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 delivery technology, today
reported financial and operational results for the third quarter
ended September 30, 2022, along with a corporate update.
“Since our last quarter’s reporting, the Company
has achieved some very significant milestones, highlighted by our
lead, Phase 3-ready asset, MAT2203, successfully completing Phase
2,” commented Jerome D. Jabbour, Chief Executive Officer of
Matinas. “Interim EnACT Cohort 4 survival data were recently
presented at IDWeek, with results that are simply unprecedented for
an oral therapy in this vulnerable patient population. Following
this impressive clinical validation of our LNC platform technology,
we are aggressively preparing MAT2203 for Phase 3, and remain
intently focused on advancing this platform into other areas of
significant need, including the intracellular delivery of nucleic
acids such as mRNA and other oligonucleotides, as we look ahead to
close 2022 in strong fashion.”
Third Quarter 2022 Highlights and Recent
Events
MAT2203
- Interim
data from Cohort 4 of the Phase 2 EnACT study (Encochleated Oral
Amphotericin for Cryptococcal Meningitis Trial) of MAT2203 (oral
amphotericin B) for the treatment of cryptococcal meningitis (CM)
were presented at IDWeek in October 2022. As part of IDWeek, the
EnACT abstract was the recipient of the Outstanding Abstract and
IDSA Awardee by the Infectious Diseases Society of America. In the
EnACT trial, MAT2203 exceeded the primary endpoint threshold for
early fungicidal activity (EFA) of 0.20 log10 CFU/mL/day, with a
mean EFA achieved of 0.30 log10 CFU/mL/day with 95% confidence
intervals from 0.22 – 0.38.
- Cohort 4
also yielded key secondary endpoints, including overall survival
and safety. For 40 patients receiving MAT2203 treatment, interim
overall survival remains at 90% through 18 weeks, while the
survival rate at Week 2 was 95% (the primary endpoint for the
upcoming Phase 3 registration trial in cryptococcal meningitis).
Importantly, the incidence of adverse events relating to kidney
function and anemia were significantly lower for MAT2203 compared
to the conventional IV amphotericin B standard of care treatment
across the entirety of the EnACT trial, with no evidence of kidney
toxicity even with up to 6 weeks of oral MAT2203 treatment.
- The
pivotal Phase 3 registration trial of MAT2203 in cryptococcal
meningitis is planned to initiate early in the first quarter of
2023 and will assess MAT2203 as step-down therapy following 2
loading doses of IV amphotericin B (similar to EnACT Cohort 2).
This open-label randomized trial, which will be partially
financially supported by the National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS),
involves a three arm non-inferiority design in approximately 270
persons living with HIV who have cryptococcal
meningitis. The primary endpoint for this Phase 3 study
will be 2-week all-cause mortality, with a pooled analysis across
the two MAT2203 treatment arms compared with IV amphotericin as the
standard of care to support either a 2-week or 6-week treatment of
cryptococcal meningitis indication as supported by the data. An
adaptive, de-risking design allows for the potential to add
additional patients once enrollment has reached 75% to offset
unforeseen patient deaths unrelated to study drug. Enrollment is
expected to take approximately 18 months, with topline data
expected in the second half of 2024.
-
Late-breaking data demonstrating the in vivo efficacy of MAT2203 in
treating two strains of mucormycosis (R. delemar and M.
circinelloides) in immunosuppressed mice were also presented at
IDWeek 2022 by Dr. Ashraf Ibrahim of the Lundquist Institute. The
preclinical data with MAT2203 demonstrated a prolonged median
survival time, enhanced overall survival, and reduced tissue fungal
burden of target organs including lung and brain as compared to
AmBisome® (IV amphotericin B), positioning MAT2203 as a potential
clinical solution for this deadly invasive fungal infection.
External Collaborations
- In April
2022, Matinas and BioNTech entered an exclusive research
collaboration centered on the combination of Matinas’ proprietary
LNC platform technology and BioNTech mRNA formats. The Companies
continue their collaborative formulation work on multiple nucleic
acids, ultimately directed toward planned preclinical in vitro and
in vivo testing. The parties remain in advanced discussions for a
potential option to license the LNC platform for various nucleic
acid applications.
Appointment of Eric Ende MD, MBA to
Chairman of the Board of Directors
In September 2022, the Company also announced
the unanimous appointment of board member, Eric J. Ende, to succeed
Herbert J. Conrad as Chairman of the Board, effective October 1,
2022. Mr. Conrad, the founding Chairman of Matinas, remains on the
Board as an independent director of the Company. Dr. Ende joined
the Company’s Board of Directors in March 2017.
Third Quarter 2022 Financial
Results
Cash, cash equivalents and marketable securities
at September 30, 2022, were approximately $33.1 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 third quarter of 2022, net loss
attributable to common shareholders was $5.5 million, or a net loss
of $0.03 per share (basic and diluted), compared to a net loss
attributable to common shareholders of $6.8 million, or a net loss
of $0.03 per share (basic and diluted), for the same period in
2021. The reduced loss resulted from the Company recording $1.1
million in revenue from its research collaboration with BioNTech
SE, along with a slight decrease in operating expenses year over
year. Conference Call and Webcast DetailsThe
Company will host a live conference call and webcast to discuss
these results today, November 2, 2022, at 4:30 p.m. ET.To
participate in the call, please dial 888-609-1607 (Toll-Free) or
(862) 298-0702 (Toll). 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.
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 ongoing research
collaboration with BioNTech and any potential license of the LNC
platform technology, 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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September 30, 2022 |
December 31, 2021 |
|
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(Unaudited) |
(Audited) |
ASSETS: |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
11,175,838 |
|
$ |
21,029,806 |
|
|
Marketable debt
securities |
|
|
21,875,015 |
|
|
28,592,049 |
|
|
Restricted cash -
security deposit |
|
50,000 |
|
|
50,000 |
|
|
Prepaid expenses
and other current assets |
|
3,997,798 |
|
|
1,321,466 |
|
|
|
Total current assets |
|
|
37,098,651 |
|
|
50,993,321 |
|
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|
|
|
|
|
|
|
Non-current
assets: |
|
|
|
|
|
|
|
Leasehold
improvements and equipment - net |
|
2,144,102 |
|
|
1,537,728 |
|
|
Operating lease
right-of-use assets - net |
|
3,742,019 |
|
|
4,218,890 |
|
|
Finance lease
right-of-use assets - net |
|
7,026 |
|
|
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 |
|
10,447,012 |
|
|
10,332,753 |
|
|
|
Total assets |
$ |
47,545,663 |
|
$ |
61,326,074 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY: |
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Current
liabilities: |
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|
|
Accounts
payable |
|
$ |
656,717 |
|
$ |
938,270 |
|
|
Accrued
expenses |
|
|
3,696,932 |
|
|
2,850,888 |
|
|
Operating lease
liabilities - current |
|
540,076 |
|
|
538,546 |
|
|
Financing lease
liabilities - current |
|
7,860 |
|
|
21,039 |
|
|
|
Total current
liabilities |
|
|
4,901,585 |
|
|
4,348,743 |
|
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|
|
|
|
|
|
|
|
Non-current
liabilities: |
|
|
|
|
|
|
|
Deferred tax
liability |
|
|
341,265 |
|
|
341,265 |
|
|
Operating lease
liabilities - net of current portion |
|
3,683,949 |
|
|
4,140,387 |
|
|
Financing lease
liabilities - net of current portion |
|
- |
|
|
2,621 |
|
|
|
Total non-current
liabilities |
|
4,025,214 |
|
|
4,484,273 |
|
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|
Total liabilities |
|
|
|
|
8,926,799 |
|
|
8,833,016 |
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Stockholders'
equity: |
|
|
|
|
|
|
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Common stock |
|
21,685 |
|
|
21,627 |
|
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Additional paid-in
capital |
|
|
188,529,404 |
|
|
184,251,138 |
|
|
Accumulated
deficit |
|
|
(148,996,657 |
) |
|
(131,634,208 |
) |
|
Accumulated other
comprehensive loss |
|
(935,568 |
) |
|
(145,499 |
) |
|
|
Total
stockholders' equity |
|
38,618,864 |
|
|
52,493,058 |
|
|
|
Total liabilities and stockholders' equity |
$ |
47,545,663 |
|
$ |
61,326,074 |
|
Matinas BioPharma Holdings, Inc. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(Unaudited) |
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Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2022 |
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|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
1,062,500 |
|
|
$ |
- |
|
|
$ |
2,125,000 |
|
|
$ |
33,333 |
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
3,706,828 |
|
|
|
4,621,255 |
|
|
|
12,811,462 |
|
|
|
10,343,451 |
|
|
General and
administrative |
|
2,818,252 |
|
|
|
2,256,689 |
|
|
|
8,423,868 |
|
|
|
7,710,625 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
6,525,080 |
|
|
|
6,877,944 |
|
|
|
21,235,330 |
|
|
|
18,054,076 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(5,462,580 |
) |
|
|
(6,877,944 |
) |
|
|
(19,110,330 |
) |
|
|
(18,020,743 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of New Jersey net operating loss & tax credits |
|
- |
|
|
|
- |
|
|
|
1,734,133 |
|
|
|
1,328,470 |
|
Other income, net |
|
988 |
|
|
|
41,394 |
|
|
|
13,748 |
|
|
|
108,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(5,461,592 |
) |
|
$ |
(6,836,550 |
) |
|
$ |
(17,362,449 |
) |
|
$ |
(16,583,975 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock
series B accumulated dividends |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(395,799 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to common shareholders |
$ |
(5,461,592 |
) |
|
|
(6,836,550 |
) |
|
$ |
(17,362,449 |
) |
|
$ |
(16,979,774 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available
for common shareholders per share - basic and diluted |
$ |
(0.03 |
) |
|
|
(0.03 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted |
|
216,864,526 |
|
|
|
215,179,949 |
|
|
|
216,792,083 |
|
|
|
208,130,431 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive loss, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on securities
available-for-sale |
|
(181,152 |
) |
|
|
(52,837 |
) |
|
|
(790,069 |
) |
|
|
(229,766 |
) |
|
Other comprehensive loss, net
of tax |
|
(181,152 |
) |
|
|
(52,837 |
) |
|
|
(790,069 |
) |
|
|
(229,766 |
) |
Comprehensive loss
attributable to shareholders |
$ |
(5,642,744 |
) |
|
$ |
(6,889,387 |
) |
|
$ |
(18,152,518 |
) |
|
$ |
(16,813,741 |
) |
Investor and Media Contacts
Ankit Bhargava, MDAllele Communications, LLC
815.721.4912matinas@allelecomms.com
Source: Matinas BioPharma Holdings, Inc.
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