Prima BioMed Limited

PRR Details

Patent grants:Prima BioMed Ltd (ASX: PRR)announced a new collaborative study investigating the intra-tumoural injection of IMP321. The Institute of Clinical Cancer Research would conduct the investigator-sponsored study in Germany. The new study would explore the potential for IMP321 as an activator of dendritic cells found within solid cancer tumours. PRR is also planning to raise funds of up to US$60 million over a period of three years and has filed shelf registration statement with the US SEC. Meanwhile, the group also entered into an agreement with the US based Sydys for licensing Prima’s CVac^tm   immune-oncology program and oversee its future development. This has potential for over $400 million in milestones and royalties when commercially successful. Prima would receive 9.9% equity in Sydys as a consideration for assets being transferred. PRR has also received Japanese patent grants for UMP321, which would support its usage as it is being used in Prima’s AIPAC trial in metastatic breast cancer and patent expiry is October 3^rd, 2028. The company has been granted the US patent for IMP731, which would offer protection for specific sequences of the antibody-dependent cell cytotoxicity. On the other hand, PRR revenue has been decreasing for last two years for $ 4.01 million in FY13 to $2.09 million in FY15 while bottom-line continued to be impacted as well. The company is in losses even at operating level while cash as on December 2015 reached $25 million. The company has been generating negative year to date returns of 19.2% (as of July 21, 2016).  We give an “Expensive” recommendation on the stock at the current price of $0.041
 

PRR Daily Chart (Source: Thomson Reuters)
 
Prana Biotechnology Limited



PBT Details

Strong cash position: Prana Biotechnology Ltd (ASX: PBT) has a strong cash position on balance sheet at $24.813 million at the end of March 2016. PBT also received orphan drug designation from European Commission and US FDA. Its PBT2 is currently on partial clinical hold by the US FDA.
 


Solid pipeline (Source: Company Reports)
 
PBT received $6.5 million cash refund from Australian government towards R&D tax incentive scheme for R&D in FY15. PBT would deploy these funds for further development of PBT2 for Huntington disease and PBT434 for the treatment of atypical Parkinsonian movement disorders. PBT recently clarified its ASX query while the stock delivered over 38.2% in the last three months (as on July 20, 2016). We give a “Speculative Buy” recommendation on the stock at the current price of  $0.098
 

PBTDaily Chart (Source: Thomson Reuters)
 
Cynata Therapeutics Ltd



CYP Details

Building base for potential growth: Cynata Therapeutics Ltd (ASX: CYP) has entered into a license option agreement with apceth GMBH & Co.KG to develop Cynata’s Cymerus^Tm mesenchymal stem cell (MSC) engineered with apceth’s proprietary genetic modification technologies. The agreement further provides an upfront payment plus series of success based milestones which potentially could be more than $40 million and royalties on product sales. CYP has received an offer to make an initial investment of $400,000 in ordinary shares by Regience K.K. of Japan with regard to a previously announced agreement for strategic alliance. Meanwhile, CYP’s contract manufacturer in the USA have begun manufacturing of supplies of CYP-001 product for specific use in clinical trial GvHD. Further more, Japanese Patent and Trademark decided to grant a patent covering certain aspects of its proprietary MSC deriving methodology from pluripotent stem cells. CYP also received favorable advice from UK Medicines and Healthcare product Regulatory Agency (MHRA) which provides a clear path to start a Phase I clinical trial in patients with graft Vs host disease in UK. CYP received $930,000 towards R&D tax incentive from Australian government for FY15. The company reported a revenue of 0.08 million and a loss of $2.47 million for half year ended as on December 2015. CYP’s stock surged 41.30% in the last six months (as of July 21, 2016). We give a “Speculative Buy” on the stock at the current market price of $0.33
 

CYP Daily Chart (Source: Thomson Reuters)
 
Admedus Ltd



AHZ Details

Focus on CardioCel: Admedus Ltd (ASX: AHZ) reported its quarterly results ending June 30, 2016 with 41.5% rise in sales over previous corresponding quarter while full year sales are up 40% over FY15. The company has been awarded a major 5-year Infusion business contract which will impact the annual revenue starting 1^st quarter FY17. AHZ further forecast FY17 total sales growth of >50% to at least $21M and decrease in operating expenditure in FY17 of over $12M to be delivered through with gross profit margins rising 50% due to manufacturing and operational cost savings and improvements. Based on the strategic review, the Company forecasts a loss for the coming financial year of between $6M and $10M excluding amortisations, depreciation and exceptionals.
 


Program Pipeline (Source: Company Reports)
 
The company reported for closing cash balance of $8.8M and $3.5M in R&D rebates are expected in FY17. AHZ earlier reported that CardioCel’s anti-calcification feature is attracting KOL interest globally, increasing its sales. The phase II study evaluating the safety of the glycoprotein D (gD2)-based DNA vaccine as an HSV-2 (herpes simplex virus) immunotherapy was said to be on track to produce data in 4Q16 while HPV phase study would initiate this year. Cost management remained a key focus while improving manufacturing capability. We give a “Speculative Buy” on the stock at the current price of  $0.50
 

AHZ Daily Chart (Source: Thomson Reuters)
 
Sirtex Medical Ltd



SRXDetails

Strong sales growth: Sirtex Medical Limited (ASX: SRX) reported a 16.4% rise in worldwide dose sales of SIR-Spheres® Y-90 resin microspheres for year ended June 2016. Earlier, SRX had guided 15%-17% dose sales growth for full year as against its earlier guidance of historical trend of ~ 19% and now have delivered upper limit of its earning guidance. SRX has good response in the US market with sales rising by 19%. SRX also announced that it has completed patient recruitment for its SIRveNIB clinical sturdy in patients with unresectable primary cancer. SRX has been granted a Medical Device License (MDL) for SIR-Spheres® Y-90 resin microspheres by Health Canada (Santé Canada) while the device would be launched in the second half of 2016 calendar year. This medical device is approved in key markets like Unites States, European Union and Australia while new license would expand the market footprint. SRX enjoys strong return ratio with EBITDA margins at 29.97% and NPM of 22.91%. We recommend a “Buy” on the stock at the current price of $31.50
 

SRX Daily Chart (Source: Thomson Reuters)
 
Mesoblast Limited



MSBDetails

Regains worldwide rights to cardiovascular field: Mesoblast Limited (ASX: MSB) recently announced that it has regained full worldwide rights and full strategic flexibility to exploit its mesenchymal precursor cell (MPC) technology platform for the cardiovascular field and the lead asset in this portfolio is MPC-150 which is in Phase III. But the stock was under pressure when Teva withdrew its financial consideration. But, the management claims that MPC-150 has multibillion dollar potential for the company without any consideration to Teva Pharmaceutical Industries. MSB announced its plans for an early data readout on its phase III chronic heart failure trial.
 


Trials pipeline (Source: Company Reports)
 
The interim analysis is to cost around US$13 million. MSB further announced that it is materially reducing projections for annualized cash burn and also has established equity facility of $60 – 120 million to offer at the company’s discretion up to next three years. MSB has also received $6.2 million from Australian Government for R&D activities conducted during 2015. Japan is second established market for MSB through its licensee JCR Pharmaceuticals which launched TEMCELL® for treatment of aGVHD in February 2016. We maintain “Hold” recommendation on the stock at the current market price of $1.135

 
MSB Daily Chart (Source: Thomson Reuters)

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