Annual Report 2015
Sydney, Oct 19, 2015 AEST (ABN Newswire) - Regeneus Ltd (
ASX:RGS) are pleased to provide the Company's Annual Report for 2015 to shareholders.
Message from the Chairman and CEO:
Dear Shareholders,
On behalf of the Board of Directors, we are pleased to report on the progress we have made during the financial year ending 30 June 2015.
In FY15 we achieved a number of significant clinical, manufacturing and commercial milestones that have set the foundations for unlocking value in the business in FY16 and beyond.
Key achievements for FY15
Key achievements during FY15 included:
- Obtaining ethics approval for commencement of first-in-human trials for:
* Progenza. Our allogeneic "off-the-shelf" stem cell therapy for osteoarthritis;
* RGSH4K. Our cancer vaccine;
- Demonstrating our capacity to manufacture millions of doses of Progenza from a single donor;
- Progressing our partnering and licensing discussions:
* For the manufacture, clinical and commercial development of Progenza in Japan;
* For the clinical development and sales and marketing of CryoShot canine, our allogeneic stem cell therapy for canine OA;
- Substantial growth in our intellectual property portfolio including:
* Granting of 11 new patents and our 1st US granted patent;
* Securing the exclusive rights to the human cancer vaccine technology developed at the Kolling Institute of Medical Research at Royal North Shore Hospital.
A more detailed review of the company's operations for the period is set out in the Directors' Report.
Strategic focus on Progenza
Over the last year, the company has made significant clinical and manufacturing progress in the Progenza program. This progress, together with the lack of scalability and regulatory certainty of the HiQCell business model, has contributed to the Board's decision to focus the company's efforts and resources on the development of Progenza and reduce the focus and expenditure on the commercialisation of HiQCell.
It has become clear that allogeneic "off-the-shelf" stem cell products like Progenza, are the preferred business model of pharmaceutical companies because of the advances in scalable production and distribution. The company will assess the licensing options for HiQCell technology once there is greater regulatory certainty for autologous stem cell products.
Financial highlights for FY15
The financial highlights for FY15 as reported in the company's financial statements included:
- Revenues of $2.06m in line with last year's revenues (FY14: $2.09m);
- Net loss down 12% to $6.6m (FY14: $7.5m);
- Net operating cash outflows of $5.9m (FY14: $6.2m);
- Successful capital raising completed in August 2014, net of costs of $6.17m;
- Receipt of $3.73m R&D tax incentive for FY14;- Cash at 30 June 2015, $3m and receipt in October of $3.4m R&D tax incentive for FY15;
A more detailed financial review is set out in the Directors' Report.
Looking forward
2016 is shaping up to be a turning point in the evolution of the company with a number of key commercial, clinical and R&D milestones in sight.
We look forward to capitalising on the effort to date in unlocking the value in the company's clinical assets and hopefully the market supports these developments.
Thanks
We'd like to thank our fellow directors and the team at Regeneus for their outstanding efforts and contribution to the business over the last financial year.
In particular, we'd like to thank Professor Graham Vesey, our founding CEO who moved from CEO to Executive Director and Chief Scientific Officer in November last year. Professor Vesey served as the founding CEO for seven years and played a vital role in the growth and development of the business.
We'd like to farewell Associate Professor Ben Herbert, a co-founder, who stepped down from the Board in November last year after serving for seven years as a founding director of the company. We'd like to thank Ben for his important contribution to the Board and the company.
Welcome to Dr. Glen Richards who joined the Board in April this year. As the founding MD of Greencross, Australia's largest listed veterinary health group, Glen brings a unique combination of clinical and business experience to the Board.
Finally, we would like to thank our shareholders for their support of the company and what we do and showing patience as we develop and seek to partner our regenerative medicine products.
Dr. Roger Aston
Chairman
John Martin
Chief Executive Officer
To view the Annual Report, please visit:
http://media.abnnewswire.net/media/en/docs/ASX-RGS-885644.pdf
About Regeneus Ltd
Regeneus Ltd (ASX:RGS) is a Sydney-based clinical-stage regenerative medicine company using stem cell technologies to develop a portfolio of novel cell-based therapies. The regenerative therapies seek to address unmet medical needs in human health markets, focusing on neuropathic pain, including osteoarthritis and various skin conditions, with its platform technologies Progenza(TM) and Sygenus. Visit www.regeneus.com.au for more information.
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