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Matinas BioPharma Holdings Inc (OTCMKTS:MTNB) Is Today's Biotech Focus

Matinas BioPharma Holdings Inc (OTCMKTS:MTNB) Is Today's Biotech Focus
Written by
Alex Carlson
Published on
September 19, 2016
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Matinas BioPharma Holdings Inc (OTCMKTS:MTNB) has been on a bull run this month. The stock is now nearly double what it was when the month started. This has made MTNB one of the top performers on the OTC Markets. While there's not much coverage right now on the stock, we think that's going to change very quickly now that new 52 weeks highs have been hit in each of the last few days.First up, a little background on the company. Matinas BioPharma is a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective broad spectrum therapeutics for the treatment of serious and life-threatening infections. The Company's technology utilizes lipid-crystal nano-particle cochleates to nano-encapsulate existing drugs, making them safer, more tolerable, less toxic and orally bioavailable. MTNB's stated goal is to become a leader in the safe and effective delivery of anti-infective therapies utilizing its proprietary lipid-crystal nano-particle cochleate formulation technology.MTNB's lead drug candidate is MAT2203, an orally-administered, encochleated formulation of amphotericin B (a broad spectrum fungicidal agent). The Company has an open Investigational New Drug (IND) application for MAT2501, which is an orally-administered, encochleated formulation of amikacin (a broad spectrum aminoglycoside antibiotic agent) for acute bacterial infections, including non-tuberculous mycobacterium (NTM) and multi-drug resistant gram negative bacterial infections.In addition, Matinas Biopharma is exploring development and partnership options for MAT9001, a prescription-only omega-3 fatty acid-based composition under development for hypertriglyceridemia, which has shown superiority versus Vascepa® (icosapent ethyl) in reducing serum triglycerides, Total- and Non-HDL-Cholesterol, apolipoproteins and PCSK9 levels.MTNB started its run earlier this month after announcing that the FDA had designated the Company’s lead drug candidate, MAT2203, as a Qualified Infectious Disease Product (QIDP) with Fast Track status for prophylactic treatment of invasive fungal infections due to immunosuppressive therapy. Prior to this, the FDA had designated MAT2203 as a QIDP with Fast Track status for the treatment of invasive candidiasis and aspergillus. MAT2203 is also being explored for treatment of additional infections including cryptococcal meningoencephalitis, and it may have the potential for Orphan Drug Designation in certain indications.QIDP designation, provided under the Generating Antibiotic Incentives Now Act (GAIN Act), offers certain incentives for the development of new antibacterial or antifungal drugs, including eligibility for Fast Track, priority review and, if MAT2203 is ultimately approved by the FDA, eligibility for an additional five years of marketing exclusivity. The award of Fast Track status enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.Enrollment is currently underway for the Phase 2a NIH/NIAID-funded clinical study with MAT2203 in patients with refractory mucocutaneous candidiasis. In a clinical Phase 1a single-dose, double-blind, dose-escalating, pharmacokinetic study of 48 healthy volunteers, oral MAT2203 demonstrated a positive safety and tolerability profile with no serious adverse events reported, including little or no nephrotoxicity as compared to placebo. Co-founder and President Jerome Jabbour said:

"With important patient data on efficacy and safety from our ongoing Phase 2a trial with MAT2203 expected in the near term, these QIDP and Fast Track designations for MAT2203 in prophylaxis position us extremely well for the balance of our planned development program as we look to utilize the disruptive benefits of our technology platform to fill significant unmet medical need.”

Currently trading with a market cap of $75 million, MTNB just completed an $8.0 million private placement equity financing. The Company sold to accredited investors an aggregate of 1,600,000 Series A Preferred Shares at a purchase price of $5.00 per share. The net proceeds will be used for research and development activities, a new manufacturing facility and for working capital and general corporate purposes. We will be updating our subscribers as soon as we know more, especially in regards to the Phase 2a NIH/NIAID-funded clinical study. For the latest updates on MTNB, sign up below!Disclosure: We have no position in MTNB and have not been compensated for this article.

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