1. BEDMINSTER, N.J., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced that it has dosed the first patient in a Phase 1 single ascending dose (SAD) pharmacokinetic study in healthy volunteers with MAT2501. The Company expects to complete enrollment of the Phase 1 SAD study in the first quarter of 2022, with data anticipated during the second quarter of 2022. Pending successful completion of the Phase 1 SAD study, the Company expects to start a Phase 2 program in patients with nontuberculous mycobacterial…

    BEDMINSTER, N.J., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced that it has dosed the first patient in a Phase 1 single ascending dose (SAD) pharmacokinetic study in healthy volunteers with MAT2501. The Company expects to complete enrollment of the Phase 1 SAD study in the first quarter of 2022, with data anticipated during the second quarter of 2022. Pending successful completion of the Phase 1 SAD study, the Company expects to start a Phase 2 program in patients with nontuberculous mycobacterial (NTM) infections by the first quarter of 2023, following required longer-term preclinical toxicology studies to be conducted during 2022.

    MAT2501 is being developed to potentially become the first oral aminoglycoside, with the application of Matinas' proprietary LNC platform technology to the broad-spectrum antibiotic drug amikacin. Amikacin is a highly potent antibiotic used to treat chronic and acute bacterial infections, including problematic gram-negative infections. Currently, amikacin's use (IV or inhalation) is severely limited due to associated major side effects including nephrotoxicity and ototoxicity (hearing loss and potentially permanent impairment of balance), as well as inhalation complications with certain approved therapies.  

    "Following the robust data from MAT2203 in the EnACT trial announced in September 2021, MAT2501 now becomes our second clinical stage product candidate demonstrating the benefits of our LNC platform delivery technology in treating infectious diseases. Our goal with MAT2501 is to develop the first oral aminoglycoside, which could transform the use of this important class of drugs," stated Jerome D. Jabbour, Chief Executive Officer of Matinas. "At its core, our LNC platform facilitates intracellular delivery. We believe that MAT2501's ability to orally, effectively, efficiently and safely deliver therapeutic levels of amikacin that specifically target the lung, without use-limiting toxicity, clearly distinguishes it from other available therapies for the treatment of NTM infections. Furthermore, we believe that the ultimate applicability of MAT2501 will not be limited to the treatment of pulmonary infections, and we expect to evaluate its use in other, more acute bacterial infections, such as gram-negative infections, where the unmet medical need is significant and unfortunately growing due to a lack of effective therapies."

    This Phase 1 study is a double-blind, placebo-controlled, SAD study designed primarily to evaluate the safety, tolerability and pharmacokinetics of single ascending oral doses of MAT2501 in healthy adult subjects. Secondary objectives include the assessment of the effect of food on the pharmacokinetics of amikacin following a single oral dose of MAT2501.

    Development of MAT2501 has been supported by a $4.2 million Therapeutics Development Award from the Cystic Fibrosis Foundation.

    The U.S. Food and Drug Administration (FDA) has designated MAT2501 as a Qualified Infectious Disease Product (QIDP) and as an Orphan Drug for the treatment of NTM. If MAT2501 is ultimately approved by the FDA, the seven-year period of marketing exclusivity from orphan designation combined with the additional five years of marketing exclusivity provided by the QIDP designation, would provide for a potential total of 12 years of marketing exclusivity.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. The Company is developing its own internal portfolio of products as well as partnering with leading pharmaceutical companies to develop new formulations that take full advantage of the unique characteristics of the LNC platform.

    Preclinical and clinical data have demonstrated that this novel technology can provide solutions to many of the complex challenges in achieving safe and effective intracellular delivery, for both small molecules and larger, more complex molecules, such as mRNA, DNA plasmids, antisense oligonucleotides and vaccines. The combination of a unique mechanism of action and flexibility in both the formulation and route of administration (including oral), position Matinas' LNC technology to potentially become the preferred next-generation intracellular drug delivery vehicle and an important improvement over both lipid nanoparticles and viral vectors.

    MAT2203 is an oral, LNC formulation of the highly effective, but also highly toxic, antifungal medicine amphotericin B, primarily used as a first-line treatment for invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. Enrollment in Cohort 3 of EnACT has commenced following unanimous approval from the Data and Safety Monitoring Board (DSMB), with enrollment completion and DSMB evaluation of Cohort 3 data expected in the fourth quarter of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic amikacin, primarily used to treat chronic and acute bacterial infections. With the support of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing important preclinical studies and commenced a Phase 1 human clinical trial in the fourth quarter of 2021. MAT2501 would be the first and only oral aminoglycoside and is being positioned with an initial indication for the treatment of nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis.

    LYPDISO™, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, intended for the treatment of cardiovascular and metabolic conditions. This next-generation omega-3 therapy has been shown in two head-to-head studies to provide effective triglyceride-lowering and significantly higher EPA blood levels than Vascepa®. The Company has initiated a process to identity and potentially secure a partner to continue development of LYPDISO.    

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to our business activities, our strategy and plans, the potential of our LNC platform delivery technology, and the future development of its product candidates, including MAT2203, MAT2501, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts

    Peter Vozzo

    ICR Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Source: Matinas BioPharma Holdings, Inc.



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  2. – Ms. Corzo brings a 25+ year successful track record in biopharma, excelling in oncology drug development with Takeda, Sanofi Genzyme, and Eli Lilly –

    BEDMINSTER, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced the nomination of Kathryn Penkus Corzo to stand for election to the Company's Board of Directors at its 2021 Annual Meeting of Stockholders, scheduled for November 1, 2021.

    Ms. Corzo is currently partner at Takeda Ventures, Inc. and previously Head of Oncology Cell Therapy…

    – Ms. Corzo brings a 25+ year successful track record in biopharma, excelling in oncology drug development with Takeda, Sanofi Genzyme, and Eli Lilly –

    BEDMINSTER, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced the nomination of Kathryn Penkus Corzo to stand for election to the Company's Board of Directors at its 2021 Annual Meeting of Stockholders, scheduled for November 1, 2021.

    Ms. Corzo is currently partner at Takeda Ventures, Inc. and previously Head of Oncology Cell Therapy Development at Takeda Pharmaceuticals, a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan. Ms. Corzo is located at Takeda's R&D hub in Cambridge, Massachusetts.

    "We are thrilled to nominate Kathryn to our Board of Directors," stated Herbert Conrad, Chairman of the Matinas BioPharma Board of Directors, and Chair of the Nominating and Governance Committee. "Kathryn is a highly-regarded biotechnology executive with an extensive record of drug development accomplishments. Her leadership roles and development successes with major pharmaceutical companies will be extremely valuable to our Company as we develop and expand the utilization of our LNC platform delivery technology."

    Ms. Corzo commented, "I am honored to have been nominated to join the Matinas Board of Directors at such an exciting time for the Company. The LNC platform presents a unique and promising opportunity to transform the intracellular delivery of complex molecules and I look forward to working with the Board and the management team to optimize the value and impact of this potentially disruptive technology."

    The Company also announced today that Patrick LePore will not stand for re-election to the Board of Directors at the Company's Annual Meeting of Stockholders on November 1, 2021.

    "On behalf of the Board of Directors and Matinas, I would like to thank Pat LePore for his service to the Company. His leadership, expertise and insight have been invaluable in our efforts to serve the best interests of all of Matinas' stakeholders these past three years. We wish him the absolute best in the future," stated Jerome D. Jabbour, Chief Executive Officer of Matinas.

    "I am extremely grateful to Jerry and Herb, as well as the entire Board of Directors, for the opportunity to serve the Company as Vice Chairman," commented Patrick LePore. "With the recently announced positive EnACT data and several other important clinical and strategic milestones in place over the next few quarters, Matinas is extremely well-positioned for the future. Kathryn is a tremendous addition to the Board and her development expertise and scientific acumen will be instrumental in maximizing the opportunity ahead with the LNC platform."

    About Kathryn Penkus Corzo

    Kathryn Corzo is a biotechnology executive who has served in senior leadership roles for several leading biotechnology and pharmaceutical companies.   Since February 2020, she has been the Head, Oncology Cell Therapy Development at Takeda Pharmaceuticals responsible for leading and overseeing development of Takeda's Oncology cell therapy pipeline including collaborations with academic and biotech innovation partnerships. Kathryn recently joined Takeda Ventures as a partner. Previously, Kathryn served in various leadership roles at Sanofi Genzyme (2010-2019) where she was Vice President of R&D and Global Program Head for Myeloma from June 2015 through December 2019. She is credited for steering multi-disciplinary teams advancing therapeutic candidates from early proof of concept through pivotal trials, worldwide regulatory approvals, indication expansions and product launches. She also led an initiative to establish Sanofi's U.S. R&D innovation center and digital accelerator based in Cambridge, MA. Before Sanofi, she successfully built a two-decade career at Hoffmann-La Roche, Roche Molecular Systems, Eli Lilly and Syndax taking on responsibility in R&D operations, global clinical development, medical affairs, business development, market access and brand management across multiple platforms and indications. Kathryn has worked to improve outcomes for cancer patients and played an integral role in the development of 12 innovative investigational drugs and five therapeutic products.

    Kathryn holds an M.B.A. from Massachusetts Institute of Technology Sloan School of Management and a B.S. in Pharmacy from Massachusetts College of Pharmacy.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. The Company is developing its own internal portfolio of products as well as partnering with leading pharmaceutical companies to develop new formulations that take full advantage of the unique characteristics of the LNC platform.

    Preclinical and clinical data have demonstrated that this novel technology can provide solutions to many of the complex challenges in achieving safe and effective intracellular delivery, for both small molecules and larger, more complex molecules, such as mRNA, DNA plasmids, antisense oligonucleotides and vaccines. The combination of a unique mechanism of action and flexibility in both the formulation and route of administration (including oral), position Matinas' LNC technology to potentially become the preferred next-generation intracellular drug delivery vehicle and an important improvement over both lipid nanoparticles and viral vectors.

    MAT2203 is an oral, LNC formulation of the highly effective, but also highly toxic, antifungal medicine amphotericin B, primarily used as a first-line treatment for invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT has completed the first two patient cohorts and efficacy dated presented from Cohort 2 demonstrated 95% survival in 40 patients and mean Early Fungicidal Activity of 0.38, well above the prespecified primary endpoint threshold of >0.20. Enrollment in Cohort 3 has commenced following unanimous DSMB approval, with enrollment completion for Cohort 3 expected by the end of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic amikacin, primarily used to treat chronic and acute bacterial infections. With the support of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing important preclinical studies and expects to enter a Phase 1 human clinical trial later in 2021. MAT2501 would be the first and only oral aminoglycoside and is being positioned with an initial indication for the treatment of nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, intended for the treatment of cardiovascular and metabolic conditions. This next-generation omega-3 therapy has been shown in two head-to-head studies to provide effective triglyceride-lowering and significantly higher EPA blood levels than Vascepa®. The Company has initiated a process to identity and potentially secure a partner to continue development of LYPDISO.    

    This Press Release Does Not Constitute a Solicitation of Proxies

    This press release is not a solicitation of proxies from holders of common stock of Matinas BioPharma Holdings, Inc. (the "Company"). The Company will provide stockholders with a proxy statement and other relevant materials in connection with the 2021 Annual Meeting of Stockholders. Any solicitation of proxies by or on behalf of the Company in connection with the 2021 Annual Meeting of Stockholders will be conducted upon and following the dissemination of the proxy statement and other materials in accordance with applicable law. We urge shareholders to read the proxy statement and any other relevant documents to be filed with the SEC when available, as such documents will contain important information. Shareholders will be able to receive the proxy statement and other relevant documents free of charge at the SEC's website at http://www.sec.gov.

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to our business activities, our strategy and plans, the potential of our LNC platform delivery technology, the election of Ms. Kathryn Penkus Corzo to the Board of Directors, the potential benefits from the potential election to the Matinas Board of Ms. Corzo, and the future development of its product candidates, including MAT2203, MAT2501, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com

    Source: Matinas BioPharma Holdings, Inc.



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  3. BEDMINSTER, N.J., Sept. 14, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, presented a Company overview at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13-15, 2021.

    A webcast of the Company's presentation is available immediately on-demand via the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following the event.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal…

    BEDMINSTER, N.J., Sept. 14, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, presented a Company overview at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13-15, 2021.

    A webcast of the Company's presentation is available immediately on-demand via the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following the event.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. The Company is developing its own internal portfolio of products as well as partnering with leading pharmaceutical companies to develop new formulations that take full advantage of the unique characteristics of the LNC platform.

    Preclinical and clinical data have demonstrated that this novel technology can provide solutions to many of the complex challenges in achieving safe and effective intracellular delivery, for both small molecules and larger, more complex molecules, such as mRNA, DNA plasmids, antisense oligonucleotides and vaccines. The combination of a unique mechanism of action and flexibility in both the formulation and route of administration (including oral), position Matinas' LNC technology to potentially become the preferred next-generation intracellular drug delivery vehicle and an important improvement over both lipid nanoparticles and viral vectors.

    MAT2203 is an oral, LNC formulation of the highly effective, but also highly toxic, antifungal medicine amphotericin B, primarily used as a first-line treatment for invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT has completed the first two patient cohorts and efficacy dated presented from Cohort 2 demonstrated 95% survival and mean Early Fungicidal Activity of 0.38, well above the prespecified primary endpoint threshold of >0.20. Enrollment in Cohort 3 has commenced following unanimous DSMB approval, with enrollment completion for Cohort 3 expected by the end of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic amikacin, primarily used to treat chronic and acute bacterial infections. With the support of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing important preclinical studies and expects to enter a Phase 1 human clinical trial later in 2021. MAT2501 would be the first and only oral aminoglycoside and is being positioned with an initial indication for the treatment of nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, intended for the treatment of cardiovascular and metabolic conditions. This next-generation omega-3 therapy has been shown in two head-to-head studies to provide effective triglyceride-lowering and significantly higher EPA blood levels than Vascepa®. The Company has initiated a process to identity and potentially secure a partner to continue development of LYPDISO. 

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com



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  4. – Step-down therapy with MAT2203 achieved effective clearance of fungal organisms; Mean Early Fungicidal Activity (EFA) was 0.38, exceeding the prespecified primary endpoint threshold target of >0.20 –

    – Overall survival was >95% in 40 patients receiving MAT2203 in Cohort 2 –

    – All 39 patients completing induction with MAT2203 achieved sterility, with no evidence of breakthrough or recurrent infections during the first 10 weeks of antifungal treatment –

    – Patients received MAT2203 for up to 6 weeks without kidney toxicity or electrolyte abnormalities attributable to MAT2203 –

    – DSMB unanimously recommends progression to Cohort 3; Enrollment has commenced –

    – Preparing to engage with FDA to review EnACT data as supportive of potential early

    – Step-down therapy with MAT2203 achieved effective clearance of fungal organisms; Mean Early Fungicidal Activity (EFA) was 0.38, exceeding the prespecified primary endpoint threshold target of >0.20 –

    – Overall survival was >95% in 40 patients receiving MAT2203 in Cohort 2 –

    – All 39 patients completing induction with MAT2203 achieved sterility, with no evidence of breakthrough or recurrent infections during the first 10 weeks of antifungal treatment –

    – Patients received MAT2203 for up to 6 weeks without kidney toxicity or electrolyte abnormalities attributable to MAT2203 –

    – DSMB unanimously recommends progression to Cohort 3; Enrollment has commenced –

    – Preparing to engage with FDA to review EnACT data as supportive of potential early approval of MAT2203 as step-down therapy –

    Management to host conference call today, Monday, September 13th, at 8:00 a.m. ET –

    BEDMINSTER, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced positive efficacy and safety data from the first two cohorts of patients in the ongoing Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT) of MAT2203 (oral amphotericin B) for the treatment of cryptococcal meningitis, which is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).

    The EnACT independent Data and Safety Monitoring Board (DSMB) recently completed a pre-specified review of available safety and efficacy data from Cohort 2 (stepdown to MAT2203 after two days of IV amphotericin) and unanimously recommended progression to the second half of the study. Enrollment in Cohort 3 of EnACT (the safety lead-in for Cohort 4, which will be an all-oral MAT2203 treatment regimen) has commenced and is expected to complete by the end of 2021.

    "These results are a major milestone for Matinas, MAT2203 and our LNC platform delivery technology," stated Jerome D. Jabbour, Chief Executive Officer of Matinas. "These data are a clear demonstration of how our LNC platform can have a meaningful clinical impact in a deadly disease, and a validation of how this technology can be used to overcome significant drug delivery challenges, including oral delivery of highly toxic drugs across the blood-brain barrier. The global invasive fungal infection market is projected to be more than $8 billion by 2025, and we believe an oral and well tolerated amphotericin B, which preserves the well-established efficacy of this potent drug, if approved, could be poised to capture a meaningful portion of this growing market, and fill a currently large unmet medical need. Finally, we believe these data are supportive of the enormous potential for our LNC platform delivery technology and a key for potential partners and collaborators who are currently evaluating MAT2203 and broader applications of the LNC platform to antivirals, vaccines, and nucleic acid polymers, such as mRNA."

    Topline Results from Cohort 2 of EnACT

    Key topline results from Cohort 2 of EnACT include eradication of the fungal infection, survival, and safety, including longer term use of MAT2203 beyond the 2-week induction period.

    Potent Early Fungicidal Activity (EFA), Cerebrospinal Fluid (CSF) Sterilization, with No Evidence of Breakthrough Infections During Treatment with MAT2203

    • The primary endpoint in EnACT is EFA, a measurement of cerebrospinal fluid fungal clearance. EFA is a well-validated quantitative measure of the efficacy of antifungal agents and is a key surrogate marker for survival. EFAs of less than 0.20 log10 Cryptococcus colony forming units (CFUs) per mL CSF per day are associated with significantly higher mortality and worse clinical outcomes1. EFA measured above this threshold is clinically meaningful and represents robust fungal clearance. In the second cohort of EnACT, the mean EFA achieved with patients treated with MAT2203 was 0.38 log10 CFU/mL/day, with 95% confidence intervals (0.30 to 0.46) significantly higher than the prespecified primary endpoint threshold of >0.20.
    • All patients treated with MAT2203 who completed the induction phase achieved sterile CSF cultures during treatment (either during induction or early consolidation phases).
    • There was no evidence of breakthrough or relapsed cryptococcal infections observed in any of the patients during treatment with MAT2203 through 10 weeks.

    Survival

    • In Cohort 2, overall survival was 95% in 40 patients randomized to receiving MAT2203.

    Safety

    • In both Cohorts 1 and 2, MAT2203 showed no evidence of renal toxicity or electrolyte abnormalities attributable to MAT2203, no major safety signals, and no use-limiting tolerability issues, even with longer-term treatment with MAT2203 extended beyond induction into the consolidation phase, from week 2 to week 6.

    "We believe that the positive data from the first half of the EnACT study represent a groundbreaking achievement in the early step-down treatment of cryptococcal meningitis with the use of an oral formulation of amphotericin and we are preparing to engage with the U.S. Food and Drug Administration (FDA) to review these data as supportive of a potential early approval of MAT2203 as step-down therapy," commented Dr. Theresa Matkovits, Chief Development Officer of Matinas. "When viewed against historical measures of survival and eradication of fungal burden and from the standpoint of safety, MAT2203 exceeded expectations. These data also set the stage for potential longer-term treatment options, including prophylaxis, for patients dealing with, or at risk for, deadly invasive fungal infections without the toxicities usually associated with IV amphotericin. We are pleased to move forward to the next part of the EnACT trial and remain grateful to the patients, the principal investigators, and the dedicated study team at the University of Minnesota and in Uganda for their commitment to this important clinical trial."

    "Overall, using only two days of intravenous amphotericin B followed by rapid transition to oral LNC amphotericin B therapy was well tolerated, resulted in excellent CSF clearance of the Cryptococcus yeast, and had a 95% survival to date, which exceeds our expectations," said David R. Boulware, M.D., MPH, Professor of Medicine, University of Minnesota Medical School, and co-principal investigator of the EnACT trial. "We are excited to continue to the next stage of the EnACT trial, testing if oral therapy alone is efficacious."

    About the EnACT Study

    EnACT is a Phase 2 prospective, randomized, open-label, sequential cohort study, financially supported by the National Institutes of Health (NIH), evaluating the safety, tolerability and efficacy of MAT2203 in approximately 100 HIV-infected patients with cryptococcal meningitis (CM). MAT2203 utilizes the Company's LNC platform delivery technology to orally deliver the traditionally IV-only fungicidal drug, amphotericin B.

    The EnACT trial includes a total of four cohorts of patients, with the first two cohorts testing MAT2203 as early stepdown therapy following initial treatment with IV amphotericin B during the induction period, and the second two cohorts testing MAT2203 as potential monotherapy. The induction period for all patients in each cohort (active or control) is 14 days, followed by an additional four weeks of treatment (active or control) during a consolidation/maintenance period.

    All patients in the induction period of EnACT (both control and MAT2203 arms) receive background therapy of flucytosine, also known as 5-FC, which is specifically recommended to be used with amphotericin B as standard-of-care treatment during induction in patients with CM. During the consolidation/maintenance period, all patients (both control and MAT2203 arms) receive 800 mg/day of fluconazole. An independent DSMB oversees the safety of the study and reviews all available data from each cohort for both safety and efficacy and makes a recommendation on whether to proceed to the next cohort of patients.

    In the MAT2203 arm of Cohort 1, 10 patients received IV amphotericin B (with 5-FC) for the first five days of induction, followed by ten days (overlapped on day 5) of oral MAT2203 (with 5-FC). In the MAT2203 arm of Cohort 2, 40 patients first received IV amphotericin B (with 5-FC) for two days, followed by thirteen days (overlapped on Day 2) of oral MAT2203 (with 5-FC). In both Cohorts 1 and 2, treatment with MAT2203 was continued after induction during the next four weeks of consolidation/maintenance treatment, administered with 800 mg/day of fluconazole.

    In the MAT2203 arm of Cohort 3, 10 patients will receive 5 days of oral MAT2203 (with 5-FC), followed by 10 days (overlapped on Day 5) of IV amphotericin (with 5-FC). In the MAT2203 arm of Cohort 4, 40 patients will receive MAT2203 (with 5-FC) for the entire 14-day induction period. In both Cohorts 3 and 4, treatment with MAT2203 will continue after induction during the next four weeks of consolidation/maintenance treatment, administered alongside 800 mg/day of fluconazole.

    The primary efficacy endpoint for EnACT is the quantitative microbiologic clearance rate of Cryptococcus yeasts from CSF, termed Early Fungicidal Activity (EFA). This is a quantitative measurement of the efficacy of antifungal agents as well as a key surrogate marker for survival. The primary EFA endpoint is measured from the first CSF culture with 3-4 repeated cultures obtained over the first two weeks of treatment. The prespecified endpoint threshold was achieving EFA >0.20 log10 CFU/mL/day, recognizing that EFAs of less than 0.20 are strongly associated with significantly higher mortality and worse clinical outcomes.

    Standard of care active control HIV patients with cryptococcal meningitis (a total of 40 across all 4 cohorts) are included in EnACT, primarily to assess patient safety. The control arms for Cohorts 1 and 2 included 4 and 17 patients, respectively, and we expect that the control arms for Cohorts 3 and 4 will include 4 patients and 16 patients, respectively. In the control arms, patients receive IV amphotericin (with 5-FC) for 7 days, followed by a high dose of oral fluconazole for 7 days (to complete the 14-day induction period), and then transition to 800 mg/day of fluconazole for the 4-week consolidation phase. Either amphotericin B deoxycholate or liposomal amphotericin B (Ambisome®) can be used in the control arm. EnACT was not powered to formally test comparisons with the control arm standard of care.

    The FDA has designated MAT2203 as a Qualified Infectious Disease Product (QIDP) with Fast Track status for four indications, specifically, the prevention of invasive fungal infections due to immunosuppressive therapy, and the treatment of invasive candidiasis, invasive aspergillus and cryptococcal meningitis. In addition, the FDA has granted orphan drug designation to MAT2203 for the treatment of cryptococcosis.

    Conference Call and Webcast Details

    The Company will host a live conference call and webcast to discuss these results today, Monday, September 13, 2021, at 8:00 a.m. ET. Presentation slides will be available on the Investors section of Matinas' website, www.matinasbiopharma.com. A question-and-answer session with the Matinas management team will follow the Company's remarks.

    To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll) and reference conference ID 13722251. The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and archived for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. The Company is developing its own internal portfolio of products as well as partnering with leading pharmaceutical companies to develop new formulations that take full advantage of the unique characteristics of the LNC platform.

    Preclinical and clinical data have demonstrated that this novel technology can provide solutions to many of the complex challenges in achieving safe and effective intracellular delivery, for both small molecules and larger, more complex molecules, such as mRNA, DNA plasmids, antisense oligonucleotides and vaccines. The combination of a unique mechanism of action and flexibility in both the formulation and route of administration (including oral), position Matinas' LNC technology to potentially become the preferred next-generation intracellular drug delivery vehicle and an important improvement over both lipid nanoparticles and viral vectors.

    MAT2203 is an oral, LNC formulation of the highly effective, but also highly toxic, antifungal medicine amphotericin B, primarily used as a first-line treatment for invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT has completed the first two patient cohorts. Enrollment in Cohort 3 has commenced following unanimous DSMB approval, with enrollment completion for Cohort 3 expected by the end of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic amikacin, primarily used to treat chronic and acute bacterial infections. With the support of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing important preclinical studies and expects to enter a Phase 1 human clinical trial later in 2021. MAT2501 would be the first and only oral aminoglycoside and is being positioned with an initial indication for the treatment of nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, intended for the treatment of cardiovascular and metabolic conditions. This next-generation omega-3 therapy has been shown in two head-to-head studies to provide effective triglyceride-lowering and significantly higher EPA blood levels than Vascepa®. The Company has initiated a process to identity and potentially secure a partner to continue development of LYPDISO.

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com

    Source: Matinas BioPharma Holdings, Inc.

    1 *Clin Infect Dis. 2020;71(5):e45-49



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  5. BEDMINSTER, N.J., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 16/312,047, covering MAT2203, the Company's oral, LNC formulation of antifungal medicine amphotericin B. The allowed patent application, entitled, "Encocholeated Antifungal Compounds for Central Nervous System Delivery and Treatment of Cryptococcus Infections," includes claims directed to using an orally administered…

    BEDMINSTER, N.J., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 16/312,047, covering MAT2203, the Company's oral, LNC formulation of antifungal medicine amphotericin B. The allowed patent application, entitled, "Encocholeated Antifungal Compounds for Central Nervous System Delivery and Treatment of Cryptococcus Infections," includes claims directed to using an orally administered amphotericin B cochleate composition in combination with a second antifungal compound, such as 5-Flucytosine or an azole antifungal, to treat or prevent a Cryptococcus infection of the central nervous system. The patent that issues from U.S. Patent Application No. 16/312,047 will have a base patent term extending to 2037, excluding any patent term adjustments or patent term extensions which may provide additional protection.

    "This new patent allowance by the USPTO is not only another important milestone in protecting the commercial potential of MAT2203, but demonstrates our strong overall commitment to protecting the innovation and commercial opportunity of our entire LNC delivery platform portfolio," commented Jerome D. Jabbour, Chief Executive Officer of Matinas.

    A Notice of Allowance is issued after the USPTO makes a determination that a patent should be granted from an application. With the issuance of this new patent, Matinas' patent portfolio includes six issued U.S. patents, as well as additional related patents outside the U.S. that cover MAT2203, with other pending patent applications that can extend patent coverage for MAT2203 beyond 2037. Overall, there are now 25 issued patents covering the LNC platform, with more than 35 additional patents pending in the U.S. and globally, which have claims directed to the LNC platform delivery technology.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. The Company is developing its own internal portfolio of products as well as partnering with leading pharmaceutical companies to develop new formulations that take full advantage of the unique characteristics of the LNC platform.

    Preclinical and clinical data have demonstrated that this novel technology can provide solutions to many of the complex challenges in achieving safe and effective intracellular delivery, for both small molecules and larger, more complex molecules, such as mRNA, DNA plasmids, antisense oligonucleotides and vaccines. The combination of a unique mechanism of action and flexibility in both the formulation and route of administration (including oral), position Matinas' LNC technology to potentially become the preferred next-generation intracellular drug delivery vehicle and an important improvement over both lipid nanoparticles and viral vectors.

    MAT2203 is an oral, LNC formulation of the highly effective, but also highly toxic, antifungal medicine amphotericin B, primarily used as a first-line treatment for invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT has completed enrollment of its second cohort of patients, with the next DSMB evaluation of safety and efficacy data anticipated to occur in September 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic amikacin, primarily used to treat chronic and acute bacterial infections. With the support of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing important preclinical studies and expects to enter a Phase 1 human clinical trial later in 2021. MAT2501 would be the first and only oral aminoglycoside and is being positioned with an initial indication for the treatment of nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, intended for the treatment of cardiovascular and metabolic conditions. This next-generation omega-3 therapy has been shown in two head-to-head studies to provide effective triglyceride-lowering and significantly higher EPA blood levels than Vascepa®. The Company has initiated a process to identity and potentially secure a partner to continue development of LYPDISO.

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com

    Source: Matinas BioPharma Holdings, Inc.



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  6. – Enrollment complete in second cohort of EnACT study of MAT2203 (oral amphotericin B) in cryptococcal meningitis; Data and Safety Monitoring Board (DSMB) review of safety and efficacy data from second cohort anticipated September 2021 –

    – Positive recent FDA feedback on MAT2501 (oral amikacin) development program allows for initiation of Phase 1 study in healthy volunteers in Q4 2021 –

    – In vitro studies of lipid nanocrystal (LNC) formulations of Gilead Sciences' remdesivir demonstrate meaningful efficacy compared to free remdesivir, with a favorable toxicity profile; National Institute of Allergy and Infectious Diseases (NIAID) preparing to initiate an in vivo efficacy study of LNC-remdesivir in Q3 2021 –

    – Management to host conference

    – Enrollment complete in second cohort of EnACT study of MAT2203 (oral amphotericin B) in cryptococcal meningitis; Data and Safety Monitoring Board (DSMB) review of safety and efficacy data from second cohort anticipated September 2021 –

    – Positive recent FDA feedback on MAT2501 (oral amikacin) development program allows for initiation of Phase 1 study in healthy volunteers in Q4 2021 –

    – In vitro studies of lipid nanocrystal (LNC) formulations of Gilead Sciences' remdesivir demonstrate meaningful efficacy compared to free remdesivir, with a favorable toxicity profile; National Institute of Allergy and Infectious Diseases (NIAID) preparing to initiate an in vivo efficacy study of LNC-remdesivir in Q3 2021 –

    – Management to host conference call today, Tuesday, August 10th, at 8:00 a.m. ET –

    BEDMINSTER, N.J., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today reported financial results for the second quarter ended June 30, 2021, along with a corporate update.

    Second Quarter Highlights and Looking Ahead

    • Completed patient enrollment in Cohort 2 of the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial); DSMB evaluation of available safety and efficacy data from Cohort 2 expected in September 2021. The Company plans to announce efficacy and safety data from the first two cohorts of EnACT together with Dr. David Boulware, Principal Investigator, following the DSMB evaluation.
    • Following the EnACT data announcement, the Company plans to meet with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2021 to discuss the potential for approval of MAT2203 under one or more accelerated regulatory pathways for important anti-infective medicines that address significant unmet medical needs in small or vulnerable patient populations.
    • The Company expects to initiate a Phase 1 single ascending dose (SAD) pharmacokinetic study of MAT2501 in healthy volunteers in the fourth quarter of 2021. Initiation of the Phase 1 SAD study follows positive feedback received from the FDA on the Company's ongoing preclinical toxicology and efficacy studies of MAT2501 conducted in collaboration with the Cystic Fibrosis Foundation (CFF).
    • The Company and NIAID have successfully completed in vitro studies of various LNC formulations of Gilead's antiviral drug remdesivir. Selected LNC-remdesivir formulations were tested for antiviral activity against SARS-CoV2 WA strain in Caco-2 cells. Unformulated remdesivir active (GS-5734, in DMSO) was tested as a comparison. LNC formulations tested in this model demonstrated meaningful antiviral activity compared to free remdesivir, with a favorable toxicity profile. Based on these results, NIAID is preparing to initiate an in vivo efficacy study of the most potent LNC-remdesivir formulation. Results are expected in the fourth quarter of 2021.

    "We are very excited to have provided an in-depth look at our LNC platform during our R&D Day in June. We believe that our platform has the potential to become the next generation in safe and effective intracellular drug delivery," commented Jerome D. Jabbour, Chief Executive Officer of Matinas. "We have made great progress with MAT2203 and MAT2501, both of which represent large potential commercial opportunities for Matinas. Completion of Cohort 2 of EnACT provides an important milestone and further validation for our LNC platform. In addition to potentially demonstrating that MAT2203 can be a safe and effective step-down oral therapy for patients with cryptococcal meningitis, we believe that the data from Cohort 2 will support a key regulatory interaction later in 2021 for a potential early registration pathway for MAT2203 as step-down therapy for patients suffering from cryptococcal meningitis. In addition, recent positive feedback from the FDA on our ongoing preclinical program with MAT2501 now positions us to initiate the Phase 1 SAD study for MAT2501 in the fourth quarter of 2021."

    "Finally, we are extremely pleased with the positive in vitro data that we have reviewed from NIAID with our LNC-remdesivir formulations," continued Mr. Jabbour. "The success of our LNC platform in vitro has provided further evidence that our LNC platform can be utilized to orally administer drugs currently otherwise limited to intravenous delivery. An oral version of Gilead's remdesivir could become an essential tool in the fight against COVID-19, as it may permit administration earlier in the disease course as well as potential for prophylactic use, should clinical studies validate such an approach. We are honored to continue to partner with NIAID on this important project and look forward to additional in vivo data later in 2021."

    Second Quarter 2021 Financial Results

    Cash, cash equivalents and marketable securities at June 30, 2021, were approximately $59.8 million, compared to $58.7 million at December 31, 2020. Based on current projections, the Company believes that cash on hand is sufficient to fund operations into 2024.

    For the second quarter of 2021, net loss attributable to common shareholders was $5.0 million, or a net loss of $0.02 per share (basic and diluted), compared to a net loss attributable to common shareholders of $5.8 million, or a net loss of $0.03 per share (basic and diluted), for the same period in 2020. The decrease was due primarily to a reduction in research and development expenses, as more fully described below.

    Research and development expenses for the second quarter of 2021 were $2.5 million, compared to $3.4 million for the same period in 2020. The decrease was primarily due to the completion of the ENHANCE-IT study of LYPDISO in January 2021.

    General and administrative expenses for the second quarter of 2021 were $2.3 million, essentially unchanged compared to $2.4 million in the same period in 2020.



    Conference Call and Webcast Details



    The Company will host a live conference call and webcast to discuss these results today, Tuesday, August 10, 2021, at 8:00 a.m. ET.



    To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll) and reference conference ID 13720567. The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and archived for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. The Company is developing its own internal portfolio of products as well as partnering with leading pharmaceutical companies to develop new formulations that take full advantage of the unique characteristics of the LNC platform.

    Preclinical and clinical data have demonstrated that this novel technology can provide solutions to many of the complex challenges in achieving safe and effective intracellular delivery, for both small molecules and larger, more complex molecules, such as mRNA, DNA plasmids, antisense oligonucleotides and vaccines. The combination of a unique mechanism of action and flexibility in both the formulation and route of administration (including oral), position Matinas' LNC technology to potentially become the preferred next-generation intracellular drug delivery vehicle and an important improvement over both lipid nanoparticles and viral vectors.

    MAT2203 is an oral, LNC formulation of the highly effective, but also highly toxic, antifungal medicine amphotericin B, primarily used as a first-line treatment for invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is nearing the completion of enrollment of its second cohort of patients, with the next DSMB evaluation of safety and efficacy data anticipated to occur in September 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic amikacin, primarily used to treat chronic and acute bacterial infections. With the support of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing important preclinical studies and expects to enter a Phase 1 human clinical trial later in 2021. MAT2501 would be the first and only oral aminoglycoside and is being positioned with an initial indication for the treatment of nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, intended for the treatment of cardiovascular and metabolic conditions. This next-generation omega-3 therapy has been shown in two head-to-head studies to provide effective triglyceride-lowering and significantly higher EPA blood levels than Vascepa®. The Company has initiated a process to identity and potentially secure a partner to continue development of LYPDISO.

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.



    Matinas BioPharma Holdings, Inc. 
    Condensed Consolidated Balance Sheets 
                
          June 30, 2021 December 31, 2020 
          (Unaudited) (Audited) 
    ASSETS:          
    Current assets:          
     Cash and cash equivalents $30,352,359  $12,432,481  
     Marketable securities   29,490,430   46,246,573  
     Restricted cash - security deposits  136,000   136,000  
     Prepaid expenses and other current assets  960,422   2,739,791  
     Total current assets   60,939,211   61,554,845  
                
    Non-current assets:         
     Leasehold improvements and equipment - net  1,406,748   1,523,950  
     Operating lease right-of-use assets - net  3,034,155   3,276,639  
     Finance lease right-of-use assets - net  37,350   58,007  
     In-process research and development  3,017,377   3,017,377  
     Goodwill    1,336,488   1,336,488  
     Restricted cash - security deposits  200,000   200,000  
     Total non-current assets  9,032,118   9,412,461  
     Total assets $69,971,329  $70,967,306  
                
    LIABILITIES AND STOCKHOLDERS' EQUITY:       
                
    Current liabilities:         
     Accounts payable  $450,461  $349,941  
     Accrued expenses   2,762,736   2,795,329  
     Operating lease liabilities - current  351,257   391,498  
     Financing lease liabilities - current  26,870   30,853  
     Total current liabilities  3,591,324   3,567,621  
                
    Non-current liabilities:         
     Deferred tax liability   341,265   341,265  
     Operating lease liabilities - net of current portion  3,123,482   3,304,063  
     Financing lease liabilities - net of current portion  11,508   23,660  
     Total non-current liabilities  3,476,255   3,668,988  
     Total liabilities  7,067,579   7,236,609  
                
    Stockholders' equity:         
     Series B Convertible preferred stock -   3,797,705  
     Common stock 21,462   20,010  
     Additional paid-in capital  180,929,263   167,192,003  
     Accumulated deficit   (118,098,218)  (107,507,193) 
     Accumulated other comprehensive income  51,243   228,172  
     Total stockholders' equity  62,903,750   63,730,697  
     Total liabilities and stockholders' equity$69,971,329  $70,967,306  
                  



    Matinas BioPharma Holdings, Inc. 
    Condensed Consolidated Statements of Operations and Comprehensive Loss 
    (Unaudited) 
                  
      Three Months Ended June 30, Six Months Ended June 30, 
      2021  2020  2021  2020  
    Revenue:            
     Research and development$-  $-  $33,333  $-  
    Costs and expenses:            
     Research and development 2,480,764   3,410,237   5,722,196   7,497,120  
     General and administrative 2,308,926   2,356,310   5,453,936   4,615,941  
                  
     Total costs and expenses 4,789,690   5,766,547   11,176,132   12,113,061  
                  
    Loss from operations (4,789,690)  (5,766,547)  (11,142,799)  (12,113,061) 
                  
     Sale of New Jersey net operating loss & tax credits -   -   1,328,470   1,073,289  
     Other income, net (1,415)  156,000   66,904   383,327  
    Net loss$(4,791,105) $(5,610,547) $(9,747,425) $(10,656,445) 
                  
    Preferred stock series B accumulated dividends (184,899)  (177,092)  (395,799)  (347,792) 
                  
    Net loss attributable to common shareholders$(4,976,004)  (5,787,639) $(10,143,224) $(11,004,237) 
                  
    Net loss available for common shareholders per share - basic and diluted$(0.02)  (0.03) $(0.05) $(0.06) 
                  
    Weighted average common shares outstanding - basic and diluted 205,215,259   197,601,500   204,547,251   194,636,326  
                  
    Other comprehensive (loss)/income, net of tax            
     Unrealized (loss)/gains on securities available-for-sale (85,163)  (41,954)  (176,929)  481,303  
     Reclassification to net loss -   (2,708)  -   (2,719) 
     Other comprehensive (loss)/income, net of tax (85,163)  (44,662)  (176,929)  478,584  
    Comprehensive loss attributable to stockholders$(4,876,268) $(5,655,209) $(9,924,354) $(10,177,861) 
                  

    Investor and Media Contacts

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com

    Source: Matinas BioPharma Holdings, Inc.



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  7. BEDMINSTER, N.J., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to participate in a fireside chat as part of the BTIG Virtual Biotechnology Conference on Tuesday, August 10, 2021 at 3:00 p.m. ET. The Company will also host investor meetings during the conference.

    If you are interested in arranging a one-on-one meeting or listening to the live event, please contact your BTIG conference representative.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform…

    BEDMINSTER, N.J., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to participate in a fireside chat as part of the BTIG Virtual Biotechnology Conference on Tuesday, August 10, 2021 at 3:00 p.m. ET. The Company will also host investor meetings during the conference.

    If you are interested in arranging a one-on-one meeting or listening to the live event, please contact your BTIG conference representative.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. The Company is developing its own internal portfolio of products as well as partnering with leading pharmaceutical companies to develop new formulations that take full advantage of the unique characteristics of the LNC platform.

      

    Preclinical and clinical data have demonstrated that this novel technology can provide solutions to many of the complex challenges in achieving safe and effective intracellular delivery, for both small molecules and larger, more complex molecules, such as mRNA, DNA plasmids, antisense oligonucleotides and vaccines. The combination of a unique mechanism of action and flexibility in both the formulation and route of administration (including oral), position Matinas' LNC technology to potentially become the preferred next-generation intracellular drug delivery vehicle and an important improvement over both lipid nanoparticles and viral vectors.

    MAT2203 is an oral, LNC formulation of the highly effective, but also highly toxic, antifungal medicine amphotericin B, primarily used as a first-line treatment for invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is nearing the completion of enrollment of its second cohort of patients, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the third quarter of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic amikacin, primarily used to treat chronic and acute bacterial infections. With the support of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing important preclinical studies and expects to enter a Phase 1 human clinical trial later in 2021. MAT2501 would be the first and only oral aminoglycoside and is being positioned with an initial indication for the treatment of nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, intended for the treatment of cardiovascular and metabolic conditions. This next-generation omega-3 therapy has been shown in two head-to-head studies to provide effective triglyceride-lowering and significantly higher EPA blood levels than Vascepa®. The Company has initiated a process to identity and secure a potential partner to continue development of LYPDISO. 

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501 and LYPDISO, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com



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  8. BEDMINSTER, N.J., July 27, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform, today announced that the Company will host a conference call and live audio webcast on Tuesday, August 10, 2021 at 8:00 a.m. ET to discuss operational and financial results for the second quarter ended June 30, 2021.

    To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll) and reference conference ID 13720567. The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com

    BEDMINSTER, N.J., July 27, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform, today announced that the Company will host a conference call and live audio webcast on Tuesday, August 10, 2021 at 8:00 a.m. ET to discuss operational and financial results for the second quarter ended June 30, 2021.

    To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll) and reference conference ID 13720567. The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and archived for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. The Company is developing its own internal portfolio of products as well as partnering with leading pharmaceutical companies to develop new formulations that take full advantage of the unique characteristics of the LNC platform.   

    Preclinical and clinical data have demonstrated that this novel technology can provide solutions to many of the complex challenges in achieving safe and effective intracellular delivery, for both small molecules and larger, more complex molecules, such as mRNA, DNA plasmids, antisense oligonucleotides and vaccines.   The combination of a unique mechanism of action and flexibility in both the formulation and route of administration (including oral), position Matinas' LNC technology to potentially become the preferred next-generation intracellular drug delivery vehicle and an important improvement over both lipid nanoparticles and viral vectors.

    MAT2203 is an oral, LNC formulation of the highly effective, but also highly toxic, antifungal medicine amphotericin B, primarily used as a first-line treatment for invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is nearing the completion of enrollment of its second cohort of patients, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the third quarter of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic amikacin, primarily used to treat chronic and acute bacterial infections. With the support of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing important preclinical studies and expects to enter a Phase 1 human clinical trial later in 2021. MAT2501 would be the first and only oral aminoglycoside and is being positioned with an initial indication for the treatment of nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, intended for the treatment of cardiovascular and metabolic conditions. This next-generation omega-3 therapy has been shown in two head-to-head studies to provide effective triglyceride-lowering and significantly higher EPA blood levels than Vascepa®. The Company has initiated a process to identity and secure a potential partner to continue development of LYPDISO. 

    Forward Looking Statements:

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501 and LYPDISO, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contact

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com

    Source: Matinas BioPharma Holdings, Inc.



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  9. Matinas will highlight progress across its lipid nanocrystal (LNC) delivery platform and associated pipeline programs

    David R. Boulware, M.D., MPH, Professor of Medicine, Infectious Disease and International Medicine, Univ. of Minnesota, and Peter G. Pappas, M.D., Professor of Medicine, Medicine/Infectious Diseases Department, Univ. of Alabama at Birmingham, to provide clinical perspectives

    BEDMINSTER, N.J., May 20, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform, today announced it will host a virtual R&D Day on Thursday, June 17, beginning…

    Matinas will highlight progress across its lipid nanocrystal (LNC) delivery platform and associated pipeline programs

    David R. Boulware, M.D., MPH, Professor of Medicine, Infectious Disease and International Medicine, Univ. of Minnesota, and Peter G. Pappas, M.D., Professor of Medicine, Medicine/Infectious Diseases Department, Univ. of Alabama at Birmingham, to provide clinical perspectives

    BEDMINSTER, N.J., May 20, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform, today announced it will host a virtual R&D Day on Thursday, June 17, beginning at 8:30 a.m. During the event, members of the Matinas management team will discuss the Company's key pipeline programs and its proprietary, highly differentiated technology that solves complex challenges relating to the safe and effective intracellular delivery of both small and large molecules. In addition, two internationally regarded clinical key opinion leaders will provide their perspectives.

    Pre-registration for the webcast is available HERE and on the Investors section of the Company's website at www.matinasbiopharma.com. An interactive online Q&A session with the presenters will be available during the event. Questions can also be submitted via email to brandon.weiner@westwicke.com in advance and prior to the event, or during the event itself.

    R&D Day Information

    Date: Thursday, June 17, 2021

    Time: 8:30 a.m. – 10:15 a.m. ET

    Presenters

    • David R. Boulware, M.D., MPH, Professor of Medicine, Infectious Disease & International Medicine, Department of Medicine, University of Minnesota
    • Peter G. Pappas, M.D., Professor of Medicine, Medicine/Infectious Diseases Department, University of Alabama at Birmingham
    • Jerome D. Jabbour, Chief Executive Officer, Matinas BioPharma
    • James J. Ferguson, M.D., FACC, FAHA, Chief Medical Officer, Matinas BioPharma
    • Theresa Matkovits, Ph.D., Chief Development Officer, Matinas BioPharma
    • Raphael J. Mannino, Ph.D., Chief Scientific Officer, Matinas BioPharma
    • Hui Liu, Ph.D., Chief Technology Officer, Matinas BioPharma

    A live webcast of the R&D Day can be accessed through the Investors section of the Company's website (www.matinasbiopharma.com). Please log in approximately 10 minutes prior to the scheduled start time. An archived webcast replay will be made available on the Company's website.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    Matinas is developing a portfolio of products based upon its proprietary LNC drug delivery platform, which can solve complex challenges relating to the safe and effective intracellular delivery of both small and larger, more complex molecules.

    MAT2203 is an oral, LNC formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential randomized trial (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the third quarter of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, the Company's product candidate intended for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA. Matinas recently announced data from the ENHANCE-IT study, a head-to-head crossover study evaluating LYPDISO vs. Vascepa in patients with elevated triglycerides. These data demonstrated superior levels of eicosapentaenoic acid (EPA) in the blood with LYPDISO, and support the potential superior cardioprotective effect of LYPDISO vs. Vascepa. The Company has initiated a process to identity and secure a potential partner to continue development of LYPDISO toward a cardiovascular outcomes indication.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501 and LYPDISO, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.



    Investor and Media Contacts



    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com





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  10. – Enrollment continues in second cohort of EnACT study of MAT2203 (oral amphotericin b) in cryptococcal meningitis; Data and Safety Monitoring Board (DSMB) evaluation of safety and efficacy data from second cohort anticipated Q3 2021 –

    – MAT2501 (oral amikacin) advanced into preclinical toxicology and efficacy studies; completion of Phase 1 SAD study in healthy volunteers anticipated by end of 2021 –

    – Matinas to host virtual R&D Day on June 17, 2021 to highlight LNC platform and related programs –

    – Data from ENHANCE-IT study of LYPDISO™ against Vascepa® reported in Q1 2021 support continued development of LYPDISO as a potential best-in-class prescription-only omega-3 for cardiovascular risk reduction; partnership process ongoing –

    – Enrollment continues in second cohort of EnACT study of MAT2203 (oral amphotericin b) in cryptococcal meningitis; Data and Safety Monitoring Board (DSMB) evaluation of safety and efficacy data from second cohort anticipated Q3 2021 –

    – MAT2501 (oral amikacin) advanced into preclinical toxicology and efficacy studies; completion of Phase 1 SAD study in healthy volunteers anticipated by end of 2021 –

    – Matinas to host virtual R&D Day on June 17, 2021 to highlight LNC platform and related programs –

    – Data from ENHANCE-IT study of LYPDISO™ against Vascepa® reported in Q1 2021 support continued development of LYPDISO as a potential best-in-class prescription-only omega-3 for cardiovascular risk reduction; partnership process ongoing –

    – Management to host conference call today, Monday, May 10th, at 8:00 a.m. ET –

    BEDMINSTER, N.J., May 10, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform, today reported financial results for the first quarter ended March 31, 2021, along with a corporate update.

    First Quarter Highlights and Looking Ahead

    • Patient enrollment in Cohort Two of the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) has reached approximately 70 percent; DSMB evaluation of full safety and efficacy data from Cohort Two is anticipated in the third quarter of 2021.
    • The Company has advanced MAT2501 into preclinical toxicology and efficacy studies, with the goal of completing a Phase 1 single ascending dose (SAD) pharmacokinetic study in healthy volunteers by the end of 2021. The Company expects to initiate a Phase 2 program in cystic fibrosis patients with nontuberculous mycobacterial infections in 2022 following successful completion of the Phase 1 SAD study.
    • Following the announcement of its collaboration with the National Institutes of Allergy and Infectious Disease (NIAID) in December 2020 to create and evaluate oral formulations of Gilead's antiviral remdesivir, the Company recently prepared and delivered several formulations to NIAID and expects to receive data from the first in vitro studies in the near term.

    • The Company is pleased to announce that it will hold a virtual R&D Day on June 17, 2021. The management team plans to provide an overview of the Company's LNC platform, including a detailed discussion on the platform's clinical programs.

    • The process of identifying and securing one or more partners for LYPDISO is ongoing, with interested parties globally, including in the United States, European Union and China.

    "We are excited by the opportunities ahead for our LNC platform and associated drug candidates, and have made meaningful progress since the beginning of 2021," commented Jerome D. Jabbour, Chief Executive Officer of Matinas. "Specifically, we continue to advance MAT2203 in cryptococcal meningitis through Cohort 2 of the EnACT trial towards its next DSMB review, which is anticipated in the third quarter of 2021. We believe that Cohort 2 data will further validate the LNC platform and highlight its ability to facilitate oral bioavailability and carry molecules safely and effectively across the blood-brain barrier in combating this deadly invasive fungal infection. We will also take the opportunity to present these data to the U.S. Food and Drug Administration in discussions about further accelerating development of MAT2203. In addition, we have advanced MAT2501 into preclinical toxicology and efficacy studies, with the goal of developing the first oral aminoglycoside for the treatment of nontuberculous mycobacterial infections, as well as gram negative bacterial infections. Finally, we continue to expand the application of the LNC platform with our collaborations with Genentech and with the NIAID in creating an oral formulation of Gilead's remdesivir."  

    First Quarter 2021 Financial Results

    Cash, cash equivalents and marketable securities at March 31, 2021, were approximately $60.7 million, compared to $58.7 million at December 31, 2020.

    In July 2020, the Company entered into an At-The-Market Sales Agreement (Sales Agreement) with BTIG, LLC (BTIG), pursuant to which the Company may offer and sell, from time to time, through BTIG, shares of its common stock having an aggregate offering price of up to $50 million, subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the Sales Agreement. During the first quarter of 2021, BTIG sold approximately 3 million shares of the Company's common stock under the Sales Agreement generating net proceeds to the Company of approximately $5.6 million.

    Based on current projections, the Company believes that cash on hand is sufficient to fund operations into 2024.

    For the first quarter of 2021, net loss attributable to common shareholders was $5.2 million, or a net loss of $0.03 per share (basic and diluted). These results are identical to those of the first quarter of 2020.

    Research and development expenses for the first quarter of 2021 were $3.2 million, compared to $4.1 million for the same period in 2020. The decrease was primarily due to the completion of the ENHANCE-IT study of LYPDISO in January 2021.

    General and administrative expenses for the first quarter of 2021 were $3.1 million, compared to $2.3 million in the same period in 2020. The increase was primarily due to higher compensation expense related to the exercise of stock options during the first quarter of 2021.

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



    Conference Call and Webcast Details



    The Company will host a live conference call and webcast to discuss these results today, Monday, May 10, 2021, at 8:00 a.m. ET.



    To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll) and reference conference ID 13719092. The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and archived for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its proprietary lipid nanocrystal (LNC) delivery platform. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    Matinas is developing a portfolio of products based upon its proprietary LNC drug delivery platform, which can solve complex challenges relating to the safe and effective intracellular delivery of both small and larger, more complex molecules.

    MAT2203 is an oral, LNC formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the third quarter of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    Each of MAT2203 and MAT2501 has received Qualified Infectious Disease Product (QIDP) and Orphan Drug designations which, upon approval, could potentially provide up to twelve years of regulatory marketing exclusivity for each product.

    LYPDISO™, the Company's product candidate intended for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, recently announced data from the ENHANCE-IT study, a head-to-head crossover study evaluating LYPDISO vs. Vascepa in patients with elevated triglycerides. Data demonstrating superior levels of eicosapentaenoic acid (EPA) in the blood with LYPDISO support the potential superior cardioprotective effect of LYPDISO vs. Vascepa. The Company has initiated a process to identity and secure a potential partner to continue development of LYPDISO toward a cardiovascular outcomes indication.

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501 and LYPDISO, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.



    Matinas BioPharma Holdings Inc.
    Condensed Consolidated Balance Sheets
           
      March 31, 2021 December 31, 2020
      (Unaudited) (Audited)
    ASSETS:      
    Current assets:      
     Cash and cash equivalents $23,382,743  $12,432,481 
     Marketable securities  37,283,697   46,246,573 
     Restricted cash - security deposits  136,000   136,000 
     Prepaid expenses and other current assets  2,333,225   2,739,791 
      Total current assets  63,135,665   61,554,845 
           
    Non-current assets:      
     Leasehold improvements and equipment - net  1,465,303   1,523,950 
     Operating lease right-of-use assets - net  3,149,744   3,276,639 
     Finance lease right-of-use assets - net  45,992   58,007 
     In-process research and development  3,017,377   3,017,377 
     Goodwill  1,336,488   1,336,488 
     Restricted cash - security deposits  200,000   200,000 
      Total non-current assets  9,214,904   9,412,461 
       Total assets $72,350,569  $70,967,306 
           
    LIABILITIES AND STOCKHOLDERS' EQUITY:      
           
    Current liabilities:      
     Accounts payable $421,645  $349,941 
     Accrued expenses  1,405,745   2,795,329 
     Operating lease liabilities - current  364,566   391,498 
     Financing lease liabilities - current  29,396   30,853 
      Total current liabilities  2,221,352   3,567,621 
           
    Non-current liabilities:      
     Deferred tax liability  341,265   341,265 
     Operating lease liabilities - net of current portion  3,214,714   3,304,063 
     Financing lease liabilities - net of current portion  17,134   23,660 
      Total non-current liabilities  3,573,113   3,668,988 
       Total liabilities  5,794,465   7,236,609 
           
    Stockholders' equity:      
     Series B Convertible preferred stock 3,673,176   3,797,705 
     Common stock 20,427   20,010 
     Additional paid-in capital  175,189,608   167,192,003 
     Accumulated deficit  (112,463,513)  (107,507,193)
     Accumulated other comprehensive income/(loss)  136,406   228,172 
      Total stockholders' equity  66,556,104   63,730,697 
       Total liabilities and stockholders' equity$72,350,569  $70,967,306 
           



    Matinas BioPharma Holdings, Inc.
    Condensed Consolidated Statements of Operations and Comprehensive Loss
    (Unaudited)
           
      Three Months Ended March 31,
      2021  2020 
    Revenue:      
     Contract research revenue $33,333  $- 
    Costs and expenses:      
     Research and development  3,241,432   4,086,883 
     General and administrative  3,145,010   2,259,631 
           
     Total costs and expenses  6,386,442   6,346,514 
           
    Loss from operations  (6,353,109)  (6,346,514)
           
    Sale of New Jersey net operating loss  1,328,470   1,073,289 
    Other income, net  68,319   227,327 
    Net loss $(4,956,320) $(5,045,898)
           
    Preferred stock series B accumulated dividends  (210,900)  (170,700)
           
    Net loss attributable to common shareholders $(5,167,220) $(5,216,598)
           
    Net loss available for common shareholders per share - basic and diluted $(0.03) $(0.03)
           
    Weighted average common shares outstanding - basic and diluted  203,871,820   191,671,153 
           
    Other comprehensive (loss)/income, net of tax      
     Unrealized (loss)/gains on securities available-for-sale  (91,766)  523,246 
     Other comprehensive (loss)/income, net of tax  (91,766)  523,246 
    Comprehensive loss attributable to stockholders $(5,048,086) $(4,522,652)
           

    Investor and Media Contacts

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com

    Source: Matinas BioPharma Holdings, Inc.



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  11. BEDMINSTER, N.J., April 28, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to participate in a fireside chat as part of the 7th Annual Truist Securities Life Sciences Summit on Wednesday, May 5, 2021 at 11:20 a.m. ET. The Company will also host investor meetings during the conference.

    A live webcast of the Company's presentation will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following the live presentation.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular…

    BEDMINSTER, N.J., April 28, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to participate in a fireside chat as part of the 7th Annual Truist Securities Life Sciences Summit on Wednesday, May 5, 2021 at 11:20 a.m. ET. The Company will also host investor meetings during the conference.

    A live webcast of the Company's presentation will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following the live presentation.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    Matinas is developing a portfolio of products based upon its proprietary LNC drug delivery platform, which can solve complex challenges relating to the safe and effective intracellular delivery of both small and larger, more complex molecules.

    MAT2203 is an oral, LNC formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the third quarter of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, the Company's product candidate intended for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, recently announced data from the ENHANCE-IT study, a head-to-head crossover study evaluating LYPDISO vs. Vascepa in patients with elevated triglycerides. Data demonstrating superior levels of eicosapentaenoic acid (EPA) in the blood with LYPDISO support the potential superior cardioprotective effect of LYPDISO vs. Vascepa. The Company has initiated a process to identity and secure a potential partner to continue development of LYPDISO toward a cardiovascular outcomes indication.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501 and LYPDISO, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.



    Investor and Media Contacts

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com



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  12. BEDMINSTER, N.J., April 27, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform, today announced that the Company will host a conference call and live audio webcast on Monday, May 10, 2021 at 8:00 a.m. ET to discuss operational and financial results for the first quarter ended March 31, 2021.

    To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll). The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and archived for 90 days.

    About Matinas

    BEDMINSTER, N.J., April 27, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform, today announced that the Company will host a conference call and live audio webcast on Monday, May 10, 2021 at 8:00 a.m. ET to discuss operational and financial results for the first quarter ended March 31, 2021.

    To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll). The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and archived for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    Matinas is developing a portfolio of products based upon its proprietary LNC drug delivery platform, which can solve complex challenges relating to the safe and effective intracellular delivery of both small and larger, more complex molecules.

    MAT2203 is an oral, LNC formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the third quarter of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, the Company's product candidate intended for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, recently announced data from the ENHANCE-IT study, a head-to-head crossover study evaluating LYPDISO vs. Vascepa in patients with elevated triglycerides. Data demonstrating superior levels of eicosapentaenoic acid (EPA) in the blood with LYPDISO support the potential superior cardioprotective effect of LYPDISO vs. Vascepa. The Company has initiated a process to identity and secure a potential partner to continue development of LYPDISO toward a cardiovascular outcomes indication. 

    Forward Looking Statements:

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501 and LYPDISO, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contact

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com

    Source: Matinas BioPharma Holdings, Inc.



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  13. BEDMINSTER, N.J., April 08, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to present a Company overview at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 4:30 p.m. ET. The Company will also host investor meetings during the conference.

    A live webcast of the Company's presentation will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following the live presentation.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving…

    BEDMINSTER, N.J., April 08, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to present a Company overview at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 4:30 p.m. ET. The Company will also host investor meetings during the conference.

    A live webcast of the Company's presentation will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following the live presentation.

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    Matinas is developing a portfolio of products based upon its proprietary LNC drug delivery platform, which can solve complex challenges relating to the safe and effective intracellular delivery of both small and larger, more complex molecules.

    MAT2203 is an oral, LNC formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the third quarter of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, the Company's product candidate intended for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, recently announced data from the ENHANCE-IT study, a head-to-head crossover study evaluating LYPDISO vs. Vascepa in patients with elevated triglycerides. Data demonstrating superior levels of eicosapentaenoic acid (EPA) in the blood with LYPDISO support the potential superior cardioprotective effect of LYPDISO vs. Vascepa. The Company has initiated a process to identity and secure a potential partner to continue development of LYPDISO toward a cardiovascular outcomes indication.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501 and LYPDISO, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com



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  14. – Matinas to internally focus on its Lipid Nanocrystal (LNC) platform to improve the intracellular delivery of critical therapeutics –

    – Enrollment continues in second patient cohort of EnACT study of MAT2203 in cryptococcal meningitis; Data and Safety Monitoring Board (DSMB) evaluation of safety and efficacy data of key second patient cohort anticipated Q3 2021 –

    – Collaboration with National Institute of Allergy and Infectious Disease (NIAID) to formulate Gilead's antiviral COVID-19 medication remdesivir has progressed into in vitro studies –

    – Data from ENHANCE-IT study of LYPDISO™ against Vascepa® support continued development of LYPDISO as a potential best-in-class prescription-only omega-3 with robust EPA-levels; partnership process

    – Matinas to internally focus on its Lipid Nanocrystal (LNC) platform to improve the intracellular delivery of critical therapeutics –

    – Enrollment continues in second patient cohort of EnACT study of MAT2203 in cryptococcal meningitis; Data and Safety Monitoring Board (DSMB) evaluation of safety and efficacy data of key second patient cohort anticipated Q3 2021 –

    – Collaboration with National Institute of Allergy and Infectious Disease (NIAID) to formulate Gilead's antiviral COVID-19 medication remdesivir has progressed into in vitro studies –

    – Data from ENHANCE-IT study of LYPDISO™ against Vascepa® support continued development of LYPDISO as a potential best-in-class prescription-only omega-3 with robust EPA-levels; partnership process ongoing –

    – Management to host conference call today, Monday, March 29th, at 8:00 a.m. ET –

    BEDMINSTER, N.J., March 29, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform, today reported financial results for the fourth quarter and full year ended December 31, 2020, along with a corporate update.

    "2020 was a year of significant progress and timely execution for Matinas, despite the ongoing global pandemic. The completion of the head-to-head ENHANCE-IT trial of LYPDISO vs. Vascepa® and the results which support the potential for LYPDISO to demonstrate a superior cardioprotective effect to Vascepa®, have positioned us to identify and potentially secure a global partner for the continued development of this promising, next-generation drug," commented Jerome D. Jabbour, Chief Executive Officer of Matinas. "This process provides us the opportunity, as we move forward, to re-focus our internal expertise and financial resources on our LNC platform delivery technology. We believe that the unique capability of our LNC formulations to mimic enveloped viruses and efficiently deliver small and large molecules intracellularly without causing adverse immune responses or damage to cellular membranes, differentiates our technology from any other available intracellular delivery technology being applied today."  

    Mr. Jabbour continued, "There are three key areas which highlight tangible progress with the LNC platform. First, DSMB review and cohort progression in the EnACT study of MAT2203 in cryptococcal meningitis is anticipated in the third quarter of 2021 and provides a near-term opportunity to further validate the LNC platform and highlight its ability to facilitate oral bioavailability and then carry molecules effectively across the blood-brain barrier in combating deadly invasive fungal infections. Second, with the support of the Cystic Fibrosis Foundation, we are rapidly advancing our second LNC platform drug, MAT2501 (oral amikacin), into preclinical toxicology and efficacy studies with the ultimate goal of developing the first oral aminoglycoside for the treatment of nontuberculous mycobacterial infections, as well as gram negative bacterial infections. Finally, we continue to make important progress in expanding the utilization of the LNC platform through our collaborations with Genentech and with NIAID in creating an oral formulation of Gilead's remdesivir. We are also evaluating additional opportunities to expand application of our LNC platform in other innovative areas, such as mRNA and gene therapy. 2021 will be an exciting and potentially transformational year for our Company, and we look forward to continuing to execute on our corporate strategy and keeping investors informed as to our progress."

    MAT2203 Program Update (orally bioavailable amphotericin B, with targeted delivery, under development for the treatment and prevention of invasive fungal infections, including cryptococcal meningitis)  

    • Data from the Phase 1 portion of the EnACT study were published in the Antimicrobial Agents and Chemotherapy, (ACC), a journal of the American Society of Microbiology, in a manuscript entitled "Safety and tolerability of a novel oral formulation of amphotericin B: Phase I EnACT trial". In the published manuscript, trial investigators concluded that MAT2203 was well-tolerated when administered in 4-6 divided daily doses without the toxicities commonly seen with IV amphotericin B, with nearly 100% of patients expressing a preference for oral MAT2203 relative to amphotericin B delivered intravenously. 
    • In October 2020, the Company announced that the independent DSMB of the EnACT study completed a pre-specified review of the first cohort and unanimously recommended progression to the second cohort.
    • We have recently reached 50 percent of patient enrollment (28/56) in Cohort Two of the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial); DSMB evaluation of full safety and efficacy data from Cohort Two is anticipated in the third quarter of 2021.
    • As previously reported, the U.S. Food and Drug Administration (FDA) has designated MAT2203 as a Qualified Infectious Disease Product (QIDP) with Fast Track status for four indications, specifically, the prevention of invasive fungal infections due to immunosuppressive therapy, and the treatment of invasive candidiasis, invasive aspergillus and cryptococcal meningitis.  In addition, the FDA has granted orphan drug designation to MAT2203 for the treatment of cryptococcosis.   If MAT2203 is ultimately approved by the FDA, the seven-year period of marketing exclusivity from orphan designation combined with the additional five years of marketing exclusivity provided by the QIDP designation, provides for a potential total of 12 years of marketing exclusivity.

    EnACT is a Phase 2 prospective, randomized, open-label, sequential cohort study, financially supported by the National Institutes of Health (NIH), evaluating the safety, tolerability and efficacy of MAT2203 in approximately 140 HIV-infected patients with cryptococcal meningitis. MAT2203 utilizes the Company's LNC platform delivery technology to orally deliver the traditionally IV-only fungicidal drug, amphotericin B. In total, the trial includes four cohorts of patients, with each cohort increasing the treatment duration of MAT2203 vs. IV amphotericin B. The primary efficacy endpoint includes a measure of reduction in fungal count in the cerebral spinal fluid. A control arm, which includes standard of care IV amphotericin B, is included with each cohort.

    MAT2501 Program Update (orally bioavailable amikacin, with targeted delivery, under development for the treatment of nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF))

    • In November 2020, the Company received a commitment for $3.75 million of funding from the Cystic Fibrosis Foundation (CFF) to support preclinical development of MAT2501 toward an indication to treat NTM lung disease, including infections in patients with CF.
    • The Company is progressing development of MAT2501 through preclinical toxicology and efficacy studies in 2021, with the goal of completing a Phase 1 single ascending dose pharmacokinetic study in healthy volunteers by the end of 2021.
    • MAT2501 has been designated as a QIDP and as an Orphan Drug for the treatment of NTM by the FDA. If MAT2501 is ultimately approved by the FDA, the seven-year period of marketing exclusivity from orphan designation combined with the additional five years of marketing exclusivity provided by the QIDP designation, provides for a potential total of 12 years of marketing exclusivity.

    LNC Platform Update

    • The Company's feasibility agreement with Genentech, which involves the formulation of up to three different Genentech compounds, was extended for an additional two years in November of 2020.

    • In December 2020, the Company announced a collaboration with the NIAID to evaluate oral formulations of Gilead's antiviral remdesivir utilizing Matinas' LNC platform delivery technology. The Company recently prepared and delivered several formulations to NIAID, which will commence planned preclinical studies promptly.

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

    • In February 2021, the Company announced topline results from ENHANCE-IT (Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in Adults with Hypertriglyceridemia), a second head-to-head comparative study of LYPDISO vs. Vascepa®. The study assessed LYPDISO's effectiveness in reducing triglyceride levels and other important lipid markers, as well as characterizing bioavailability and blood levels of eicosapentaenoic acid (EPA) and other omega-3 fatty acids. While the primary endpoint of percent change in triglycerides (TGs) from baseline to end-of-treatment did not meet statistical significance in the pre-specified pharmacodynamic population, analysis of the per protocol population demonstrated statistically significant improvement and superiority of LYPDISO over Vascepa® in reducing TGs, total cholesterol and very-low-density lipoprotein cholesterol.   A key secondary endpoint in ENHANCE-IT was the measurement of EPA levels in the blood, as that has become a key surrogate marker in determining cardiovascular risk reduction. In ENHANCE-IT, plasma EPA concentrations were significantly higher with LYPDISO vs. Vascepa® (46% relative percent increase in the change from baseline EPA level vs. Vascepa®), which the Company believes indicates the potential for superior cardioprotection with LYPDISO vs. Vascepa®.

    • The Company believes that the results from ENHANCE-IT suggest potential for LYPDISO as a best-in-class prescription-only omega-3 drug for cardiovascular risk reduction and is pursuing a partnership to continue further development of LYPDISO toward a cardiovascular outcomes indication. Accordingly, the Company no longer plans to pursue an indication for the treatment of severe hypertriglyceridemia.

    Fourth Quarter and Full Year 2020 Financial Results

    Cash, cash equivalents and marketable securities at December 31, 2020 were approximately $58.7 million, compared to $27.8 million at December 31, 2019.

    In January 2020, the Company sold an aggregate of 32.3 million shares of its common stock at a price of $1.55 per share for net proceeds of approximately $46.7 million, after deducting underwriting discounts and commissions and other offering expenses.

    In July 2020, the Company entered into an At-The-Market Sales Agreement (Sales Agreement) with BTIG, LLC (BTIG), pursuant to which the Company may offer and sell, from time to time, through BTIG, shares of its common stock having an aggregate offering price of up to $50 million, subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the Sales Agreement. As of December 31, 2020, the Company did not sell any shares of its common stock under the Sales Agreement. During January 2021, BTIG sold approximately 3 million shares of the Company's common stock under the Sales Agreement generating net proceeds to the Company of approximately $5.6 million.

    Based on current projections, the Company believes that cash on hand, including net proceeds from issuances under the Sales Agreement in January 2021, is sufficient to fund operations into 2024.

    For the fourth quarter of 2020, net loss attributable to common shareholders was $6.6 million, or a net loss of $0.03 per share (basic and diluted), compared to a net loss attributable to common shareholders of $5.8 million, or a net loss of $0.04 per share (basic and diluted) for the same period in 2019. For the full year of 2020, net loss attributable to common shareholders was $23.2 million, or a net loss per share of $0.12 (basic and diluted), compared to a net loss attributable to common shareholders of $18.3 million, or a net loss per share of $0.13 (basic and diluted) for the full year of 2019. The increase for both periods was due primarily to an increase in operating expenses, as more fully described below.

    Research and development (R&D) expenses for the fourth quarter of 2020 were $3.5 million, compared to $3.4 million for the same period in 2019. For the full year of 2020, R&D expenses were $14.4 million, compared to $11.2 million for the full year of 2019. The increase for full year 2020 was due primarily to higher preclinical and clinical development expenses and employee compensation related to the development of LYPDISO, MAT2203 and MAT2501.

    General and administrative (G&A) expenses for the fourth quarter of 2020 were $3.0 million, compared to $2.3 million in the same period in 2019. For the full year of 2020, G&A expenses were $10.0 million, compared to $7.8 million for the full year of 2019. The increase was due primarily to employee related expenses and professional fees.

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



    Conference Call and Webcast Details



    The Company will host a live conference call and webcast to discuss these results on Monday, March 29, 2021, at 8:00 a.m. ET.



    To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll) and reference conference ID 13716272. The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and archived for 90 days

    About Matinas BioPharma

    Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    Matinas is developing a portfolio of products based upon its proprietary LNC drug delivery platform, which can solve complex challenges relating to the safe and effective intracellular delivery of both small and larger, more complex molecules.

    MAT2203 is an oral, LNC formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the third quarter of 2021.

    MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    LYPDISO™, the Company's product candidate intended for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, recently announced data from the ENHANCE-IT study, a head-to-head crossover study evaluating LYPDISO vs. Vascepa in patients with elevated triglycerides. Data demonstrating superior levels of eicosapentaenoic acid (EPA) in the blood with LYPDISO support the potential superior cardioprotective effect of LYPDISO vs. Vascepa. The Company has initiated a process to identity and secure a potential partner to continue development of LYPDISO toward a cardiovascular outcomes indication.

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company's strategic focus and the future development of its product candidates, including MAT2203, MAT2501 and LYPDISO, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.



    Matinas BioPharma Holdings Inc.

    Consolidated Balance Sheets

      December 31, 
      2020  2019 
    ASSETS:        
           
    Current assets:        
    Cash and cash equivalents $12,432,481  $22,170,438 
    Marketable securities  46,246,573   5,604,634 
    Restricted cash  136,000   250,000 
    Prepaid expenses and other current assets  2,739,791   1,897,784 
    Total current assets  61,554,845   29,922,856 
             
    Non-current assets:        
    Leasehold improvements and equipment - net  1,523,950   1,749,259 
    Operating lease right-of-use assets - net  3,276,639   3,761,207 
    Finance lease right-of-use assets - net  58,007   116,968 
    In-process research and development  3,017,377   3,017,377 
    Goodwill  1,336,488   1,336,488 
    Restricted cash - security deposits  200,000   336,000 
    Total non-current assets  9,412,461   10,317,299 
    Total assets $70,967,306  $40,240,155 
             
    LIABILITIES AND STOCKHOLDERS' EQUITY:        
             
    Current liabilities:        
    Accounts payable $349,941  $679,310 
    Accrued expenses and other liabilities  2,795,329   1,939,510 
    Operating lease liabilities - current  391,498   423,741 
    Financing lease liabilities - current  30,853   54,673 
    Total current liabilities  3,567,621   3,097,234 
             
    Non-current liabilities:        
    Deferred tax liability  341,265   341,265 
    Operating lease liabilities - net of current portion  3,304,063   3,695,561 
    Financing lease liabilities - net of current portion  23,660   54,513 
    Total non-current liabilities  3,668,988   4,091,339 
    Total liabilities  7,236,609   7,188,573 
             
    Stockholders' equity:        
    Series B Convertible preferred stock, stated value $1,000 per share, 8,000 shares authorized as of December 31, 2020 and 2019, respectively; 4,361 and 4,577 shares issued and outstanding as of December 31, 2020 and 2019, respectively; (liquidation preference - $4,361,000 at December 31, 2020)  3,797,705   3,985,805 
    Common stock par value $0.0001 per share, 500,000,000 shares authorized at December 31, 2020 and 2019, respectively; 200,113,431 and 163,156,984 issued and outstanding as of December 31, 2020 and 2019, respectively  20,010   16,315 
    Additional paid-in capital  167,192,003   113,427,897 
    Accumulated deficit  (107,507,193)  (84,377,555)
    Accumulated other comprehensive income/(loss)  228,172   (880)
    Total stockholders' equity  63,730,697   33,051,582 
    Total liabilities and stockholders' equity $70,967,306  $40,240,155 



     
    Matinas BioPharma Holdings, Inc.
    Consolidated Statements of Operations and Comprehensive Loss
                 
      Three Months Ended December 31, For the Year Ended December 31,
      2020 2019 2020 2019
    Revenue:           
     Contract research revenue$62,500  $-  $158,333  $89,812 
    Costs and expenses:           
     Research and development 3,525,573   3,419,706   14,358,918   11,234,548 
     General and administrative 3,025,812   2,316,277   10,005,967   7,776,300 
                 
     Total costs and expenses 6,551,385   5,735,983   24,364,885   19,010,848 
                 
    Loss from operations (6,488,885)  (5,735,983)  (24,206,552)  (18,921,036)
                 
    Sale of New Jersey net operating loss -   -   1,073,289   1,007,082 
    Other income, net 148,005   163,152   686,425   541,303 
    Net loss$(6,340,880) $(5,572,831) $(22,446,838) $(17,372,651)
                 
    Preferred stock series A accumulated dividends -   -   -   (338,613)
    Preferred stock series B accumulated dividends (218,050)  (236,047)  (793,442)  (585,547)
                 
    Net loss attributable to common shareholders$(6,558,930) $(5,808,878) $(23,240,280) $(18,296,811)
                 
    Net loss available for common shareholders per share - basic and diluted$(0.03) $(0.04) $(0.12) $(0.13)
                 
    Weighted average common shares outstanding - basic and diluted 199,347,750   162,791,879   196,894,628   145,195,196 
                 
    Other comprehensive (loss)/income, net of tax           
     Net unrealized (loss)/gain on securities available-for-sale (129,596)  (880)  237,537   (880)
     Reclassification of realized gain on securities available-for-sale to net loss (5,777)  -   (8,485)  - 
     Other comprehensive (loss)/income, net of tax (135,373)  (880)  229,052   (880)
    Comprehensive loss attributable to stockholders$(6,476,253) $(5,573,711) $(22,217,786) $(17,373,531)
                 
    The accompanying notes are an integral part of these condensed consolidated financial statements
                 



    Investor and Media Contacts


    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com

    Source: Matinas BioPharma Holdings, Inc.



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  15. BEDMINSTER, N.J., March 15, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that the Company will host a conference call and live audio webcast on Monday, March 29, 2020 at 8:00 a.m. ET to discuss operational and financial results for the fourth quarter and full year ended December 31, 2020.

    To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll). The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and archived for 90 days.

    About Matinas BioPharma

    BEDMINSTER, N.J., March 15, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that the Company will host a conference call and live audio webcast on Monday, March 29, 2020 at 8:00 a.m. ET to discuss operational and financial results for the fourth quarter and full year ended December 31, 2020.

    To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll). The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and archived for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    LYPDISO, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nanocrystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them orally bioavailable, less toxic, and targeted to cells and tissues.

    MAT2203 is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.

    MAT2501 is an oral, encochleated formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).. 

    Forward Looking Statements:

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the ENHANCE-IT study, the Company's strategic focus and the future development of its product candidates, including MAT9001, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contact

    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com

    Source: Matinas BioPharma Holdings, Inc.



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  16. BEDMINSTER, N.J., March 01, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to present a Company overview at the Barclays Global Healthcare Conference on Tuesday, March 9, 2021 at 4:45 p.m. ET. The Company will also host investor meetings during the conference.

    A live webcast of the Company's presentation will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following the live presentation.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation…

    BEDMINSTER, N.J., March 01, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to present a Company overview at the Barclays Global Healthcare Conference on Tuesday, March 9, 2021 at 4:45 p.m. ET. The Company will also host investor meetings during the conference.

    A live webcast of the Company's presentation will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following the live presentation.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    LYPDISO, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nanocrystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them orally bioavailable, less toxic, and targeted to cells and tissues.

    MAT2203 is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.

    MAT2501 is an oral, encochleated formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the ENHANCE-IT study, the Company's strategic focus and the future development of its product candidates, including MAT9001, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts



    Peter Vozzo

    Westwicke/ICR

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com 



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  17. – LYPDISO demonstrated a statistically significant 46% relative percent increase in EPA change from baseline over Vascepa®

    – LYPDISO demonstrated a 39% relative difference in response over Vascepa in TG reduction –

    – Primary endpoint of percent change from baseline to end of treatment in triglycerides in the pharmacodynamic population did not meet statistical significance over Vascepa®

    – Per protocol analysis demonstrated statistical significance and superiority vs. Vascepa® on several key lipid and inflammatory markers –

    – Management to host conference call today, Monday, February 1, 2021 at 8:00 a.m. ET –

    BEDMINSTER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc.

    – LYPDISO demonstrated a statistically significant 46% relative percent increase in EPA change from baseline over Vascepa®

    – LYPDISO demonstrated a 39% relative difference in response over Vascepa in TG reduction –

    – Primary endpoint of percent change from baseline to end of treatment in triglycerides in the pharmacodynamic population did not meet statistical significance over Vascepa®

    – Per protocol analysis demonstrated statistical significance and superiority vs. Vascepa® on several key lipid and inflammatory markers –

    – Management to host conference call today, Monday, February 1, 2021 at 8:00 a.m. ET –

    BEDMINSTER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced topline results from the ENHANCE-IT study (Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in Adults with Hypertriglyceridemia), the second head-to-head comparative study of LYPDISO™ vs. Vascepa®.

    In ENHANCE-IT, the key parameters evaluated included triglycerides (TGs), other lipoprotein and inflammatory markers, and blood levels of omega-3 fatty acids.  The primary endpoint was the percent change from baseline to end-of-treatment in TG and superiority vs. Vascepa®.

    Analyses were performed on a Pharmacodynamic (PD) population (n=94; all subjects with evaluable measurements in the two-treatment period, regardless of compliance with study drug treatment), and a Per Protocol (PP) population (n=82; those subjects in the PD population where overall compliance in both treatment periods was at least 80% with no clinically important protocol violations or deviations).

    Plasma eicosapentaenoic acid (EPA) concentrations were statistically significantly higher with LYPDISO™, with a 46% relative percentage improvement in EPA blood level concentrations over Vascepa®.

    In the PD population there was a greater reduction in TGs with LYPDISO™ (21.9%) as compared with Vascepa (15.7%); this 39% relative improvement did not achieve statistical significance. In the PP population, there were statistically significant superior reductions in TGs, total cholesterol (TC), VLDL cholesterol (VLDL-C) and high sensitivity C-reactive protein (hsCRP), a well-established inflammatory marker.

    "In this ENHANCE-IT study, LYPDISO™ achieved significantly higher EPA levels, and lowered triglycerides as well as hsCRP levels to a greater extent than Vascepa®," said John J.P. Kastelein, M.D., Ph.D., Matinas Scientific Advisory Board member and Professor of Medicine at the Department of Vascular Medicine at the Academic Medical Center of the University of Amsterdam, The Netherlands. "The REDUCE-IT outcomes trial with Vascepa® has shown that achieved EPA levels drive the cardiovascular protection conferred by omega-3 fatty acids.   The impressive biomarker changes in ENHANCE-IT with LYPDISO™ support a potential robust protection against cardiovascular disease in a pivotal Phase 3 outcome program."

    PLASMA FATTY ACIDS – Pharmacodynamic (PD) Population

             
    PD Population (n=94)
    Fatty AcidBaselineEnd-of-Treatment% Δ from BaselineRelative % Increase in Omega-3 level Δ vs. VascepaP-value
    (Median)(Median)(Median)
     LYPDISO™Vascepa®LYPDISOVascepa®LYPDISOVascepa®
    EPA13.815.5143115100969046%<0.001
    (μg/mL)
    DPA20.320.757.850.318314526%<0.001
    (μg/mL)
    DHA48.650.249.748.14.5-1.4--  0.01
    (μg/mL)
    EPA+DPA+DHA25426378969622116038%<0.001
    (nmol/mL )

    The pharmacodynamic (PD) population included all subjects for whom the estimation of PD parameters was possible for 2 treatment periods.



    Blood fatty acids levels increased with both LYPDISO™ and Vascepa®, with similar findings in both the PD and the PP populations.   In the PD population the change in fatty acid level with LYPDISO™ was 46% greater for EPA, 26% greater for DPA, and 38% greater for total omega-3 levels than with Vascepa® – all highly statistically significant.  DHA levels did not change meaningfully with either therapy but increased slightly with LYPDISO™. 

    These findings highlight and further confirm the greater bioavailability of LYPDISO's free fatty acid formulation in delivering substantially higher blood levels of EPA.

    LIPOPROTEINS AND INFLAMMATORY MARKERS – Pharmacodynamic (PD) Population

        
    Variable*PD Population (N = 94)P-value
    Median % Δ
    LYPDISOVascepa®
    TG-21.9-15.70.27
    TC-5.2-2.90.17
    LDL-C-5.4-2.50.24
    VLDL-C-16.3-12.90.26
    HDL-C-1.3-1.50.69
    Non-HDL-C-7.5-3.80.19
    Apo A1-5.0-3.50.46
    Apo B-4.7-1.90.54
    Apo C3-12.5-10.50.53
    PCSK9-7.7-6.10.80
    hs-CRP-5.79.40.03

    *Units of mg/dL for lipoprotein lipids, units of ng/mL for PCSK9, and units of mg/L for hs-CRP



    In the PD population LYPDISO™ reduced TGs by 21.9%, compared to a 15.7% reduction with Vascepa®; this difference (a relative improvement of 39%) did not achieve statistical significance. 

    There were similar numerical trends for all other lipid parameters.  Of note, LYPDISO™ did not raise LDL cholesterol, as has been noted with other omega-3 formulations containing DHA.

    With regard to changes in hs-CRP, there were statistically significant and superior differences between groups – LYPDISO™ was associated with reductions in hs-CRP, while Vascepa was associated with increases in hs-CRP.

    LIPOPROTEINS AND INFLAMMATORY MARKERS – Per Protocol (PP) Population

        
    Variable*PP Population (N = 82)P-value
    Median % Δ
    LYPDISOVascepa®
    TG- 20.9*-13.80.04
    TC- 5.5*-2.30.04
    LDL-C-5.6-2.10.17
    VLDL-C- 16.0*-10.90.03
    HDL-C-1.6-2.00.52
    Non-HDL-C-7.6-3.20.07
    Apo A1-5.0-2.90.44
    Apo B-4.1-1.80.60
    Apo C3-11.1-8.70.10
    PCSK9-6.7-5.50.68
    hs-CRP - 6.1*9.90.01

    *The per protocol population (PP) included all subjects in the PD population for whom compliance for both study periods was at least 80% and for whom no clinically important protocol violations or deviations occurred during the trial.

    *Statistically significant (superiority) vs. Vascepa



    In the prespecified PP population, there were similar numerical trends as seen within the PD population; however, given the more stringent compliance requirements for this population, with less inter-individual variability, some of the differences between groups now emerged as statistically significant. 

    In the PP population, LYPDISO™ reduced TGs by 20.9%, compared to a 13.8% reduction with Vascepa®; this difference was significant with a P-value of 0.04 (a relative improvement of 51%).

    There were additional statistically significant superior reductions with LYPDISO™ in total cholesterol (5.5% vs 2.3%) and VLDL-C (16.0% vs 10.9%), with similar non-significant numerical trends for the other lipid parameters. 

    In the PP population, there were again significant differences between groups in hs-CRP response.

    "We are very grateful for all the hard work and dedication on the part of the study team, the investigators, and most importantly, the study subjects, especially during a pandemic," commented James J. Ferguson, M.D, FACC, FAHA, Chief Medical Officer of Matinas. "These results have advanced our understanding of the potential role of LYPDISO™ in the management of patients with elevated triglycerides and cardiovascular disease.   Bioavailability is clearly an important consideration in achieving higher EPA levels. Even when Vascepa is given the advantage of being dosed with meals, LYPDISO™ provides TG lowering that is better than with Vascepa®, with no increase in LDL-C, and with the added advantage of substantially higher blood levels of EPA, total omega-3 and significant impact on hs-CRP."

    "We are very pleased with the topline data from ENHANCE-IT," said Jerome D. Jabbour, Chief Executive Officer of Matinas. "The statistically significant superior EPA levels achieved with LYPDISO are an important differentiator vs. Vascepa®. Although we did not achieve statistical significance on the primary endpoint of triglycerides in the prespecified population, these data point to the potential for robust cardiovascular risk reduction with LYPDISO™. We further believe that these data could position LYPDISO™ to potentially become the best-in-class prescription omega-3 for the reduction of cardiovascular risk and we will begin a process to identify a partner with which to collaborate on a cardiovascular outcomes study."

    ENHANCE-IT was an open-label, randomized, 28-day crossover study assessing the pharmacodynamic effects of LYPDISO vs. Vascepa. The study enrolled 100 adult men and women with elevated triglycerides (150-499 mg/dL), with approximately 58% of study subjects with TGs ≥ 200 mg/dL. The study protocol involved two 28-day treatment periods, with a washout period of at least 28 days in between treatments and was conducted at eight sites in the U.S. LYPDISO and Vascepa were each administered as 2g twice daily with food in accordance with currently approved Vascepa labeling. Lipid parameters (triglycerides, Total-, LDL-, VLDL-, HDL-, and non-HDL cholesterol, apolipoproteins A1, B and C3, and PCSK9), a key inflammatory marker (hs-CRP), and omega-3 blood levels were measured at each baseline and at the end of each treatment period. The primary endpoint measured the percent change from baseline to end-of-treatment in plasma triglycerides.

    Analysis of the safety database for ENHANCE-IT remains ongoing. There were no serious adverse events reported for this study and no dropouts related to study drug adverse events.

    Further analyses of additional clinical data from the study are continuing and the Company expects to present the full data from this study at upcoming scientific congresses and in peer-reviewed journals over the course of the year.

    Conference Call and Webcast Information

    Matinas will host a live conference call and webcast today, February 1, 2021, at 8:00 a.m. Eastern Time to discuss the results from ENHANCE-IT. A slide presentation will accompany the call and webcast and will be available on the Company's website.

    Participating on the conference call will be members of the Matinas management team as well as Dr. Kastelein.

    The conference call can be accessed by dialing 877-407-5976 for participants in the U.S. or Canada and 412-902-0031 for international callers (reference passcode 13715418).

    The conference call will also be webcast live on Matinas' website, www.matinasbiopharma.com, under the ‘Investors' section and will be archived there for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    LYPDISO, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia.  

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nanocrystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them orally bioavailable, less toxic, and targeted to cells and tissues.  

    MAT2203 is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.

    MAT2501 is an oral, encochleated formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company recently announced that it has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the ENHANCE-IT study, the Company's strategic focus and the future development of its product candidates, including MAT9001, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts



    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

     



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  18. BEDMINSTER, N.J., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to present a Company overview at the ICR Conference 2021 on Thursday, January 14, 2021 at 1:00 p.m. ET.

    Mr. Jabbour will also host investor meetings during the conference. Investors interested in arranging a virtual meeting with the Company's management during this conference should contact the conference coordinator or brandon.weiner@westwicke.com.

    A live webcast of the Company's presentation will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days…

    BEDMINSTER, N.J., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to present a Company overview at the ICR Conference 2021 on Thursday, January 14, 2021 at 1:00 p.m. ET.

    Mr. Jabbour will also host investor meetings during the conference. Investors interested in arranging a virtual meeting with the Company's management during this conference should contact the conference coordinator or brandon.weiner@westwicke.com.

    A live webcast of the Company's presentation will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following the live presentation.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    LYPDISO™ (MAT9001), the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. LYPDISO is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nanocrystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them orally bioavailable, less toxic, and targeted to cells and tissues. 

    MAT2203 is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.

    MAT2501 is an oral, encochleated formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company recently announced that it has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts

    Peter Vozzo

    Westwicke, an ICR Company

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com



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  19. BEDMINSTER, N.J., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced the U.S. Food and Drug Administration (FDA) has conditionally accepted LYPDISO™ as the proposed brand name for MAT9001, the Company's investigational drug for treatment of cardiovascular and metabolic conditions. The Company also announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance, approving the Company's application to register the LYPDISO brand name as a federal trademark.

    The name LYPDISO (pronounced "Lip-DEE-so…

    BEDMINSTER, N.J., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced the U.S. Food and Drug Administration (FDA) has conditionally accepted LYPDISO™ as the proposed brand name for MAT9001, the Company's investigational drug for treatment of cardiovascular and metabolic conditions. The Company also announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance, approving the Company's application to register the LYPDISO brand name as a federal trademark.

    The name LYPDISO (pronounced "Lip-DEE-so") was developed in compliance with FDA's Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. Based on the development program, which included research with physicians and pharmacists, as well as an international name assessment, the Company believes LYPDISO is a proprietary name with strong marketing potential that is also consistent with FDA's goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. A request for proprietary name review and final approval for LYPDISO will be included when Matinas submits a New Drug Application (NDA) for MAT9001.

    "We are pleased that the FDA has conditionally accepted the name LYPDISO for our lead product candidate and that we have also received a Notice of Allowance from the USPTO toward registering this brand as a federal trademark," said Jerome D. Jabbour, Chief Executive Officer of Matinas. "These meaningful steps align with our continued clinical progress, as well as preparation for the commercialization of LYPDISO, if approved. We eagerly await topline data from our ENHANCE-IT head-to-head study vs. Vascepa® in the first quarter of 2021, followed by the commencement of our Phase 3 program for LYPDISO in the second half of 2021. We continue to believe that LYPDISO, if approved, would provide an important and potentially best in class product to help treat patients suffering from cardiovascular and metabolic conditions."

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nanocrystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them orally bioavailable, less toxic, and targeted to cells and tissues.  

    MAT2203 is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.

    MAT2501 is an oral, encochleated formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company recently announced that it has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's strategic focus and the future development of its product candidates, including MAT9001, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts
     
    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

     
    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com



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  20. BEDMINSTER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that they plan to collaborate with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to test oral formulations of remdesivir in preclinical models. Remdesivir is owned by Gilead Sciences, Inc. (NASDAQ:GILD) and the lipid nanocrystal (LNC) platform is owned by Matinas. Any product generated as a part of efforts by Matinas and NIAID would require a license from Gilead for the use of remdesivir and…

    BEDMINSTER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that they plan to collaborate with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to test oral formulations of remdesivir in preclinical models. Remdesivir is owned by Gilead Sciences, Inc. (NASDAQ:GILD) and the lipid nanocrystal (LNC) platform is owned by Matinas. Any product generated as a part of efforts by Matinas and NIAID would require a license from Gilead for the use of remdesivir and a license from Matinas for the use of the LNC formulation.

    One or more formulations of remdesivir will be developed using Matinas' Lipid Nanocrystal (LNC) platform delivery technology, which enables the development of a wide range of difficult-to-deliver molecules. Matinas plans to utilize NIAID's suite of preclinical services to carry out antiviral testing with selected formulations. Gilead will provide remdesivir and work with Matinas to evaluate the data generated from the planned series of preclinical studies.

    "We believe that our LNC technology may be applied to remdesivir to allow for the potential for oral administration of this important drug in the fight against COVID-19," commented Jerome D. Jabbour, Chief Executive Officer of Matinas.     

    Matinas' LNC platform delivery technology offers an oral intracellular drug delivery solution with potential advantages over other delivery technologies across a broad range of therapeutics. The Company has demonstrated in preclinical animal models the ability to formulate and deliver a wide variety of molecules and drugs (including oligonucleotides, peptides, proteins, vaccines, and small molecules) which, (a) require delivery technology to improve the stability of molecules inside and outside of the body; (b) could benefit from efficient delivery and cellular uptake by target cells; (c) are currently only available in IV formulations or (d) otherwise experience significant toxicity-related adverse events.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nanocrystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them orally bioavailable, less toxic and targeted to cells and tissues. 

    MAT2203 is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is preparing to enroll patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021. 

    MAT2501 is an oral, encochleated formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company recently announced that it has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    Gilead is a trademark of Gilead Sciences, Inc., or its related companies.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts

    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com



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  21. - Special Meeting of Stockholders Scheduled for January 26, 2021 Seeking Authorization to Potentially Effectuate a Discretionary Reverse Stock Split Prior to January 26, 2022 -

    - Company's Proposal to Stockholders Intended to Enhance Appeal of Common Stock to Institutional Investors, Position its Common Stock for Potential Eligibility for Inclusion in Certain Biotechnology and Pharmaceutical Trading Indices and for Potential Inclusion on the NYSE "Big Board" or NASDAQ Global Market -

    BEDMINSTER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet…

    - Special Meeting of Stockholders Scheduled for January 26, 2021 Seeking Authorization to Potentially Effectuate a Discretionary Reverse Stock Split Prior to January 26, 2022 -

    - Company's Proposal to Stockholders Intended to Enhance Appeal of Common Stock to Institutional Investors, Position its Common Stock for Potential Eligibility for Inclusion in Certain Biotechnology and Pharmaceutical Trading Indices and for Potential Inclusion on the NYSE "Big Board" or NASDAQ Global Market -

    BEDMINSTER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that its Board of Directors has approved a proposal, to be submitted to stockholders for approval at a Special Meeting of Stockholders anticipated to be held on January 26, 2021, to authorize the Board of Directors to potentially effect a reverse split of the Company's common stock. The reverse stock split proposal includes a proposed range between 1-for-2 and 1-for-15 shares of outstanding common stock. The final ratio will be determined, if at all, by Matinas' Board of Directors following stockholder approval at the Special Meeting.

    "We believe the filing of this preliminary proxy statement to authorize a potential reverse split of stock is an important proactive and strategic step to position Matinas for long term success and to potentially be able to capitalize on some of the important milestones and catalysts we have in front of us during 2021," said Jerome D. Jabbour, Chief Executive Officer of Matinas. "We believe that there are many potential benefits to increasing the price per common share, including making the Company's stock more attractive to institutional investors, potentially position us for eligibility and inclusion in certain biotechnology and pharmaceutical trading indices and exchange traded funds, and even potentially position Matinas for an "uplisting" to the NYSE "Big Board" or NASDAQ Global Market. However, we only intend to make a reverse split effective if we believe that doing so would be in the best interests of the Company and our stockholders."

    Matinas filed a preliminary proxy statement with the U.S. Securities and Exchange Commission as required by SEC rules. The proposal requires the affirmative vote of a majority of the Company's outstanding shares. Stockholders may obtain a free copy of the preliminary proxy statement or the definitive proxy statement (once available), as well as other documents that the Company files with the SEC at the SEC's website at www.sec.gov. The Company will file with the SEC and distribute to its stockholders a definitive proxy statement regarding the special meeting and the reverse stock split proposal.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nanocrystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them orally bioavailable, less toxic and targeted to cells and tissues.  

    MAT2203, is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is preparing to enroll patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.

    MAT2501 is an oral, encochleated formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company recently announced that it has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the reverse stock split proposal, the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001, MAT2203 and MAT2501, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts

    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com



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  22. BEDMINSTER, N.J., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced the appointment of Hui Liu, Ph.D., M.B.A. as Chief Technology Officer. Dr. Liu joins Matinas with extensive experience in pharmaceutical formulation and delivery technologies, including lipid nanoparticle formulations of mRNA, siRNA and vaccines. In this new role, Dr. Liu will work closely with Raphael Mannino, Ph.D., Matinas' Chief Scientific Officer, and lead efforts to further strengthen the Company's proprietary lipid nanocrystal (LNC) drug delivery platform…

    BEDMINSTER, N.J., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced the appointment of Hui Liu, Ph.D., M.B.A. as Chief Technology Officer. Dr. Liu joins Matinas with extensive experience in pharmaceutical formulation and delivery technologies, including lipid nanoparticle formulations of mRNA, siRNA and vaccines. In this new role, Dr. Liu will work closely with Raphael Mannino, Ph.D., Matinas' Chief Scientific Officer, and lead efforts to further strengthen the Company's proprietary lipid nanocrystal (LNC) drug delivery platform and accelerate its potential applications for both internal programs and external collaborations.       

    "Dr. Liu has spent his career studying, developing, and optimizing drug delivery technologies. His substantial expertise and technical depth complement our existing internal team and fills an essential role in our organization as we look to capitalize upon our proprietary, unique and differentiated LNC delivery platform," commented Jerome D. Jabbour, Chief Executive Officer of Matinas. "Hui's accomplishments, especially within the biologics and gene therapy fields, should serve us well as we continue to advance our product candidates and collaborations with an aim to transform the current paradigm for the delivery of innovative medicines."

    "I am honored to join the Matinas team and to help accelerate the growth of the Company's LNC delivery platform," commented Dr. Liu. "I am very excited by the possibilities of this potentially disruptive technology and I look forward to working closely with the team to deliver our ambitious vision."

    Dr. Liu has more than two decades of experience in the formulation of small molecules, biologics, and gene therapies. Dr. Liu joins Matinas directly from Seqirus, a global leader in influenza and pandemic response, where he served as Director of Formulation and Delivery. At Seqirus, Dr. Liu built and led development of lipid nanoparticle technology platforms for next generation gene therapy products. Earlier in his career, Dr. Liu held positions at Cellics Therapeutics, Alcon (a spinoff of Novartis) and Allergan. Dr. Liu is a named inventor on 19 patents related to drug delivery technologies and biodegradable polymers. Dr. Liu holds a Ph.D. in polymer chemistry from the University of Michigan, an M.B.A. from the University of Massachusetts, Amherst, and a B.S. from The University of Science and Technology of China.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nanocrystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them orally bioavailable, less toxic and targeted to cells and tissues.  

    MAT2203, is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is preparing to enroll patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.

    MAT2501 is an oral, encochleated formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company recently announced that it has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001, MAT2203 and MAT2501, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts



    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com



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  23. BEDMINSTER, N.J., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that it has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF). The award will support preclinical development of MAT2501, Matinas' lipid nano-crystal (LNC) oral formulation of the broad-spectrum aminoglycoside amikacin, toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    "We are grateful to the Cystic Fibrosis Foundation for their support in accelerating…

    BEDMINSTER, N.J., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that it has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF). The award will support preclinical development of MAT2501, Matinas' lipid nano-crystal (LNC) oral formulation of the broad-spectrum aminoglycoside amikacin, toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

    "We are grateful to the Cystic Fibrosis Foundation for their support in accelerating the development of MAT2501 as a potential best in class treatment for NTM lung disease. These are debilitating, potentially life-threatening, and increasingly prevalent pulmonary infections, especially in patients with cystic fibrosis," commented Jerome D. Jabbour, Chief Executive Officer of Matinas. "We believe that an orally bioavailable amikacin, which takes advantage of our LNC delivery platform, would be the first oral aminoglycoside and would represent a significant improvement over currently available therapy. Furthermore, an oral, well tolerated, and targeted aminoglycoside would also potentially be of considerable value in treating other acute bacterial infections, especially gram-negative infections, where oral options are very limited and drug resistance is an increasing challenge. We look forward to continuing to work with the CF Foundation on realizing the potential of our LNC delivery platform."   

    The CFF award will allow Matinas to rapidly advance the development of MAT2501 and will support preclinical in vitro and in vivo studies, along with several of the toxicology studies necessary to progress MAT2501 into Phase 2. Pending a successful preclinical program, the CFF has indicated to Matinas a willingness to consider a request for further monetary support for the continuation of clinical studies, including dose determination and Phase 2 efficacy studies in CF patients suffering from NTM lung disease.  

    MAT2501 has been designated as a Qualified Infectious Disease Product (QIDP) and as an Orphan Drug for the treatment of NTM by the U.S. Food and Drug Administration (FDA). Orphan Drug designation of MAT2501 provides for a seven-year marketing exclusivity period against competition in the United States upon FDA approval, as well as other incentives and exemptions, including waiver of Prescription Drug User Fee Act (PDUFA) filing fees and tax credits for the cost of the clinical research. If MAT2501 is ultimately approved by the FDA, the seven-year period of marketing exclusivity from orphan designation combined with the additional five years of marketing exclusivity provided by the QIDP designation, provides for a potential total of 12 years of marketing exclusivity.

    About NTM Lung Disease

    NTM lung disease is a chronic, debilitating condition arising from an NTM infection in the lungs and is associated with significant patient morbidity and mortality. The signs and symptoms of NTM lung disease often overlap with the underlying lung conditions that increase risk for NTM, like cystic fibrosis, bronchiectasis, COPD, and asthma. The most common pathogens for NTM infections in the United States are Mycobacterium avium complex (MAC), which accounts for more than 80% of all NTM infections in the U.S. Patients with NTM lung infections frequently require lengthy hospital stays and prolonged courses of antibiotics to manage their disease.

    The prevalence of human disease attributable to NTM has increased over the past two decades and is now growing at more than 8% per year and is even more prevalent than tuberculosis in the U.S. In 2018, it was estimated that between 75,000 and 100,000 patients were diagnosed with NTM lung disease in the U.S. alone.

    About MAT2501

    MAT2501 is an oral, encochleated formulation of the broad-spectrum aminoglycoside antibiotic agent amikacin, which utilizes the Company's proprietary LNC platform to achieve oral bioavailability, limit toxicity and enable targeted delivery to sites of infection. Currently, amikacin can only be delivered parenterally or through inhalation and is used to treat a variety of chronic and acute bacterial infections, including both NTM infections and various multidrug-resistant gram-negative bacterial infections. IV and inhaled amikacin, however, are associated with major side effects including nephrotoxicity and ototoxicity (permanent loss of hearing) with long-term use.  Matinas believes that MAT2501's ability to orally deliver high levels of amikacin directly to the lung and without use-limiting toxicity, distinguishes it from all available therapies and could provide an important solution for patients and physicians.



    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nano-crystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them more targeted, less toxic and orally bioavailable.

    MAT2203, the Company's lead product candidate utilizing its LNC platform, is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT will promptly begin enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT2203 and MAT2501, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts



    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

     



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  24. BEDMINSTER, N.J., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, has been invited to participate in a fireside chat as part of the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held December 1-3, 2020. The Company will also host investor meetings during the conference.

    The pre-recorded fireside chat will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com) beginning November 23, 2020. A webcast replay will be accessible for 90 days following the event.

    About Matinas

    BEDMINSTER, N.J., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, has been invited to participate in a fireside chat as part of the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held December 1-3, 2020. The Company will also host investor meetings during the conference.

    The pre-recorded fireside chat will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com) beginning November 23, 2020. A webcast replay will be accessible for 90 days following the event.



    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nano-crystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them more targeted, less toxic and orally bioavailable.

    MAT2203, the Company's lead product candidate utilizing its LNC platform, is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is set to begin enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT2203 and MAT2501, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts



    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com



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  25. EnACT study of MAT2203 in cryptococcal meningitis received unanimous Data and Safety Monitoring Board (DSMB) recommendation to proceed into second patient cohort

    ENHANCE-IT study of MAT9001 against Vascepa® fully enrolled with topline data anticipated Q1 2021; Phase 3 program on track to initiate H1 2021

    – Management to host conference call today, Friday, November 6th, at 8:30 a.m. ET –

    BEDMINSTER, N.J., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today reported financial results for the third quarter ended September 30, 2020…

    EnACT study of MAT2203 in cryptococcal meningitis received unanimous Data and Safety Monitoring Board (DSMB) recommendation to proceed into second patient cohort

    ENHANCE-IT study of MAT9001 against Vascepa® fully enrolled with topline data anticipated Q1 2021; Phase 3 program on track to initiate H1 2021

    – Management to host conference call today, Friday, November 6th, at 8:30 a.m. ET –

    BEDMINSTER, N.J., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today reported financial results for the third quarter ended September 30, 2020, along with a corporate update.

    "The third quarter was very productive for the Company, as we continued to execute on our strategic priorities. We achieved a significant milestone in the EnACT study of MAT2203 with cohort progression, completed enrollment in the ENHANCE-IT study of MAT9001, and aligned with the FDA on key elements of our Phase 3 program for MAT9001," commented Jerome D. Jabbour, Chief Executive Officer of Matinas. "Cohort progression in the EnACT study is both an important milestone for the development of MAT2203 as well as another critical step forward in further clinically validating the potential of our LNC platform delivery technology. As we look toward the remainder of the year and into 2021, we will intently focus on progressing our drug candidates through clinical development, with topline data from ENHANCE-IT anticipated in the first quarter of 2021 and a DSMB evaluation on progression from cohort 2 to cohort 3 in EnACT expected to occur in the middle of 2021. Finally, we continue to make good progress in identifying and advancing opportunities to expand the utilization of our LNC platform delivery technology with additional internal product candidates and external collaborations."

    MAT2203 Program Update (orally bioavailable amphotericin B, with targeted delivery, under development for the treatment and prevention of invasive fungal infections, including cryptococcal meningitis)

    • In October, the Company announced that the independent DSMB of the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) completed a pre-specified review of the first cohort and unanimously recommended progression to the second cohort. Enrollment in this next randomized EnACT cohort, with 40 active-treatment patients, is expected to begin shortly, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.
    • Data from the Phase 1 portion of the EnACT study were published in the Antimicrobial Agents and Chemotherapy, (ACC), a journal of the American Society of Microbiology, in a manuscript entitled "Safety and tolerability of a novel oral formulation of amphotericin B: Phase I EnACT trial". In the published manuscript, trial investigators concluded that MAT2203 was well-tolerated when administered in 4-6 divided daily doses without the toxicities commonly seen with IV amphotericin B. 
    • As previously reported, the U.S. Food and Drug Administration (FDA) has designated MAT2203 as a Qualified Infectious Disease Product (QIDP) with Fast Track status for four indications, specifically, the prevention of invasive fungal infections due to immunosuppressive therapy, and the treatment of invasive candidiasis, invasive aspergillus and cryptococcal meningitis. In addition, the FDA has granted orphan drug designation to MAT2203 for the treatment of cryptococcosis.

    EnACT is a Phase 2 prospective, randomized, open-label, sequential cohort study, financially supported by the National Institutes of Health (NIH), evaluating the safety, tolerability and efficacy of MAT2203 in approximately 100 HIV-infected patients with cryptococcal meningitis. MAT2203 utilizes the Company's LNC platform delivery technology to orally deliver the traditionally IV-only fungicidal drug, amphotericin B. In total, the trial includes four cohorts of patients, with each cohort increasing the treatment duration of MAT2203 vs. IV amphotericin B. The primary efficacy endpoint includes a measure of reduction in fungal count in the cerebral spinal fluid. A control arm, which includes standard of care IV amphotericin B, is included with each cohort.

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

    • The Company completed enrollment in ENHANCE-IT (Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in Adults with Hypertriglyceridemia), a second head-to-head comparative study of MAT9001 vs. Vascepa. The study is assessing MAT9001's effectiveness in reducing triglyceride levels and other important lipid markers, as well as characterizing bioavailability and blood levels of eicosapentaenoic acid (EPA) and other omega-3 fatty acids. The Company continues to expect to have topline data available in the first quarter of 2021.

    • A positive End of Phase 2 Meeting with the FDA during the third quarter of 2020, along with a review of the official minutes of the meeting, confirm that the FDA and Matinas are aligned on key next steps for MAT9001's Phase 3 development program and registration pathway for an initial indication to treat severe hypertriglyceridemia (SHTG). The Company and the FDA agreed on key elements of the Phase 3 program to support a New Drug Application (NDA) filing, including the requirement for a single 12-week study to support efficacy in SHTG. Moreover, FDA provided flexibility to Matinas in the totality of patient safety data needed to meet regulatory requirements for NDA submission. The Company continues to evaluate several ways to both meet these requirements and to potentially provide additional data differentiating MAT9001 from other prescription omega-3 drugs. The Company remains on track to initiate its Phase 3 program in the first half of 2021.

    ENHANCE-IT is an open-label, randomized, 28-day crossover study assessing the pharmacodynamic effects of MAT9001 vs. Vascepa. The study is now fully enrolled and includes adult men and women with elevated triglycerides (150-499 mg/dL), with at least 50% of study subjects with TGs ≥ 200 mg/dL. The study protocol involves two 28-day treatment periods, with a washout period of at least 28 days in between treatments and is being conducted at eight sites in the United States. MAT9001 and Vascepa are each administered as 2g twice daily with food in accordance with currently approved Vascepa labeling. Lipid parameters (triglycerides, Total-, LDL-, VLDL-, HDL-, and non-HDL cholesterol, apolipoproteins A1, B and C3, and PCSK9) and omega-3 blood levels are being measured at each baseline and at the end of each treatment period. The primary endpoint is the percent change from baseline to end-of-treatment in plasma triglycerides.

    Third Quarter 2020 Financial Results

    Cash, cash equivalents and marketable securities at September 30, 2020 were approximately $62.8 million, compared to $27.8 million at December 31, 2019. In January 2020, the Company sold an aggregate of 32,260,000 shares of its common stock at a price of $1.55 per share for net proceeds of approximately $46.7 million, after deducting underwriting discounts and commissions and other offering expenses. Based on current projections, the Company continues to believe that cash on hand is sufficient to fund operations into the first half of 2023.

    For the third quarter of 2020, net loss attributable to common shareholders was $5.7 million, or a net loss of $0.03 per share (basic and diluted), compared to a net loss attributable to common shareholders of $4.6 million, or a net loss of $0.03 per share (basic and diluted) for the same period in 2019. The increase in net loss attributable to common shareholders was due primarily to an increase in operating expenses.

    Research and development (R&D) expenses for the third quarter of 2020 were $3.3 million, compared to $2.7 million for the same period in 2019. The increase was due primarily to higher clinical development expenses and employee compensation related to the development of MAT9001 and MAT2203.

    General and administrative (G&A) expenses for the third quarter of 2020 were $2.4 million, compared to $1.9 million in the same period in 2019. The increase was due primarily to higher employee compensation expense associated with increased headcount.

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



    Conference Call and Webcast Details



    The Company will host a live conference call and webcast to discuss these results on Friday, November 6, 2020, at 8:30 a.m. ET.



    To participate in the call, please dial (877) 407-5976 (domestic) or (412) 902-0031 (international). The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and archived for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nano-crystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them more targeted, less toxic and orally bioavailable.

    MAT2203, the Company's lead product candidate utilizing its LNC platform, is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT will promptly begin enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.





    Matinas BioPharma Holdings Inc.

    Condensed Consolidated Balance Sheets

      September 30, 2020  December 31, 2019 
      (Unaudited)  (Audited) 
    ASSETS:        
    Current assets:        
    Cash and cash equivalents $7,051,225  $22,170,438 
    Marketable securities  55,719,661   5,604,634 
    Restricted cash  186,000   250,000 
    Prepaid expenses and other current assets  2,246,128   1,897,784 
    Total current assets  65,203,014   29,922,856 
             
    Non-current assets:        
    Leasehold improvements and equipment - net  1,581,762   1,749,259 
    Operating lease right-of-use assets - net  3,401,136   3,761,207 
    Finance lease right-of-use assets - net  66,649   116,968 
    In-process research and development  3,017,377   3,017,377 
    Goodwill  1,336,488   1,336,488 
    Restricted cash - security deposits  200,000   336,000 
    Total non-current assets  9,603,412   10,317,299 
    Total assets $74,806,426  $40,240,155 
             
    LIABILITIES AND STOCKHOLDERS' EQUITY:        
             
    Current liabilities:        
    Accounts payable $373,066  $679,310 
    Accrued expenses  2,015,102   1,939,510 
    Operating lease liabilities - current  417,874   423,741 
    Financing lease liabilities - current  32,278   54,673 
    Total current liabilities  2,838,320   3,097,234 
             
    Non-current liabilities:        
    Deferred tax liability  341,265   341,265 
    Operating lease liabilities - net of current portion  3,391,568   3,695,561 
    Financing lease liabilities - net of current portion  30,054   54,513 
    Total non-current liabilities  3,762,887   4,091,339 
    Total liabilities  6,601,207   7,188,573 
             
    Stockholders' equity:        
    Series B Convertible preferred stock  3,964,034   3,985,805 
             
    Common stock  19,896   16,315 
    Additional paid-in capital  165,024,057   113,427,897 
    Accumulated deficit  (101,166,313)  (84,377,555)
    Accumulated other comprehensive income/(loss)  363,545   (880)
    Total stockholders' equity  68,205,219   33,051,582 
    Total liabilities and stockholders' equity $74,806,426  $40,240,155 





    Matinas BioPharma Holdings, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    Unaudited

      Three Months Ended September 30,  Nine Months Ended September 30, 
      2020  2019  2020  2019 
    Revenue:            
    Contract research revenue $95,833  $-  $95,833  $89,812 
    Costs and expenses:                
    Research and development  3,336,225   2,671,365   10,833,345   7,814,842 
    General and administrative  2,364,214   1,889,892   6,980,155   5,460,023 
                     
    Total costs and expenses  5,700,439   4,561,257   17,813,500   13,274,865 
                     
    Loss from operations  (5,604,606)  (4,561,257)  (17,717,667)  (13,185,053)
    Sale of New Jersey net operating loss  -   -   1,073,289   1,007,082 
    Other income, net  155,093   156,872   538,420   378,151 
                     
    Net loss $(5,449,513) $(4,404,385) $(16,105,958) $(11,799,820)
                     
    Preferred stock series A accumulated dividends  -   (45,041)  -   (338,613)
    Preferred stock series B accumulated dividends  (227,600)  (115,500)  (575,392)  (349,500)
                     
    Net loss attributable to common shareholders $(5,677,113) $(4,564,926) $(16,681,350) $(12,487,933)
                     
    Net loss available for common shareholders per share - basic and diluted $(0.03) $(0.03) $(0.09) $(0.09)
    Weighted average common shares outstanding - basic and diluted  198,909,016   156,889,602   196,070,952   139,265,178 
    Other comprehensive (loss)/income, net of tax                
    Net unrealized (loss)/gain on securities available-for-sale  (114,159)  -   367,144   - 
    Reclassifications to net loss  -   -   (2,719)  - 
    Other comprehensive (loss)/income, net of tax  (114,159)  -   364,425   - 
    Comprehensive loss attributable to shareholders $(5,563,672) $(4,404,385) $(15,741,533) $(11,799,820)



    Investor and Media Contacts

    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

    Source: Matinas BioPharma Holdings, Inc.

     

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  26. BEDMINSTER, N.J., Oct. 23, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Friday, November 6, 2020 at 8:30 a.m. ET to discuss operational and financial results for the third quarter ended September 30, 2020.

    To participate in the call, please dial (877) 407-5976 (domestic) or (412) 902-0031 (international). The live webcast will be accessible on the Investors section of Matinas’ website, www.matinasbiopharma.com, and will be archived for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics…

    BEDMINSTER, N.J., Oct. 23, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Friday, November 6, 2020 at 8:30 a.m. ET to discuss operational and financial results for the third quarter ended September 30, 2020.

    To participate in the call, please dial (877) 407-5976 (domestic) or (412) 902-0031 (international). The live webcast will be accessible on the Investors section of Matinas’ website, www.matinasbiopharma.com, and will be archived for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company’s lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nano-crystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them more targeted, less toxic and orally bioavailable.

    MAT2203, the Company’s lead product candidate utilizing its LNC platform, is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT will promptly begin enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021. 

    Forward Looking Statements:

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company’s anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company’s ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma’s product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contact

    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director â€" Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

    Source: Matinas BioPharma Holdings, Inc.

     

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  27. DSMB evaluated both safety and efficacy data in recommending cohort progression

    Enrollment in second cohort of patients expected to commence imminently with next DSMB evaluation anticipated mid-2021

    BEDMINSTER, N.J., Oct. 19, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that the independent Data and Safety Monitoring Board (DSMB) of the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) has completed a pre-specified review of the first cohort and unanimously recommended progression to the second…

    DSMB evaluated both safety and efficacy data in recommending cohort progression

    Enrollment in second cohort of patients expected to commence imminently with next DSMB evaluation anticipated mid-2021

    BEDMINSTER, N.J., Oct. 19, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that the independent Data and Safety Monitoring Board (DSMB) of the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) has completed a pre-specified review of the first cohort and unanimously recommended progression to the second cohort of patients. Enrollment in this next randomized EnACT cohort, with 40 active-treatment patients, is expected to begin shortly, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.  

    "Cohort progression in the EnACT study is an important milestone for the development of MAT2203," commented Theresa Matkovits, Ph.D., Chief Development Officer of Matinas BioPharma. "The unanimous DSMB recommendation is very encouraging and supports our views of the overall safety and efficacy profile of MAT2203. We look forward to promptly commencing enrollment in the next cohort of EnACT, which will provide more robust evidence about the efficacy and safety of MAT2203."

    "Cryptococcal meningitis is a deadly fungal disease which results in severe, invasive infections of the brain and imposes a major burden and high mortality in vulnerable immunocompromised patients around the world," continued Dr. Matkovits. "We believe that an oral amphotericin B formulation, with targeted drug delivery directly to infected tissues throughout the body, substantially reduces the risk of toxicity without sacrificing efficacy. Based on this profile, MAT2203 has the potential to provide an invaluable solution for physicians and patients and ultimately advance the standard of care for the treatment of severe, invasive fungal infections."

    "Overall, we are pleased with the safety and performance of MAT2203 following 5 days of initial intravenous (IV) amphotericin B. In the next stage of the trial, we will continue to test MAT2203 following only 2 days of initial IV amphotericin B, and we would be very pleased to see similar performance," commented David Boulware, M.D., M.P.H, Professor of Medicine at the University of Minnesota and Principal Investigator for the trial.

    "Cohort progression in EnACT is also another step forward in further validating the potential of our LNC platform delivery technology," commented Raphael J. Mannino, Ph.D., Chief Scientific Officer of Matinas BioPharma. "DSMB approval to proceed to the second patient cohort is a promising signal that MAT2203 is orally bioavailable and successfully crosses the blood brain barrier. Continued success in EnACT will further demonstrate that oral, LNC delivery of therapeutic agents to the brain is possible, and we remain optimistic that our LNC platform could become an important alternative to other traditional, but problematic, delivery vehicles such as lipid nanoparticles or viral vectors, across a wide variety of therapeutic applications."

    EnACT is a Phase 2 prospective, randomized, open-label, sequential cohort study, financially supported by the National Institutes of Health (NIH), evaluating the safety, tolerability and efficacy of MAT2203 in approximately 100 HIV-infected patients with cryptococcal meningitis. MAT2203 utilizes the Company's LNC platform delivery technology to orally deliver the traditionally IV-only fungicidal drug, amphotericin B.

    The induction period for all patients in each cohort of EnACT is 14 days, followed by an additional 4 weeks of treatment with MAT2203 for all patients during a maintenance period. In total, the trial includes four cohorts of patients, with each cohort increasing the treatment duration of MAT2203 vs. IV amphotericin B. The first cohort received IV amphotericin B for the first five days of the induction period, followed by nine days of oral administration of MAT2203. The second cohort of 40 actively treated patients will receive IV amphotericin B for the first two days of the induction period, followed by twelve days of oral administration of MAT2203. The primary efficacy endpoint will be measured at Day 14, the last day of the induction period, and will include a measure of reduction in fungal count in the cerebral spinal fluid. A control arm, which includes standard of care IV amphotericin B, is included with each cohort. An independent DSMB oversees the safety of the study and reviews all data from each cohort for safety and efficacy and makes a recommendation to proceed to the next cohort of patients.

    As previously reported, the U.S. Food and Drug Administration (FDA) has designated MAT2203 as a Qualified Infectious Disease Product (QIDP) with Fast Track status for four indications, specifically, the prevention of invasive fungal infections due to immunosuppressive therapy, and the treatment of invasive candidiasis, invasive aspergillus and cryptococcal meningitis.   In addition, the FDA has granted orphan drug designation to MAT2203 for the treatment of cryptococcosis.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nano-crystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them more targeted, less toxic and orally bioavailable. 

    MAT2203, the Company's lead product candidate utilizing its LNC platform, is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT will promptly begin enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021. 

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.



    Investor and Media Contacts



    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com



    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com



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  28. - FDA Agreement to Move Directly into Phase 3 -

    - FDA to Require a Single Phase 3 Trial of 12 Weeks Duration to Support Efficacy for an NDA filing in SHTG -

    BEDMINSTER, N.J., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced the result of its End of Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) concerning the development and registration pathway for MAT9001, a potential best-in-class prescription omega-3 therapy. The official minutes of the meeting confirmed that the FDA and Matinas are aligned on key next…

    - FDA Agreement to Move Directly into Phase 3 -

    - FDA to Require a Single Phase 3 Trial of 12 Weeks Duration to Support Efficacy for an NDA filing in SHTG -

    BEDMINSTER, N.J., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced the result of its End of Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) concerning the development and registration pathway for MAT9001, a potential best-in-class prescription omega-3 therapy. The official minutes of the meeting confirmed that the FDA and Matinas are aligned on key next steps for MAT9001's Phase 3 development program and registration pathway for an initial indication to treat severe hypertriglyceridemia (SHTG), a clinical disorder associated with major complications such as pancreatitis and atherosclerotic cardiovascular disease. The Company remains on track to initiate its Phase 3 program in the first half of 2021.

    "We are extremely pleased with the outcome of our meeting with FDA and are encouraged by the highly collaborative and strategic input we received for our program. I am very proud of what we have accomplished as a team and look forward to initiating the Phase 3 trial in SHTG and maximize the clinical opportunities for MAT9001," said Theresa Matkovits, Ph.D., Chief Development Officer of Matinas BioPharma.

    The Company and the FDA agreed on key elements of the Phase 3 program to support a New Drug Application (NDA) filing, including the requirement for a single 12-week study to support efficacy in SHTG. Moreover, FDA provided flexibility to Matinas in the totality of patient safety data needed to meet regulatory requirements for NDA submission. The Company is evaluating several ways to both meet these requirements and to potentially provide additional data differentiating MAT9001 from other prescription omega-3 drugs. 

    "Alignment with the FDA on our Phase 3 development program provides clarity about our development pathway for MAT9001 in SHTG," said Jerome D. Jabbour, CEO of Matinas BioPharma. "With this important feedback from FDA, we can confidently move forward with our streamlined 505(b)2 registration for MAT9001. Our level of enthusiasm for this potential best-in-class omega-3 therapy remains high, and we look forward to forthcoming near-term data from our ongoing ENHANCE-IT head to head trial of MAT9001 vs. Vascepa to once again highlight the differentiation between these two products and the potential significant clinical benefits of MAT9001 for patients with hypertriglyceridemia and cardiovascular disease."

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nano-crystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them more targeted, less toxic and orally bioavailable. 

    MAT2203, the Company's lead product candidate utilizing its LNC platform, is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis, with potential cohort progression anticipated in the fourth quarter of 2020. 

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.



    Investor and Media Contacts



    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

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  29. BEDMINSTER, N.J., Sept. 14, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced the appointment of Natasha Giordano to its Board of Directors as an independent director and a member of the audit committee, effective Monday, September 14, 2020.

    Ms. Giordano brings over 25 years of extensive experience in healthcare, including senior leadership positions and board director roles spanning across several pharmaceutical companies and sales and marketing service providers. She has served as President, Chief Executive Officer, and a director of PLx Pharma Inc. since January 2016. Previously, Ms. Giordano served as the President and Chief Executive Officer of both ClearPoint Learning, Inc., and Healthcare…

    BEDMINSTER, N.J., Sept. 14, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced the appointment of Natasha Giordano to its Board of Directors as an independent director and a member of the audit committee, effective Monday, September 14, 2020.

    Ms. Giordano brings over 25 years of extensive experience in healthcare, including senior leadership positions and board director roles spanning across several pharmaceutical companies and sales and marketing service providers. She has served as President, Chief Executive Officer, and a director of PLx Pharma Inc. since January 2016. Previously, Ms. Giordano served as the President and Chief Executive Officer of both ClearPoint Learning, Inc., and Healthcare Corporation of America.  From June 2009 to August 2012, Ms. Giordano served as Chief Operating Officer and then as Chief Executive Officer, President and a director of Xanodyne Pharmaceuticals, Inc. Ms. Giordano also served as a director for Aceto Corporation from December 2011 through September 2019.  Prior to that, she served as President, Americas, for Cegedim Dendrite (formerly Dendrite International Inc.) from 2007 to 2008 and as Senior Vice President, Global Customer Business Unit of Cegedim Dendrite from 2004 to 2007.  Earlier in her career, she worked for Parke-Davis/Warner Lambert then Pfizer, in several sales and marketing leadership positions.

    "We are delighted to welcome Natasha to the Matinas Board," commented Herbert Conrad, Chairman of the Matinas BioPharma Board of Directors. "Natasha's background includes significant commercial and strategic expertise and will complement the experience of our other Board members.  This will be invaluable as our lead products move through clinical development.  We are honored she has chosen to join us."

    Ms. Giordano commented, "I am extremely pleased to join the team at Matinas at such an exciting time.  With several important clinical and strategic milestones over the next few quarters, I look forward to working with Herb, Jerry and the entire Matinas team to help maximize our opportunities and position the Company for commercial success to drive significant shareholder value."

    The Company also announced today that Adam Stern will not stand for re-election to the Company's Board of Directors at the Company's Annual Meeting of Stockholders on November 2, 2020, instead transitioning to a consulting role where he will be available to the Chief Executive Officer and the Board of Directors on matters related to overall corporate and financial strategy.

    "Adam has served on our Board of Directors since inception, providing tremendous leadership, insight and guidance throughout his long-standing tenure," said Jerome D. Jabbour, Chief Executive Officer of Matinas. "Our Company, as well as I personally, have benefited greatly from his extensive expertise and deep relationships within the investment community.  On behalf of our entire Board and senior management team, we are extremely grateful for Adam's dedication and commitment over these past seven years, and I am thrilled that we will be able to continue to work closely with Adam in his new role."

    "I am extremely grateful to Jerry, as well as the entire Board of Directors, for the opportunity to serve the Company as a board member," commented Adam Stern.  "I believe that Matinas is extremely well-positioned for the future and look forward to continuing to help the Company.  I would also like to welcome Natasha Giordano to the Matinas family. Her significant commercial expertise comes at exactly the right time and makes her an ideal board member at this pivotal time for the Company."

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance the standard of care for patients in areas of significant unmet medical need.  Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nano-crystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them more targeted, less toxic and orally bioavailable. 

    MAT2203, the Company's lead product candidate utilizing its LNC platform, is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, to treat serious invasive fungal infections.  MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis, with potential cohort progression anticipated in the fourth quarter of 2020. 

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts



    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

    Primary Logo

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  30. BEDMINSTER, N.J., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to participate on a panel of top innovators in anti-infective drug development as part of Maxim Group's M-VEST Virtual Conference Series.

    Date: Thursday, September 17, 2020

    Panel details: A discussion among CEOs of top anti-fungal innovators, moderated by Maxim Group analyst, Jason McCarthy, Ph.D.

    Time: 11:00 a.m. ET

    Panel title: A Too Quiet Pandemic – Fungal Disease

    A live audio webcast of the panel discussion will be available on the Events page of the Investors section of the Company's website (www.matinasbiopharma.com) and at…

    BEDMINSTER, N.J., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to participate on a panel of top innovators in anti-infective drug development as part of Maxim Group's M-VEST Virtual Conference Series.

    Date: Thursday, September 17, 2020

    Panel details: A discussion among CEOs of top anti-fungal innovators, moderated by Maxim Group analyst, Jason McCarthy, Ph.D.

    Time: 11:00 a.m. ET

    Panel title: A Too Quiet Pandemic – Fungal Disease

    A live audio webcast of the panel discussion will be available on the Events page of the Investors section of the Company's website (www.matinasbiopharma.com) and at M-Vest. A webcast replay will be accessible for 90 days following the live presentation.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance the standard of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

    MAT9001, the Company's lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

    In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nano-crystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them more targeted, less toxic and orally bioavailable. 

    MAT2203, the Company's lead product candidate utilizing its LNC platform, is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis, with potential cohort progression anticipated in the fourth quarter of 2020. 

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts



    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

    Primary Logo

    View Full Article Hide Full Article
  31. BEDMINSTER, N.J., Aug. 27, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that it has completed enrollment in the ENHANCE-IT Study (Pharmacodynamic Effects of a Free Fatty Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in Adults with Hypertriglyceridemia), a second head-to-head comparative study of MAT9001 against Vascepa®. The ENHANCE-IT study is assessing MAT9001's effectiveness in reducing triglyceride levels and other important lipid markers, as well as characterizing bioavailability and blood levels of eicosapentaenoic acid (EPA) and other omega-3 fatty acids. The Company expects to have topline data available in the first quarter of 2021.

    "Successful completion of ENHANCE-IT…

    BEDMINSTER, N.J., Aug. 27, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that it has completed enrollment in the ENHANCE-IT Study (Pharmacodynamic Effects of a Free Fatty Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in Adults with Hypertriglyceridemia), a second head-to-head comparative study of MAT9001 against Vascepa®. The ENHANCE-IT study is assessing MAT9001's effectiveness in reducing triglyceride levels and other important lipid markers, as well as characterizing bioavailability and blood levels of eicosapentaenoic acid (EPA) and other omega-3 fatty acids. The Company expects to have topline data available in the first quarter of 2021.

    "Successful completion of ENHANCE-IT enrollment is a key milestone for Matinas, and this study will provide important data for both MAT9001 and Vascepa. We believe the data generated in this clinical trial should further differentiate MAT9001's superior clinical profile over Vascepa. The data from ENHANCE-IT will be an important addition to our understanding of the rapidly-growing omega-3 class and help guide the future treatment of patients with cardiovascular disease and elevated triglycerides," commented James J. Ferguson, M.D., Chief Medical Officer of Matinas. "The dedication and commitment of the clinical trial sites, the investigators, and the study participants allowed us to complete enrollment in less than three months during an otherwise challenging time. We eagerly anticipate completing the trial in 2020 and reporting topline data in early 2021."

    ENHANCE-IT is an open-label, randomized, 28-day crossover study assessing the pharmacodynamic effects of MAT9001 vs. Vascepa. The study is now fully enrolled and includes adult men and women with elevated triglycerides (150-499 mg/dL), with at least 50% of study subjects with TGs ≥ 200 mg/dL. The study protocol involves two 28-day treatment periods, with a washout period of at least 28 days in between treatments and is being conducted at eight sites in the United States. MAT9001 and Vascepa are each administered as 2g twice daily with food in accordance with currently approved Vascepa labeling. Lipid parameters (triglycerides, Total-, LDL-, VLDL-, HDL-, and non-HDL cholesterol, apolipoproteins A1, B and C3, and PCSK9) and omega-3 blood levels are being measured at each baseline and at the end of each treatment period. The primary endpoint is the percent change from baseline to end-of-treatment in plasma triglycerides.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on development of its lead product candidate, MAT9001, for the treatment of cardiovascular and metabolic conditions. MAT9001 is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia, that was specifically designed to overcome the shortcomings seen from other agents in the omega-3 class. Company leadership has a deep history and knowledge of cardiovascular drug development and is supported by a world-class team of scientific advisors.

    In addition, the Company is developing MAT2203, an oral, encochleated formulation of amphotericin B, to treat serious invasive fungal infections. The drug is based on Matinas' proprietary lipid nano-crystal (LNC) platform technology which can help solve complex challenges relating to the safe and effective delivery of potent medicines, potentially making them more targeted, less toxic and orally bioavailable. 

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts



    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

    Primary Logo

    View Full Article Hide Full Article
  32. BEDMINSTER, N.J., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced the publication of data from the Phase 1 portion of the EnACT (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) study for MAT2203, a novel oral formulation of amphotericin B, investigating its safety and tolerability. The data were published online in Antimicrobial Agents and Chemotherapy, (AAC), a journal of the American Society of Microbiology, in a manuscript entitled "Safety and tolerability of a novel oral formulation of amphotericin B: Phase I EnACT trial".

    "We were pleased with the safety and tolerability of MAT2203 as demonstrated in the Phase 1 trial. Moreover, we are excited about the Phase 2 trial…

    BEDMINSTER, N.J., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced the publication of data from the Phase 1 portion of the EnACT (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) study for MAT2203, a novel oral formulation of amphotericin B, investigating its safety and tolerability. The data were published online in Antimicrobial Agents and Chemotherapy, (AAC), a journal of the American Society of Microbiology, in a manuscript entitled "Safety and tolerability of a novel oral formulation of amphotericin B: Phase I EnACT trial".

    "We were pleased with the safety and tolerability of MAT2203 as demonstrated in the Phase 1 trial. Moreover, we are excited about the Phase 2 trial currently underway," commented David Boulware, M.D., M.P.H, Professor of Medicine at the University of Minnesota and Principal Investigator for the trial.

    In the published manuscript, trial investigators reported results from the Phase 1A and 1B portions of the study. They concluded that MAT2203 was well tolerated when given in 4-6 divided daily doses without the toxicities commonly seen with IV amphotericin B. 

    EnACT is a Phase 2 open-label, sequential cohort study of approximately 100 patients, financially supported by the National Institutes of Health, utilizing the Company's LNC platform delivery technology to orally deliver the traditionally IV-only fungicidal drug, amphotericin B. This study is a prospective, randomized trial evaluating the safety, tolerability and efficacy of MAT2203 in HIV-infected patients with cryptococcal meningitis, compared to treatment with standard IV-administered amphotericin B as induction therapy, and then followed by maintenance treatment with MAT2203.

    As previously reported, the U.S. Food and Drug Administration (FDA) has designated MAT2203 as a Qualified Infectious Disease Product (QIDP) with Fast Track status for four indications, specifically, the prevention of invasive fungal infections due to immunosuppressive therapy, and the treatment of invasive candidiasis, invasive aspergillus and cryptococcal meningitis. In addition, the FDA has granted orphan drug designation to MAT2203 for the treatment of cryptococcosis.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on development of its lead product candidate, MAT9001, for the treatment of cardiovascular and metabolic conditions. MAT9001 is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia, that was specifically designed to overcome the shortcomings seen from other agents in the omega-3 class. Company leadership has a deep history and knowledge of cardiovascular drug development and is supported by a world-class team of scientific advisors.

    In addition, the Company is developing MAT2203, an oral, encochleated formulation of amphotericin B, to treat serious invasive fungal infections. The drug is based on Matinas' proprietary lipid nano-crystal (LNC) platform technology which can help solve complex challenges relating to the safe and effective delivery of potent medicines, potentially making them more targeted, less toxic and orally bioavailable. 

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts 



    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

    Primary Logo

    View Full Article Hide Full Article
  33. – ENHANCE-IT study of MAT9001 against Vascepa® expected to be fully enrolled in August 2020; topline data anticipated Q1 2021 –

    – EnACT study of MAT2203 in cryptococcal meningitis resumed enrollment; on track for potential cohort progression Q4 2020 –

    – Management to host conference call today, Monday, August 10th, at 4:30 p.m. ET –

    BEDMINSTER, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2020, along with a corporate update and outlook for 2020.

    "We are pleased to announce that both the ENHANCE-IT study of MAT9001 and the EnACT study of MAT2203 have resumed rapid enrollment after…

    – ENHANCE-IT study of MAT9001 against Vascepa® expected to be fully enrolled in August 2020; topline data anticipated Q1 2021 –

    – EnACT study of MAT2203 in cryptococcal meningitis resumed enrollment; on track for potential cohort progression Q4 2020 –

    – Management to host conference call today, Monday, August 10th, at 4:30 p.m. ET –

    BEDMINSTER, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2020, along with a corporate update and outlook for 2020.

    "We are pleased to announce that both the ENHANCE-IT study of MAT9001 and the EnACT study of MAT2203 have resumed rapid enrollment after a temporary pause due to the COVID-19 pandemic," commented Jerome D. Jabbour, Chief Executive Officer of Matinas. "We continued meaningful progress across our business in the first half of 2020, despite challenging circumstances and conditions. As we look ahead to the second half of 2020 and into 2021, we are well positioned and approaching a number of important catalysts and milestones for the Company and our lead product candidates. We expect potential cohort progression in EnACT in the fourth quarter of this year and topline data from ENHANCE-IT in the first quarter of 2021. In addition, our team continues to advance our key collaborations with our partners applying our LNC platform, as well as identifying opportunities and advancing discussions on potential new applications for this promising and unique delivery technology."

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

    • Rapidly approaching completion of enrollment in ENHANCE-IT (Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in Adults with Hypertriglyceridemia), a second head-to-head comparative study of MAT9001 vs. Vascepa. Enrollment resumed in early June after having temporarily paused in the first quarter of 2020 due to the COVID-19 pandemic. The Company expects to complete enrollment in ENHANCE-IT in August and have topline data available in the first quarter of 2021.

       
    • The Company remains on track to meet with the U.S. Food and Drug Administration (FDA) in an End-of-Phase 2 meeting. During this meeting, the Company will discuss data from the completed comparative clinical bridging bioavailability study and 90-day comparative toxicology study to support a potential 505(b)(2) registration pathway. In addition, the Company will review and seek approval for the protocol for a planned Phase 3 trial of MAT9001 in patients with severe hypertriglyceridemia.  

    ENHANCE-IT is an open-label, randomized, 28-day crossover study to assess the pharmacodynamic (PD) effects of MAT9001 vs. Vascepa. The study will enroll approximately 100 adult men and women with elevated triglycerides (150-499 mg/dL), with at least 50% of study subjects with TGs ≥ 200 mg/dL. The study will consist of two 28-day treatment periods, with a washout period of at least 28 days in-between treatments and will be conducted at eight sites in the United States. MAT9001 and Vascepa will each be administered as 2g twice daily with food in accordance with currently approved Vascepa labeling. Measurements of lipid parameters (triglycerides, Total-, LDL-, VLDL-, HDL-, and non-HDL cholesterol, apolipoproteins A1, B and C3, and PCSK9) and omega-3 blood levels will be obtained at each baseline and at the end of each treatment period. The primary endpoint is the percent change from baseline to end-of-treatment in plasma triglycerides.

    MAT2203 Program Update (orally bioavailable amphotericin B, with targeted delivery, under development for the treatment and prevention of invasive fungal infections, including cryptococcal meningitis)  

    • Enrollment has resumed in the EnACT (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) study for the treatment of HIV-infected patients with cryptococcal meningitis after temporary suspension by mandate of the Uganda National Drug Authority due to the COVID-19 Pandemic earlier this year. 



    • To date, several patients have been randomized and dosed in the first cohort of 10 patients in the Phase 2 portion of EnACT. The Company expects to make an announcement as to potential progression from the first cohort of patients to the second cohort of 40 patients during the fourth quarter of 2020. More complete data from EnACT could be available in the second half of 2021, depending on the progression of patients through each cohort.

    EnACT is a Phase 2 open-label, sequential cohort study of approximately 100 patients, financially supported by the National Institutes of Health (NIH), utilizing the Company's LNC platform delivery technology to orally deliver the traditionally IV-only fungicidal drug, amphotericin B. This study is a prospective, randomized trial evaluating the safety, tolerability and efficacy of MAT2203 in HIV-infected patients with cryptococcal meningitis, compared to treatment with standard IV-administered amphotericin B as induction therapy, and then followed by maintenance treatment with MAT2203.

    The induction period for all patients will be 14 days, followed by an additional 4 weeks of treatment with MAT2203 during the maintenance period. In total, there will be four cohorts of patients, with each cohort increasing the treatment duration of MAT2203 vs. IV amphotericin B. The first cohort of 10 patients will be administered IV amphotericin for the first five days of the induction period, followed by nine days of oral administration of MAT2203. The primary efficacy endpoint will be measured at Day 14, the last day of the induction period and will include a measure of reduction in fungal count in the cerebral spinal fluid. An independent DSMB will review all data for safety and efficacy and make the recommendation to proceed to the next cohort of patients. 

    Second Quarter 2020 Financial Results

    Cash, cash equivalents and marketable securities at June 30, 2020 were approximately $68.0 million, compared to $27.8 million at December 31, 2019. In January 2020, the Company sold an aggregate of 32,260,000 shares of its common stock at a price of $1.55 per share for net proceeds of approximately $46.7 million, after deducting underwriting discounts and commissions and other offering expenses. Based on current projections, the Company continues to believe that cash on hand is sufficient to fund operations into the first half of 2023.

    For the second quarter of 2020, net loss attributable to common shareholders was $5.8 million, or a net loss of $0.03 per share (basic and diluted), compared to a net loss attributable to common shareholders of $3.6 million, or a net loss of $0.03 per share (basic and diluted) for the same period in 2019. The increase in net loss attributable to common shareholders was due primarily to an increase in operating expenses.

    Research and development (R&D) expenses for the second quarter of 2020 were $3.4 million, compared to $2.8 million for the same period in 2019. The increase was due primarily to higher clinical development expenses and employee compensation related to the development of MAT9001 and MAT2203.

    General and administrative (G&A) expenses for the second quarter of 2020 were $2.4 million, compared to $1.8 million in the same period in 2019. The increase was due primarily to higher employee compensation expense associated with increased headcount.

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



    Conference Call and Webcast Details



    The Company will host a live conference call and webcast to discuss these results on Monday, August 10, 2020, at 4:30 p.m. ET.



    To participate in the call, please dial (877) 407-5976 (domestic) or (412) 902-0031 (international). The live webcast will be available on the Events page of the Investors section of the Company's website (www.matinasbiopharma.com) and archived for 60 days

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on development of its lead product candidate, MAT9001, for the treatment of cardiovascular and metabolic conditions. MAT9001 is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia, that was specifically designed to overcome the shortcomings seen from other agents in the omega-3 class. Company leadership has a deep history and knowledge of cardiovascular drug development and is supported by a world-class team of scientific advisors.

    In addition, the Company is developing MAT2203, an oral, encochleated formulation of amphotericin B, to treat serious invasive fungal infections. The drug is based on the Company's proprietary lipid nano-crystal (LNC) platform delivery technology, which can help solve complex challenges relating to the safe and effective delivery of potent medicines, potentially making them more targeted, less toxic and orally bioavailable.

    Forward Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.



    Matinas BioPharma Holdings Inc.

    Condensed Consolidated Balance Sheets

      June 30, 2020  December 31, 2019 
      (Unaudited)  (Audited) 
    ASSETS:        
    Current assets:        
    Cash and cash equivalents $14,903,928  $22,170,438 
    Marketable securities  53,053,709   5,604,634 
    Restricted cash  200,000   250,000 
    Prepaid expenses and other current assets  1,051,219   1,897,784 
    Total current assets  69,208,856   29,922,856 
             
    Non-current assets:        
    Leasehold improvements and equipment - net  1,639,575   1,749,259 
    Operating lease right-of-use assets - net  3,523,298   3,761,207 
    Finance lease right-of-use assets - net  75,290   116,968 
    In-process research and development  3,017,377   3,017,377 
    Goodwill  1,336,488   1,336,488 
    Restricted cash - security deposits  286,000   336,000 
    Total non-current assets  9,878,028   10,317,299 
    Total assets $79,086,884  $40,240,155 
             
    LIABILITIES AND STOCKHOLDERS' EQUITY:        
             
    Current liabilities:        
    Accounts payable $494,577  $679,310 
    Accrued expenses  1,434,880   1,939,510 
    Operating lease liabilities - current  443,801   423,741 
    Financing lease liabilities - current  34,573   54,673 
    Total current liabilities  2,407,831   3,097,234 
             
    Non-current liabilities:        
    Deferred tax liability  341,265   341,265 
    Operating lease liabilities - net of current portion  3,474,739   3,695,561 
    Financing lease liabilities - net of current portion  38,378   54,513 
    Total non-current liabilities  3,854,382   4,091,339 
    Total liabilities  6,262,213   7,188,573 
             
    Stockholders' equity:        
    Series B Convertible preferred stock  3,964,034   3,985,805 
             
    Common stock  19,886   16,315 
    Additional paid-in capital  164,079,847   113,427,897 
    Accumulated deficit  (95,716,800)  (84,377,555)
    Accumulated other comprehensive income/(loss)  477,704   (880)
    Total stockholders' equity  72,824,671   33,051,582 
    Total liabilities and stockholders' equity $79,086,884  $40,240,155 



    Matinas BioPharma Holdings, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    Unaudited

      Three Months Ended June 30,  Six Months Ended June 30, 
      2020  2019  2020  2019 
    Revenue:                
    Contract research revenue $-  $89,812  $-  $89,812 
    Costs and expenses:                
    Research and development  3,410,237   2,828,776   7,497,120   5,143,477 
    General and administrative  2,356,310   1,781,717   4,615,941   3,570,131 
                     
    Total costs and expenses  5,766,547   4,610,493   12,113,061   8,713,608 
                     
    Loss from operations  (5,766,547)  (4,520,681)  (12,113,061)  (8,623,796)
    Sale of New Jersey net operating loss  -   1,007,082   1,073,289   1,007,082 
    Other income/(expense), net  156,000   168,872   383,327   221,279 
                     
    Net loss $(5,610,547) $(3,344,727) $(10,656,445) $(7,395,435)
                     
    Preferred stock series A accumulated dividends  -   (146,786)  -   (293,572)
    Preferred stock series B accumulated dividends  (177,092)  (115,750)  (347,792)  (234,000)
                     
    Net loss attributable to common shareholders $(5,787,639) $(3,607,263) $(11,004,237) $(7,923,007)
                     
    Net loss available for common shareholders per share - basic and diluted $(0.03) $(0.03) $(0.06) $(0.06)
    Weighted average common shares outstanding - basic and diluted  197,601,500   143,104,941   194,636,326   130,306,907 
    Other comprehensive (loss)/income, net of tax                
    Net unrealized (loss)/gain on securities available-for-sale  (41,954  -   481,303   - 
    Reclassifications to net loss  (2,708  -   (2,719  - 
    Other comprehensive (loss)/income, net of tax  (44,662  -   478,584   - 
    Comprehensive loss attributable to shareholders $(5,655,209) $(3,344,727) $(10,177,861) $(7,395,435)



    Investor and Media Contacts

    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

    Source: Matinas BioPharma Holdings, Inc.

    Primary Logo

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  34. BEDMINSTER, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to participate in a fireside chat during the BTIG Virtual Biotech Conference 2020 on Tuesday, August 11, 2020 at 9:00 a.m. ET.

    Mr. Jabbour will also host investor meetings during the conference. Investors interested in arranging a virtual meeting with the Company's management during this conference should contact the conference coordinator.

    A live webcast of the panel discussion will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following…

    BEDMINSTER, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to participate in a fireside chat during the BTIG Virtual Biotech Conference 2020 on Tuesday, August 11, 2020 at 9:00 a.m. ET.

    Mr. Jabbour will also host investor meetings during the conference. Investors interested in arranging a virtual meeting with the Company's management during this conference should contact the conference coordinator.

    A live webcast of the panel discussion will be available on the IR Calendar page of the Investors section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following the live presentation.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on development of its lead product candidate, MAT9001, for the treatment of cardiovascular and metabolic conditions. MAT9001 is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia, that was specifically designed to overcome the shortcomings seen from other agents in the omega-3 class. Company leadership has a deep history and knowledge of cardiovascular drug development and is supported by a world-class team of scientific advisors.

    In addition, the Company is developing MAT2203, an oral, encochleated formulation of amphotericin B, to treat serious invasive fungal infections. The drug is based on the Company's proprietary lipid nano-crystal (LNC) platform delivery technology, which can help solve complex challenges relating to the safe and effective delivery of potent medicines, potentially making them more targeted, less toxic and orally bioavailable. 

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts

    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

    Primary Logo

    View Full Article Hide Full Article
  35. BEDMINSTER, N.J., July 28, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. ("Matinas BioPharma" or the "Company") -- (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Monday, August 10, 2020 at 4:30 p.m. ET to discuss operational and financial results for the second quarter ended June 30, 2020.

    To participate in the call, please dial (877) 407-5976 (domestic) or (412) 902-0031 (international). The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and will be archived for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on…

    BEDMINSTER, N.J., July 28, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. ("Matinas BioPharma" or the "Company") -- (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Monday, August 10, 2020 at 4:30 p.m. ET to discuss operational and financial results for the second quarter ended June 30, 2020.

    To participate in the call, please dial (877) 407-5976 (domestic) or (412) 902-0031 (international). The live webcast will be accessible on the Investors section of Matinas' website, www.matinasbiopharma.com, and will be archived for 90 days.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on development of its lead product candidate, MAT9001, for the treatment of cardiovascular and metabolic conditions. MAT9001 is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia, that was specifically designed to overcome the shortcomings seen from other agents in the omega-3 class. Company leadership has a deep history and knowledge of cardiovascular drug development and is supported by a world-class team of scientific advisors.

    In addition, the Company is developing MAT2203, an oral, encochleated formulation of amphotericin B, to treat serious invasive fungal infections. The drug is based on the Company's proprietary lipid nano-crystal (LNC) platform delivery technology, which can help solve complex challenges relating to the safe and effective delivery of potent medicines, potentially making them more targeted, less toxic and orally bioavailable. 

    Forward Looking Statements:

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contact

    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

    Source: Matinas BioPharma Holdings, Inc.

    Primary Logo

    View Full Article Hide Full Article
  36. -   Topline data from ENHANCE-IT study of MAT9001 vs. Vascepa® expected in Q1 2021   - 

    -   EnACT remains on track for cohort progression in Q4 2020   -

    BEDMINSTER, N.J., June 30, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that it has commenced enrollment and started dosing patients in the ENHANCE-IT study and that it expects to resume dosing patients in the EnACT study imminently, following the recent receipt of necessary governmental and regulatory approvals in Uganda.  Both studies had temporarily paused enrollment in March due to the COVID-19 pandemic.

    "I am extremely pleased with our execution and progress during a period of significant uncertainty, given all of the ramifications of…

    -   Topline data from ENHANCE-IT study of MAT9001 vs. Vascepa® expected in Q1 2021   - 

    -   EnACT remains on track for cohort progression in Q4 2020   -

    BEDMINSTER, N.J., June 30, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that it has commenced enrollment and started dosing patients in the ENHANCE-IT study and that it expects to resume dosing patients in the EnACT study imminently, following the recent receipt of necessary governmental and regulatory approvals in Uganda.  Both studies had temporarily paused enrollment in March due to the COVID-19 pandemic.

    "I am extremely pleased with our execution and progress during a period of significant uncertainty, given all of the ramifications of the ongoing COVID-19 pandemic. Resuming enrollment in both ENHANCE-IT and EnACT were critical milestones for our Company and position us to deliver potentially clinically meaningful Phase 2 data for our lead products relatively quickly," stated Jerome D. Jabbour, Chief Executive Officer of Matinas. "We believe we have taken the appropriate steps to ensure the safety of clinical trial participants and caregivers and we remain grateful for their commitment to our important clinical work. We look forward to completing these studies within our previously communicated timelines and believe each study represents a significant value-creating opportunity."

    ENHANCE-IT Study Update

    • In early June, the Company resumed enrollment and began dosing patients in the ENHANCE-IT (Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in Adults with Hypertriglyceridemia) trial, a head-to-head study of MAT9001 vs. Vascepa.



    • The Company expects to complete enrollment in August of 2020, with topline data available in the first quarter of 2021. 

    EnACT Study Update

    • In late June, Matinas received approval from the Uganda National Drug Authority to restart the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) and is preparing to begin dosing patients imminently. The first cohort of patients is expected to fully enroll by early September based upon projections from Dr. David Boulware, the Principal Investigator for the EnACT trial.



    • Evaluation of data from the first cohort of patients by the independent Data and Safety Monitoring Board and anticipated progression from the first patient cohort to the second patient cohort is expected during the fourth quarter of 2020.

    About Matinas BioPharma

    Matinas BioPharma is a clinical-stage biopharmaceutical company focused on development of its lead product candidate, MAT9001, for the treatment of cardiovascular and metabolic conditions. MAT9001 is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia, that was specifically designed to overcome the shortcomings seen from other agents in the omega-3 class. Company leadership has a deep history and knowledge of cardiovascular drug development and is supported by a world-class team of scientific advisors.

    In addition, the Company is developing MAT2203, an oral, encochleated formulation of amphotericin B, to treat serious invasive fungal infections. The drug is based on the Company's proprietary lipid nano-crystal (LNC) platform delivery technology, which can help solve complex challenges relating to the safe and effective delivery of potent medicines, potentially making them more targeted, less toxic and orally bioavailable. 

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company's ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

    Investor and Media Contacts



    Peter Vozzo

    Westwicke

    443-213-0505

    peter.vozzo@westwicke.com



    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    icooney@matinasbiopharma.com

    Primary Logo

    View Full Article Hide Full Article
  37. BEDMINSTER, N.J., May 26, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to present a company overview during the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020 at 8:00 a.m. ET.

    Mr. Jabbour will also host investor meetings during the conference. Investors interested in arranging a virtual meeting with the Company's management during this conference should contact the conference coordinator.

    A live webcast of the panel discussion will be available on the IR Calendar page of the Investors  section of the Company's website (www.matinasbiopharma.com). A webcast replay will be accessible for 90 days following the live…