Current Report Filing (8-k)
January 30 2023 - 04:01PM
Edgar (US Regulatory)
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2023-01-30 iso4217:USD xbrli:shares iso4217:USD xbrli:shares
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):
January 30, 2023
MATINAS BIOPHARMA HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-38022 |
|
46-3011414 |
(State
or other jurisdiction
of
incorporation)
|
|
(Commission
File
Number)
|
|
(IRS
Employer
ID
Number)
|
1545 Route 206 South,
Suite 302
Bedminster,
New Jersey
|
|
07921 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code:
(908)
484-8805
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):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class |
|
Trading
Symbol |
|
Name
of Each Exchange on Which Registered |
Common Stock |
|
MTNB |
|
NYSE American |
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. ☐
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.
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. |
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● |
Successful
delivery of multiple larger nucleic acids coded with reporter genes
across multiple cell lines (HeLa, HEK293, A375, etc.). |
|
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● |
Multiple
oligonucleotide formulations that have demonstrated strong gene
expression potency at nanogram per well dosage level, comparable to
industry standard Lipofectamine. |
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● |
Internal
mRNA formulations that have shown excellent stability and remain
biologically active over 10 weeks at 4o C storage
conditions. |
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● |
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. |
|
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● |
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. |
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. |
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|
|
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● |
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. |
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● |
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. |
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. |
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.
|
MATINAS
BIOPHARMA HOLDINGS, INC. |
|
|
|
Dated:
January 30, 2023 |
By: |
/s/
Jerome D. Jabbour |
|
Name: |
Jerome
D. Jabbour |
|
Title: |
Chief
Executive Officer |
Matinas Biopharma (AMEX:MTNB)
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