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

22 March 2021News

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

22 March 2021News

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

4 March 2021News

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 questions.

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