UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 23, 2014

MATINAS BIOPHARMA HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Registrant’s telephone number, including area code: (908) 443-1860

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

On October 20, 2014, Matinas BioPharma Holdings, Inc. (the “Company”) submitted an Investigational New Drug application, or IND, to the United States Food and Drug Administration, or FDA, for its lead drug candidate, MAT9001, with an initial indication for the treatment of severe hypertriglyceridemia (TG>500 mg/dL).

Recently, the Company received feedback from FDA with respect to its IND submission for MAT9001. Although FDA did not raise any clinical hold issues, FDA has provided recommendations for certain revisions to the planned four-week rat comparative bridging toxicity study as well as the Company’s planned 4-way crossover single dose Fed/Fast PK study of MAT9001 in comparison to another omega-3 product. Previously, the Company had planned to initiate and complete each of these studies concurrently with its Phase III clinical study for MAT 9001. Based on FDA’s comments, the Company now intends to submit modified protocols for the four-week rat comparative bridging toxicity study, as well as the Company's 4-way crossover single dose Fed/Fast PK study early in the first quarter of 2015 and, following dialogue with FDA, to initiate and complete these two studies. There can be no guarantee that FDA will meet with the Company in a timely fashion. As such, there may be a delay in the commencement of these two studies and therefore in the commencement of the Company’s planned Phase III clinical study for MAT9001. As recommended by FDA, the Company will submit the results of these two studies to FDA for review and comment in advance of initiating dosing with MAT9001 in its planned Phase III clinical study. As previously disclosed, the final protocol and clinical trial design for the Company’s Phase III clinical program is also subject to FDA review and comment. In addition, the Company needs to raise at least $20.0 to $60.0 million of additional financing to initiate and complete its intended Phase III clinical program for MAT9001 and to compile and submit its New Drug Application (NDA) to FDA for MAT9001. We do not currently have any arrangements or credit facilities in place as a source of funds, and there can be no assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all. 

This Current Report on Form 8-K, including exhibit 99.1, contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, cash flow 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 successfully complete research and further development and commercialization of MAT9001; 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 for MAT9001; 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. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation. Matinas does not undertake any obligation to release publicly any revisions to such forward-looking statement to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma’s lead product candidate MAT9001 is in a development stage and is not available for sale or use.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautions not to place undue reliance on any forward-looking statements, which speak only as of the date of this Current Report on Form 8-K. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.