Sydney-based Regeneus (ASX: RGS) says it made significant progress in the development of its portfolio of cell-based therapies in the past year.
Reporting its 2015 financial results and business update, the company said the year was highlighted by approval for commencement of first-in-human trials of Progenza, its allogeneic 'off-the-shelf' stem cell therapy for osteoarthritis, and cancer vaccine, RGSH4K.
According to CEO, John Martin, "Last financial year was an important one for the company. We achieved a number of significant clinical, manufacturing and business milestones that should set the foundations for unlocking value in the business in FY16 and beyond".
The company said the Board has decided to focus its resources on the development of Progenza and reduce expenditure on the commercialisation of HiQCell.
"Allogeneic 'off-the-shelf' stem cell products, like Progenza, are the preferred business model of pharmaceutical companies because of scalable production and distribution," it said. "The company will assess the licensing options for HiQCell once there is greater regulatory certainty for autologous stem cell products."
In its business update, the company also highlighted progress in partnering and licensing discussions for the manufacture, clinical and commercial development of Progenza in Japan, as well as for global sales and marketing of canine CryoShot, its allogeneic stem cell therapy for canine OA.
It also pointed to substantial growth in its intellectual property portfolio, including the granting of 10 new patents and its first US patent, as well has securing the exclusive rights to the human cancer vaccine developed at the Kolling Institute of Medical Research.
In relation to financials, the company reported revenues of $2.06 million, largely in line with last year's revenues of $2.09 million, and a net loss down 12 per cent to $6.6 million. It completed a successful $6.17 million capital raise in August last year and received $3.73 million via the R&D tax incentive for financial year 2014. The company held $3 million in cash at 30 June 2015 and expects to receive $3.4 million from the R&D tax incentive in October.