2021 Annual General Meeting

Regeneus Limited 2021 Annual General Meeting will be held virtually at 3:00pm AEDT on Thursday, 18 November 2021.

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.

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.

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