NeuroVive - presentation till utländska aktieanalytiker inför börsnotering

2013-04-02 12:21, Edited at: 2013-04-02 13:54

Jag tycker utländska aktieanalytiker som redan bevakar svenska biotechbolag inte ska behöva komma på efterkälken utan mailade dem nedanstående förhoppningsvis intresseväckande text om NeuroVive - ett ledande företag inom mitokondriell medicin med specialitet på cyklofilin-D-hämmare.

Imagine if there were new drugs which significantly could reduce the negative effects of an acute myocardial infarction, ischemic stroke, traumatic brain injury and as a bonus could mitigate diet-induced obesity which affect millions and millions of people. Such drugs would be blockbusters.

NeuroVive's cyclophilin-D-inhibitor-based drug candidates might do just that !

Thus a new exciting object for the dedicated or potential analyst of promising Swedish drug developing companies has emerged since NeuroVive Pharmaceutical's shares will be listed on NASDAQ OMX

Stockholm April 10 2013, ticker NVP. NeuroVive's focus is on mitochondrial medicine and cyclophilin-D inhibitors in particular.

A link to a complete stock analysis, in Swedish :

http://hem.passagen.se/fingerpr/loparn/PDF/NeuroVive.pdf

As far as is known, no professional analyst covers NeuroVive now, but that will change...

My presentation with estimated stock potential for your convenience :

NeuroVive Pharmaceutical is a leading mitochondrial medicine company which in April 2011 entered an external French Phase III clinical study with their promising cyclosporin-A-based formulation and drug candidate CicloMulsion, just over a year after NeuroVive had completed its own Phase I trial. The Phase III trial is almost free for NeuroVive since the company is only sponsoring the study with CicloMulsion and placebo.The Phase III study will enroll nearly 1,000 patients with the aim to investigate the efficacy of CicloMulsion in cardiac cell protection after myocardial infarction before PCI treatment to prevent reperfusion injury which otherwise occurs when the blood flow is restored to the heart. A promising French external combined Phase I-II pilot study was completed in 2008. An article was published in The New England Journal of Medicine :

http://www.nejm.org/doi/full/10.1056/NEJMoa071142#t=article

A potential market entry in Europe may occur around 2016 if the study outcome and registration process both are successful. As of March 2013 over 600 patients had been included in the study and all was going well. The world market for drugs against reperfusion injury is very big (several billion dollars) since millions of people suffer from acute myocardial infarction annually, and many of these patients are undergoing PCI treatment. There are currently no effective drugs available. CicloMulsion is now the first promising drug candidate against reperfusion injury that is known to have commenced Phase III trials. Thus a CicloMulsion licensee could get an important so-called first-mover advantage in the market.

Research also indicates a very big Orphan Drug Designation-protected market potential for NeuroVive in traumatic brain injury (TBI). An external promising combined Phase I-II trial in the USA has previously been completed successfully.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2770729/

NeuroVive will begin its own Phase IIa clinical trial in 2013 any day now. Phase III is scheduled to follow around 2015. Around 1 million people in the world suffer from severe TBI annually.There are no effective neuroprotective drugs on the market today. NeuroVive will probably look for a partner to co-finance and finance Phase III clinical trials in EU and USA respectively.

The estimated probability for success in NeuroVive's Phase III clinical trials is relatively high or could roughly be estimated to 65 % as a common assumption for such advanced trials after the two promising Phase II external clinical trials in each case and much positive preclinical work. Moreover NeuroVive has a scientific strength in their major projects regarding the mechanism of the cyclophilin-D-inhibiting cyclosporin-A (CsA) which is now well researched and understood including the mitochondria based nerve cell and cardiac cell protection mechanism after several preclinical and clinical trials. In addition, the side effects has since long ago been well known due to the fact that CsA has been a drug for decades as an immune system suppressant in organ transplantation. Furthermore in neuroprotection and cardioprotection CsA is administered for a much shorter time and therefore the risk for a backlash due to unknown adverse effects should be relatively low. The mechanism of CsA in neuro- and cardioprotection is thoroughly explained in a well written article published in USA titled Cyclosporine TBI`s Miracle Drug.

In Nov 2012 NeuroVive and the fast growing Chinese company Sihuan Pharmaceutical entered a very important agreement to develop and commercialize CicloMulsion and NeuroSTAT for cardio- and neuroprotection in the Chinese market estimated to be worth more than 2 billion RMB annually at peak sales. Sihuan will be responsible for clinical development, regulatory and market approval, market access and promotion as well as marketing, distribution and sales. NeuroVive will receive upfront and milestone payments from Sihuan totaling RMB 47 million (around SEK 50 million) and a 10 % royalty of net sales for a period of ten years after market introduction. Thus NeuroVive´s revenues from the deal may annually reach up to around SEK 200 million.

An ischemic stroke project is in preclinical work in a collaboration with the Dutch company to-BBB . Here they combine NeuroSTAT with toBBB´s G-technology to a drug candidate called NVP014, with the aim to be able to transport the drug through the blood brain barrier. The same known neuroprotective mechanism of CsA binding to cyclophilin-D is in effect also in stroke. The project has received a grant from EU after having been highly ranked. Neither in this case are there any effective neuroprotective drugs on the world market today, although the free radical scavenger edaravone is approved in Japan.

NeuroVive is also looking for other cyclophilin-D-inhibiting molecules for mitochondria protection in neurological and other deceases. In this case they work together with the British company Selcia.They are also performing advanced research concerning molecules for controlling mitochondria energy production. An example is NVP015 which is expected to reach Phase I around 2014.

In 2013 NeuroVive made an acquisition of a portfolio of novel cyclophilin inhibitors from the UK company Biotica Ltd. The portfolio is from a new class of molecules called Sangamides based on a novel and unique chemistry platform of polyketides around which NeuroVive has also acquired the intellectual property rights. These novel cyclophilin inhibitors are expected to form the basis of the next-generation of NeuroVive products for a broad range of diseases including cardio- and neuroprotection. There might even be an exciting possibility for cyclophilin-D-inhibiting Sangamides in the huge obesity market which this American preclinical study clearly indicates Cyclophilin D deficiency prevents diet-induced obesity in mice. There is a new Chinese study that underline this conclusion Cyclosporin A attenuates weight gain and improves glucose tolerance in diet-induced obese mice even if the researchers draw the conclusion that it is the immunosuppressive effect of CsA that was responsible.

However I and my wife PhD Ann-Cathrin Engwall believe it is due to CsA binding to cyclophilin-D that causes this effect as the first group of researchers also concluded. In either way though it still is a NeuroVive related drug that is relevant here.

The NeuroVive clinical research portfolio may look something like this during 2013 to 2015 if the company can fulfill its plans successfully :

Reperfusion injury EU completion of Phase III with CicloMulsion

Reperfusion injury China and USA Phase III with CicloMulsion

TBI completion of Phase II followed by Phase III in EU, USA and China with NeuroSTAT

Ischemic stroke Phase I followed by Phase II EU with NVP014

Ischemic stroke China Phase III with NVP014

Energy regulation Phase I with NVP015

NeuroVive if successful in both their reperfusion injury and TBI projects has a potential to achieve annual royalties of roughly SEK 500-1000 million 2018-2019 and several years after that, which could be compared to the company market value of less than SEK 535 million as of March 28 2013 when the share price was SEK 27.80 on the Aktietorget market place. The potential revenues from the ischemic stroke project is much bigger than the current ongoing clinical projects, over SEK 1000 million. The burn rate is very small with a slim organization.

The stock is a long term multi bagger candidate with an estimated long term potential to reach over SEK 100 within just two years if NeuroVive is successful in the Phase III reperfusion injury clinical study outcome which will be official in the beginning of 2015 and if the stroke project reaches Phase I. In an even longer term within four to five years or so, the stock potential is far higher assuming also the TBI project will be successful. Naturally on the other hand the level of risk generally in this type of small drug developing companies is very high since there is a rather high probability that at least one or two of the three most important projects fail in the end. The management and some board members directly and indirectly through the founder Maas Biolab, LLC together control over 30 % of the outstanding shares.

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Web site:http://www.neurovive.com/en/