD) grant to investigate Sygenus for potential treatment of combat casualties. As part of this funding, I am involved in the product development, production and analysis of Sygenus to be assessed in models of acute pain at the University of Adelaide.

Currently, most of my time is spent in the laboratory, where myself and my colleagues are responsible for designing, conducting, and reporting on experimental work related to Regeneus’ research project activities, and Phase II development of our keystone product Progenza™ for knee osteoarthritis. This work involves culturing, vialing, and testing Progenza™, plus further development to Phase II trials. Further to my research role, I also coordinate Regeneus’ laboratory management and inventory, ensuring we have all the equipment and reagents needed to conduct R&D and manufacture product for preclinical trials and Phase II product development.

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

A. My focus for the next 12 months is to support the product development of our Progenza™ and Sygenus technology platforms.

Working with our R&D team and collaborating with our contract research organisations or CROs, I will focus on product development for the Sygenus product platform and the production and design of preclinical datasets for new indications including neuropathic and acute pain. This work stems from our previous work on the MSCs and their secretome and their ability to modulate pain.

Further to this, I will be working on Phase II product development for Progenza™ and working with our contract manufacturer to assist in ensuring that the best product will be made for our Phase II trials.

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 space is one of dynamic change and development, needing products that are not just unimodal but are able to have multiple mechanisms to address symptoms and, crucially, have a disease modifying effect on complex diseases. Something that always sticks in my mind is that “where we have complex pharmacology and disease progression, complex treatments are needed”.

This is where I believe the next stage in regenerative medicine is, where regulators can collaborate more closely with the sector to allow proven, safe and efficacious products an easier pathway to market.

Regeneus is at the cutting edge of this type of treatment. Our Progenza™ and Sygenus platforms can provide the complexity of treatment to target complex diseases, such as osteoarthritis and neuropathic pain, in a disease modifying way. Single molecule drugs or treatments have not been shown to achieve the same effect, as they typically only address the symptoms, not the underlying cause of the disease.

Q. What are you most excited about for Regeneus’ technology and as a company? How does your role help support this?

A. Regeneus is at the forefront of the development of treatments for complex diseases and we are currently undergoing a time of growth and product development that has the potential to one day improve patient care and modify disease.

The ability to be behind a company making such achievements in the regenerative medicine space, while seeing the potential of our products in preclinical trials with the vision for them to ultimately be administered in a person to cure disease, is most exciting.

Q&A with Brian Saputro, R&D Scientist at Regeneus

Q. How did you develop your interest in the regenerative medicine and stem cell space?

A. Born and raised in Indonesia, where the curriculum was quite focused on science, I have always been intrigued in life sciences and everything related.

I came to Australia for university in 2008 and completed a Bachelor of Biotechnology at the University of New South Wales (UNSW). While there was a myriad of biotech fields covered during my study, my interest piqued at stem cells. Regeneus’ CEO at the time, John Martin, also delivered a lecture to my cohort focused on Biotech in Business, which is what initially drew me to Regeneus and its work in the regenerative medicine field.

I then completed my honours thesis at UNSW with Regeneus, focusing on blood-based assays to increase the detection sensitivity of the stem cell secretome.

Following my thesis, I started with Regeneus in the Human Health team for two years, before transferring to the R&D team where I now support the development of our Progenza™ product in the lead up to Phase II trials.

Q. As Regeneus progresses toward Phase II trials, what role do you play in optimizing Regeneus’ lead technology platform Progenza™?

A. Optimising Regeneus’ technology to solve problems for human health is incredibly fulfilling. It has always felt like scratching a brain itch for me.

A total of 28 combinations of various types of , such as basal media and growth supplements, were thrown into the mix with our donor MSCs, with the aim of finding the ideal combination that would optimise growth, while maintaining optimal viability and functionality.

Since then, I’ve been mainly focused on further optimising the culturing process for Progenza™ Phase II trials, as well as performing and optimising the battery of MSC potency assays that Regeneus performs to ensure the Progenza™ product is of the highest quality. This includes cell surface markers analysis, multiplex platform cytokine analysis, T Cell Assays and Priming Assays. Since the completion of our Phase I Clinical Trial manufacture, we’ve successfully obtained new cell lines from different donors, and these potency assays became crucial for assessing each cell line.

We utilise potency assays to assess the qualities of each batch of cells and conduct further assessments to ensure the cells are optimised to deliver the best effect for patients. This work is crucial to predicting the scalability of our donor cells which informs our process for manufacturing for preclinical and clinical trials.

Q. You also support the development of Regeneus’ second platform technology Sygenus. What does this involve?

A. For our second platform technology, Sygenus, I have been involved in developing a 3D bioreactor system, which has been quite intriguing to optimise.

MSCs require surface attachment to metabolise and grow. In planar culture, MSCs can only grow within the limits of the flask surface area before the cells produced become too dense. Our goal with 3D culture development is to provide a larger growth surface area, that can be scaled easily without a significant increase in labour and cost of goods. Bioreactors also allow for increased in-process testing and control of the culture environment to ensure we produce a consistent MSC secretome for every Sygenus batch and to maintain the strong anti-inflammatory activity of the secretome. We are now excited to explore this manufacturing technology further with our Department of Defence grant work to investigate Sygenus for potential treatment of battlefield combat wounds.

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

A. Within the regenerative medicine sector, the understanding of the mechanism of action of MSCs has changed over the past decade. Initially, it was understood that the therapeutic effect of MSCs came from the cells themselves. Then, it was realised that it is the bioactive secretome, that the cells produce, that have the true effect. Now, more work is being done to understand the role of the bioactive secretome and the components within them.

Regeneus was one of the first in the industry to identify the role of the secretome in modulating the immune system, contributing to addressing patient symptoms, but also to the disease modifying effects. Regeneus has built a strong patent portfolio around the combination of the MSCs and the bioactive MSC secretome to ensure we can utilise this science to address key conditions, such as pain and inflammation, where other companies cannot.

Disease modifying treatments are not currently available in the market for knee osteoarthritis and many patients suffering from significant pain are particularly dissatisfied with the current treatments available. For example, of the around 1.5 billion people globally who suffer from pain[1], 50 per cent of patients report inadequate relief from existing therapies[2]. This makes the work we do at Regeneus particularly exciting, as we may be the first to fill the gap in these markets and address the unmet needs for these patients.

Q. What are you most excited about for Regeneus’ technology and as a company?

A. At Regeneus, our goal has always been to find solutions that address unmet medical needs for patients of highly prevalent conditions, such as osteoarthritis and pain. Our current pipeline for Progenza™ and Sygenus means we have the potential to make a real difference.


[1] Chronic Pain and Health of Populations. Boston University, 2017

[2] Chronic Pain and Health of Populations. Boston University, 2017

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.

Regeneus partners with Australian Department of Defence to develop Sygenus for combat casualty care

Regeneus is excited to announce it is partnering with the Australian Department of Defence to develop its platform stem cell bioactive secretome technology Sygenus for combat casualty care. As part of the grant, Regeneus will receive $300k in funding to optimise the Sygenus formulation to treat combat casualties, including conducting Sygenus’ first in human study on pain.

Read the full announcement here.

Q&A with Dr Charlotte Morgan, Head of R&D at Regeneus


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

A. I arrived in Australia in 2001 with an extensive background in biotechnology product development. Before Regeneus, I worked for a start-up biotech called BTF Pty Ltd and over 10 years completed a part-time PhD covering the development of a successful microbiological control standard, used in food, water and Pharmaceutical industries for quality control purposes. During this time, over 30 different product formulations were designed and successfully launched until 2007, when BTF was acquired by French life sciences company Biomerieux. Biomerieux distributed the products over their sales force covering 150 countries and 35 subsidiaries, and I was responsible for the successful technology transfer and integration of the R&D and manufacturing processes.

Right from my PhD, my focus has always been on science that could be commercialized, so I joined Regeneus in 2011 to apply that commercial focus and my product design and development expertise.

Q. Tell us about your role as the Head of Research & Development at Regeneus?

A. I am involved in all aspects of the development of our platform technology products Progenza™ and Sygenus, right from early design phase and creating data for our extensive patent portfolio, through to proof-of-concept studies and determining the right product for the right market need.

Since joining Regeneus in 2011, I have supported the development of the animal stem cell products that the Company initially commercialized, and Progenza™ for the STEP (Safety, Tolerability and Efficacy of Progenza) Trial, which was the first-in-human study for the technology.

Now, I’m responsible for overseeing the manufacture and development of Progenza™ for Phase 2 trials in Japan and the US, including engaging with regulatory bodies to ensure we have all the data we need to open an Investigational New Drug application with the US FDA, and ensuring our commercialization partner, Kyocera Corporation, is supported to complete their manufacturing of Progenza™ in Japan.

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

A. Our primary focus is to increase the value of our product assets for shareholders and the next step to achieve this is obtaining successful Phase 2 trial data in Japan and the US. This data will enable us to achieve conditional and market approval in Japan – so that revenues can start to be realized – and support us to target the US as the largest osteoarthritis (OA) market in the world.

My role in this process is to ensure the product manufactured is efficacious and safe for Phase 2 clinical trials. The next 12-months will see us complete this manufacture.

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

A. We believe – and our IP portfolio supports this – that Mesenchymal Signalling Cells (MSCs) work by producing different proteins that communicate with cells in the body to alter destructive and painful diseases, achieving reduced inflammation and the promotion of self-repair.

With the opioid crisis there is significant opportunity for non-opioid pain relief to be invested in, and due to their disease modifying capabilities, I believe our platform technologies Progenza™ and Sygenus will be key products for this in the future.

Sygenus is a mix of MSC produced proteins that shows a very potent pain reduction effect, while for Progenza™, we have a long list of potential pain and inflammatory diseases that we believe we can target, in addition to what we are currently doing with knee OA in Japan.

While the field of regenerative medicine is still very much in its infancy, I believe cellular therapies are the drugs of the future, and as more of these products receive worldwide approvals, the science continues to prove its essential role in addressing unmet medical needs.

Q. What are you most excited about for Regeneus’ technology and your role in the Company?

A. The most exciting aspect of product development is when you see technology that you have helped design become a successful, marketable product. The bonus of working with Regeneus is knowing that a successful Progenza™ or Sygenus product will also bring pain relief to patients, and potentially even halt a disease such as OA that previously has had no effective treatment.

Our goal is to provide patients with an effective, alternative treatment to opioids and surgery, as this is where the gap in the market currently lies, and considering the pathway we are currently on, I believe Progenza™ has real potential to be the first disease modifying knee OA treatment on market.

Regeneus to Present at 2021 Virtual Cell & Gene Meeting on the Mediterranean

Regeneus Ltd (ASX: RGS) (Regeneus or the Company) announced today that Regeneus Chief Executive Officer Karolis Rosickas will present at the annual Cell & Gene Meeting on the Mediterranean to be held virtually April 6-9.

Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mediterranean is a four-day virtual conference featuring more than 80 dedicated company presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies. The meeting also includes over 50 panelists and featured speakers taking part in 13 in-depth sessions covering all aspects of cell and gene therapy commercialization.

Please see details of the conference below:

Event:    2021 Virtual Cell & Gene Meeting on the Mediterranean

Date:     Tuesday, April 6 – Friday, April 9

Time:     Company presentations will be available to view on-demand throughout the entirety of the conference

Please visit www.meetingonthemed.com for full information including registration. Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Laura Stringham at lstringham@alliancerm.org and interested media should contact Kaitlyn Dupont at kdupont@alliancerm.org.

Regeneus (ASX:RGS) Company Update Investor Webcast Recording

During a webcast for investors on Wednesday 3 March 2021, Regeneus CEO Karolis Rosickas provided an update on Regeneus, its lead technology platforms Progenza™ and Sygenus, and where the Company is headed in 2021.

The second half of the session contained a Q&A where Karolis was joined by, Regeneus' Head of Research and Development Dr Charlotte Morgan and Director of Clinical Development and Medical Affairs Dr Sinead Blaber to answer several investor mymedic.es questions.

A recording of the webcast is available below. You can also download Karolis' presentation deck here.

Regeneus (ASX:RGS) Company Update Investor Webcast

Regeneus Ltd (ASX: RGS) (Regeneus) invites its shareholders and interested parties to attend a live webcast and Q&A with Regeneus CEO Karolis Rosickas on Wednesday 3 March at 11:00am Australian Eastern Daylight Time (AEDT).

During the session, Karolis Rosickas will provide an update on the Company’s technology and ongoing strategy. Please see details of the webcast and a link to register here.

Investors are invited to submit questions relating to the Company’s technology ahead of the webcast by emailing WE-AURegeneus@we-worldwide.com. Please note, this session will not cover financial updates.

Regeneus Half Year Results H1 FY21

Regeneus' (ASX:RGS) CEO Karolis Rosickas announces the release of the Company's Half Year Results for the period ending 31 December 2020. Read the full report here​ and the cover note here​.

Regeneus to be granted new patent to target pain in Japan

Regeneus announced it has been granted a key patent for its lead stem cell technology platform Progenza™ for the treatment of pain in Japan. Read the full announcement on the ASX here.

Regeneus Quarterly Report Q2 FY21

Regeneus' (ASX:RGS) CEO Karolis Rosickas announces the release of the Company's Q2 FY21 results. Read Regeneus' Quarterly Cashflow report for the period ending 31 December 2020 here.

Q&A with Dr Sinead Blaber, Director of Clinical Development and Medical Affairs 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 started my PhD in 2009, investigating the mechanisms of bacterial spore formation with the overall aim to identify new antibiotic targets. My husband worked in the lab next door and his supervisor was branching out into the regenerative medicine space and had just co-founded Regeneus.

Through discussions with this group, I quickly became fascinated with how stem cells work and the therapeutic potential of the regenerative medicine space. Ultimately, I transferred my PhD and completed it in conjunction with Regeneus. My PhD involved investigating the therapeutic adipose-derived stem cells and their secretions. I subsequently took up a position as a Research Fellow, acting as a bridge between the University-based research and Regeneus, before branching into the clinical research space at the company.

Q. Tell us about your current role as the Director of Clinical Development and Medical Affairs at Regeneus?

A. I am very excited to have rejoined Regeneus at such a critical time in the company’s development. My role is multi-factorial as it covers both clinical development and medical affairs.

On the clinical development side, my role involves designing and executing the strategic clinical development programs for both Progenza™ and Sygenus. This involves leading high quality pre-clinical and clinical studies to support their development and interacting with regulatory bodies in jurisdictions of interest.

On the medical affairs side, my role involves being the link between Regeneus and the wider medical community. This includes representing Regeneus at a variety of forums, such as conferences, and establishing and managing relationships with external key opinion leaders. Regeneus has numerous collaborations with experts at the University of Adelaide, Monash University, the University of New South Wales, the University of Technology Sydney and the Agency for Science, Technology and Research in Singapore. These collaborations are valued by Regeneus and contribute to building the knowledge base on our products.

Q. You were previously employed at Regeneus in a scientific and clinical research capacity, including leading the Phase I Progenza™ STEP Trial. Why did you decide to return to the company?

A. I joined Regeneus when it was a small company and worked there for over 8 years in multiple roles across the scientific and clinical research areas. In that time, the team grew substantially and achieved significant milestones in developing and commercialising autologous cell therapies for animals and humans.

During this time, I led the Phase I Progenza™ STEP Trial which met its primary endpoint of safety and showed very encouraging signs of efficacy, including pain relief and halting cartilage degradation in patients with knee osteoarthritis. These were very exciting results for the entire Regeneus team. There are no disease-modifying treatments available for osteoarthritis. so our Phase I trial results highlighted the potential of Progenza™ to be the first disease-modifying treatment for this condition.

In the years I spent away from Regeneus, I gathered experience not only in running Phase I and II clinical trials, but also in the overall strategy for developing different therapeutic modalities, including in the scientific, clinical, regulatory, intellectual property and commercialisation areas across multiple indications.

Given the additional experience I had gained outside of Regeneus, - coupled with my knowledge of the potential of Progenza™ and Sygenus - I decided to rejoin the company. I believe that our products can make a difference to patients and I wanted to apply my skills to develop and deliver Progenza™ and Sygenus to patients in need. I am passionate about developing therapeutics with the potential to help patients and rejoin the company.

Q. What do you believe is next for regenerative medicine and what role can Regeneus’ technology play?

A. In recent years there has been an explosion in the regenerative medicine space with many cell and gene products being developed for a variety of indications. Additionally, regulatory agencies have become much more familiar with regenerative medicines and recognize their potential resulting in initiatives such as the Japanese regulatory body, the PMDA, offering an accelerated approval pathway for cell therapies.

Since I left Regeneus after the completion of the Phase I Progenza™ STEP trial, the company has made significant progress through the Progenza™ licence and collaboration agreement with Kyocera, which highlights the significant commercial value and confidence in our technology. This agreement provides a clear commercialisation pathway for Progenza™ in osteoarthritis. Approximately 25.6 million people in Japan suffer from osteoarthritis with the market expected to grow to US$350 million by 2026 in Japan and US$3.5 billion globally.

Given our positive safety and efficacy results in the Phase I STEP trial, coupled with the Kyocera agreement, Progenza™ is well placed to change patients’ lives through pain relief and halting cartilage degradation associated with osteoarthritis, a serious condition with an unmet medical need, given as yet no disease-modifying treatments are available.

Q. What are you most excited about for Regeneus’ technology and as a company? How does your role help support this?

A. Progenza™ is a unique cell therapy product. One of the ways mesenchymal stem cells (MSCs) exert their therapeutic effect is through the secretions they produce. These secretions include a mixture of factors that act on multiple cells in the body, including immune cells and cartilage cells within a joint. These secretion factors can shift the pro-inflammatory environment commonly seen in osteoarthritic joints to an anti-inflammatory environment conducive with repair, regeneration and a reduction in pain. MSCs continue to secrete these factors once they are administered to a patient.

Unlike other stem cell therapies in development, Regeneus freezes the stem cells with their secretions. We have found that in doing so, the stem cells have enhanced viability and functionality upon thawing. This means the stem cells in our Progenza™ product when thawed are healthier and can exert their therapeutic effect quickly when introduced into a patient.

Sygenus contains just the secretion factors produced by stem cells and is being developed as a topical product for the treatment of pain and inflammatory conditions. We have shown positive safety and efficacy results in human pilot studies in conditions such as acne.

Regeneus has significant potential and is well placed to deliver Progenza™ to Japanese osteoarthritis patients in collaboration with Kyocera. However, there is also potential for Progenza™ beyond the Japanese market and for Sygenus in a variety of pain and inflammatory indications. My role involves establishing and maintaining partnerships with collaborators to continue to build on the knowledge base for our unique products, coupled with driving strategic clinical development of our technology to support their commercialisation in markets and indications of interest.

Company update and season's greetings from Regeneus

Regeneus CEO Karolis Rosickas shares a company update as we look ahead to 2021.