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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):
October 21, 2022
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
announcing interim data from the fourth and final cohort of the
Phase 2 EnACT trial of the Company’s MAT2203 product candidate. A
copy of the press release is furnished as Exhibit 99. 1 hereto and
incorporated herein by reference.
The
Company updated its corporate presentation (the “Corporate
Presentation”) which it intends to use at various conferences and
investor meetings. The Corporate Presentation is attached hereto as
Exhibit 99.2 and incorporated herein by reference.
The
information in this Item 7.01 and 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
October 21, 2022, the Company announced positive interim data from
the fourth and final cohort of the Phase 2 EnACT trial evaluating
the safety and efficacy of an all-oral regimen of its MAT2203
(administered with adjunctive flucytosine) product candidate
(“Cohort 4”). Interim EnACT Cohort 4 data from 40 MAT2203 treatment
arm participants and 40 standard of care (“SOC”) controls will be
presented on October 21, 2022 by Drs. Mucunguzi Atukunda, MBChB,
MPH of the Infectious Diseases Institute of Makarere University in
Uganda and David Boulware, MD, MPH of the University of Minnesota
Medical School. Cohort 4 (an all-oral treatment regimen with
MAT2203) met its prespecified primary endpoint, exceeding the
target rate of cerebrospinal fluid (“CSF”) yeast clearance
threshold of >0.20 colony forming units (“CFU”) per mL of CSF
per day. Overall survival in Cohort 4, a key secondary endpoint of
the study, is 95% at two weeks and currently 90% overall, with
ongoing final follow-up through 18 weeks. The Company plans to
initiate a Phase 3 registration trial of MAT2203 as step-down
therapy in cryptococcal meningitis in the first quarter of
2023.
Interim
Results from Cohort 4
● |
The
CSF yeast clearance rate exceeded the prespecified primary endpoint
threshold target of >0.20, with a mean early fungicidal activity
achieved of 0.30 log10 CFU/mL/day with 95% confidence
intervals from 0.22 – 0.38. |
● |
Several
participants with high baseline fungal burdens had noteworthy
antifungal activity within the MAT2203 treatment arm, including one
patient with quantitative cryptococcal culture as high as 915,000
CFU/mL at the time of screening with effective clearance during the
induction period, a key demonstration of potent antifungal
activity, even in the most challenging of cases. |
Survival
● |
In 40
patients receiving MAT2203 treatment, interim survival is currently
90%, while the survival rate at Week 2 was 95%; note that Week 2
survival is the prespecified primary endpoint for the MAT2203 Phase
3 registration trial in cryptococcal meningitis. |
Safety
● |
MAT2203
patients had fewer Grade ≥3 Clinical Adverse Events (42%) vs. SOC
treatment (59%). |
● |
The
incidence of adverse events relating to kidney function and anemia
were significantly lower for MAT2203 compared with the SOC
treatment, with no evidence of kidney toxicity seen with six weeks
of oral MAT2203 treatment. |
● |
The
favorable safety and tolerability data seen in Cohort 4 support the
use of oral MAT2203 for longer-term use, something not previously
feasible due to associated toxicities with currently available IV
formulations of amphotericin B. |
The
Company may leverage data from the EnACT trial to further the
development of MAT2203 and secure multiple orphan indications for
the treatment of other life-threatening invasive fungal infections,
such as mucormycosis and aspergillosis.
The
Company expects that a pivotal Phase 3 registration trial of
MAT2203 in cryptococcal meningitis will be initiated early in the
first quarter of 2023 and will assess MAT2203 as step-down therapy
after two loading doses of IV amphotericin B. This open-label
randomized trial, which will be partially financially supported by
the National Institutes of Health National Institute of
Neurological Disorders and Stroke, involves a three arm
non-inferiority design in persons living with HIV who have
cryptococcal meningitis: (A) step-down therapy with MAT2203 with
treatment continuing for 2 weeks; (B) step-down therapy with
MAT2203 with treatment out to 6 weeks; and (C) a SOC control arm of
IV amphotericin induction transitioning to fluconazole. The
non-inferiority margin for both the primary and key secondary
endpoints will be 10% and total enrollment is planned to be
approximately 270 patients, with an adaptive, de-risking design
allowing for the potential for additional patients once enrollment
has reached 75%. The primary endpoint will be 2-week all-cause
mortality, with a pooled analysis across the two MAT2203 treatment
arms compared with SOC control to support a potential indication
for the treatment of cryptococcal meningitis. A secondary endpoint
is 10-week relapse free survival of optimized treatment (2-weeks or
6-weeks) against SOC will be evaluated for non-inferiority.
Selection of the optimal treatment regimen will be based on
predefined and protocolized clinical criteria and will form the
basis for a final New Drug Application submission with the U.S.
Food and Drug Administration.
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 topline results of the ENHANCE-IT study, 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:
October 21, 2022 |
By: |
/s/
Jerome D. Jabbour |
|
Name: |
Jerome
D. Jabbour |
|
Title: |
Chief
Executive Officer |
Matinas Biopharma (AMEX:MTNB)
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