Regeneus reports half-year results

Monday, 29 February 2016

Regeneus Ltd (ASX:RGS), a clinical-stage regenerative medicine company, today reported financial results and operational highlights for the 6 month period ended 31 December 2015.

Financial Highlights

The financial highlights for the reporting period included:

  • Loss from ordinary activities (before tax) down 46% to $3.1m;
  • $3.4m R&D tax incentive received for FY15 ($3.7m for FY14);
  • Cash at 31 December 2015, $3.4m;
  • Net operating cash outflows (prior to R&D tax incentive of $2.8m), compares favourably to outflows of $5.7m during the previous half-year corresponding period;

Operational Highlights

During the reporting period, the company continued to make good progress on the clinical development of its portfolio of cell-based therapies for the treatment of osteoarthritis and other musculoskeletal disorders and oncology disease in humans and animals.

Operational highlights for the reporting period included:

Human Health – clinical trials

  • Completed enrollment and positive safety review of Cohort 1 for STEP trial for knee osteoarthritis;
  • First patient dosed safely and commenced treatment of new enrolments for ACTIVATE immuno-oncology trial;

Animal Health – clinical trials

  • Commenced pre-pivotal trial for CryoShot for canine osteoarthritis at University of Pennsylvania;
  • Commenced trial for Kvax for canine lymphoma at Small Animal Specialist Hospital in Sydney;

Commercial and IP developments

  • Entered into agreement with top 5 animal health pharma to partner the development and commercialisation of CryoShot Canine;
  • In-licensed rights for development and commercialisation of next–generation stem cell identification and selection technology for high potency secreting stem cells developed at Centre for Nanoscale BioPhotonics at Macquarie University;
  • Advanced discussions for licensing of Progenza stem cell technology for development,manufacture and commercialisation in Japan;
  • Australian patent granted for allogeneic stem cells for osteoarthritis and other inflammatory conditions in human and animals;
  • Australian patent granted for cancer vaccine technology for humans and animals;

Looking forward

Over the next 12 months, the company will seek to unlock value in its clinical and technology assets through achieving milestones including:

  • Complete enrollment of Cohort 2 and report on preliminary safety in STEP trial – H2FY16;
  • Enter into an agreement for the licensing of Progenza in Japan - H2 FY16;
  • Report on Kvax osteosarcoma trial – H2 FY16;
  • Report on CryoShot canine trial – H1FY17;
  • Complete recruitment of ACTIVATE trial – H1FY17