Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
clinical-stage biopharmaceutical company, today announced its
financial results for the quarter ended March 31, 2019 and provided
an update on its corporate activities and product pipeline.
“Throughout the first quarter, we made great
progress across all aspects of our business, while adding impactful
clinical and financial expertise to our management team. Most
importantly, we closed on a $32 million financing, led by
fundamental healthcare institutional investors, which will fund our
operations into the first quarter of 2021. This now enables us to
return our focus to executing on our streamlined development plans
for MAT9001 which are designed to yield data we believe could
differentiate this product from any other prescription-only omega-3
product approved or in development for the treatment of
cardiovascular or metabolic conditions. We have secured
supply of MAT9001 necessary to conduct our studies through 2020 and
eagerly anticipate starting multiple studies with MAT9001 in the
coming months,” commented Jerome D. Jabbour, Chief Executive
Officer of Matinas.
“Furthermore, on the LNC platform side of our
business, we are also now positioned for an important FDA meeting
in late June to discuss our NIH-funded development program for our
MAT2203 antifungal therapy toward an indication for the treatment
of cryptococcal meningitis. Finally, we have continued
to advance discussions with key third parties regarding the
utilization of our delivery technology in areas of innovative
medicine. We believe that these early-stage collaborations
could represent a significant opportunity for us moving forward,”
added Mr. Jabbour.
FIRST QUARTER 2019 AND SUBSEQUENT
HIGHLIGHTS
- Added strategic financial expertise with the appointment of
Keith A. Kucinski, CPA, MBA as Chief Financial Officer;
- Signed first LNC platform research evaluation with top global
pharmaceutical company in the oligonucleotide space;
- Bolstered team with cardiovascular expert, James J. Ferguson
III, M.D., formerly of Amgen, as Chief Medical Officer to assist in
leading clinical development of MAT9001;
- Closed $32 million financing led by fundamental healthcare
institutional investors;
- FDA Type-C Meeting for MAT2203 scheduled for late June to
discuss Phase 2 NIH-funded study in cryptococcal meningitis
anticipated to commence in Q3 2019;
- Secured clinical supplies of MAT9001 to support all planned
studies through 2020;
- Plans to commence 28-day comparative bridging toxicology study
of MAT9001 in Q2 2019; and
- Plans to commence a clinical bioavailability study and
comparison of PK parameters for MAT9001 in Q3 2019.
FIRST QUARTER 2019 SUMMARY OF FINANCIAL
RESULTS
For the three months ended March 31, 2019, the
Company reported a net loss attributable to common shareholders of
approximately $4.3 million, or a net loss per share basic and
diluted of $0.04, compared to a net loss attributable to common
shareholders of approximately $4.3 million, or a net loss per share
basic and diluted of $0.05, for the three months ended March 31,
2018.
The Company ended the quarter with cash and cash
equivalents of approximately $39.4 million. In March 2019, the
Company completed a public offering of its common stock for gross
proceeds of $32.4 million, before deducting underwriting discounts
and commissions and other estimated offering expenses. Based on
Management’s current projections the Company believes that cash on
hand is sufficient to fund operations into the first quarter of
2021.
CONFERENCE CALL AND WEBCAST
DETAILS
As previously announced, Matinas will host a
live conference call and webcast for investors, analysts and other
interested parties today, Tuesday, May 14, 2019 at 8:30 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
will be archived for 60 days.
About Matinas BioPharma
Matinas BioPharma is a clinical-stage
biopharmaceutical company focused on creating value through the
streamlined development of its lead product candidate, MAT9001, for
the treatment of cardiovascular and metabolic conditions and the
application of its lipid nano-crystal (“LNC”) platform technology
to solve complex challenges relating to the safe and effective
delivery of small molecules, gene therapies, proteins, peptides and
vaccines.
The Company is actively pursuing the development
of MAT9001 with the support of a world-class team of clinical key
opinion leaders and regulatory consultants. MAT9001 is a
prescription-only omega-3 fatty acid-based composition, comprised
primarily of EPA and DPA, under development for
hypertriglyceridemia, which has shown superiority versus Vascepa®
(icosapent ethyl) in reducing serum triglycerides, Total- and
Non-HDL-Cholesterol, apolipoprotein CIII and PCSK9 levels.In
addition, the Company's proprietary, disruptive technology utilizes
lipid-crystal nano-particle cochleates to encapsulate small
molecules, nucleic acid polymers, vaccines and other medicines
potentially making them safer, more tolerable, less toxic and
orally bioavailable.
Matinas BioPharma Holdings
Inc.Condensed Consolidated Balance
SheetsUnaudited
|
|
March 31,2019 |
|
|
December 31, 2018 |
|
ASSETS: |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
39,412,546 |
|
|
$ |
12,446,838 |
|
Restricted cash |
|
|
100,000 |
|
|
|
100,000 |
|
Prepaid expenses |
|
|
391,027 |
|
|
|
538,646 |
|
Total current assets |
|
|
39,903,573 |
|
|
|
13,085,484 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Leasehold improvements and equipment - net |
|
|
1,522,413 |
|
|
|
2,042,893 |
|
Operating lease right-of-use assets |
|
|
4,102,985 |
|
|
|
- |
|
Finance lease right-of-use assets |
|
|
203,371 |
|
|
|
- |
|
In-process research and development |
|
|
3,017,377 |
|
|
|
3,017,377 |
|
Goodwill |
|
|
1,336,488 |
|
|
|
1,336,488 |
|
Restricted cash - security deposit |
|
|
486,000 |
|
|
|
461,000 |
|
Total non-current assets |
|
|
10,668,634 |
|
|
|
6,857,758 |
|
Total assets |
|
$ |
50,572,207 |
|
|
$ |
19,943,242 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
394,692 |
|
|
$ |
295,652 |
|
Note payable |
|
|
79,937 |
|
|
|
199,842 |
|
Accrued expenses |
|
|
1,010,589 |
|
|
|
1,086,868 |
|
Stock dividends payable - current |
|
|
1,174,286 |
|
|
|
1,174,286 |
|
Operating lease liabilities - current |
|
|
374,998 |
|
|
|
- |
|
Financing lease liabilities - current |
|
|
81,425 |
|
|
|
83,245 |
|
Total current liabilities |
|
|
3,115,927 |
|
|
|
2,839,893 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
341,265 |
|
|
|
341,265 |
|
Operating lease liabilities - net of current portion |
|
|
4,020,089 |
|
|
|
- |
|
Financing lease liabilities - net of current portion |
|
|
89,240 |
|
|
|
107,656 |
|
Deferred rent liability |
|
|
- |
|
|
|
512,704 |
|
Total non-current liabilities |
|
|
4,450,594 |
|
|
|
961,625 |
|
Total liabilities |
|
|
7,566,521 |
|
|
|
3,801,518 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Series A Convertible preferred stock, stated value $5.00 per share,
1,600,000 shares authorized as of March 31, 2019 and December 31,
2018; 1,467,858 shares issued and outstanding as of March 31, 2019
and December 31, 2018 (liquidation preference - $8,513,576 at March
31, 2019) |
|
|
5,583,686 |
|
|
|
5,583,686 |
|
|
|
|
|
|
|
|
|
|
Series B Convertible preferred stock, stated value $1,000 per
share, 8,000 shares authorized as of March 31, 2019 and December
31, 2018; 4,730 and 4,819 shares issued and outstanding as of March
31, 2019 and December 31, 2018; (liquidation preference -
$4,370,000 at March 31, 2019) |
|
|
4,119,043 |
|
|
|
4,196,547 |
|
|
|
|
|
|
|
|
|
|
Common stock par value $0.0001 per share, 250,000,000 shares
authorized at March 31, 2019 and December 31, 2018; 142,991,442 and
113,287,670 issued and outstanding as of March 31, 2019 and
December 31, 2018, respectively |
|
|
14,299 |
|
|
|
11,329 |
|
|
|
|
|
|
|
|
|
|
Additional paid in capital |
|
|
103,284,125 |
|
|
|
72,294,921 |
|
Accumulated deficit |
|
|
(69,995,467 |
) |
|
|
(65,944,759 |
) |
Total stockholders’ equity |
|
|
43,005,686 |
|
|
|
16,141,724 |
|
Total liabilities and stockholders’ equity |
|
$ |
50,572,207 |
|
|
$ |
19,943,242 |
|
The accompanying notes are an integral part of
these condensed consolidated financial statements.
Matinas BioPharma Holdings,
Inc.Condensed Consolidated Statements of
OperationsUnaudited
|
|
Three Months Ended March 31, |
|
|
|
2019 |
|
|
2018 |
|
Revenue: |
|
|
|
|
|
|
Contract research revenue |
|
$ |
- |
|
|
$ |
29,937 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
2,314,701 |
|
|
|
2,192,888 |
|
General and administrative |
|
|
1,788,414 |
|
|
|
1,957,798 |
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
4,103,115 |
|
|
|
4,150,686 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(4,103,115 |
) |
|
|
(4,120,749 |
) |
Other income, net |
|
|
52,407 |
|
|
|
10,745 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,050,708 |
) |
|
$ |
(4,110,004 |
) |
|
|
|
|
|
|
|
|
|
Preferred stock series A
accumulated dividends |
|
|
(146,786 |
) |
|
|
(147,286 |
) |
Preferred stock series B
accumulated dividends |
|
|
(118,250 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net loss attributable to
common shareholders |
|
$ |
(4,315,744 |
) |
|
$ |
(4,257,290 |
) |
|
|
|
|
|
|
|
|
|
Net loss available for common
shareholders per share - basic and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding - basic and diluted |
|
|
117,366,673 |
|
|
|
93,542,552 |
|
The accompanying notes are an integral part of
these condensed consolidated financial statements.
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.
Investor and Media ContactJenene ThomasJenene
Thomas Communications, LLCPhone: +1 (833) 475-8247Email:
mtnb@jtcir.com |
Source: Matinas BioPharma Holdings, Inc.
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