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Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) Has A Billion Dollar Market In Its Sights

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) Has A Billion Dollar Market In Its Sights
Written by
Chris Sandburg
Published on
February 7, 2017
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Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) just presented at NobleCon13, Noble Capital Markets’ 13th Annual Small Cap & Emerging Growth Investor Conference in Boca Raton, Florida, and the company is picking up some speculative interest as a result. It is a microcap biotechnology entity, and as such, it's a risky allocation at this stage, but if the just given presentation is to be relied on, there looks to be plenty of reward on offer to offset said risk. TNXP Daily ChartHere's why.According to company materials, Tonix focuses on the development and commercialization of pharmaceutical products for the treatment of so-called emerging public health challenges. Forget that, however. All you need to know is that Tonix is developing two post-traumatic stress disorder (PTSD) assets, one of which is pretty advanced, and it is these two assets on which markets are currently basing the vast majority of the company's circa $21 million market capitalization right now.The lead asset, and by far the largest contributor to said market capitalization, is a drug called TNX-102. TNX-02 was recently granted Breakthrough Therapy designation by the FDA for its target PTSD indication, and is – at active ingredient level – a reformulation of a currently approved drug called cyclobenzaprine HCl. Cyclobenzaprine HCl is approved right now as a drug for the treatment of skeletal muscle conditions such as pain or injury. Basically, it stops muscles and nerves sending impulses to the brain, which in turn, stops the latter from registering pain. Combine it with rest, and it offers an effective solution for long-term physical resuscitation.Tonix is using the chemical MOA to target a different indication, however. Basically, the method through which the drug inhibits pain transmission is rooted in the blocking of certain receptors, including those associated with serotonin and histamine. Block these two receptors, and it leads to improved sleep. Improved sleep, in turn, leads to a reduction in the symptoms of PTSD. It is a pretty roundabout approach, but pretty elegant in its own right.Data to date has demonstrated that TNX-102 is highly effective in its endgame of reduction in PTSD symptoms, and it is on this data on which the company hopes to build in a pivotal trial (which, in turn, will underpin an NDA submission to the FDA).And therein lies our catalyst.As per the recent presentation, management outlined a time frame within which it expects to get a pivotal trial underway, suggesting that it should start enrolling at some point during this quarter. The trial is a 12-week study, paving the way for some pretty near term results, and in line with these expectations, management has stated that it expects to put out the topline from the study at some point during the second half of the year. To put this another way, this mid-stage asset is about to move into a position from which it could become an NDA asset in the space of around four to six months.Of course, this brings with it a host of potential updates, each of which could inject some upside momentum into the company as they hit press. Initially, we're looking for trial initiation to draw speculative attention to the asset. Beyond that, enrollment completion (which shouldn't take too long at all) and trial wrap up give us the next events to watch. Shortly after trial completion, and as mentioned, at some point during the second half of this year, topline is the endgame major catalyst.If the data comes out as indicative of efficacy, and supports the hypothesis of the already collected results, this company could really take off. It is currently trading for around $.50 a share, for a market capitalization of – as mentioned - $21 million. With an approved PTSD asset, Tonix would be targeting a multi-billion-dollar market.Cash at September 30, 2016, came in at $15.6 million, and that should be enough to carry the drug through a pivotal trial. As such, near-term dilution isn't an immediate risk. With that said, the company will likely have to raise to fund commercialization activity, unless it can find a partner.We will be updating our subscribers as soon as we know more. For the latest updates on TNXP, sign up below!Disclosure: We have no position in TNXP and have not been compensated for this article.

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