Item 7.01 Regulation FD Disclosure.

Matinas BioPharma Holdings, Inc. (the "Company") issued a press release providing a business update on each of its ongoing programs and discussing its strategic outlook for 2023. A copy of the press release is furnished as Exhibit 99. 1 hereto and incorporated herein by reference.

The Company also prepared an update presentation (the "Update Presentation"), which it intends to use for today's scheduled conference call and for future investor meetings. The Update Presentation is attached hereto as Exhibit 99.2 and incorporated herein by reference.

The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.




Item 8.01. Other Events.

On January 30, 2023, the Company announced, among other things, that:

LNC Platform Internal Data Generated





  ? Developed multiple flow cytometry and florescence cell-based assays with
    compelling validations of intracellular uptake and gene expression with our
    LNC formulations.

  ? Successful delivery of multiple larger nucleic acids coded with reporter genes
    across multiple cell lines (HeLa, HEK293, A375, etc.).

  ? Multiple oligonucleotide formulations that have demonstrated strong gene
    expression potency at nanogram per well dosage level, comparable to industry
    standard Lipofectamine.

  ? Internal mRNA formulations that have shown excellent stability and remain
    biologically active over 10 weeks at 4o C storage conditions.

  ? Multiple formulations have shown little to no cytotoxicity during in vitro
    cell viability evaluations supporting an anticipated favorable safety profile
    compared with other drug delivery technologies.

LNC Internal Pipeline Development





  ? Based on historical data with the LNC platform, along with recent learnings
    from internal work and its collaborations, the Company believes the greatest
    chance of success in developing our own pipeline of nucleic acid drug
    candidates is with smaller oligonucleotides like antisense oligonucleotides
    (ASOs) and small interfering or silencing RNA (siRNAs). The properties of
    these molecules are particularly suited for our LNC platform, and the Company
    believes that its technology can facilitate oral delivery and extrahepatic
    targeting - currently two of the greatest challenges in this developing area.

  ? The Company has commenced a research program focused on ASOs/siRNAs that it
    expects will generate in vitro delivery data early in the second quarter of
    this year, followed by multiple in vivo biodistribution and animal efficacy
    studies in the second half of 2023. If successful, the Company anticipates
    being in position to identify our next internal product candidate in late
    2023. The Company believes success in these studies could position it to
    develop an entire pipeline of ASO and siRNA therapies.




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MAT2203 (oral amphotericin B) Program





  ? In November 2022, the Biomedical Advanced Research and Development Authority
    (BARDA) announced an initiative seeking private sector partners developing
    late-stage, broad-spectrum antifungal drugs to treat high priority fungal
    infections, including aspergillus, mucormycosis, and certain forms of
    candidiasis. BARDA has solicited proposals from industry, and the Company
    believes MAT2203 is a strong candidate for funding based upon its oral,
    well-tolerated and broad-spectrum profile, along with its recent clinical
    success in Phase 2 with cryptococcal meningitis. The Company is scheduled to
    meet with BARDA during the first quarter of 2023 and has included all
    associated costs for full development for MAT2203 in its proposal. The Company
    believes pausing the start of its Phase 3 clinical trial in cryptococcal
    meningitis pending the outcome of BARDA's evaluation of MAT2203 is the best
    possible course for this life-saving drug. In 2021, BARDA funding for vaccines
    stood at $36.9 billion, therapeutics at $14.1 billion, and diagnostics at $51
    million.

  ? The Company is preparing to submit a formal Meeting Request to the U.S. Food
    and Drug Administration (FDA) to discuss plans for a second Phase 3 study to
    assess the efficacy, safety, and tolerability of MAT2203 in patients with
    serious, life-threatening invasive fungal infections with limited treatment
    options. The protocol synopsis currently includes the treatment of four
    invasive fungal infections: invasive aspergillosis, invasive candidiasis,
    chronic coccidioidomycosis (Valley Fever), and invasive Mucormycosis. The
    Company's strategy is to leverage the success and data from EnACT to limit the
    required size of this study. The Company currently plans to enroll
    approximately 100 patients in a single arm design with no head-to-head active
    comparator, which it believes should be acceptable given historical precedent
    and the challenges associated with the target patient population to be
    evaluated. The Company anticipates meeting with FDA in the second quarter of
    2023 to discuss its proposed design and strategy for approval. The Company
    believes that FDA guidance on this Phase 3 study is critical to its BARDA
    proposal as well as to prospective domestic and global partners currently
    evaluating MAT2203, based on feedback received to date.

  ? The success of MAT2203 in the EnACT Phase 2 clinical trial in cryptococcal
    meningitis has attracted the attention of clinicians and patients without
    viable options for the treatment of a variety of fungal infections for which
    amphotericin B may be suitable, except for significant concerns relating to
    the toxicity of the currently available intravenous formulations of
    amphotericin B. Currently, there are four (4) patients who have been approved
    by FDA to receive MAT2203 on an emergency use basis since August of 2022,
    including one patient suffering from both mucor and aspergillosis. Overall,
    these patients have responded well to treatment with notable clinical
    improvements. The Company will continue to evaluate opportunities to provide
    MAT2203 on an emergency basis for patients as it believes these are
    opportunities to showcase the safety and efficacy of MAT2203 outside clinical
    trial settings which represent important additional patient data for both FDA
    and prospective partners to review.




Financial Outlook



  ? The Company's preliminary estimate of cash, cash equivalents and marketable
    securities at December 31, 2022, is approximately $28.8 million, subject to
    completion of the audit of the Company's consolidated financial statements for
    the year ended December 31, 2023, compared to $49.6 million at December 31,
    2021. This amount may differ from the amount that will be reflected in the
    Company's audited 2022 financial statements. Additional information and
    disclosures are required for a more complete understanding of the Company's
    financial position and results of operations as of December 31, 2022. Based on
    current projections, the Company believes that cash on hand is sufficient to
    fund planned operations into the second quarter of 2024.




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Forward- Looking Statements

This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's business activities, the Company's strategy and plans, collaborations with National Resilience and BioNTech SE, the potential of its LNC platform delivery technology, and the future development of its product candidates, the Company's ability to identify and pursue development, licensing 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, the Company's ability to obtain additional capital to meet its liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of its product candidates; its ability to successfully complete research and further development and commercialization of its product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; the Company's ability to protect its 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.

Item 9.01 Financial Statements and Exhibits.






Exhibit No.   Description
99.1            Press Release, dated January 30, 2023.
99.2            2023 Business Update and Strategic Outlook Presentation, January
              30, 2023.
104           Cover Page Interactive Data File (embedded within the Inline XBRL
              document)




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