Stocks’ Details
 

Mesoblast Limited (ASX: MSB)

Expansion of product line: Recently, Mesoblast received FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for its cell therapy in heart failure in patients with left ventricular assist devices (LVADs). This has been granted to expediate the development of regenerative medicine therapies which are intended for the treatment of serious diseases and life-threatening conditions. It allows for multi-disciplinary, comprehensive interactions with the FDA to support the efficient development and it accelerates the potential for Mesoblast’s allogenic MPCs for the treatment of heart failure patients with LVADs. FDA has also invited Mesoblast to have a multidisciplinary comprehensive discussion regarding the development strategy and for an evidence which is needed to achieve an approval in an efficient manner. MSB also announced that the Phase 3 trial of its proprietary mesenchymal stem cell product candidate MSC-100-IV in children with steroid-refractory acute graft versus host disease has been advanced with the required enrolment and top line results are expected to be out in Q1 2018. MSB intends to use the results to support a Biologics License Application (BLA) for filing the accelerated product approval. Lately it also granted TiGenix the exclusive access to certain of its patients to support global commercialization of the adipose-derived mesenchymal stem cell product Cx601 for the local treatment of fistulae. TiGenix also has the right to grant sub-licenses to affiliates and to third parties. As a consideration, MSB will receive approximately USD$24 million in payment and additionally it will receive single digit royalties to net sales of Cx601. Through these efforts, MSB will expand in Europe and it reflects the strength of MSB’s extensive portfolio. On the other hand, MSB stock has fallen 17.87% in three months as on January 10, 2018 owing to volatile conditions. While the group seems to have some potential updates expected from the ongoing programs in 2018, we give a “Hold” recommendation at the current price of $1.395
 

Advanced Product Candidate Portfolio (Source: Company Reports)
 

Sirtex Medical Limited (ASX: SRX)

Headwinds continue in new year: SRX has been lately served with an additional class action which has been filed in the Federal Court of Australia. The claim against the Company has been served by Maurice Blackburn and will be a concern for the investors. The case is due to the allegations which were in relation to the contraventions by the Company for demonstrating a misleading and deceptive conduct, and due to the breach of continuous disclosure obligations as per the Corporation Act. On the other hand, SRX aims to vigorously defend this new action. Lately, IMF (IMF Bentham Limited) announced that it will not be possible to fund SRX and it will continue to enter into its funding agreements with the current and former shareholders who acquired an interest in SRX shares on ASX previously.On the other hand, SRX had announced about the results of three large clinical studies during FY2017. While the group highlighted that the treatment of cancer continues to evolve, the group may find revenue streaming in from Canada and Brazil based on the efforts. SRX also updated about flat 1Q FY18 worldwide dose sales against the prior corresponding period at the back of organisation distraction from FY17 and competitive pressures. 1Q FY18 sales revenue of $53.3 million was down 4.8% owing to currency headwinds. Its sales growth is still weakening in its core U.S. market. This weakness was reflected in stock prices that decreased by 3.70% in the past six months and the company’s share price has been volatile after a turbulence in 12 months that included a big profit downgrade. SRX is still very positive on growth based on its targets. Until we see some key catalysts, we give a “Hold” on the stock (that fell 7% in last five days) at the current price of $15.64
 

SIR-Spheres Growth Plans (Source: Company Reports)
 

Viralytics Limited (ASX: VLA)

Improved capital position for clinical trials: Recently, VLA received $6.4 million from the Australian Taxation Office under the Research and Development Tax Incentive Program. With the receipt of these funds and by the investment done by Lepu Medical Group, the Company has more than $57 million in total cash which can fund current and the planned clinical activities in 2020 with allocation of funds into progressing its MITCI (Melanoma Intra-Tumoral CAVATAK and Ipilimumab) clinical studies and for initiating a pivot trial in melanoma. The potentially transformative KEYNOTE-200 trial was delivered by intravenous administration. It is also seeking to demonstrate a potential in its further substantial oncology markets. VLA now plans to initiate a pivotal Phase 3 clinical trial of CAVATAK in melanoma patients in 2018 and also to begin new clinical studies of CAVATAK across few treatment settings like colorectal cancer, head and neck cancer and ocular melanoma.The prices fell by 23% in the past six months but the success of its lead drug Cavatek is the growth trigger for the company’s outlook. We believe that the stock is a “Speculative Buy” at the current price of $0.74

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