MTNB Matinas Biopharma Holdings Inc.

0.93
+0.04  (+5%)
Previous Close 0.89
Open 0.93
52 Week Low 0.49
52 Week High 2.49
Market Cap $184,793,235
Shares 198,873,477
Float 184,060,179
Enterprise Value $113,704,521
Volume 2,785,983
Av. Daily Volume 2,445,202
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Upcoming Catalysts

Drug Stage Catalyst Date
MAT2203 (EnACT)
Cryptococcal meningitis
Phase 1/2
Phase 1/2
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MAT9001 (ENHANCE-IT)
Severe hypertriglyceridemia
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
MAT2203
Vulvovaginal candidiasis (VVC)
Phase 2
Phase 2
Phase 2 (part 2) to commence 1Q 2020.

Latest News

  1. 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

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    Primary Logo

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  2. 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

    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    Source: Matinas BioPharma Holdings, Inc.

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  3. -   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





    Ian Cooney

    Director – Investor Relations & Corporate Development

    Matinas Biopharma, Inc.

    (415) 722-4563

    Primary Logo

    View Full Article Hide Full Article
  4. 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…

    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 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

    Ian Cooney
    Director – Investor Relations & Corporate Development
    Matinas Biopharma, Inc.
    (415) 722-4563

    Primary Logo

    View Full Article Hide Full Article
  5. – ENHANCE-IT study of MAT9001 against Vascepa® set to resume in June 2020 –

    – EnACT study of MAT2203 in cryptococcal meningitis expected to resume in June 2020 –

    – Management to host conference call today, Monday, May 11th, at 4:30 p.m. ET –

    BEDMINSTER, N.J., May 11, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company, today reported financial results for the first quarter ended March 31, 2020, along with a corporate update and outlook for 2020.

    "During the past few months, our team has worked diligently to adjust to the impacts of the COVID-19 pandemic. We believe we have taken all appropriate and necessary steps to ensure the safety of clinical trial participants and caregivers…

    – ENHANCE-IT study of MAT9001 against Vascepa® set to resume in June 2020 –

    – EnACT study of MAT2203 in cryptococcal meningitis expected to resume in June 2020 –

    – Management to host conference call today, Monday, May 11th, at 4:30 p.m. ET –

    BEDMINSTER, N.J., May 11, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company, today reported financial results for the first quarter ended March 31, 2020, along with a corporate update and outlook for 2020.

    "During the past few months, our team has worked diligently to adjust to the impacts of the COVID-19 pandemic. We believe we have taken all appropriate and necessary steps to ensure the safety of clinical trial participants and caregivers, to preserve trial integrity and to ensure successful delivery of clinically meaningful data," commented Jerome D. Jabbour, Chief Executive Officer of Matinas. "We are pleased to announce today that we expect to resume both the ENHANCE-IT study of MAT9001 and the EnACT study of MAT2203 in June of 2020. With these adjusted timelines, we now anticipate announcing cohort progression in EnACT in the second half of this year and topline data from the ENHANCE-IT study in the first quarter of 2021. We believe each of these studies represent important milestones for our Company, and we remain focused on advancing these clinical studies as rapidly and carefully as possible."

    Mr. Jabbour added, "Overall, the COVID-19 pandemic has not had a material impact on our business, and we remain in a strong financial position. Based on current projections, we have sufficient cash resources to fund our operations into the first half of 2023, well beyond potentially clinically meaningful data points for our clinical stage product candidates."  

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

    • 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, was temporarily paused in the first quarter of 2020. The Company expects to resume enrollment in June of 2020, with topline data available in the first quarter of 2021.  
    • In an effort to help mitigate the impact COVID-19 has had on timelines for the ENHANCE-IT trial, the Company has increased the number of clinical trial sites from 6 to 8 in order to facilitate rapid enrollment. In addition, the Company has selected a number of back-up clinical trial sites to reduce the risk for any further disruptions. 
    • The Company is actively preparing for an End-of-Phase 2 meeting with the Food and Drug Administration (FDA), which is expected to occur in the third quarter of 2020.  Central to this FDA interaction are the recently completed comparative clinical bridging bioavailability study and a 90-day comparative toxicology study to support a 505(b)(2) registration pathway. During this meeting, the Company will also review the protocol for the planned Phase 3 registration 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 approximately eight sites in the United States. MAT9001 and Vascepa will each be administered 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 (intracellular delivery of potentially life-saving medicines)

    • During the first quarter of 2020, enrollment of new patients into the efficacy phase of the EnACT (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) study for the treatment of HIV-infected patients with cryptococcal meningitis was temporarily suspended by mandate of the Uganda National Drug Authority due to the COVID-19 pandemic. The two patients who had been enrolled and dosed in the efficacy phase were discontinued and transitioned onto standard of care therapy consistent with established guidelines. These actions were taken to mitigate any potential risk to the integrity of clinical data. 
    • Following discussion with the clinical site in Uganda, the Company believes that the EnACT study will resume in June 2020 with the first cohort of 10 patients.  Based upon this timeline, the Company expects to make an announcement as to progression from the first cohort of patients to the second cohort of patients during the second half of 2020. Full data from EnACT could be available in the second half of 2021, depending on the progression of patients through each cohort.

    EnACT is an 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. The part 2 efficacy phase 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, 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. The independent DSMB will review all data for safety and efficacy and make the recommendation to proceed to the next cohort of patients. 

    First Quarter 2020 Financial Results

    Cash, cash equivalents and marketable securities at March 31, 2020 were approximately $71.2 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 believes that cash on hand is sufficient to fund operations into the first half of 2023.

    For the first quarter of 2020, net loss attributable to common shareholders was $5.2 million, or a net loss per share of $0.03 (basic and diluted), compared to a net loss attributable to common shareholders of $4.3 million, or a net loss per share of $0.04 (basic and diluted) for the same period in 2019. The increase was due primarily to an increase in research and development expenses.

    Research and development (R&D) expenses for the first quarter of 2020 were $4.1 million, compared to $2.3 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 first quarter of 2020 were $2.3 million, compared to $1.8 million in the same period in 2019. The increase was due primarily to higher employee compensation expense.

    *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, May 11, 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
    (in thousands)

        March 31, 2020   December 31, 2019
        (Unaudited)   (Audited)
    ASSETS                
    Current assets:            
      Cash and cash equivalents   $   10,078     $   22,170  
      Marketable securities       61,090         5,605  
      Restricted cash - security deposits       150         250  
      Prepaid expenses and other current assets       2,671         1,898  
        Total current assets       73,989         29,923  
                 
    Non-current assets:            
      Leasehold improvements and equipment - net       1,698         1,750  
      Operating lease right-of-use assets - net       3,643         3,761  
      Finance lease right-of-use assets - net       94         117  
      In-process research and development       3,017         3,017  
      Goodwill       1,336         1,336  
      Restricted cash - security deposits       336         336  
        Total non-current assets       10,124         10,317  
          Total assets   $   84,113     $   40,240  
                 
    LIABILITIES AND STOCKHOLDERS' EQUITY:            
                 
    Current liabilities:            
      Accounts payable   $   953     $   679  
      Accrued expenses       1,106         1,939  
      Operating lease liabilities - current       441         424  
      Financing lease liabilities - current       43         55  
        Total current liabilities       2,543         3,097  
                 
    Non-current liabilities:            
      Deferred tax liability       341         341  
      Operating lease liabilities - net of current portion       3,579         3,696  
      Financing lease liabilities - net of current portion       47         55  
        Total non-current liabilities       3,967         4,092  
          Total liabilities       6,510         7,189  
                 
    Stockholders' equity:            
      Series B Convertible preferred stock     3,964         3,986  
      Common stock     20         16  
      Additional paid-in capital       162,520         113,428  
      Accumulated deficit       (89,423 )       (84,378 )
      Accumulated other comprehensive income/(loss)       522         (1 )
        Total stockholders' equity       77,603         33,051  
          Total liabilities and stockholders' equity $   84,113     $   40,240  
                 

    Matinas BioPharma Holdings, Inc.
    Condensed Consolidated Statements of Operations and Comprehensive Loss
    Unaudited
    (in thousands, except per share data)

          Three Months Ended March 31,
          2020     2019  
    Costs and expenses:            
      Research and development   $   4,087     $   2,315  
      General and administrative       2,260         1,788  
                   
      Total costs and expenses       6,347         4,103  
                   
    Loss from operations       (6,347 )       (4,103 )
                   
    Sale of New Jersey net operating loss       1,073         -   
    Other income, net       228         52  
    Net loss    $   (5,046 )    $   (4,051 )
                   
    Preferred stock series A accumulated dividends       -           (147 )
    Preferred stock series B accumulated dividends       (171 )       (118 )
                   
    Net loss attributable to common shareholders   $   (5,217 )    $   (4,316 )
                   
    Net loss available for common shareholders per share - basic and diluted   $   (0.03 )   $   (0.04 )
                   
    Weighted average common shares outstanding - basic and diluted       191,671         117,367  
                   
    Other comprehensive income/(loss), net of tax            
      Unrealized gains on securities available-for-sale       523         -   
      Other comprehensive income/(loss), net of tax       523         -   
    Comprehensive loss attributable to stockholders    $ (4,523 )   $ (4,051 )
                   

    Investor and Media Contact

    Peter Vozzo
    Westwicke
    443-213-0505

    Ian Cooney
    Director – Investor Relations & Corporate Development
    Matinas Biopharma, Inc.
    (415) 722-4563

    Source: Matinas BioPharma Holdings, Inc.

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