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Regeneus

Potential Japan licence deal a STEP closer

Update | Pharmaceutical & healthcare | 19 May 2016

Regeneus reported that its STEP Phase I trial of Progenza in patients with knee osteoarthritis has completed recruitment and that a review of safety data did not identify any safety concerns. The study will complete in H117 when all patients have completed 12 months follow-up. We believe the positive safety review augurs well for the company's plan to secure a manufacturing and commercial partner for its Progenza mesenchymal stem cell therapy technology in Japan in the current quarter, which may prompt a re-rating of the stock. We leave our valuation unchanged at A$106m (A$0.51/share) ahead of this potential re-rating catalyst.

Simavita

Edison healthcare quarterly: It’s getting personal

Sector Commentary: | Pharmaceutical & healthcare | 30 Jun 2014

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Regeneus

Preparing for a clinical licence deal in Japan

Update | Pharmaceutical & healthcare | 07 Sep 2017

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

Positive STEP data and Japan patent grant

Update | Pharmaceutical & healthcare | 31 May 2017

Regeneus announced that its Phase I STEP knee osteoarthritis (OA) trial met its primary safety endpoint at 12 months and produced promising signs of efficacy, including clinically meaningful reductions in pain for the majority of patients and improvement in knee cartilage volume. Separately, it has also been granted a key patent that protects Progenza in Japan until 2032. The positive data and patent grant will be helpful as the company seeks to advance licensing discussions for Progenza for OA and other indications in Japan (in conjunction with JV partner AGC). We increase our valuation to A$145m or A$0.70/share.

Regeneus

Japan collaboration validates Progenza

Outlook | Pharmaceutical & healthcare | 29 Jan 2017

Regeneus has entered into a US$16.5m collaboration with AGC Asahi Glass (AGC) for manufacture of Progenza for the Japanese market. Regeneus and AGC have formed a 50:50 JV for clinical development and commercialisation of Progenza in Japan – we expect the JV to sub-license one or more partners to undertake clinical trials in a number of indications in Japan. We welcome the deal, which strengthens Regeneus’s balance sheet and provides significant validation for the Progenza technology and IP. Our valuation of Regeneus increases to A$120m or A$0.57/share, with the AGC cash and larger addressable market in Japan partly offset by longer timelines and revised assumptions for CryoShot and Kvax.

Regeneus

Japan licence deal close to finalisation

Update | Pharmaceutical & healthcare | 14 Sep 2016

Regeneus anticipates entering a binding arrangement with a manufacturing and commercialisation partner for its Progenza mesenchymal stem cell therapy technology in Japan by the end of the current quarter. Following on from the positive safety review of its STEP Phase I trial of Progenza in patients with knee osteoarthritis, it has already begun procuring donor material in preparation for manufacturing Progenza for a Phase II trial in Japan. Our valuation is virtually unchanged at A$108m (A$0.52/share) ahead of this potential re-rating catalyst.

Regeneus

Partner for CryoShot a vote of confidence

Update | Pharmaceutical & healthcare | 02 Dec 2015

The agreement with one of the top five veterinary pharma companies to collaborate on the development of CryoShot Canine is recognition of the good progress that Regeneus has made developing its regenerative medicine products and cancer vaccines. At its recent AGM, Regeneus confirmed that it anticipates winning the much bigger prize of a manufacturing and development partner in Japan for its Progenza off-the-shelf human stem cell product by Q116. We maintain our valuation of A$106m (A$0.51/share) ahead of this potential re-rating catalyst.

Regeneus

Potentially two partnering deals in H215

Update | Pharmaceutical & healthcare | 09 Sep 2015

Regeneus has sharpened its focus on its area of expertise in early-stage development of regenerative medicine products and cancer vaccines. This strategy appears to be bearing fruit, with partnering arrangements for both its human and veterinary off-the-shelf stem cell therapies expected to be finalised before the end of CY15. A partnering deal for Progenza in Japan is likely to be a re-rating catalyst. Our valuation is A$106m (A$0.51/share).

Regeneus

Moving to human clinical trials for key products

Outlook | Pharmaceutical & healthcare | 17 Apr 2015

Regeneus will take a significant step forwards in the current quarter when it launches first-in-man trials for its Progenza off-the-shelf stem cell therapy and its human cancer therapeutic vaccine. The cancer vaccine could make Regeneus a player in the buoyant immuno-oncology space. Licensing deals, particularly for Kvax, CryoShot and Cell Secretions cream are further potential catalysts in 2015. After reviewing our clinical development timelines, our valuation is now A$106m (A$0.51 per share).

Regeneus

Streamlining operations

Update | Pharmaceutical & healthcare | 19 Dec 2014

The recent conclusion of Regeneus's strategic review should result in a streamlining of its operations that brings much-needed focus and portfolio prioritisation. We welcome the shift in emphasis from self-commercialisation (HiQCell in Australia) to pipeline development. The major valuation drivers remain PRG/Progenza (allogeneic stem cells for osteoarthritis) and autologous cancer vaccines for humans and animals; these products should start clinical studies in H115. Licensing deals (particularly for Kvax/CryoShot) are further potential catalysts in 2015.

Regeneus

Funding for the next level

Update | Pharmaceutical & healthcare | 01 Oct 2014

Regeneus has raised A$6m in equity to accelerate the development and commercialisation of a number of its products. With a further A$3.7m R&D tax rebate just received, the company is well placed to advance its stem cell and cancer vaccine franchises. Of particular note, capital is now available to complete the preclinical work required for Progenza (allogeneic stem cells for osteoarthritis) and a human cancer vaccine, and initiate first-in-man clinical studies with both candidates in H115. Adjusting for the recent financing, our valuation is now A$148m, or A$0.71 per share.

Regeneus

Pipeline expansion

Update | Pharmaceutical & healthcare | 22 Jul 2014

Regeneus has added another project to its portfolio, with licensing of global rights to an autologous human cancer vaccine that is expected to enter the clinic in Q115. Developed at the Kolling Institute, Sydney, the technology was already licensed to Regeneus for veterinary applications (Kvax), which is now in a US marketing trial for osteosarcoma in dogs. Cancer immunotherapy, including multiple approaches to cancer vaccines, is a biotech hotspot and we look forward to progress with Regeneus's new candidate. Our overall valuation is now A$145m, or A$0.79 per share.