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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): February 26, 2024
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
February 26, 2024, Matinas BioPharma Holdings, Inc. (the “Company”) provided an update for its ongoing Compassionate/Expanded
Use Access Program (the “Program”) with MAT2203, the Company’s proprietary, LNC-delivered oral formulation of the broad-spectrum
antifungal drug amphotericin B. 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.
On
February 26, 2024, the Company announced that all patients who transitioned to its MAT2203 product candidate after developing
renal toxicity following treatment with AmBisome® (liposomal amphotericin B) saw a reversal of renal impairment with a return to
baseline renal function with no subsequent renal issues. 19 patients to date have been enrolled in the Program at multiple healthcare
institutions, including the University of Michigan, Johns Hopkins, Nationwide Children’s Hospital, City of Hope, Vanderbilt University
Medical Center, the National Institutes of Health, Children’s Hospital of Philadelphia, Memorial Sloan Kettering Cancer Center,
and the University of California, San Diego School of Medicine. The majority of enrolled patients are post-transplant or are undergoing
treatment for underlying malignancies. The infections being treated with MAT2203 include a variety of micro-organisms (including Aspergillus,
Mucorales species, Candidiasis, Fusarium and suspected Coccidioides) occurring at multiple sites of infection,
including brain, bladder/colon, bone, lung, sinus, and skin. Most patients were receiving AmBisome® prior to enrollment but developed
treatment-limiting nephrotoxicity and most also required treatment for either azole-resistant organisms or had clinically failed azole
therapy and had no other treatment options.
Of
the 19 patients enrolled in the Program, 15 have available follow-up and 4 recently initiated or will soon commence treatment with MAT2203.
| ● | 12
of the 15 patients had either complete clinical resolution or objective improvement in clinical
markers of infection (including radiologic and mycologic). |
| ● | Of
the 5 patients who completed their full individually specified course of treatment (ranging
from 2 weeks to 1 year, depending on the infection) - all have had complete clinical resolution
with no relapses or recurrence of their infection. |
| ● | 5
additional patients have shown objective improvement in clinical markers and are continuing
treatment with MAT2203 as planned. |
| ● | 5
of the 15 patients were unable to complete their individually specified course of treatment,
although 2 saw significant clinical improvement of their fungal infection and are included
in the 12 overall successful cases. |
| – | 2
patients transitioned to palliative care shortly after starting therapy with MAT2203 because
of unanticipated progression of their malignant disease. |
| – | 1
patient discontinued therapy after two days due to underlying GI issues (i.e., Crohn’s
disease). |
| – | 1
patient passed away due to progression of their underlying disease approximately 8 weeks
into therapy (but previously experienced significant clinical improvement of their fungal
infection). |
| – | 1
patient discontinued MAT2203 treatment following 10 weeks of therapy due to underlying GI
issues (long-standing nausea/vomiting), but with improvement in their fungal infection. |
Importantly,
all patients who experienced renal toxicity following treatment with AmBisome saw their renal function return to baseline after transitioning
to MAT2203 therapy and suffered no further renal side effects over the course of extended treatment with MAT2203.
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 strategic focus and the future development of its product candidates, including MAT2203, 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.
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 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 our
product candidates; the 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 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:
February 26, 2024 |
By: |
/s/
Jerome D. Jabbour |
| |
Name: |
Jerome D. Jabbour |
| |
Title: |
Chief Executive Officer |
Exhibit
99.1
Matinas
BioPharma Provides Positive Outcomes Update on the MAT2203 Compassionate/Expanded Use Access Program, Including Multiple Patients with
Complete Clinical Resolution
A
total of 19 patients with serious/life-threatening invasive fungal infections have been enrolled, including aspergillosis, mucormycosis,
fusarium, candidiasis, cryptococcosis, and endemic mycoses such as coccidioidomycosis and histoplasmosis
All
5 patients who completed the desired course of treatment had complete clinical resolution of their infection; patients with ongoing treatment
continue to experience significant clinical improvement
All
patients who transitioned to MAT2203 after developing renal toxicity following treatment with AmBisome® (liposomal amphotericin B)
saw a reversal of renal impairment with a return to baseline renal function with no subsequent renal issues
BEDMINSTER,
N.J. (February 26, 2024) – Matinas BioPharma (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused
on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, today provided an update from
its ongoing Compassionate/Expanded Use Access Program (the “Program”) with MAT2203, the Company’s proprietary, LNC-delivered
oral formulation of the broad-spectrum antifungal drug amphotericin B.
To
date, 19 patients have been enrolled in the Program at prestigious healthcare institutions, including the University of Michigan, Johns
Hopkins, Nationwide Children’s Hospital, City of Hope, Vanderbilt University Medical Center, the National Institutes of Health,
Children’s Hospital of Philadelphia, Memorial Sloan Kettering Cancer Center, and the University of California, San Diego School
of Medicine.
The
majority of enrolled patients are post-transplant or are undergoing treatment for underlying malignancies. The infections being treated
with MAT2203 include a variety of micro-organisms (including Aspergillus, Mucorales species, Candidiasis, Fusarium
and suspected Coccidioides) occurring at multiple sites of infection, including brain, bladder/colon, bone, lung, sinus, and
skin. Most patients were receiving AmBisome prior to enrollment but developed treatment-limiting nephrotoxicity and most also required
treatment for either azole-resistant organisms or had clinically failed azole therapy and had no other treatment options.
“We
are encouraged by the positive clinical impact of MAT2203 in each of our patients who faced few or no treatment options,” said
Dr. Marisa Miceli, an internationally recognized infectious disease physician specializing in the treatment of invasive fungal infections
and Professor of Medicine in the Division of Infectious Diseases at the University of Michigan. “Of the seven patients we have
treated to date under the Program, all were either unable to receive azole therapy due to drug-drug interactions, intolerance or resistance
and some of them experienced serious treatment-limiting toxicities while attempting therapy with IV-administered amphotericin B. Treatment
with MAT2203 was well tolerated and led to favorable clinical and radiological response and we did not observe any renal toxicity. While
additional study is warranted, MAT2203 may be particularly promising for the treatment of invasive fungal infections in patients with
limited options and therefore satisfy a currently significant unmet medical need.”
Of
the 19 patients enrolled in the Program, 15 have available follow-up and 4 recently initiated or will soon commence treatment with MAT2203.
| ● | 12
of the 15 patients had either complete clinical resolution or objective improvement in clinical
markers of infection (including radiologic and mycologic). |
| ● | Of
the 5 patients who completed their full individually specified course of treatment (ranging
from 2 weeks to 1 year, depending on the infection) all have had complete clinical resolution
with no relapses or recurrence of their infection. |
| ● | 5
additional patients have shown objective improvement in clinical markers and are continuing
treatment with MAT2203 as planned. |
| ● | 5
of the 15 patients were unable to complete their individually specified course of treatment,
although 2 saw significant clinical improvement of their fungal infection and are included
in the 12 overall successful cases. |
| – | 2
patients transitioned to palliative care shortly after starting therapy with MAT2203 because
of unanticipated progression of their malignant disease. |
| – | 1
patient discontinued therapy after two days due to underlying GI issues (i.e., Crohn’s
disease). |
| – | 1
patient passed away due to progression of their underlying disease approximately 8 weeks
into therapy (but previously experienced significant clinical improvement of their fungal
infection). |
| – | 1
patient discontinued MAT2203 treatment following 10 weeks of therapy due to underlying GI
issues (long-standing nausea/vomiting), but with improvement in their fungal infection. |
Importantly,
all patients who experienced renal toxicity following treatment with AmBisome saw their renal function return to baseline after transitioning
to MAT2203 therapy and suffered no further renal side effects over the course of extended treatment with MAT2203.
“We
continue to be excited about the ongoing, consistent positive clinical impact of MAT2203, seen in these extremely ill patients,”
said Theresa Matkovits, PhD, Chief Development Officer at Matinas. “We look forward to advancing MAT2203 into Phase 3 development
in the ORALTO registration trial and to validating these results in a well-controlled clinical trial in which we believe the clinical
probability of success is quite high. If approved, oral, effective, and safe MAT2203 could represent a dramatic improvement to current
clinical standard of care and become the treatment of choice for patients and physicians battling invasive fungal infections. We are
grateful to the participants in the Program and to their physicians for recognizing the clinical potential of MAT2203 in treating a broad
spectrum of deadly invasive fungal infections.”
MAT2203
is not yet licensed or approved anywhere globally.
About
MAT2203
Matinas
BioPharma is developing MAT2203 as a potential oral broad-spectrum treatment for invasive deadly fungal infections. Although amphotericin
B is a fungicidal agent, it is currently only available through an intravenous route of administration, which is known to be associated
with several significant safety issues such as renal toxicity and anemia due to very high circulating levels of amphotericin B. MAT2203
has the potential to overcome the significant limitations of the currently available amphotericin B products due to its targeted oral
delivery. Combining comparable fungicidal activity with targeted delivery results in a lower risk of toxicity and potentially creates
the ideal antifungal agent for the treatment of invasive fungal infections. MAT2203 was successfully evaluated in the completed Phase
2 EnACT study in HIV patients suffering from cryptococcal meningitis, meeting its primary endpoint, and achieving robust survival. MAT2203
will be further evaluated in a single Phase 3 registration trial (the “ORALTO” trial) as an oral step-down monotherapy following
treatment with AmBisome (liposomal amphotericin B) compared with the standard of care in patients with invasive aspergillosis who have
limited treatment options.
About
Matinas BioPharma
Matinas
BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery
technology.
In
addition to MAT2203, preclinical and clinical data have demonstrated that this novel technology can potentially provide solutions to
many challenges of achieving safe and effective intracellular delivery of both small molecules and larger, more complex molecular cargos
including 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 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 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, 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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