World News: 13:15 GMT Friday 10th August 2018. [Matinas BioPharma Holdings, Inc. via Globe Newswire via SPi World News]
BEDMINSTER, N.J., Aug. 10, 2018 (GLOBE NEWSWIRE) -- (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on enabling targeted intracellular delivery of life-changing medicines using its proprietary lipid nano-crystal (LNC) platform technology, yesterday reported its financial results for the second quarter ended June 30, 2018.
“With the anticipated completion of one or more strategic and research collaborations in the near term, we believe we have successfully positioned the Company to capitalize on the opportunity enabled by our unique and highly differentiated drug delivery technology platform. These potential relationships with large pharmaceutical companies and well known research institutions should provide the Company with valuable data demonstrating the unique capabilities of our technology,” commented . “We continue to advance our lead platform-validating asset, MAT2203, toward a potential pivotal trial in an area of significant unmet medical need, which could provide the basis for aggressive expansion of the utilization of MAT2203 as the preferred drug for the prevention and treatment of invasive fungal infections. During the second half of 2018 we will continue to be intently focused on expanding the reach of our LNC technology and building the organizational expertise necessary to take our Company to the next level and fulfill the exciting potential for our platform.”
In July 2018, Matinas entered into a research collaboration with the National Institutes of Health (NIH) to identify a novel human immunodeficiency virus (HIV) therapy through the combination of antisense oligonucleotides with Matinas’ proprietary LNC delivery technology. This unique joint research effort is representative of the broad applicability and significant potential of Matinas disruptive and differentiated LNC delivery technology. The goal of this particular collaboration is to leverage the unique attributes of Matinas’ LNC technology to safely, effectively and efficiently deliver antisense oligonucleotides (ASO) intracellularly to inhibit Trans-Activator of Transcription (Tat)/viral mRNA translation. Tat is a contributing factor in three major aspects of HIV infection post treatment with antiretroviral therapy (ART): viral replication/latency, chronic inflammation and neurological complications. Tat is a key regulatory protein not specifically targeted by currently available ART. and studies will be conducted to determine optimal structures for incorporating ASOs into the LNC technology platform, delivery into target cells and the effective inhibition of Tat and/or viral replication while monitoring Tat-induced cytotoxicity.
Based upon existing and consistently replicated preclinical and clinical data, the Company believes that its unique and proprietary LNC delivery technology platform can be used to formulate and thereby redesign a wide variety of molecules and drugs which, (i) require a delivery technology to improve the stability of molecules inside and outside the body, (ii) could benefit from efficient delivery and cellular uptake by target cells, and (iii) are currently only available in IV formulations or (iv) otherwise experience significant toxicity-related adverse events. Leveraging its LNC delivery technology, the Company believes it can develop a pipeline of product candidates, both internally and through strategic partnerships with pharmaceutical and biotech companies. Matinas has demonstrated the safety and efficacy of its LNC platform technology to deliver a broad range of compounds, including small molecules, oligonucleotides (mRNA, siRNA, DNA plasmids), vaccines, peptides, proteins, anti-inflammatory agents, NSAIDs and anti-microbials in a number of clinical and preclinical studies.
Matinas continues to advance its discussions with multiple strategic and research partners and expects to utilize this strategy to expand the successful application of its LNC Technology and capitalize upon partner’s expertise and significant financial resources in numerous high-profile therapeutic categories to drive development and potentially create additional shareholder value.
The Company's lead and platform-validating product candidate, MAT2203, utilizes its proprietary LNC formulation technology to enable the safe and effective delivery of the broad-spectrum fungicidal agent, amphotericin B. Based on the positive patient clinical data reported in 2017 and a positive face-to-face interaction with the U.S. Food and Drug Administration (FDA) in 2018, Matinas has designed a streamlined and risk-mitigated development program focused on a potential pivotal Phase 2 trial of MAT2203 for the prevention of IFIs in patients with acute lymphoblastic leukemia (ALL). This initial indication represents a significant unmet medical need and we believe that Matinas’ ability to formulate a safe and effective oral formulation of amphotericin B, which is designed for longer term use, uniquely positions MAT2203 to potentially become the ideal antifungal therapy for the prevention and treatment of invasive fungal infections.
Matinas expects to engage with FDA frequently over the next 6-12 months as it prepares to commence its potential pivotal Phase 2 adaptive-designed study in 2019. The Company has positioned MAT2203 for approval with a targeted indication for prevention of IFIs in ALL patients. The first aspect of this pivotal Phase 2 trial will be an evaluation of the PK/PD and tolerability of MAT2203 in leukemia patients. The second part of this study will evolve to become an evaluation of PK/PD, efficacy and safety of MAT2203 versus placebo in ALL patients, where there is no standard of care in prevention of IFIs. Due to significant drug-drug interactions or the lack of an oral dosing mode, there is limited utility of currently approved antifungal therapies for the prevention of IFIs. The Company believes that orally-administered MAT2203 has the potential to become a highly differentiated therapy in the antifungal field.
The FDA has granted MAT2203 designations for Fast Track and Qualified Infectious Disease Product (QIDP) for the treatment of invasive candidiasis and aspergillosis and for the prevention of IFIs in patients on immunosuppressive therapy.
For the three months ended June 30, 2018, the Company reported a net loss attributable to common shareholders of approximately $3.6 million, or a net loss per share basic and diluted of $0.4, compared to a net loss attributable to common shareholders of approximately $4.1 million, or a net loss per share basic and diluted of $0.4, for the three months ended June 30, 2017. The net loss for the quarter ended June 30, 2018 was primarily attributable to ongoing research and development activities related to the Company’s MAT2203 antifungal product candidate as well as the costs associated with operating as a public company. The Company ended the quarter with cash and cash equivalents of approximately $8.9 million.
The Company's lead anti-fungal product candidate, MAT2203, positions Matinas BioPharma to become a leader in the safe and effective delivery of anti-infective therapies utilizing its proprietary LNC formulation technology.
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Source: Matinas BioPharma Holdings, Inc.
Globe Newswire: 13:15 GMT Friday 10th August 2018
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