Regeneus is aiming to sign one or more clinical development licence deals for Progenza in the current financial year. It is well placed to achieve this goal, having already granted AGC an exclusive licence to manufacture Progenza for Japan, reported promising signs of efficacy from the successful Phase I trial of Progenza in knee osteoarthritis and been granted a Progenza patent in Japan.
Regeneus reported an A$3.3m profit in FY17, thanks to the US$5.5m upfront payment and US$1m milestone from the AGC licence deal; further milestone payments are likely to keep it in the black in FY18. Other potential catalysts for FY18 include results from the ACTIVATE Phase I cancer vaccine trial and the CryoShot Canine pre-pivotal trial. Our valuation is virtually unchanged at A$146m or A$0.70/share.
Regeneus Ltd (ASX: RGS), a clinical-stage regenerative medicine company, today released its Full-Year Report for the 12 months ending 30 June 2017.
This financial period has seen the company achieve major milestones that build the foundation for the businesses future success. Strategic collaboration with AGC of Japan As part of our Japan strategy, we were successful in securing a strategic collaboration and licensing agreement of our Progenza stem cell technology with AGC of Japan (TYO:5201). AGC is a world-leading glass solution provider and a leading manufacturer of biopharmaceuticals. This is the first collaboration of its type by an Australian biotechnology company in Japan.
Under the terms of the collaboration:
• AGC has the exclusive rights to manufacture Progenza in Japan
• AGC will have a 50% interest in Regeneus Japan, which holds the exclusive rights for the clinical development and commercialisation of Progenza for osteoarthritis and all other clinical indications in Japan
• In January 2017, Regeneus received US$5.5 million as an upfront payment and a further US$1million in June upon meeting the primary endpoint in the Progenza STEP trial for osteoarthritis. The company will be entitled to 2 further payments of US$5m upon meeting specific development and approval milestones. Successful STEP trial results On 22 May, we announced the positive results from the Phase 1 STEP trial of Progenza in patients with knee osteoarthritis, meeting the primary endpoint of safety and tolerability.
Other key outcomes from the trial were:
• significant, rapid and sustained reduction in knee pain at both Progenza doses
• significant improvement in cartilage volume compared to placebo • positive signs of disease modification consistent with preclinical results
Other key achievements Other key achievements for the period include:
• advanced discussions with potential partners for clinical development of Progenza for a range of indications in Japan and other territories
• patent allowed in Japan covering Progenza technology for the treatment of OA and other inflammatory conditions
• patent allowed in EU, USA and China covering Sygenus stem cell secretions technology for the topical treatment of acne • commenced Australian Research Council linkage funded collaborative research project with Macquarie University and University of Adelaide to explore Progenza and Sygenus use in the treatment of chronic pain.
Regeneus (ASX: RGS), a clinical-stage regenerative medicine company, today announced that a preclinical post-operative pain study has shown that topical application of Sygenus, has significantly greater and longer lasting analgesic effect than an injection of morphine.
Sygenus is an allogeneic cell secretions technology platform that comprises cytokines, growth factors and exosomes from adipose-derived mesenchymal stem cells (MSCs). These bioactive molecules are known to reduce pain and inflammation and encourage accelerated healing and repair.
These promising results show that Sygenus is having a sustained analgesic effect above and beyond the anti-inflammatory effect that others have observed with MSCs and their secretions.
The study report titled 'Sygenus technology shows more potent and longer lasting effect on pain than morphine' has been published on the Regeneus website.