Chairman's Address to Shareholders

Wednesday, 19 October 2016

Good morning and welcome to the annual general meeting of Regeneus.

I have been informed that there is a quorum present and I am pleased to declare the meeting open.

Let me introduce my fellow Directors. To my right John Martin, our CEO; next to John is Professor Graham Vesey, co-founder and Chief Scientific Officer; then introducing our non-executive directors Barry Sechos and Dr Glen Richards.

I would also like to introduce you to representatives from Link Market Services, our share registry provider and to our external auditors Grant Thornton who have kindly allowed us to use their facilities to host this meeting. Thank you.

I will now lead the meeting with my Chairman’s address which will be followed by a presentation by our Chief Executive Officer, John Martin. Both these presentations have been lodged on the ASX announcements platform prior to the meeting. Following the presentations, we will proceed with the formal business of the AGM.

We are pleased to report that during the last financial year we achieved a number of important R&D, manufacturing, clinical and commercial milestones that we believe will help unlock significant value in the business over the next 12 months.

As an R&D biotechnology company, meeting these milestones is key to developing our products to their next value inflexion point and improves our clinical and commercial partnering efforts. Finding and collaborating with the optimal manufacturing, clinical development and commercialisation partners at the right time is critical for the long-term success of the business. Successful partnering allows us to de-risk our investment in our clinical assets and access non-dilutive licence fees and royalties for further investment.

Prior to the end of the last financial year, your Board reviewed the company’s strategy and plans for the next year and have set the strategic priorities and milestones for the next 12-18 months to maximise longterm value for shareholders.

I’d like to address some key areas of achievement over the last 12 months. Our CEO will cover these in more detail in his presentation.

Key achievements for FY16

We have made excellent progress on our clinical trials:

Progenza STEP trial – our lead allogeneic off-the-shelf stem cell therapy for human osteoarthritis has commenced and completed enrollment with positive safety review for both dose cohorts.

RGSH4K ACTIVATE trial – our autologous cancer vaccine has commenced. We have established a tumour bank and patients have been safely dosed in all 3 cohorts. Recruitment is active.

We have commenced various clinical trials for our animal health therapies including a pre-pivotal trial for CryoShot Canine, our allogeneic stem cell therapy for canine osteoarthritis at the University of Pennsylvania with more than 40% of dogs recruited.

For our Kvax trials – our autologous canine cancer vaccine, we have completed an osteosarcoma trial with VCA Hospitals Inc in USA and we have commenced enrollment of a lymphoma trial at Small Animal Hospital in Sydney.

We have also made progress on our partnering developments which include entering into an agreement with a top animal health pharma to partner development and commercialisation of CryoShot for canine osteoarthritis.

We are well advanced in licensing discussions for manufacturing and clinical development of Progenza in Japan. To pause for a moment, I can add that our senior management led by John Martin have worked relentlessly to deliver what I believe is a transformational deal for the company in one of the largest stem cell markets, namely Japan. We had hoped this would have been signed off by today but we are still a few weeks off.

We have an exclusive licence for next generation cell identification and selection technology for high potency secreting stem cells developed at Macquarie University node of Centre for Nanoscale Biophotonics. This relationship has helped secure ARC linkage grant funding for collaboration research with Macquarie University and University of Adelaide into treating chronic pain with stem cells.

We have entered a collaboration with CSIRO on the manufacture scale-up for Progenza and Secretions technologies as well as making improvement to cell growth media to enhance the cell yield for Progenza and Secretions and we have optimised the secretions formulation.

We continue to grow our strategic IP portfolio with 2 key patents being granted: one in Australia covering the Progenza technology covering allogeneic stem cells and secretions for the treatment of osteoarthritis and other inflammatory conditions in humans and animals and another in Australia covering the cancer vaccine technology for the treatment of cancers in humans (RGSH4K) and animals (Kvax).

Outlook and thanks

On behalf of the Board I thank the Regeneus senior management team and each of our employees and R&D partners for their hard work and commitment over the past year. 2017 is shaping up to be a transformational year for the company with some key R&D, clinical and commercial milestones in sight.

The Board looks forward to capitalising on the progress we are making and unlocking the value in our technology and clinical assets and gaining market recognition for our successes.

Finally, may I thank you, our shareholders for your support of our company and what we do and showing patience as we develop and seek to partner our regenerative medicine products.

I would now like to ask our Chief Executive, John Martin, to provide further insight into the past year’s activities and to share with you our plans for the future and specific milestones and catalysts for FY17 and beyond in a slide presentation.

Thank you.
Dr Roger Aston