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Sydney, Feb 29, 2016 AEST (ABN Newswire) - 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