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 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.

2020 Annual General Meeting - Recording

Regeneus (ASX:RGS) held its 2020 Annual General Meeting on Wednesday 14 October, 2020 at 2:30pm.

For shareholders that missed it, you can listen to the recording below, and refer to the Results of Annual General Meeting ASX announcement here.


Regeneus CEO Leo Lee with Proactive at the ASX Small and Mid-Cap Conference 2020

Regeneus CEO Leo Lee speaks to Proactive Investors' Andrew Scott while at the virtual ASX Small and Mid-Cap Conference 2020. During the interview, Leo talks about how Regeneus is working towards its mission to improve the quality of life for patients suffering from pain through their regenerative medicine products Progenza and Sygenus, the recent deal with Japanese manufacturing giant Kyocera Corporation, the experience of Regeneus' Board, and the current opportunity for investors.

Watch Leo's full interview with Proactive Investors here.

Mesenchymal Stem Cells: The Next Generation of Pain Treatments

Regeneus CEO Leo Lee is featured in the October 2020 edition of the European Pharmaceutical Review, writing on the field of regenerative medicine and its potential to dramatically transform the way that pain is treated.

Read Leo's full article in the European Pharmaceutical Review October 2020 digital edition here.

Regeneus featured in Morgans ‘Under The Microscope’ podcast

Morgans analyst Iain Wilkie sat down with Regeneus CEO Leo Lee to talk about the company's recent collaboration and licensing deal for Progenza OA for knee osteoarthritis in Japan and what it means for the company.

Listen to the podcast here.

Dr Boreham's Crucible: Regeneus is now riding the stem cell rollercoaster upwards

Business and life sciences writer Tim Boreham recently featured Regeneus in his regular biotech stocks column, Dr Boreham’s Crucible.

The column, published on Stockhead, reported that Regeneus' deal with Kyocera was important as it provided a clear commercialisation pathway for the lead stem cell platform technology Progenza.

Read the full article via Stockhead here.

Aussie stem cell company Regeneus out-licenses Progenza to Kyocera for Japan market

Biotechnology and biopharmaceutical industry publication, BioWorld, also covered the news on Regeneus out-licensing its lead mesenchymal stem cell (MSC) and Secretome therapy, Progenza, to Japan’s Kyocera Corporation for osteoarthritis of the knee for the Japan market, The report noted Kyocera has a strong presence among, and relationships with, physicians who treat osteoarthritis, and that this would help Progenza in the long term.

Read the full article here.

Regeneus, Kyocera ink $19M deal for knee osteoarthritis treatment

Bio and Health Sciences publication BioSpectrum covered Regeneus' deal with Kyocera for Progenza OA in Japan in their Asia Edition.

Read the full article in BioSpectrum Asia here.

Regeneus (ASX:RGS) Announces Collaboration With Kyocera

Regeneus CEO Leo Lee caught up with Finance News Network to talk about the company's collaboration with Japan's Kyocera Corporation to licence, manufacture and commercialise its stem cell therapy treatment Progenza.

Watch Leo's interview via The West Australian here

Regeneus CEO Leo Lee interviewed on ausbiz

Regeneus CEO Leo Lee was interviewed by Australian business, markets, startups news outlet, ausbiz, on Tuesday 11 August following the announcement that Regeneus had signed a new collaboration and licensing agreement with Kyocera for Progenza OA in Japan. In the interview, Leo noted the upfront and milestones payments were worth $27M, and that Regeneus would also receive royalties on product sales.

In the interview, Leo also noted that there were more than 25M potential patients with osteoarthritis in Japan, and that the number of people receiving treatment is rising each year.

Watch Leo's interview here.

Regeneus and Kyocera ink lucrative deal to commercialise Progenza in $3.5 billion dollar market

Financial news outlet finfeed featured Regeneus' Kyocera deal on the day of the announcement, offering in depth analysis of the company, the progress made so far in addressing the global pain market through its differentiated technologies, and the upcoming milestones investors can look forward to.

Read the full article via finfeed here.

Regeneus receives milestone payment from Kyocera

Australian biotechnology and life sciences online news source, BiotechDaily, reported that Regeneus received a non-refundable milestone payment of approximately $1.6 million (100 million Japanese Yen) from Kyocera Corporation as set out in the non-binding Memorandum of Understanding (MOU) signed on 2 March 2020.

Read the full article here.