Full Press Release Details
Matinas BioPharma Establishes Lipid-Based,
Anti-Infective Platform, with Acquisition of Aquarius BioTechnologies Inc.
Novel lipid-crystal nano-particle cochleate formulation delivery platform with opportunity for broad use in anti-infectives featuring
targeted delivery and multi-organ protection -
Lead program for oral administration of Amphotericin B antifungal (MAT2203) with positive safety and tolerability in a Phase 1
clinical study expected to enter Phase 2a in 2015 in collaboration with NIH -
- Proof of principle
in vivo animal efficacy demonstrated via oral administration in NIH-sponsored pre-clinical studies for an Amikacin-based antibiotic
potentially fulfilling significant need to treat life-threatening Gram-negative bacterial infections -
Investor conference call and webcast scheduled for Monday, February 2, 2015, at 4:30pm EST -
BEDMINSTER, NJ (January 30, 2015) - Matinas
BioPharma Holdings, Inc. ("Matinas BioPharma" or the "Company") (OTCQB: MTNB), a clinical-stage
biopharmaceutical company focused on the development and commercialization of lipid-based prescription therapeutics for the treatment
of metabolic and cardiovascular conditions and the treatment of infectious diseases, announced today that it has acquired all
of the outstanding stock of Aquarius BioTechnologies Inc. (Aquarius), an innovative bio-delivery drug discovery company with a
novel and proprietary lipid-crystal nano-particle cochleate formulation technology platform.
"Through the acquisition of Aquarius and its novel lipid-based,
targeted drug delivery platform, Matinas BioPharma significantly expands its technological portfolio with several product candidates
in the field of infectious diseases, which have been supported through the collaboration with and investment by the National Institutes
of Health via grants and research contracts," commented Roelof Rongen, President & CEO of Matinas BioPharma.
"Furthermore, this innovative delivery platform complements
our focus in lipidomics and allows us to further leverage our significant internal expertise in the development of lipid-based
therapies. Following this transaction, 2015 is poised to be an important year for Matinas BioPharma as we continue to advance our
product candidates, including MAT9001 and MAT2203 which represent our two lead clinical programs," added Mr. Rongen.
Matinas BioPharma does not anticipate any material increase
in its cash burn in the short term as a result of this transaction, primarily due to the various National Institutes of Health
(NIH) grants and contracts currently in place with Aquarius and its subsidiary, Coordinated Program Development LLC.
"Aquarius and its stockholders are extremely enthusiastic
about this merger, as the combined platform builds on both companies' technological strengths and is expected to further
enhance the opportunity to develop novel drugs to treat various infectious diseases," said Dr. Raphael J. Mannino, the founder
of Aquarius and an inventor of the cochleate bio-delivery platform technology.
Dr. Mannino, Associate Professor of Pathology and Laboratory
Medicine at the Rutgers New Jersey Medical School, will act as an advisor to Matinas BioPharma on the continued development of
the acquired product candidates. Aquarius' lipid-crystal nano-particle cochleate formulation was developed in collaboration
with Rutgers, The State University of New Jersey, which has granted Aquarius exclusive worldwide licenses under applicable patents.
"The Office of Research Commercialization at Rutgers is
pleased with this transaction, both as licensor to this novel technology and as a stockholder of Aquarius," said S. David
Kimball, Ph.D., Associate Vice President, Research Commercialization in the Office of Research and Economic Development. "This
promising technology platform that we developed with Aquarius is now bolstered by the combination with Matinas BioPharma, whose
team has a great track record of developing lipid-based therapies and driving commercial success. We believe Matinas is well positioned
to capitalize on the potential for this platform. We are also pleased that Matinas BioPharma is a New Jersey-based company, further
demonstrating our commitment to strengthen Rutgers' and New Jersey's reputation as a cradle of scientific innovation."
Aquarius Product Candidates in Development
Aquarius' pipeline includes five (5) products currently
under development, each of which is progressing in collaboration with the National Institute of Allergy and Infectious Diseases
(NIAID), part of the NIH.
The most advanced programs are described in more detail below:
The most advanced anti-infective product candidate is a lipid-crystal
nano-particle formulation of Amphotericin B (CAmB). Amphotericin B is a well-known broad spectrum fungicidal currently available
by IV-only administration with significant side effects (including nephrotoxicity). MAT2203 has an active Investigational New Drug
(IND) application with the U.S. Food and Drug Administration (FDA) and is under development as an oral antifungal. In a clinical
Phase 1a single-dose, double-blind, dose-escalating, pharmacokinetic (PK) study of 48 healthy volunteers, oral CAmB demonstrated
a positive safety and tolerability profile with no adverse events reported. The study provides support for multi-dose pharmacokinetic
studies and Phase 2 efficacy studies for oral administration of CAmB and may have the potential to be awarded an Orphan Drug Designation
for certain of the intended indications. Indications currently being explored for MAT2203 include resistant candidiasis, cryptococcal
meningoencephalitis, aspergillosis and leishmaniasis. Matinas BioPharma plans to advance MAT2203 into Phase 2a studies as quickly
as possible in 2015 with anticipated collaboration with the NIH.
C-Amikacin (MAT2501)
MAT2501 is a lipid-crystal nano-particle formulation of Amikacin
in the preclinical development stage. Amikacin is an aminoglycoside antibiotic most often used for treating severe, hospital-acquired
infections, including Gram-negative bacterial infections. Like Amphotericin B, Amikacin is currently only delivered through an
IV and has very serious side effects. Proof-of-principle testing in animal models showing in vivo efficacy for oral administration
of C-Amikacin using a lipid-crystal nano-particle cochleate formulation has been completed at Aquarius and the NIH and additional
in vivo studies are underway.
Terms of the Transaction
Pursuant to the terms of the Merger Agreement, Matinas is obligated
to issue an aggregate of 5,000,000 shares of its common stock at closing, subject to adjustment as set forth in the Merger Agreement.
At closing, Matinas BioPharma issued 4,608,020 shares (the "Closing Shares") of its common stock. The number of Closing
Shares may be adjusted after the closing under the terms of the Merger Agreement but in no event shall the number of Closing Shares
exceed 5,000,000 shares of Matinas' common stock. In addition, subject to the Matinas BioPharma right of setoff for indemnification
claims, Matinas BioPharma may issue up to an additional 3,000,000 shares (the "Additional Shares") of common stock
upon the achievement of certain milestones. The milestone consideration consists of: (i) 1,500,000 shares issuable upon the dosing
of the first patient in a Phase 3 trial sponsored by Matinas BioPharma for a product utilizing Aquarius' proprietary drug
cochleate technology, and (ii) 1,500,000 shares issuable upon FDA approval of the first NDA submitted by Matinas BioPharma for
a product utilizing Aquarius' proprietary drug cochleate technology.
As of the effective time of the Merger, which excludes the effect
of any future milestone consideration or indemnification claims, the former Aquarius stockholders own approximately 8% of the aggregate
number of shares of the common stock outstanding (on a fully diluted basis), and the stockholders of Matinas BioPharma as of immediately
prior to the Merger (the "Matinas Stockholders") own approximately 92% of the aggregate number of shares of common
stock outstanding (on a fully diluted basis).
Conference Call and Webcast
Matinas BioPharma will host a conference call for investors
and analysts on Monday, February 2, 2015, beginning at 4:30 pm U.S. Eastern Time. This call can be accessed in three ways:
About Cochleate Technology
Cochleates have a multilayer crystalline, structure with no
internal aqueous space. The structure is formed when a series of solid lipid sheets engulf drug molecules, a process referred to
as "encochleation." Encochleation involves combining calcium and soy-derived phosphatidylserine (PS), two naturally
occurring materials classified as GRAS (generally recognized as safe) by the FDA, through a tightly controlled crystallization
process to envelop the Active Pharmacological Ingredient (API). The result is a nano-size encochleated drug formulation. The unique
cochleate structure protects the drug from degradation when it passes through the gastrointestinal (GI) tract and into the blood
stream. Cochleates can be used to reformulate a wide variety of both large and small molecules with both high and low solubility.
About Matinas BioPharma
Matinas BioPharma is a clinical-stage biopharmaceutical company,
founded in 2011, with a focus on identifying and developing novel lipid-based pharmaceutical products for the treatment cardiovascular
and metabolic conditions and infectious diseases. Led by an experienced management team and a board of directors with a history
of building pharmaceutical companies, Matinas is focused on creating highly differentiated, safe and efficacious therapies utilizing
its expertise in drug formulation and development. Our lead product, MAT9001, which takes advantage of advancements in the field
of lipidomics, has been specifically designed and formulated for therapeutic applications in the dyslipidemia field. Recent additions
to our product pipeline, including MAT2203 and MAT2501, position the Company to become a leader in the safe and effective delivery
of anti-infective therapies utilizing our proprietary lipid-crystal nano-particle cochleate formulations.