Regeneus AGM 2023

Regeneus will hold its 2023 Annual General Meeting on Thursday 30th November 2023 commencing at 1 pm (Sydney time)

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.

Latest news & insights

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

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.

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