Matinas BioPharma Reports 2016 Third Quarter Financial Results And Provides Corporate Update

- Company to commence initial study in the Phase 1 program for MAT2501 and second Phase 2 study for MAT2203 in Q4 2016 -

- On track to report Phase 2 topline data for MAT2203 in the first half of 2017 -

BEDMINSTER, N.J., Nov. 15, 2016 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (OTCQB:MTNB), 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, today announced its financial results for the quarter ended September 30, 2016.

The Company also reviewed the progress of its lead anti-infective product in development, MAT2203, an orally-administered, encochleated formulation of amphotericin B (a broad spectrum fungicidal agent), and the development plans for MAT2501, an orally administered, encochleated formulation of the broad spectrum aminoglycoside antibiotic amikacin to treat gram-negative bacterial infections and other intracellular bacterial infections.

"We have made notable progress this year with MAT2203 and MAT2501, specifically in the past quarter with the commencement of patient dosing in our Phase 2a study of MAT2203," said Roelof Rongen, Chief Executive Officer. "Our recent regulatory and clinical achievements have established a strong foundation on which we can build in a meaningful way in the near term.  Importantly, we have taken significant steps forward in providing physicians and patients with orally-delivered encochleated drug formulations of two very powerful anti-infective medicines to address a significant unmet medical need with the potential to transform the way potent medicines are delivered and administered; all of which we expect to unlock significant value for our shareholders."

KEY RECENT CORPORATE HIGHLIGHTS

ANTI-INFECTIVE DEVELOPMENT PROGRAM ACHIEVEMENTS

MAT2203: orally-administered, encochleated amphotericin B, a broad spectrum fungicidal agent, currently in Phase 2a clinical studies for the treatment of refractory mucocutaneous candidiasis

MAT2501: orally-administered, encochleated amikacin, a broad spectrum aminoglycoside antibiotic agent, with a lead chronic indication for treatment of non-tuberculous mycobacterium (NTM) infections
  • Prepared for the initiation of Phase 1 clinical study under the open IND for the treatment of NTM.

Matinas received FDA clearance to initiate a Phase 1 clinical study of MAT2501 under the open  IND for the treatment of non-tuberculous mycobacterium infections. The FDA has designated MAT2501 as a QIDP and an Orphan Drug for the treatment of NTM infections. The Company intends to initially develop MAT2501 for the treatment of NTM infections and will also explore the development of MAT2501 for the treatment of a variety of multi-drug resistant, gram negative bacterial infections. If approved, Matinas believes MAT2501 would become the first orally bioavailable aminoglycoside and represent a significant improvement over existing therapies from a treatment and health economic perspective.

EXPECTED NEAR-TERM MILESTONES
  • Commence the initial study in the Phase 1 program for MAT2501 in Q4 2016;
  • Commence Phase 2 study for the treatment of vulvovaginal candidiasis (VVC) in Q4 2016;
  • Commence tolerability/PK study of MAT2203 in patients with a hematologic malignancy in H1 2017;
  • Up-list to a National Exchange in the next two quarters;
  • Report topline data from the Phase 2a clinical study of MAT2203 in the first half of 2017;
  • Report topline data from Phase 2 clinical study of VVC in the first half of 2017; and
  • Engage with the FDA on a MAT2203 pivotal registration-directed clinical development program and enter Phase 3 as quickly as possible.

Summary of Financial Results for Third Quarter 2016

For the nine months ended September 30, 2016, the Company reported a net loss of approximately $5.7 million, or a net loss share basic and diluted of $0.11, compared to a net loss of approximately $7.1 million, or a net loss per share basic and diluted of $0.14, for the nine months ended September 30, 2015. The net loss for the nine months ended September 30, 2016 is attributable to additional expenses related to the acquisition of Aquarius Biotechnologies, the ongoing research and development activities related to the Company's MAT2203 antifungal and MAT2501 antibacterial product candidates, and the clinical development expenses related to the human trials for MAT9001, as well as the costs associated with operating as a public company. The Company ended the quarter with approximately $6.2 million of cash and cash equivalents.