Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
clinical-stage biopharmaceutical company, today announced financial
results for the quarter ended September 30, 2019, and provided an
update on its product pipeline.
“I am extremely pleased with the progress we
made in the third quarter, positioning the Company to commence two
important studies for our lead assets, MAT9001 and MAT2203,”
commented Jerome D. Jabbour, Chief Executive Officer of Matinas.
“With respect to MAT9001, we began pre-screening patients in
September for our confirmatory head to head ENHANCE-IT study vs.
Vascepa, and remain on track to start dosing patients in early
2020. This is an exciting time for the omega-3 class as there are
multiple upcoming catalysts that could help validate the
blockbuster potential of prescription-only omega-3 therapy. We look
forward to reporting data from the ENHANCE-IT trial in the fourth
quarter of 2020, and continue to believe that MAT9001 has the
potential to become the best-in-class prescription-only omega-3
product.”
“Importantly, we have also commenced dosing in
the EnACT study of MAT2203, our oral formulation of amphotericin B,
applying our lipid nano-crystal (LNC) platform delivery technology.
Just recently the US Food and Drug Administration (FDA)
granted MAT2203 orphan drug designation for the treatment of
cryptococcosis. This designation, along with the previously
granted Qualified Infectious Disease Product Designation (QIDP)
with Fast Track status, positions MAT2203 for up to 12 years of
exclusivity, if approved. We believe MAT2203, beginning with
the EnACT trial, has the potential to provide a much-needed
solution for patients and doctors in the battle against invasive
fungal infections. We look forward to providing updates on
this study throughout 2020,” added Mr. Jabbour.
MAT9001 Program Update (next
generation, prescription-only omega-3 fatty acid-based composition
under development for treatment of cardiovascular or metabolic
conditions, including hypertriglyceridemia)
- Commenced pre-screening of patients for head-to-head
comparative study of MAT9001 and Vascepa®, and on track to initiate
enrollment in the first quarter of 2020. This study will evaluate
pharmacodynamic (PD) markers for MAT9001 and Vascepa in a 28-day
crossover study in patients with elevated triglycerides (150 – 499
mg/dL). It follows a previous study showing that, compared to
Vascepa, MAT9001 provided significantly greater reductions in PD
markers known to be associated with increased risk of
cardiovascular disease, including triglycerides, Total
cholesterol, VLDL-C, non-HDL-C, ApoC3, and PCSK9, without any
meaningful increase in LDL cholesterol. The objective of this
second study is to further validate the enhanced bioavailability
and greater potency of MAT9001 relative to Vascepa in order to best
position the drug for commercial success. The Company expects to
announce data from the study in the fourth quarter of 2020.
- On track to commence a comparative clinical bridging
bioavailability study by the end of 2019 to support 505(b)(2)
registration pathway, with expected completion in the first half of
2020.
MAT2203 and Lipid Nano-Crystal (LNC)
Technology Platform Update (intracellular delivery of
potentially life-saving medicines)
- Dosing initiated in Phase 2 EnACT (Encochleated Oral
Amphotericin for Cryptococcal Meningitis Trial) study of MAT2203
for the treatment of HIV-infected patients with cryptococcal
meningitis in October 2019. This open-label, sequential cohort
study, financially supported by the National Institutes of Health
(NIH), will utilize the Company’s LNC drug delivery technology to
orally deliver the traditionally IV-only fungicidal drug,
amphotericin B. Updates on EnACT will be provided over the course
of 2020.
- FDA granted MAT2203 orphan drug designation for the treatment
of cryptococcosis in October 2019. As previously reported, the FDA
has designated MAT2203 as a QIDP with Fast Track status for four
indications, specifically, the prevention of invasive fungal
infections due to immunosuppressive therapy, and the treatment of
invasive candidiasis, invasive aspergillus and cryptococcal
meningitis.
Third Quarter 2019 Financial Results
For the third quarter of 2019, the Company
reported a net loss attributable to common shareholders of $4.6
million, or a net loss per share of $0.03 (basic and diluted),
compared to a net loss attributable to common shareholders of $3.3
million, or a net loss per share of $0.03 (basic and diluted) for
the same period in 2018.
Research and development (R&D) activities
for the third quarter of 2019 were $2.7 million, compared to $1.4
million for the same period in 2018. The increase in R&D was
due primarily to higher manufacturing process development, clinical
development and overhead costs, specifically around the development
of MAT9001.
General and administrative (G&A) expenses
for the third quarter of 2019 were $1.9 million, compared to $1.6
million in the same period in 2018. The increase in G&A was due
primarily to increased employee compensation expense.
Cash and cash equivalents at September 30, 2019
were approximately $32.7 million, compared to $12.4 million at
December 31, 2018. This increase includes net proceeds of $30.1
million from the Company’s public offering of its common stock
completed in March 2019. Based on Management’s current projections
the Company believes that cash on hand is sufficient to fund
operations into the first quarter of 2021.
*VASCEPA® is a registered trademark of the
Amarin group of companies. Conference Call and
Webcast Details
The Company will host a live conference call and
webcast to discuss these results on Wednesday, November 13, 2019 at
8:00 a.m. ET.
To participate in the call, please dial (877)
407-5976 (domestic) or (412) 902-0031 (international). The live
webcast will be available on the Events page of the Investors
section of the Company’s website (www.matinasbiopharma.com) and
archived for 60 days.
About Matinas BioPharma
Matinas BioPharma is a clinical-stage
biopharmaceutical company focused on development of its lead
product candidate, MAT9001, for the treatment of cardiovascular and
metabolic conditions. MAT9001 is a prescription-only omega-3 fatty
acid-based composition, comprised primarily of EPA and DPA, under
development for hypertriglyceridemia, that was specifically
designed to overcome the shortcomings seen from other agents in the
omega-3 class. Company leadership has a deep history and knowledge
of cardiovascular drug development and is supported by a
world-class team of scientific advisors.
In addition, the Company is developing MAT2203,
an oral, encochleated formulation of amphotericin B, to treat
serious invasive fungal infections. The drug is based on Matinas’
proprietary lipid nano-crystal (LNC) platform technology which can
help solve complex challenges relating to the safe and effective
delivery of potent medicines, potentially making them more
targeted, less toxic and orally bioavailable.
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 the Company's
anticipated capital and liquidity needs, strategic focus and the
future development of its product candidates, including MAT9001 and
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. 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.
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|
Matinas BioPharma Holdings Inc. |
Condensed Consolidated Balance Sheets |
|
|
|
September 30, 2019 |
|
|
December 31, 2018 |
|
|
|
(Unaudited) |
|
|
(Audited) |
|
ASSETS: |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
32,664,782 |
|
|
$ |
12,446,838 |
|
Restricted cash |
|
|
200,000 |
|
|
|
100,000 |
|
Prepaid expenses |
|
|
1,386,130 |
|
|
|
538,646 |
|
Total current assets |
|
|
34,250,912 |
|
|
|
13,085,484 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Leasehold improvements and equipment - net |
|
|
1,806,304 |
|
|
|
2,042,893 |
|
Operating lease right-of-use assets - net |
|
|
3,877,069 |
|
|
|
- |
|
Finance lease right-of-use assets - net |
|
|
141,972 |
|
|
|
- |
|
In-process research and development |
|
|
3,017,377 |
|
|
|
3,017,377 |
|
Goodwill |
|
|
1,336,488 |
|
|
|
1,336,488 |
|
Restricted cash - security deposits |
|
|
386,000 |
|
|
|
461,000 |
|
Total non-current assets |
|
|
10,565,210 |
|
|
|
6,857,758 |
|
Total assets |
|
$ |
44,816,122 |
|
|
$ |
19,943,242 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
685,802 |
|
|
$ |
295,652 |
|
Note payable |
|
|
- |
|
|
|
199,842 |
|
Accrued expenses |
|
|
1,462,767 |
|
|
|
1,086,868 |
|
Stock dividends payable |
|
|
- |
|
|
|
1,174,286 |
|
Operating lease liabilities - current |
|
|
407,026 |
|
|
|
- |
|
Financing lease liabilities - current |
|
|
66,743 |
|
|
|
83,245 |
|
Total current liabilities |
|
|
2,622,338 |
|
|
|
2,839,893 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
341,265 |
|
|
|
341,265 |
|
Operating lease liabilities - net of current portion |
|
|
3,809,442 |
|
|
|
- |
|
Financing lease liabilities - net of current portion |
|
|
62,331 |
|
|
|
107,656 |
|
Deferred rent liability |
|
|
- |
|
|
|
512,704 |
|
Total non-current liabilities |
|
|
4,213,038 |
|
|
|
961,625 |
|
Total liabilities |
|
|
6,835,376 |
|
|
|
3,801,518 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Series A Convertible preferred stock, stated value $5.00 per share,
1,600,000 shares authorized as of September 30, 2019 and December
31, 2018; 0 and 1,467,858 shares issued and outstanding as of
September 30, 2019 and December 31, 2018, respectively (liquidation
preference - $0 at September 30, 2019) |
|
|
- |
|
|
|
5,583,686 |
|
|
|
|
|
|
|
|
|
|
Series B Convertible preferred stock, stated value $1,000 per
share, 8,000 shares authorized as of September 30, 2019 and
December 31, 2018; 4,620 and 4,819 shares issued and outstanding as
of September 30, 2019 and December 31, 2018; (liquidation
preference - $4,620,000 at September 30, 2019) |
|
|
4,023,251 |
|
|
|
4,196,547 |
|
|
|
|
|
|
|
|
|
|
Common stock par value $0.0001 per share, 250,000,000 shares
authorized at September 30, 2019 and December 31, 2018; 162,720,274
and 113,287,670 issued and outstanding as of September 30, 2019 and
December 31, 2018, respectively |
|
|
16,271 |
|
|
|
11,329 |
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
112,745,948 |
|
|
|
72,294,921 |
|
Accumulated deficit |
|
|
(78,804,724 |
) |
|
|
(65,944,759 |
) |
Total stockholders’ equity |
|
|
37,980,746 |
|
|
|
16,141,724 |
|
Total liabilities and stockholders’ equity |
|
$ |
44,816,122 |
|
|
$ |
19,943,242 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Matinas BioPharma Holdings, Inc. |
Condensed Consolidated Statements of
Operations |
Unaudited |
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract research revenue |
|
$ |
- |
|
|
|
- |
|
|
$ |
89,812 |
|
|
|
119,750 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,671,365 |
|
|
|
1,379,525 |
|
|
|
7,814,842 |
|
|
|
5,095,110 |
|
General and administrative |
|
|
1,889,892 |
|
|
|
1,574,712 |
|
|
|
5,460,023 |
|
|
|
5,504,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
4,561,257 |
|
|
|
2,954,237 |
|
|
|
13,274,865 |
|
|
|
10,599,669 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(4,561,257 |
) |
|
|
(2,954,237 |
) |
|
|
(13,185,053 |
) |
|
|
(10,479,919 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of New Jersey net operating loss |
|
|
- |
|
|
|
- |
|
|
|
1,007,082 |
|
|
|
- |
|
Other income, net |
|
|
156,872 |
|
|
|
18,660 |
|
|
|
378,151 |
|
|
|
23,304 |
|
Net loss |
|
$ |
(4,404,385 |
) |
|
|
(2,935,577 |
) |
|
$ |
(11,799,820 |
) |
|
|
(10,456,615 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock series A
accumulated dividends |
|
|
(45,041 |
) |
|
|
(146,786 |
) |
|
|
(338,613 |
) |
|
|
(440,857 |
) |
Preferred stock series B
accumulated dividends |
|
|
(115,500 |
) |
|
|
(175,075 |
) |
|
|
(349,500 |
) |
|
|
(196,924 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to
common shareholders |
|
$ |
(4,564,926 |
) |
|
|
(3,257,438 |
) |
|
$ |
(12,487,933 |
) |
|
|
(11,094,396 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available for common
shareholders per share - basic and diluted |
|
$ |
(0.03 |
) |
|
|
(0.03 |
) |
|
$ |
(0.09 |
) |
|
|
(0.12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding - basic and diluted |
|
|
156,889,602 |
|
|
|
94,697,049 |
|
|
|
139,265,178 |
|
|
|
94,098,372 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor and Media Contacts
Peter
VozzoWestwicke443-213-0505peter.vozzo@westwicke.com
Ian CooneyDirector – Investor Relations & Corporate
DevelopmentMatinas Biopharma, Inc.(415)
722-4563icooney@matinasbiopharma.com
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