BEDMINSTER, N.J.— Matinas BioPharma Holdings, Inc., 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, has acquired all of the outstanding stock of Aquarius BioTechnologies Inc., 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 [NIH] 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 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.
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, which has granted Aquarius exclusive worldwide licenses under applicable patents.
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, 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. The result is a nano-size encochleated drug formulation. The unique cochleate structure protects the drug from degradation when it passes through the gastrointestinal 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.
"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' pipeline includes five 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 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 PK 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.
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.
Pursuant to the terms of the merger agreement, Matinas is obligated to issue an aggregate of 5 million shares of its common stock at closing, subject to adjustment as set forth in the agreement. Matinas BioPharma may issue up to an additional 3 million 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 percent 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 percent of the aggregate number of shares of common stock outstanding (on a fully diluted basis).
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 of 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. Their 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 the company’s product pipeline, including MAT2203 and MAT2501, position the company to become a leader in the safe and effective delivery of anti-infective therapies utilizing its proprietary lipid-crystal nano-particle cochleate formulations.