Regeneus FY16 Results Presentation
Sydney, Aug 24, 2016 - (ABN Newswire) - Regeneus Ltd (ASX:RGS) are pleased to provide a Company Presentation for the Full Year Results for FY16.
FY16 Financial Results Overview
- Licence fee revenues up 35% to $1.2m (FY15: $0.9m)
- R&D tax incentive of $2.7m claimed (FY15: $3.4m)
- Expenditure levels reduced in all categories a key benefit of the strategic changes taken throughout FY15
- Loss from ordinary activities reduced by 45% to $3.6 m (FY15: $6.6m)
Operating Cash Burn
- Quarterly cash burn down 37% to $1.48m per quarter (FY15: $2.35m per quarter) - better than stated target of $1.7m
- Net cash used in operating activities of $2.25m (including R&D tax incentive) (FY15: $5.92m)
- $2m R&D tax funding facility in place
- R&D tax incentive of $2.7m expected to be received mid September '16
Progenza FY16 Achievements
STEP Trial Update
- Commenced and completed recruitment for Progenza Phase 1 Study for osteoarthritis (STEP Trial)
- Positive safety review for both cohorts
- 12 month follow up on participants
Collaboration and licensing
- Progressed licensing discussions for manufacturing, clinical development and commercialisation in Japan
Product development and scale-up
- Collaboration with CSIRO on manufacture scale up-technologies
- Improvements to cell growth media to enhance yield
- Developed potency and identity assays
RGSH4K - Human Cancer Vaccine FY16 Achievements
- Established tumour bank - receiving patient samples to support vaccine manufacture
- First patient dosed safely Nov '15 - ACTIVATE trial open for enrollment
- Patients dosed safely in all 3 cohorts
- Assess emerging study data to:
-- investigate vaccine safety, and
-- identify a biologically active dose for further studies
- Exploring partnering for combination with check point inhibitors
CryoShot FY16 Achievements
- Commenced recruitment for 80 dog prepivotal trial at U.Penn to assess CryoShot for canine osteoarthritis more than 30% recruited
- Entered into agreement with top animal health pharma to partner development and commercialisation of CryoShot
- Positive clinical results for using CryoShot on early orthopaedic development disease in yearling thoroughbreds
- Commenced study in assessing CryoShot for strengthening equine tendons
Kvax - Canine Cancer Vaccine FY16 Achievements
- Completed clinical trial assessing Kvax for canine osteosarcoma as standalone treatment with Dr Bergman of VCA Hospital Inc., largest US vet services group
-- data readout from osteosarcoma trial in Oct '16
- Commenced clinical trial for Kvax in combination with chemotherapy for canine lymphoma with SASH
To view the full presentation, please visit: http://abnnewswire.net/lnk/E733157G
WEB: FY16 Results Presentation
About: Regeneus Ltd
Regeneus Ltd (ASX:RGS) is a clinical-stage regenerative medicine company using stem cell and immuno-oncology technologies to develop a portfolio of cell-based therapies to address significant unmet medical needs in the human and animal health markets with a focus on osteoarthritis and other musculoskeletal disorders, oncology and dermatology diseases.
FY16 Financial Results Overview
- Licence fee revenues up 35% to $1.2m (FY15: $0.9m)
- R&D tax incentive of $2.7m claimed (FY15: $3.4m)
- Expenditure levels reduced in all categories a key benefit of the strategic changes taken throughout FY15
- Loss from ordinary activities reduced by 45% to $3.6 m (FY15: $6.6m)
Operating Cash Burn
- Quarterly cash burn down 37% to $1.48m per quarter (FY15: $2.35m per quarter) - better than stated target of $1.7m
- Net cash used in operating activities of $2.25m (including R&D tax incentive) (FY15: $5.92m)
- $2m R&D tax funding facility in place
- R&D tax incentive of $2.7m expected to be received mid September '16
Progenza FY16 Achievements
STEP Trial Update
- Commenced and completed recruitment for Progenza Phase 1 Study for osteoarthritis (STEP Trial)
- Positive safety review for both cohorts
- 12 month follow up on participants
Collaboration and licensing
- Progressed licensing discussions for manufacturing, clinical development and commercialisation in Japan
Product development and scale-up
- Collaboration with CSIRO on manufacture scale up-technologies
- Improvements to cell growth media to enhance yield
- Developed potency and identity assays
RGSH4K - Human Cancer Vaccine FY16 Achievements
- Established tumour bank - receiving patient samples to support vaccine manufacture
- First patient dosed safely Nov '15 - ACTIVATE trial open for enrollment
- Patients dosed safely in all 3 cohorts
- Assess emerging study data to:
-- investigate vaccine safety, and
-- identify a biologically active dose for further studies
- Exploring partnering for combination with check point inhibitors
CryoShot FY16 Achievements
- Commenced recruitment for 80 dog prepivotal trial at U.Penn to assess CryoShot for canine osteoarthritis more than 30% recruited
- Entered into agreement with top animal health pharma to partner development and commercialisation of CryoShot
- Positive clinical results for using CryoShot on early orthopaedic development disease in yearling thoroughbreds
- Commenced study in assessing CryoShot for strengthening equine tendons
Kvax - Canine Cancer Vaccine FY16 Achievements
- Completed clinical trial assessing Kvax for canine osteosarcoma as standalone treatment with Dr Bergman of VCA Hospital Inc., largest US vet services group
-- data readout from osteosarcoma trial in Oct '16
- Commenced clinical trial for Kvax in combination with chemotherapy for canine lymphoma with SASH
To view the full presentation, please visit: http://abnnewswire.net/lnk/E733157G
WEB: FY16 Results Presentation
About: Regeneus Ltd
Regeneus Ltd (ASX:RGS) is a clinical-stage regenerative medicine company using stem cell and immuno-oncology technologies to develop a portfolio of cell-based therapies to address significant unmet medical needs in the human and animal health markets with a focus on osteoarthritis and other musculoskeletal disorders, oncology and dermatology diseases.