Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
clinical-stage biopharmaceutical company focused on improving the
intracellular delivery of nucleic acids and small molecules with
its lipid nanocrystal (LNC) platform technology, today reported
financial results for the first quarter ended March 31, 2022, along
with a corporate update.
“We have made substantial progress in continuing
to validate our LNC platform delivery technology by delivering
consistent and compelling clinical and preclinical data through
advancing our internal pipeline over the past few months,”
commented Jerome D. Jabbour, Chief Executive Officer of Matinas.
“Our recently announced collaboration with BioNTech provides clear
external validation for our LNC platform from a global
pharmaceutical leader and creates the opportunity for oral
administration of mRNA vaccines and other cutting-edge
therapeutics, which could potentially benefit hundreds of millions
of patients. Our own internal discovery programs built around
preclinical data validating the LNC delivery of nucleic acids and
antisense oligonucleotides, combined with our ongoing projects with
Genentech and Gilead, provide momentum as we seek to capitalize
upon the significant potential for our proprietary, next generation
delivery technology. We could not be more pleased with our progress
in 2022, and believe that we are well-positioned, with numerous
value-creating milestones on the horizon.”
First Quarter 2022 Highlights and Recent
Events
External Collaborations
- In April
2022, Matinas and BioNTech entered an exclusive research
collaboration to evaluate the combination of mRNA formats and
Matinas’ proprietary LNC platform technology. The Companies have
initiated collaborative formulation, development, and optimization
work toward planned preclinical efficacy testing. BioNTech and
Matinas have also commenced formal license agreement discussions
for Matinas’ LNC delivery platform technology.
- Data from
a second in vivo study of oral LNC-remdesivir in mice infected with
SARS-CoV-2 demonstrated that oral LNC remdesivir reduced viral lung
titers (as early as Day 2), improved lung congestion scores, and
reduced COVID-associated weight loss. The study was performed in
collaboration with the National Institute of Allergy &
Infectious Diseases (NIAID) and the Department of Epidemiology at
the University of North Carolina at Chapel Hill (UNC).
- The
Company expanded its collaboration with Genentech, a member of the
Roche Group, to include a third compound, which is a type of
antibody fragment. Matinas will be focusing on creating an
optimized oral formulation applying the LNC platform for
preclinical testing, with potential results anticipated later in
2022.
Internal Pipeline Progress
MAT2203
-
Enrollment continues in Cohort 4 of the ongoing EnACT study
(Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial)
of MAT2203 (oral amphotericin B) for the treatment of cryptococcal
meningitis, with 28 patients (out of a total of 56) enrolled to
date in Uganda. Cohort 4 is testing an all-oral regimen of MAT2203
during the 14-day induction period, followed by four additional
weeks of oral consolidation therapy with MAT2203. The Company
continues to anticipate reporting topline data from Cohort 4 in the
third quarter of 2022.
- Matinas
recently held a productive follow-up clinical Type C meeting with
the FDA and has received written feedback concerning the
confirmatory data required to support the submission of a New Drug
Application (NDA) for MAT2203. As reflected in the official minutes
of the meeting, FDA is now considering the potential registration
of MAT2203 for both a step-down induction indication as well as a
consolidation treatment indication based upon a single Phase 3
confirmatory trial. This pivotal registration trial will feature a
non-inferiority trial design comparing MAT2203 (administered with
5FC) with a control arm of IV amphotericin (also administered with
5-FC), randomized 2:1 in favor of MAT2203, as induction and then
consolidation therapy in HIV patients with cryptococcal meningitis.
Critical elements of the pivotal registration trial will likely
include:
- Primary
endpoint of 2-week all-cause mortality for induction
indication
-
Non-inferiority margin of 10%, translating into a total trial size
of approximately 250 patients (with 80% power)
- A key
secondary endpoint may include meningitis culture-positive relapse
free survival time through 18 weeks to evaluate consolidation
treatment in support of a single NDA filing for both induction and
consolidation treatment with MAT2203 in patients with cryptococcal
meningitis
This streamlined development pathway represents
a meaningful improvement from customary requirements for an NDA
submission, which traditionally requires two adequate and
well-controlled Phase 3 trials for registration. The Company plans
to meet with FDA in the third quarter of 2022 to finalize the trial
design and anticipates that the pivotal Phase 3 registration trial
will commence later in 2022, with the anticipated financial support
of the National Institutes of Health.
- The
Company has recently submitted a formal Request for Scientific
Advice to the European Medicines Agency (EMA) to facilitate a
development and registration program in support of expanding the
regulatory footprint for MAT2203 globally. Concurrent with the EMA
process, the Company remains in discussions with key third parties
interested in obtaining rights to MAT2203 on a global and regional
basis.
-
Preclinical studies of MAT2203 in Candida auris and mucormycosis
have been initiated to support potential label expansion for
MAT2203 into the treatment of other invasive fungal infections.
Preliminary data generated to date demonstrate that MAT2203 is as
effective as liposomal amphotericin B in protecting against
mucormycosis, a deadly invasive fungal infection. Additional
confirmatory studies in different strains of mucormycosis are
ongoing. Preclinical evaluation of MAT2203 against Candida auris
was initiated in April 2022 and preliminary data is expected in the
third quarter of 2022.
- In the
first quarter of 2022, the Company selected and reached agreement
with Thermo Fisher Scientific to support scale-up and manufacturing
for MAT2203 in anticipation of a potential NDA submission. Thermo
Fisher Scientific, with more than 65 locations around the world,
provides integrated, end-to-end capabilities across all phases of
development, including APIs, biologics, viral vectors, cGMP
plasmids, formulation, clinical trials solutions, logistics
services and commercial manufacturing and packaging.
MAT2501
- Results
from a single ascending dose (SAD) study of MAT2501 (oral amikacin)
in healthy volunteers demonstrated rapid absorption of MAT2501
following oral administration with a time to maximal concentration
of approximately 2 hours. Circulating plasma levels of
LNC-delivered amikacin were significantly lower than
IV-administered amikacin, which is expected to translate into a
significantly improved safety profile for MAT2501. There were no
serious adverse events and no evidence of any renal or ototoxicity
observed, two of the most common toxicities seen with
IV-administered amikacin.
First Quarter 2022 Financial
Results
Cash, cash equivalents and marketable securities
at March 31, 2022, were approximately $43.9 million, compared to
$49.6 million at December 31, 2021. Based on current projections,
the Company believes that cash on hand is sufficient to fund
planned operations through 2023.
For the first quarter of 2022, net loss
attributable to common shareholders was $6.0 million, or a net loss
of $0.03 per share (basic and diluted), compared to a net loss
attributable to common shareholders of $5.2 million, or a net loss
of $0.03 per share (basic and diluted), for the same period in
2021. The increase was due primarily to an increase in research and
development expenses.Conference Call and Webcast
DetailsThe Company will host a live conference call and
webcast to discuss these results today, Thursday, May 12, 2022, 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
13727955. The live webcast will be accessible on the Investors
section of Matinas’ website, www.matinasbiopharma.com, and archived
for 90 days
About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company
focused on improving 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 route of administration (including oral),
positions Matinas’ LNC technology to potentially become the
preferred next-generation intracellular drug delivery vehicle with
distinct advantages over both lipid nanoparticles and viral
vectors.
The Company is focused on developing an internal
and external pipeline of drugs candidates based on the LNC
platform. Internally, the Company has two clinical stage assets.
MAT2203 is an oral, LNC formulation of the highly potent antifungal
medicine amphotericin B, currently in Phase 2 clinical trials;
MAT2501 is an oral, LNC formulation of the broad-spectrum
aminoglycoside, amikacin, primarily used to treat chronic and acute
bacterial infections, and currently in Phase 1. Externally, the
Company has established a broad set of relationships with multiple
global pharmaceutical collaborators, including BioNTech (mRNA), the
National Institutes of Health and Gilead Sciences (antivirals), and
Genentech, a member of the Roche Group (small molecules, antisense
oligonucleotides, and antibody fragments).
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, our collaboration with
BioNTech, 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.
Matinas
BioPharma Holdings Inc. |
|
Condensed
Consolidated Balance Sheets |
|
|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
|
|
|
|
|
|
|
(Unaudited) |
|
(Audited) |
|
ASSETS: |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
19,328,135 |
|
|
$ |
21,029,806 |
|
|
|
Marketable securities |
|
|
|
24,541,834 |
|
|
|
28,592,049 |
|
|
|
Restricted cash - security deposit |
|
|
50,000 |
|
|
|
50,000 |
|
|
|
Prepaid expenses and other current assets |
|
|
1,199,111 |
|
|
|
1,321,466 |
|
|
|
|
Total current assets |
|
|
|
45,119,080 |
|
|
|
50,993,321 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
Leasehold improvements and equipment - net |
|
|
2,013,322 |
|
|
|
1,537,728 |
|
|
|
Operating lease right-of-use assets - net |
|
|
4,082,763 |
|
|
|
4,218,890 |
|
|
|
Finance lease right-of-use assets - net |
|
|
15,835 |
|
|
|
22,270 |
|
|
|
In-process research and development |
|
|
3,017,377 |
|
|
|
3,017,377 |
|
|
|
Goodwill |
|
|
|
1,336,488 |
|
|
|
1,336,488 |
|
|
|
Restricted cash - security deposit |
|
|
200,000 |
|
|
|
200,000 |
|
|
|
|
Total non-current assets |
|
|
10,665,785 |
|
|
|
10,332,753 |
|
|
|
|
|
Total assets |
|
|
$ |
55,784,865 |
|
|
$ |
61,326,074 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY: |
|
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|
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|
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|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
$ |
1,351,905 |
|
|
$ |
938,270 |
|
|
|
Accrued expenses |
|
|
|
1,840,748 |
|
|
|
2,850,888 |
|
|
|
Operating lease liabilities - current |
|
|
558,702 |
|
|
|
538,546 |
|
|
|
Financing lease liabilities - current |
|
|
17,134 |
|
|
|
21,039 |
|
|
|
|
Total current liabilities |
|
|
3,768,489 |
|
|
|
4,348,743 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
|
341,265 |
|
|
|
341,265 |
|
|
|
Operating lease liabilities - net of current portion |
|
|
3,993,396 |
|
|
|
4,140,387 |
|
|
|
Financing lease liabilities - net of current portion |
|
|
- |
|
|
|
2,621 |
|
|
|
|
Total non-current liabilities |
|
|
4,334,661 |
|
|
|
4,484,273 |
|
|
|
|
|
Total liabilities |
|
|
8,103,150 |
|
|
|
8,833,016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
|
Common stock |
|
21,685 |
|
|
|
21,627 |
|
|
|
Additional paid-in capital |
|
|
185,901,685 |
|
|
|
184,251,138 |
|
|
|
Accumulated deficit |
|
|
|
(137,612,481 |
) |
|
|
(131,634,208 |
) |
|
|
Accumulated other comprehensive loss |
|
|
(629,174 |
) |
|
|
(145,499 |
) |
|
|
|
Total stockholders' equity |
|
|
47,681,715 |
|
|
|
52,493,058 |
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
55,784,865 |
|
|
$ |
61,326,074 |
|
|
Matinas
BioPharma Holdings, Inc. |
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
Contract research revenue |
|
$ |
- |
|
|
$ |
33,333 |
|
|
Costs and
expenses: |
|
|
|
|
|
|
|
Research and development |
|
|
4,978,105 |
|
|
|
3,241,432 |
|
|
General and administrative |
|
|
2,744,195 |
|
|
|
3,145,010 |
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
7,722,300 |
|
|
|
6,386,442 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(7,722,300 |
) |
|
|
(6,353,109 |
) |
|
|
|
|
|
|
|
|
|
Sale of New Jersey net operating loss & tax credits |
|
|
1,734,133 |
|
|
|
1,328,470 |
|
|
Other income, net |
|
|
9,894 |
|
|
|
68,319 |
|
|
Net
loss |
|
$ |
(5,978,273 |
) |
|
$ |
(4,956,320 |
) |
|
|
|
|
|
|
|
|
|
Preferred
stock series B accumulated dividends |
|
|
- |
|
|
|
(210,900 |
) |
|
|
|
|
|
|
|
|
|
Net loss
attributable to common shareholders |
|
$ |
(5,978,273 |
) |
|
$ |
(5,167,220 |
) |
|
|
|
|
|
|
|
|
|
Net loss
available for common shareholders per share - basic and
diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding - basic and diluted |
|
|
216,644,783 |
|
|
|
203,871,820 |
|
|
|
|
|
|
|
|
|
|
Other
comprehensive loss, net of tax |
|
|
|
|
|
|
|
Unrealized loss on securities available-for-sale |
|
|
(483,675 |
) |
|
|
(91,766 |
) |
|
Other comprehensive loss, net of tax |
|
|
(483,675 |
) |
|
|
(91,766 |
) |
|
Comprehensive loss attributable to shareholders |
|
$ |
(6,461,948 |
) |
|
$ |
(5,048,086 |
) |
|
|
|
|
|
|
|
|
|
Investor and Media Contacts
Peter VozzoICR
Westwicke443-213-0505peter.vozzo@westwicke.com
Source: Matinas BioPharma Holdings, Inc.
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