Current Report Filing (8-k)
28 December 2020 - 10:51PM
Edgar (US Regulatory)
0001582554
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0001582554
2020-12-28
2020-12-28
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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 28, 2020
MATINAS BIOPHARMA HOLDINGS, INC.
(Exact name of registrant as specified in
its charter)
Delaware
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001-38022
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46-3011414
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(State
or other jurisdiction
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(Commission
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(IRS
Employer
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of
incorporation)
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File
Number)
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ID
Number)
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1545
Route 206 South, Suite 302
Bedminster,
New Jersey
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07921
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(Address
of principal executive offices)
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(Zip
Code)
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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
(see General Instruction A.2. below):
☐
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Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b)
of the Act:
Title
of Each Class
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Trading
Symbol
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Name
of Each Exchange on Which Registered
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Common Stock
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MTNB
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NYSE American
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Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the
Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by
check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Recently, the Company became
aware that one of its contract manufacturers of MAT9001 suffered an explosion at its manufacturing facilities in Asia. None of
the Company’s key omega-3 intermediates stored at the facility were damaged or destroyed. The Company is in the process of
determining the impact, if any, on the future manufacture of MAT9001 for use in the Company’s planned Phase 3 AMPLIFY trial
in patients with severe hypertriglyceridemia, which is currently scheduled to commence in the second half of 2021. The Company’s
head-to-head ENHANCE-IT trial of MAT9001 vs. Amarin’s Vascepa® is not affected by this incident and is scheduled to report
topline data in the first quarter of 2021.
Forward-Looking Statements
This Report on Form 8-K
contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including
those relating to the impact of the damage to one of the Company’s contract manufacturers of MAT9001 and potential impact
on the commencement of the Company’s Phase 3 AMPLIFY trial, 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 Report on
Form 8-K. 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.
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.
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MATINAS
BIOPHARMA HOLDINGS, INC.
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Dated:
December 28, 2020
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By:
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/s/
Jerome D. Jabbour
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Name:
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Jerome
D. Jabbour
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Title:
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Chief
Executive Officer
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