On Tuesday, well before the opening bell, Matinas BioPharma Holdings, Inc. (OTCQB: MTNB), a clinical-stage biopharmaceutical, announced that the U.S. Food and Drug Administration (FDA) designated the Company’s lead drug candidate, MAT2203, as a Qualified Infectious Disease Product (QIDP) with Fast Track status. Had they been listed on the NASDAQ exchange, shares of MTNB stock would have exploded like Amarin Corp. (NASDAQ: AMRN) did when they produced data from their clinical trials of Vascepa, a similar drug, but instead just saw a bump up to $1.15 before closing at $0.98. With the billions of dollars that could potentially be earmarked for this company in the years ahead, those who have longed their positions will be looking for these shares to graduate upwards accordingly.
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When trading began Tuesday and the news was already out about the FDA fast track designation, shares of MTNB sprang to life, rising to as high as $1.15 within the first hour of trading. Because of their OTC listing designation, love for the best news on the OTC was not embraced as volume died off and shares of MTNB eventually returned back below $1 by the closing bell. The news was about MAT2203, but MAT9001 could be even bigger.
Back in June, Matinas BioPharma published their top-line results from their head-to-head comparative pharmacokinetic and pharmacodynamic study versus Amarin Corp.’s Vascepa®. In an even more definitive result driven testing, Matinas gave 42 patients one drug for a period of 14 days then, after a 5 week washout period, administered the same 42 patients the other drug. The testing of the company’s MAT9001 not only met all primary and secondary endpoints in a head-to-head comparative pharmacokinetic and pharmacodynamic study, but they showed a 33% reduction in triglycerides from baseline compared to Vascepa’s 10.5% reduction.
Testing is expensive and Matinas will need to raise some more capital to move ahead with further testing of MAT9001 – a procedure Aegis Capital has been participating in each step forward the Company has made. In April, the company raised $8.5 million in a private placement which, following closely behind the pace Amarin is on, could prove to become more valuable as their phase 3 trials progress.
MAT9001 is a proprietary prescription-only omega-3 fatty acid-based composition, comprising docosapentaenoic acid (DPA) and other omega-3 fatty acids, which is under development for therapeutic applications with severe hypertriglyceridemia (TG>500 mg/dL) as the lead indication. Promising pre-clinical studies with DPA and MAT9001 indicate distinctive therapeutic response properties. Matinas has, MAT2203 and MAT2501 as drug candidates, of which the company has stated that stated that a Phase 2a NIH/NIAID-funded clinical study with MAT2203 in patients with refractory mucocutaneous candidiasis is expected to commence during the third quarter of 2015. The FDA Fast Track status announcement is a big bonus.
The reason why these omega 3 fatty acid drugs are even considered to be potential blockbusters is because they are taken together with the greatest pharmaceutical creation, in terms of sales, of all time: Lipitor. The fatbastardness and high cholesterol levels of the population could prove to be a 9 digit market place for MAT9001 if it can produce better results than their competitors.
While I never calmed to be a biopharmaceutical expert by any means, I well versed with the OTC Markets and had MTNB shares been listed on the Nasdaq, the news yesterday would have produced exponential short-term gains. Since that won’t happen on the currently listed market for MTNB shares, longing it with a 1-2 year plan while keeping abreast to further private placements could be a triple-digit winner in roughly the time it takes to enroll and graduate from a community college (the OTC) and enroll in a real university (the Nasdaq).
Find out more about MTNB shares here: $MTNB
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