Item 7.01 Regulation FD Disclosure.

Matinas BioPharma Holdings, Inc. (the "Company") issued a press release announcing that the independent Data and Safety Monitoring Board ("DSMB") of its EnACT trial (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) ("EnACT Trial") of MAT2203 (oral amphotericin B) for the treatment of cryptococcal meningitis has completed a pre-specified review of the third cohort of patients in the EnAct Trial and unanimously recommended progression to the fourth and final cohort of patients. A copy of the press release is furnished as Exhibit 99. 1 hereto and incorporated herein by reference.

The information in this Item 7.01 and Exhibit 99.1 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 December 16, 2021, the Company announced that the DSMB of its EnACT Trial has completed a pre-specified review of the third cohort of patients in the EnAct Trial and unanimously recommended progression to the fourth and final cohort of patients. Enrollment in the next randomized EnACT cohort, with 40 active-treatment patients, is expected to begin in the first quarter of 2022. Cohort 3 of the ENACT Trial tested whether commencing therapy with an all-oral regimen of amphotericin and flucytosine was possible. Participants in the EnACT Trial received 5 days of oral combination therapy before a scheduled switch to intravenous amphotericin. In this cohort with 10 participants receiving MAT2203, the direct antifungal therapy activity measured in cerebrospinal fluid was above the pre-defined target threshold for success.





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 results of the EnACT Trial, 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 may be identified by the use of forward-looking expressions, including, but not limited to, "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; the Company's 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 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 hereof. 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. The Company's product candidates are all in a development stage and are not available for sale or use.





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Item 9.01 Financial Statements and Exhibits.






Exhibit No.   Description
99.1            Press Release, dated December 16, 2021
104           Cover Page Interactive Data File (embedded within the Inline XBRL
              document)




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