Item 7.01 Regulation FD Disclosure.
Matinas BioPharma Holdings, Inc. (the "Company") issued a press release
announcing positive efficacy and safety data from the first two cohorts of
patients in the ongoing Encochleated Oral Amphotericin for Cryptococcal
Meningitis Trial ("EnACT") of MAT2203 (oral amphotericin B) for the treatment of
cryptococcal meningitis. A copy of the press release is furnished as Exhibit 99.
1 hereto and incorporated herein by reference.
The Company created a presentation which includes the data from EnACT trial (the
"Presentation") which it intends to use during a planned conference call on
September 13, 2021 and then at various conferences and investor meetings. The
Presentation is attached hereto as Exhibit 99.2.
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 99.3.
The information in this Item 7.01 and Exhibits 99.1, 99.2 and 99.3 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 September 13, 2021, the Company announced positive efficacy and safety data
from the first two cohorts of patients in the ongoing Encochleated Oral
Amphotericin for Cryptococcal Meningitis Trial (EnACT) of MAT2203 (oral
amphotericin B) for the treatment of cryptococcal meningitis, which is being
sponsored by the National Institute of Allergy and Infectious Diseases
The EnACT independent Data and Safety Monitoring Board ("DSMB") recently
completed a pre-specified review of available safety and efficacy data from
Cohort 2 (stepdown to MAT2203 after two days of IV amphotericin) and unanimously
recommended progression to the second half of the study. Enrollment in Cohort 3
of EnACT (the safety lead-in for Cohort 4, which will be an all-oral MAT2203
treatment regimen) has commenced and is expected to complete by the end of 2021.
Topline Results from Cohort 2 of EnACT
Key topline results from Cohort 2 of EnACT include eradication of the fungal
infection, survival, and safety, including longer term use of MAT2203 beyond the
2-week induction period.
Potent Early Fungicidal Activity (EFA), Cerebrospinal Fluid (CSF) Sterilization,
with No Evidence of Breakthrough Infections During Treatment with MAT2203
? The primary endpoint in EnACT is EFA, a measurement of cerebrospinal fluid
fungal clearance. EFA is a well-validated quantitative measure of the efficacy
of antifungal agents and is a key surrogate marker for survival. EFAs of less
than 0.20 log10 Cryptococcus colony forming units (CFUs) per mL CSF per day
are associated with significantly higher mortality and worse clinical
outcomes1. EFA measured above this threshold is clinically meaningful and
represents robust fungal clearance. In the second cohort of EnACT, the mean
EFA achieved with patients treated with MAT2203 was 0.38 log10 CFU/mL/day,
with 95% confidence intervals (0.30 to 0.46) significantly higher than the
prespecified primary endpoint threshold of >0.20.
1 *Clin Infect Dis. 2020;71(5):e45-49
? All patients treated with MAT2203 who completed the induction phase achieved
sterile CSF cultures during treatment (either during induction or early
? There was no evidence of breakthrough or relapsed cryptococcal infections
observed in any of the patients during treatment with MAT2203 through 10
? In Cohort 2, overall survival was 95% in 40 patients randomized to receiving
? In both Cohorts 1 and 2, MAT2203 showed no evidence of renal toxicity or
electrolyte abnormalities attributable to MAT2203, no major safety signals,
and no use-limiting tolerability issues, even with longer-term treatment with
MAT2203 extended beyond induction into the consolidation phase, from week 2 to
The Company is preparing to engage with the U.S. Food and Drug Administration
("FDA") to review these data as supportive of a potential early approval of
MAT2203 as step-down therapy. These data may also set the stage for potential
longer-term treatment options, including prophylaxis, for patients dealing with,
or at risk for, deadly invasive fungal infections without the toxicities usually
associated with IV amphotericin.
The EnAct trial demonstrated that two days of intravenous amphotericin B
followed by rapid transition to oral LNC amphotericin B therapy was well
tolerated, resulted in excellent CSF clearance of the Cryptococcus yeast, and
had a 95% survival to date.
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 results of the EnECT study, the
LNC platform delivery technology, the Company's strategic focus and the future
development of its product candidates, including MAT2203, MAT2501, 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.
Forward-looking 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, 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; 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 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
Item 9.01 Financial Statements and Exhibits.
Exhibit No. Description
99.1 Press Release, dated September 13, 2021.
99.2 Slide Presentation, dated September 13, 2021.
99.3 Corporate Presentation, dated September 13, 2021.
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