Mesoblast Limited (ASX:MSB)
Quality Products - Mesoblast is a leading Global Cellular Medicines Company with a disruptive technology platform and multiple revenue generating products & phase 3 assets. The Group has developed a lengthy, complex process to bring a new medicine to patients ethically and with Integrity. This process includes few steps like applying for a clinical trial and submitting relevant documents for registration for further regulatory approvals. The Group has implemented a regulatory environment to protect the patients in terms of Quality and Safety aspects. It has approved 2 products which have been commercialized by licensees in Japan and Europe.
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Clinical Pipeline and Status of commercialization of products by licensees (Source: Company Reports)
Further, revenue from approved and late-stage assets will help to fund deep product pipeline. The Global IP Estate provides a substantial competitive advantage. It targets paediatric patients with steroid refractory-aGVHD first, it seeks label extension for high-risk adult patients with steroid refractory-aGVHD. The Group recently announced its outcomes of key Day 100 survival of its Phase 3 trial for remestemcel-L, an allogeneic mesenchymal stem cell product candidate, in children with steroid refractory acute Graft Versus Host Disease (aGVHD). These results were positive and reflected promising survival rates at Day 100 in children suffering from this devastating disease. The Company disclosed that Dr. Ben-Zion Weiner, the director has a relevant interest in the Company and holds 40,000 ordinary shares and 80,000 options. The stock price was down by 5.16 per cent in last five days and was up by 63.17 per cent in last 10 years as on 28 June 2018. We recommend to “Hold” the stock at the current market price of $1.48 as the Group aims to bring this new therapy in the market which will help against life-threatening complication of an allogeneic bone marrow transplant.
Bionomics Limited (ASX:BNO)
Commencement of BNC210 Phase 2 Agitation trial - Bionomics is a global, clinical stage biopharmaceutical company leveraging its proprietary platform technologies to discover and develop a deep pipeline of best in class, novel drug candidates. Few months have been very busy and productive for the Group and was marked by solid ongoing progress in developing its portfolio of novel drug candidates to treat conditions such as anxiety, Alzheimer’s disease, chronic pain and post-traumatic stress disorder (PTSD). The Group concluded the March quarter in a solid financial position, with a cash position of $32 million and which will provide a solid foundation for its clinical programs in the second half of the financial year. It successfully completed the recruitment in its Phase 2 clinical trial for PTSD, a difficult to treat condition suffered by approximately one million Australians and an estimated eight million Americans and the primary endpoint of the RESTORE trial is to decrease the PTSD symptoms. The Group reported a cash balance of $32.254 million (31 December 2017: $32.021 million) at 31 March 2018 with net operating cash inflow during the quarter ended 31 March 2018 of $0.158 million.Moreover, the Group announced a new Phase 2 trial of BNC210 for the treatment of agitation in the elderly. Meanwhile, Private Portfolio Managers Pty Ltd (PPM) and its subsidiary Portfolio Nominees Pty Ltd. ceased to be the substantial holder of the Group since 8 June 2018. The stock price was declining for last three months that is by 10.34 per cent but started recovering since last one week and was up by 1.96 per cent as on 28 June 2018. The stock climbed up by 1.92 per cent as on 29 June 2018. We give a “Hold” recommendation at the current market price of $0.53 by looking at the potential of BNC210 which is gaining a global recognition.
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