BEDMINSTER, N.J. , Aug. 13, 2019 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company, today announced financial results for the quarter ended June 30, 2019, and provided an update on its product pipeline.

“I am extremely pleased with the progress we have made to date this year in advancing MAT9001, our potential best-in-class cardiovascular prescription-only omega-3 drug candidate,” commented Jerome D. Jabbour, Chief Executive Officer of Matinas. “We have designed a pathway to approval intended to yield clinical data we believe could differentiate MAT9001 from the leading approved prescription-only omega-3 products and take advantage of exciting new developments within this class of drugs to potentially treat millions of patients. We have completed a required bridging toxicology study ahead of schedule, and expect to commence additional studies in the coming months for MAT9001, including an additional Phase 2 head-to-head pharmacokinetic (PK) and pharmacodynamic (PD) study against Vascepa® early in 2020 with topline data expected in the back half of 2020.”

“Regarding our LNC platform technology, we recently had a positive meeting with FDA focused on our development program for MAT2203 where we received important feedback in moving forward with our NIH-funded Phase 1/2 EnACT study. We also just received our fourth Qualified Infectious Disease Product (QIDP) designation with Fast Track status from the FDA for MAT2203 for the treatment of cryptococcal meningitis (CM). In leveraging our unique LNC Platform to deliver amphotericin B orally to patients suffering from this deadly brain fungal infection, we are positioning this important product for both potential induction and maintenance indications,” added Mr. Jabbour.

MAT9001 Program Update (next generation, prescription-only omega-3 fatty acid-based composition under development for treatment of cardiovascular or metabolic conditions, including hypertriglyceridemia)

• Completed 28-day comparative bridging toxicology study of MAT9001.
• On track to commence a comparative clinical bridging bioavailability study in Q4 2019, with expected completion in Q1 2020.
• On track to initiate an additional head-to-head comparative study of MAT9001 and Vascepa® in Q1 2020. This study will evaluate pharmacokinetic (PK) and pharmacodynamic (PD) markers for MAT9001 and Vascepa in a 28-day crossover study in patients with elevated triglycerides (150 – 499 mg/dL), building on an earlier study showing that, compared to Vascepa, MAT9001 provided significantly greater reductions in PD markers known to be associated with increased risk of cardiovascular disease, including triglycerides, Total cholesterol, VLDL-C, non-HDL-C, ApoC3, and PCSK9, without any meaningful increase in LDL cholesterol. The objective of this second study is to further validate the enhanced bioavailability and greater PD effect of MAT9001 relative to Vascepa. The Company expects to announce data from the study in Q4 of 2020.
• Secured clinical intermediates of MAT9001 to support all planned studies through 2020; currently manufacturing proprietary capsules for the entirety of the next 12-months’ clinical trials supply.

MAT2203 and Lipid Nano-Crystal (LNC) Technology Platform Update (intracellular delivery of potentially life-saving medicines)

• July 2019 – received Qualified Infectious Disease Product (QIDP) designation with Fast Track status for MAT2203 for the treatment of cryptococcal meningitis from the U.S. Food and Drug Administration (FDA).
• Plans underway to initiate Phase 1/2 EnACT (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) of MAT2203 for the treatment of HIV-infected patients with cryptococcal meningitis in Q4 2019. This open-label, sequential cohort study, fully funded by the National Institutes of Health (NIH), will utilize the Company’s Lipid- Nano-Crystal (LNC) drug delivery technology to orally deliver the traditionally IV-only fungicidal drug, Amphotericin B. While cumulative data from this study is expected to be available in the first half of 2021, management believes that progression of the study from cohort to cohort during 2020 may be interpreted positively.
• May 2019 – publication of efficacy results from NIH studies using preclinical animal models evaluating MAT2203 for the treatment of cryptococcal meningitis in the American Society for Microbiology Journal, mBio.
• May 2019 – Matinas entered into a research collaboration with ViiV Healthcare to evaluate the use of Matinas’ LNC platform delivery technology in the delivery of antivirals targeting HIV infection.

Second Quarter 2019 Financial Results

For the second quarter of 2019, the Company reported a net loss attributable to common shareholders of $3.6 million, or a net loss per share of $0.03 (basic and diluted), compared to a net loss attributable to common shareholders of $3.6 million, or a net loss per share of $0.04 (basic and diluted) for the same period in 2018.

Research and development (R&D) activities for the second quarter of 2019 were $2.8 million, compared to $1.5 million for the same period in 2018. The increase in R&D is due primarily to higher clinical development and overhead costs, specifically around the development of MAT9001.

General and administrative (G&A) expenses for the second quarter of 2019 were $1.8 million, compared to $2.0 million in the same period in 2018.

Cash and cash equivalents at June 30, 2019 were approximately $36.8 million, compared to $12.4 million at December 31, 2018. This increase includes net proceeds of $30.1 million from the Company’s public offering of its common stock completed in March 2019. Based on Management’s current projections, the Company believes that cash on hand is sufficient to fund operations into the first quarter of 2021.

*VASCEPA® is a registered trademark of the Amarin group of companies.

About Matinas BioPharma

Matinas BioPharma is a clinical-stage biopharmaceutical company focused on the development of its lead product candidate, MAT9001, for the treatment of cardiovascular and metabolic conditions, and the advancement of its proprietary lipid nano-crystal (“LNC”) platform technology for the safe delivery of therapies previously limited by toxicity or bioavailability issues.

MAT9001 is a prescription-only omega-3 fatty acid-based formulation, comprised primarily of EPA and DPA, under development for the treatment of hypertriglyceridemia. With the support of a world-class team of clinical key opinion leaders and regulatory consultants, MAT9001 is moving rapidly forward along a streamlined registration pathway.

In parallel, the Company's LNC Platform is a unique potential solution for complex challenges arising in the delivery of both small molecules and biologics. This novel technology allows for the delivery of life-saving compounds in ways that can make them more tolerable, less toxic, potentially more effective, and even orally bioavailable. The most advanced compound using the LNC platform is MAT2203 – an orally-delivered formulation of Amphotericin-B that has the potential to substantially improve an otherwise challenging safety profile in critically ill patients.