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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 27, 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.
On
December 27, 2023, Matinas BioPharma Holdings, Inc. (the “Company”) issued a press release announcing results from a series
of in vivo studies demonstrating successful oral delivery of two lipid nanocrystal (“LNC”)-formulated small single-strand
oligonucleotides that specifically target key inflammatory cytokines TNFα and IL-17A in well-established and validated animal models
that mimic acute inflammatory responses seen in human diseases. 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 21, 2023, the Company announced results from a series of in vivo studies demonstrating successful oral delivery of two
LNC-formulated small single-strand oligonucleotides that specifically target key inflammatory cytokines TNFα and IL-17A in well-established
and validated animal models that mimic acute inflammatory responses seen in human diseases.
Acute
Colitis Study (“TNFα”)
A
dextran sulfate sodium (“DSS”)-induced murine colitis model was used to evaluate an orally administered LNC-delivered small
oligonucleotide that specifically targets TNFα mRNA synthesis. Colon tissue TNFα mRNA levels, as assessed by quantitative
real-time PCR analysis, were lower following orally administered active LNCs, resulting in statistically significant reductions of serum
TNFα levels by 37% compared with diseased, but untreated animals. Importantly, clinical disease activity scores at key time points
in the studies were also significantly improved with an active LNC formulation.
Acute
Psoriasis Study (“IL-17A”)
An
imiquimod (“IMQ”)-induced murine psoriasis model was used to evaluate an orally administered, LNC-delivered small oligonucleotide
designed to inhibit IL-17A mRNA synthesis, which contributes significantly to the progression of psoriatic skin lesions. Similar to the
DSS colitis model, skin tissue levels of IL-17A mRNA in the IMQ psoriasis model were lower with orally administered active LNCs compared
with IMQ alone. In this model, while IL-17A serum levels were not expected to change, improvement was demonstrated in clinical disease
markers of skin redness and scaling, further validating the biological activity of these small oligonucleotides.
Additional
tissue and histologic analyses from both studies are ongoing and the Company plans to present these data at future scientific meetings.
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, the potential of the Company’s LNC platform
technology, and the future development of its product candidates, including MAT2203, the Company’s ability to identify and pursue
development, licensing and partnership opportunities for its products, including MAT2203, or platform delivery technologies 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.
These
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, the Company’s ability to continue as a going concern, 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; 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 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 the Company’s 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.
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:
December 27, 2023 |
By:
|
/s/
Jerome D. Jabbour |
| |
Name: |
Jerome
D. Jabbour |
| |
Title: |
Chief
Executive Officer |
Exhibit
99.1
Matinas
BioPharma Demonstrates in vivo Biological Activity and Disease Improvement in Two Inflammatory Disease Models with Oral LNC-Delivered
Small Oligonucleotides
In
an acute colitis model, data show statistically significant knockdown of elevated levels of serum TNFα, reductions in tissue TNFα
mRNA and improvement in disease activity scores
In
an acute psoriasis model, data show reductions in tissue IL-17A mRNA and improvement in clinical disease markers including skin lesions
BEDMINSTER,
N.J. (December 27, 2023) – Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a clinical-stage biopharmaceutical
company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform technology, announces results from
a series of in vivo studies demonstrating successful oral delivery of two LNC-formulated small single-strand oligonucleotides
that specifically target key inflammatory cytokines TNFα and IL-17A in well-established and validated animal models that mimic
acute inflammatory responses seen in human diseases.
“These
studies demonstrate successful oral delivery and biological activity of two different LNC-formulated small oligonucleotides targeting
inflammatory cytokines with reductions in tissue cytokine mRNA in both colitis and psoriasis, along with significant reductions in serum
TNFα levels in colitis. Commensurate improvements in clinical disease markers and scores were also documented in both models,”
said James Ferguson, M.D., Matinas’ Chief Medical Officer.
“While
additional study is warranted, the successful oral delivery of small oligonucleotides is very exciting and we believe these data demonstrate
how Matinas’ LNC platform could be used for the oral delivery of functional small oligonucleotides with potential therapeutic applications,”
Dr. Ferguson added. “Importantly, the unique nature of the particular oligonucleotides evaluated in these studies, which interfere
with cytokine synthesis rather than simply targeting the cytokine itself, creates additional opportunities for potential future applications
of LNC-delivered therapeutics, either alone or in combination with other therapeutics with different mechanisms of action.”
Earlier
this year, Matinas established the in vitro potency of these proprietary oligonucleotides and their LNC formulations in knocking
down their respective cytokine targets in cultured cells. Both were advanced to in vivo studies to evaluate meaningful biological
activity in relevant disease models.
Acute
Colitis Study (TNFα)
A
dextran sulfate sodium (DSS)-induced murine colitis model was used to evaluate an orally administered LNC-delivered small oligonucleotide
that specifically targets TNFα mRNA synthesis. Colon tissue TNFα mRNA levels, as assessed by quantitative real-time PCR analysis,
were lower following orally administered active LNCs, resulting in statistically significant reductions of serum TNFα levels by
37% compared with diseased, but untreated animals. Importantly, clinical disease activity scores at key time points in the studies were
also significantly improved with an active LNC formulation.
Acute
Psoriasis Study (IL-17A)
An
imiquimod (IMQ)-induced murine psoriasis model was used to evaluate an orally administered, LNC-delivered small oligonucleotide designed
to inhibit IL-17A mRNA synthesis, which contributes significantly to the progression of psoriatic skin lesions. Similar to the DSS colitis
model, skin tissue levels of IL-17A mRNA in the IMQ psoriasis model were lower with orally administered active LNCs compared with IMQ
alone. In this model, while IL-17A serum levels were not expected to change, improvement was demonstrated in clinical disease markers
of skin redness and scaling, further validating the biological activity of these small oligonucleotides.
Additional
tissue and histologic analyses from both studies are ongoing and the Company plans to present these data at future scientific meetings.
“We
believe that our proprietary encapsulation and oral delivery methods could be applied to other small oligonucleotides, including RNAi
therapeutics such as siRNA and antisense oligonucleotides,” said Jerome D. Jabbour, Chief Executive Officer of Matinas.
“While a variety of methods for administering small oligonucleotides exist, most are primarily directed to the liver, and none
provide oral administration and delivery capabilities. The opportunity to orally deliver small oligonucleotides with extra-hepatic targeting
could be key differentiating features in rapidly advancing anti-inflammatory therapy.
“We
plan to further review the data from these inflammatory disease models to determine the best path forward for this program,” he
added. “Further study and optimization of these LNC-delivered small oligonucleotides will be required to assess the most appropriate
therapeutic targets and the associated magnitude of benefit.”
About
Matinas BioPharma
Matinas
BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery
technology.
Matinas’
lead LNC-based therapy is MAT2203, an oral formulation of the broad-spectrum antifungal drug amphotericin B, which although highly potent,
can be associated with significant toxicity. Matinas’ LNC platform provides oral delivery of amphotericin B without the significant
nephrotoxicity otherwise associated with IV-delivered formulations. MAT2203 also allows for safe, longer-term use outside of a hospital
setting, which could have substantial favorable pharmacoeconomic impact. MAT2203 was successfully evaluated in the completed Phase 2
EnACT study in cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 will be further evaluated
as an oral step-down monotherapy treatment following IV amphotericin B in a single pivotal Phase 3 study in the treatment of aspergillosis
in persons with limited treatment options who are unable to be treated with azoles for reasons related to drug-drug interactions, resistance
or for whom these antifungal agents are unable to be used for other clinical reasons.
In
addition to MAT2203, preclinical and clinical data have demonstrated that this novel technology can potentially provide solutions to
many of the challenges standing in the way of achieving safe and effective intracellular delivery of both small molecules and larger,
more complex molecular cargos such as small oligonucleotides such as ASOs and siRNA. The combination of its unique mechanism of action
and flexibility with routes of administration (including oral) positions Matinas’ LNC technology to potentially become a preferred
next-generation orally available intracellular drug delivery platform. For more information, please visit www.matinasbiopharma.com.
Forward-looking
Statements
This
release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995,
including those relating to our business activities, our strategy and plans, the potential of our LNC platform technology, and the future
development of its product candidates, including MAT2203, the Company’s ability to identify and pursue development, licensing and
partnership opportunities for its products, including MAT2203, or platform delivery technologies 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, our ability to continue as a going concern, 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 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.
Investor
Contact
LHA
Investor Relations
Jody
Cain
Jcain@lhai.com
310-691-7100
#
# #
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