Chairman's Address to Shareholders

Thursday, 22 November 2018

2018 Annual General Meeting, Chairman’s Address

Welcome and Introduction

Ladies and gentlemen, good afternoon and welcome to the 2018 annual general meeting for Regeneus. My name is Roger Aston and I am Chairman of Regeneus. I have been advised that there is a quorum present and I declare this meeting open.

I would like to start by introducing you to my fellow Directors. With us today are Executive Director and CEO, John Martin, Executive Director, Chief Scientific Officer and co-founder, Professor Graham Vesey, Non-Executive Director, Barry Sechos, Non-Executive Director, Dr Glen Richards and Non-Executive Director, Leo Lee.

I would like to make a special welcome to our newest director Leo Lee who joins us for his first AGM. Leo is based in Tokyo and as an experienced executive leader in the Japanese pharmaceutical market, he provides us with valuable insight and assistance as we seek to grow and develop our business in Japan.

Before we commence the formal items of business, I will give a brief overview of the highlights for the year, and then hand over to our CEO, John Martin who will take you through a presentation of our key accomplishments during the period.

FY18 Overview

We are pleased with the progress we have made during the 2018 financial year. We are well positioned to achieve important commercial milestones in this financial year which we now anticipate will create significant shareholder value and be well supported by the market.

We have made significant progress in identifying and negotiating terms and conditions for our first clinical partner for Progenza in Japan. We are working towards being in a position to make an announcement about the collaboration in this quarter. This clinical collaboration will be an inflexion point for our company and complement our existing manufacturing relationship and commercial joint venture with AGC in Japan and set us up for growing long term shareholder value in Japan and providing a foundation for new collaborations in other key markets.

Our CEO will provide further detail in his presentation.

We have delivered a number of key milestones across Regeneus’ platforms.

For Progenza, we received further strong validation of the platform’s therapeutic benefits, delivering a number of key achievements. In March, the positive results of our Phase 1 STEP safety trial on patients suffering from knee osteoarthritis were published in the well-respected Journal of Translational Medicine. The exciting trial results - which showed Progenza was safe, well tolerated, delivered long lasting pain relief and improved tibial cartilage volume – and their publication, were a key milestone for Regeneus and has played an important part in advancing our clinical licensing efforts in Japan.

The United States and European Patent Offices confirmed patents would be granted for Progenza, providing commercial rights to Regeneus in the United States and across 38 European member states until 2032. The US and European patents will join corresponding patents already granted in Australia, New Zealand and Japan and provides strong protection around the world for Regeneus’ intellectual property. Progenza was also granted an Advanced Therapy Medicinal Product classification, recognising Progenza as a regenerative therapy within the EU’s legal and regulatory framework.

In September 2017, we released positive results from our preclinical study of Sygenus and its effects on post-operative pain. The study showed the topical application of Sygenus delivered pain relief which was longer lasting that morphine. This was an exciting preclinical trial result and we continue to conduct additional preclinical studies of Sygenus and Progenza, in the treatment of pain.

Additionally, the topical application of Sygenus gel delivered some exciting results when topically applied in the treatment of acne and age spots. The gel was found to reduce the appearance and severity of acne in acne patients and reduce the size of 95% of age spots and reduce the size and lighten 63% of age spots for age spot sufferers. We have been granted a broad Australian Patent for the topical application of Sygenus in the treatment of both aging skin and age spots, and a Chinese patent for the use of Sygenus to treat acne, with commercial rights protected to 2032. We completed our Phase 1 Safety Study of our RGSH4K cancer vaccine immunotherapy treatment across a wide range of tumours in humans. The trial met its primary endpoint of safety and tolerability and showed encouraging signs of immune stimulation in patients and anti-tumour activity. We anticipate the publication of the study results in the second half of this financial year. We will also pursue a clinical development and commercialisation partner for this technology.

Finally, we are in discussions with our CryoShot study partner about the next step for the development of the product.


It is through the hard work and dedication of our team that we have been able to deliver a number of key milestones across all our platforms, and significantly, a second Japanese deal which delivers additional revenue streams and progress towards the commercialisation of Progenza.

Before I hand over to our CEO, John Martin, I’d like to take this opportunity on behalf of the Board to thank our senior management team, employees and R&D partners for their ongoing commitment and hard work.

I would also like to thank our shareholders for your continued support and patience, as we continue to focus on commercialising our regenerative products and building long term shareholder value.

I’ll now hand over to John to provide you with further details of the past year and some of the key milestones ahead of us.

Dr Roger Aston