Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
clinical-stage biopharmaceutical company focused on redefining
the intracellular delivery of nucleic acids and small molecules
with its lipid nanocrystal (LNC) platform technology, today is
providing a business update on each of its ongoing programs and
discussing its strategic outlook for 2022.
“We made tremendous progress in 2021, completely
transitioning our Company and significantly advancing our LNC
platform technology,” commented Jerome D. Jabbour, Chief Executive
Officer of Matinas. “Despite the resurgence of COVID-19 with both
Delta and Omicron variants, our team was able to deliver compelling
data for MAT2203 in the first three cohorts of the EnACT trial,
which then facilitated an important and highly productive End of
Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in
December of 2021. Based upon FDA’s support and feedback, we are
preparing to expand the EnACT trial to provide additional
confirmatory data in support of MAT2203 as step-down therapy for
induction treatment, which we believe could position us to submit a
New Drug Application (NDA) in late 2023.”
Jabbour added, “We continue to be pleased with
our collaborations with Genentech and NIAID/Gilead, and each has
yielded encouraging data in support of our LNC platform which will
lead to further studies during 2022. Finally, during 2021 we
conducted an internal evaluation of our LNC platform and believe
that applying our proprietary and differentiated intracellular
delivery technology to complex nucleic acids represents a highly
promising opportunity. We anticipate expanding the application of
our technology into this area, both internally and in partnership
with carefully selected third parties during 2022.”
Key Program Updates and Anticipated
Upcoming Milestones
MAT2203 Program (oral
amphotericin B, with targeted delivery, under development for the
treatment and prevention of invasive fungal infections, including
cryptococcal meningitis)
- Additional
analyses of final data from Cohort 2 of EnACT demonstrated (i)
survival at Day 30 (early survival) of 98% in patients receiving
MAT2203 vs. 88% in patients receiving IV Amphotericin B (SOC); and
(ii) culture conversion (sterility) assessed at any time during the
trial of 97% in patients receiving MAT2203 and 76% in patients
receiving SOC.
- Positive FDA
Meeting in December 2021 reinforced FDA’s ongoing commitment to
anti-infective drug development generally and to MAT2203
specifically. The FDA expressed no concerns with any data generated
to date related to the efficacy, safety, or tolerability of
MAT2203. Additional confirmatory evidence was requested for an
indication for step-down therapy during induction treatment, but
there was no requirement for a separate stand-alone study or
enrollment of U.S. patients. The FDA expressed openness to an
expansion of EnACT to include a new Cohort 5 to run alongside
Cohort 4 in Uganda, increasing the number of clinical sites from
two to five to streamline the development program in support of an
accelerated NDA submission. The Company is planning to meet with
FDA in the second quarter of 2022 to finalize cohort design,
including sample size required for non-inferiority and discussing
potential primary endpoint of 30-day survival. NIH financial
support of EnACT expansion anticipated and the Company continues to
evaluate the timing for submission of an application for
Breakthrough Designation.
- Key chemistry,
manufacturing, and controls (CMC) meeting with FDA to be scheduled
late in the first quarter of 2022 to discuss and evaluate MAT2203
formulation in support of a potential NDA submission in late
2023.
- Cohort 4 of
EnACT has commenced in Uganda, with six patients enrolled to date.
Cohort 4 is designed to study an all-oral regimen of MAT2203 during
the 14-day induction period, followed by four additional weeks of
oral consolidation therapy with MAT2203. Cohort 4 is comprised of
40 patients on MAT2203 and a control group of 16 patients receiving
IV amphotericin B. Enrollment in this open-label cohort is expected
to complete in the second quarter of 2022, with availability of
topline interim data anticipated in the third quarter of 2022.
- Additional
preclinical studies of MAT2203 are planned to investigate the
treatment of invasive fungal infections, such as Candida auris and
mucormycosis (black fungus), to position MAT2203 for label
expansion. Data is expected in the second half of 2022.
- Company plans
to submit a formal Request for Scientific Advice to the European
Medicines Agency (EMA) by the second quarter of 2022 to align and
plan for expanding the regulatory footprint for MAT2203
globally.
LNC Platform Collaborations
-
NIAID/Gilead – In the fourth quarter of 2021, the
National Institute of Allergy and Infectious Diseases (NIAID),
together with the Department of Epidemiology at the University of
North Carolina at Chapel Hill (UNC), conducted an in vivo test of
our LNC formulation of Gilead Science’s remdesivir (LNC-RDV) in a
standard genetically modified mouse model of SARS-CoV-2 infection.
In this animal model, orally administered LNC-RDV reduced viral
titers and improved clinical parameters of body weight and
congestion scores five days following infection, with effects
similar to those seen with subcutaneous administered remdesivir.
Following discussion with both NIAID and Gilead, these highly
encouraging results position LNC-RDV for further in vivo work to be
conducted at UNC and supported by NIAID. This preclinical study is
anticipated to commence late in the first quarter of 2022, with
data expected in the second half of 2022.
-
Genentech – Genentech recently extended this
collaboration for another year, through 2022. The original
agreement provided for cooperation on up to three proprietary
Genentech compounds for initial in vitro testing. Two of the
programs have been completed. Each demonstrated the successful
intracellular delivery of LNC-formulated small molecules and
oligonucleotides, without accompanying toxicity. Genentech is
evaluating the third proprietary compound to provide the Company
for testing, and the Company anticipates additional data from this
program during 2022.
MAT2501 Program (oral amikacin,
with targeted delivery, under development for the treatment of
nontuberculous mycobacterial (NTM) lung disease, including
infections in patients with cystic fibrosis (CF))
- A single
ascending dose (SAD) study of MAT2501 in healthy volunteers is
ongoing with data expected later in the second quarter of
2022.
- In the fourth
quarter of 2021, the Cystic Fibrosis Foundation (CFF) provided an
additional grant award in connection with ongoing preclinical work
in support of MAT2501, bringing the total amount of CFF financial
support for MAT2501 to over $4.5 million.
- Long-term
preclinical toxicology studies planned for 2022 and protocol design
for Phase 2 in consultation with the CFF are ongoing. Phase 2
trials of MAT2501 for the treatment of NTM are expected to commence
in 2023, pending additional financial support from the CFF.
LYPDISO™ Program (next
generation, prescription-only omega-3 fatty acid-based composition
under development for treatment of cardiovascular and metabolic
conditions, including hypertriglyceridemia)
- A global
process to identity and potentially secure a partner to continue
development of LYPDISO remains ongoing. Interest in this legacy
non-LNC based cardiovascular asset has emerged from a collection of
companies and Matinas is evaluating several strategic alternatives.
Further update is anticipated in the second quarter of 2022.
Financial Outlook
The Company’s preliminary, unaudited estimate of
cash, cash equivalents and marketable securities at December 31,
2021, is approximately $49.9 million, subject to completion of the
audit of the Company’s consolidated financial statements for the
year ended December 31, 2021. This compares to $58.7 million at
December 31, 2020. Based on current projections, the Company
believes that cash on hand is sufficient to fund planned operations
through 2023.
At the Special Meeting of Stockholders held on
January 26, 2021, stockholders of Matinas approved an amendment to
the Company’s Certificate of Incorporation to effect a reverse
stock split of our common stock at a ratio in the range of 1-for-2
to 1-for-15, with such reverse stock split to be effected at such
ratio, time, and date, if at all, as determined by the Company’s
Board of Directors in its sole discretion. Following a review of
the Company and its strategic positioning, the Board of Directors
has determined that it is not in the best interest of the Company
or its stockholders to effect a reverse split.
Conference Call and Webcast
Details
The Company will host a live conference call and
webcast to discuss this corporate update and 2022 business outlook
today, Tuesday, January 25th at 8:30 a.m. ET. To participate in the
call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031
(Toll) and reference conference ID 13726163. The live webcast will
be accessible on the Investors section of Matinas BioPharma’s
website, www.matinasbiopharma.com, and archived for 90 days.
About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company
focused on redefining the intracellular delivery of nucleic acids
and small molecules with its lipid nanocrystal (LNC) platform
technology. The Company is developing its own internal portfolio of
products as well as partnering with leading pharmaceutical
companies to develop novel formulations that capitalize on the
unique characteristics of the LNC platform.
Preclinical and clinical data have demonstrated
that this novel technology can provide solutions to many of the
challenges in achieving safe and effective intracellular delivery,
for both small molecules and larger, more complex molecules, such
as mRNA, DNA plasmids, antisense oligonucleotides and vaccines. The
combination of a unique mechanism of action and flexibility with
formulation and in route of administration (including oral),
position Matinas’ LNC technology to potentially become the
preferred next-generation intracellular drug delivery vehicle with
distinct advantages over both lipid nanoparticles and viral
vectors.
MAT2203 is an oral, LNC formulation of the
highly effective, but also highly toxic, antifungal medicine
amphotericin B, primarily used as a first-line treatment for
invasive fungal infections. MAT2203 is currently in a Phase 2
open-label, sequential cohort study (EnACT) in HIV-infected
patients with cryptococcal meningitis. The DSMB unanimously
approved the progression of EnACT into Cohort 4 in December of
2021. Cohort 4 commenced in January of 2022, with data expected in
the second half of 2022.
MAT2501 is an oral, LNC formulation of the
broad-spectrum aminoglycoside antibiotic amikacin, primarily used
to treat chronic and acute bacterial infections. With the support
of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing
important preclinical studies and commenced a Phase 1 human
clinical trial in the fourth quarter of 2021. MAT2501 would be the
first and only oral aminoglycoside, and is being positioned with an
initial indication for the treatment of nontuberculous
mycobacterial (NTM) lung disease, including infections in patients
with cystic fibrosis.
LYPDISO™, is a prescription-only omega-3 fatty
acid-based composition, comprised primarily of EPA and DPA,
intended for the treatment of cardiovascular and metabolic
conditions. This next-generation omega-3 therapy has been shown in
two head-to-head studies to provide effective triglyceride-lowering
and significantly higher EPA blood levels than Vascepa®. A global
process to identity and potentially secure a partner to continue
development of LYPDISO remains ongoing.
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 delivery technology, 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 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 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 and Media Contacts
Peter VozzoICR
Westwicke443-213-0505peter.vozzo@westwicke.com
Source: Matinas BioPharma Holdings, Inc.
Matinas Biopharma (AMEX:MTNB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Matinas Biopharma (AMEX:MTNB)
Historical Stock Chart
From Apr 2023 to Apr 2024