– Key focus on advancing the development of
MAT9001, a proprietary, potential best-in-class cardiovascular
therapy in what is projected to be a new, multi-billion dollar
prescription-only omega-3 drug class –
Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
clinical-stage biopharmaceutical company, today announced its
financial results for the third quarter ended September 30, 2018
and provided a corporate update.
“The third quarter of 2018 through the date of
our filing has been a transformational time for Matinas,” commented
Jerome D. Jabbour, Chief Executive Officer of Matinas. “In
witnessing the enthusiasm and potential surrounding our
differentiated LNC platform delivery technology, coupled with
recent third-party landmark data announcements demonstrating that
certain omega-3 fatty acids can have a significant impact on
overall cardiovascular health, we find ourselves in the enviable
position of having two potential best-in-class assets. As the
only drug currently in development with head-to-head data
demonstrating statistical superiority to Vascepa® on a variety of
lipid measures, highlighted by an approximately six-fold higher AUC
and Cmax and higher bloods levels of EPA, MAT9001 is uniquely
positioned to aggressively move forward in development with the
assistance of a world class team of advisors. While recently
announced data in this space is very impressive, we believe there
are exciting opportunities to create potential differentiation and
be very thoughtful with trial design and execution. Our goal
with this clinical development program is to establish MAT9001 as a
potential best-in-class therapy for the benefit of patients in this
projected multi-billion dollar emerging prescription-only omega-3
class.”
“Equally as exciting is the progress we have
made with our LNC platform delivery technology. With the
recent addition of Dr. Matkovits to our team, we are in a stronger
position to assess the clinical development program for MAT2203,
and we remain very enthusiastic about its profile as we advance
that important drug candidate towards our next clinical trial. In
addition, our discussions with potential partners in the gene
therapy space continue to progress. Finally, in having
secured additional financing to extend our cash runway into the
fourth quarter of next year, I believe our collective momentum is
setting the stage for a breakthrough year for Matinas in 2019,”
added Mr. Jabbour.
MAT9001 DEVELOPMENT UPDATE: RENEWED
FOCUS ON PROPRIETARY LIPID-BASED CARDIOVASCULAR
PRODUCT
The Company’s lead cardiovascular product,
MAT9001, is a uniquely engineered, prescription-only omega-3 fatty
acid medication comprising docosa-pentaenoic acid (DPA),
eicosapentaenoic acid (EPA) and other omega-3 fatty acids. MAT9001
was developed based on the newest scientific advancements in the
field, incorporating and building upon the knowledge of almost 40
years of scientific research in the omega-3 discipline and has been
uniquely and purposefully designed with the goal of providing a
differentiated pharmacotherapy for the treatment of dyslipidemia
and cardiovascular disease. In 2015, the Company completed its
comparative PK/PD Phase 2-like study with 42 enrolled patients.
Results from the study showed that MAT9001 demonstrated superiority
versus Vascepa® (icosapent ethyl) in reducing lipids,
triglycerides, apolipoproteins and PCSK9 levels without an
associated increase in LDL cholesterol.
Given recently announced developments in the
cardiovascular space with Vascepa® and the Company’s possession of
the potential best-in-class data generated by MAT9001, Matinas is
well prepared to advance MAT9001 through thoughtful, well-designed
clinical pathways in order to capitalize on its potentially
differentiated and best-in-class product profile. Matinas plans to
evaluate the use of MAT9001 in an initial indication for the
treatment of highly elevated triglycerides (greater than or equal
to 500 mg/dL) or severe hypertriglyceridemia. The Company believes
that MAT9001 may also be a potential treatment for additional
indications and is in advanced discussions with key opinion leaders
and regulatory experts to design next best steps in its clinical
development program.
LNC PLATFORM TECHNOLOGY UPDATE:
CONTINUED ADVANCEMENT OF STRATEGIC COLLABORATION
DISCUSSIONS
The Company’s proprietary LNC delivery
technology platform utilizes lipid nano-crystals which can
encapsulate small molecules, nucleic acid polymers such as
oligonucleotides, vaccines, peptides, proteins and other medicines
potentially making them safer, more tolerable, less toxic and
orally bioavailable. Matinas is currently focused on leveraging its
LNC delivery platform in advancing and developing its own pipeline
of product candidates within the anti-infective space, including
lead platform-validating product, MAT2203, as well as identifying
strategic partners whose drug candidates and molecules, in
combination with its LNC delivery technology, present the greatest
value and innovation while addressing significant markets of unmet
medical need, specifically in the gene therapy space.
Based upon existing and consistently replicated
preclinical and clinical data, the Company believes that its unique
and proprietary LNC delivery technology platform can be used to
formulate and thereby redesign a wide variety of molecules and
drugs which, (i) require a delivery technology to improve the
stability of molecules inside and outside the body, (ii) could
benefit from efficient delivery and cellular uptake by target
cells, and (iii) are currently only available in IV formulations or
(iv) otherwise experience significant toxicity-related adverse
events.
Matinas continues to advance its discussions
with multiple strategic and research partners and expects to
utilize this strategy to expand the successful application of its
LNC Technology.
Q3 2018 SUMMARY OF FINANCIAL
RESULTS
For the nine months ended September 30, 2018,
the Company reported a net loss attributable to common shareholders
of approximately $10.5 million, or a net loss per share basic and
diluted of $0.12, compared to a net loss attributable to common
shareholders of approximately $11.9 million, or a net loss per
share basic and diluted of $0.32, for the nine months ended
September 30, 2017. The net loss for the quarter ended September
30, 2018 was primarily attributable to ongoing activities to
develop and seek regulatory approval for MAT2203 and any other
product candidates we choose to develop based upon the Company’s
LNC delivery technology platform as well as the costs associated
with operating as a public company. The Company ended the quarter
with cash and cash equivalents of approximately $6.6 million.
Subsequent to September 30, 2018, the Company raised an additional
$8.8 million in gross proceeds through its Controlled Equity Sales
Offering. We believe the total cash and cash equivalents on hand as
of the date of this filing are sufficient to fund planned
operations through November 2019.
About MAT9001
MAT9001 is a proprietary prescription-only
omega-3 fatty acid-based composition, comprising docosapentaenoic
acid (DPA) and other omega-3 fatty acids, which is under
development for therapeutic applications with severe
hypertriglyceridemia (TG>500 mg/dL) as the lead indication.
Promising pre-clinical studies with DPA and MAT9001 indicate
distinctive therapeutic response properties. The Company
believes that its development program and related clinical
investigations may yield an improved therapeutic profile compared
to existing therapies, based on MAT9001's differentiating
mechanistic features associated with its unique composition.
MAT9001 is the only omega-3 that has been
studied head-to-head versus Vascepa® (icosapent ethyl). Data
from this study demonstrated that MAT9001 met all primary and
secondary endpoints in a head-to-head comparative pharmacokinetic
and pharmacodynamic study. The PK/PD cross-over clinical
study, with administration of the study drugs with food to 42
patients with high triglycerides (200-400 mg/dL), was conducted in
Canada under scientific guidance of a distinguished Steering
Committee, comprised of Drs. Christie M. Ballantyne (Baylor College
of Medicine), Kevin C. Maki (DePaul University) and William F.
Keane (University of Minnesota, retired).
In addition to meeting the statistical
non-inferiority test for all primary and secondary endpoints,
further statistical analysis demonstrated superiority of MAT9001
over Vascepa for omega-3 bioavailability (baseline adjusted AUC and
Cmax, approximately 6-fold higher with MAT9001 on day 14, with very
high statistical significance) and triglyceride reduction (median
TG-reduction from baseline: -33.2% for MAT9001 versus -10.5% for
Vascepa; p<0.0001). MAT9001 also demonstrated a statistically
significantly greater reduction in total-cholesterol,
VLDL-cholesterol and non-HDL-cholesterol for MAT9001 versus
Vascepa. Although both study drugs exhibited a reduction of LDL
cholesterol, the difference between the two was not statistically
significant. In addition, MAT9001 demonstrated a statistically
significant reduction in PCSK9 versus Vascepa, which did not
decrease PCSK9 levels.
About Matinas BioPharma Matinas
BioPharma is a clinical-stage biopharmaceutical company focused on
(i) the development of MAT9001 for abnormalities in blood lipids,
referred to as dyslipidemia, and the treatment of cardiovascular
and metabolic disease, and (ii) enabling the delivery of
life-changing medicines using our unique and proprietary, lipid
nano-crystal (“LNC”) platform technology, including development of
MAT2203, our lead antifungal platform drug candidate.
The Company's proprietary, disruptive technology
utilizes lipid-crystal nano-particle cochleates to nano-encapsulate
small molecules, oligonucleotides, vaccines and other medicines
potentially making them safer, more tolerable, less toxic and
orally bioavailable. The Company's lead anti-fungal product
candidate, MAT2203, positions Matinas BioPharma to become a leader
in the safe and effective delivery of anti-infective therapies
utilizing its proprietary LNC formulation technology.
In addition, 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
under development for hypertriglyceridemia, which has shown
superiority versus Vascepa® (icosapent ethyl) in reducing serum
triglycerides, Total- and Non-HDL-Cholesterol, apolipoproteins and
PCSK9 levels.
For more information, please visit
www.matinasbiopharma.com and connect with the Company on Twitter,
LinkedIn and Facebook.
Matinas BioPharma Holdings
Inc.Consolidated Balance Sheets
|
|
September
30,2018 |
|
|
December 31,2017 |
|
|
|
Unaudited |
|
|
Audited |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
6,632,468 |
|
|
$ |
7,306,507 |
|
Restricted cash – security deposit |
|
|
200,000 |
|
|
|
155,431 |
|
Prepaid
expenses |
|
|
692,400 |
|
|
|
502,032 |
|
Total
current assets |
|
|
7,524,868 |
|
|
|
7,963,970 |
|
|
|
|
|
|
|
|
|
|
Leasehold
improvements and equipment - net |
|
|
2,097,149 |
|
|
|
1,569,858 |
|
In-process research and development |
|
|
3,017,377 |
|
|
|
3,017,377 |
|
Goodwill |
|
|
1,336,488 |
|
|
|
1,336,488 |
|
Restricted cash – security deposit |
|
|
436,000 |
|
|
|
535,999 |
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS |
|
$ |
14,411,882 |
|
|
$ |
14,423,692 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
303,360 |
|
|
$ |
582,867 |
|
Note
payable |
|
|
319,746 |
|
|
|
170,236 |
|
Accrued
expenses |
|
|
758,340 |
|
|
|
959,147 |
|
Stock
dividends payable |
|
|
1,174,286 |
|
|
|
- |
|
Deferred
revenue |
|
|
- |
|
|
|
29,937 |
|
Lease
liability |
|
|
83,341 |
|
|
|
26,975 |
|
Total
current liabilities |
|
|
2,639,073 |
|
|
|
1,769,162 |
|
|
|
|
|
|
|
|
|
|
LONG TERM
LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
tax liability |
|
|
848,185 |
|
|
|
848,185 |
|
Deferred
rent liability |
|
|
501,816 |
|
|
|
455,554 |
|
Lease
liability - net of current portion |
|
|
122,578 |
|
|
|
67,683 |
|
Stock
dividends payable - long term |
|
|
- |
|
|
|
601,143 |
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES |
|
|
4,111,652 |
|
|
|
3,741,727 |
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A
Convertible preferred stock, stated value $5 per share, 1,600,000
shares authorized as of September 30, 2018 and December 31, 2017,
respectively; 1,467,858 and 1,502,858 shares outstanding at
September 30, 2018 and December 31, 2017, respectively (liquidation
preference - $8,513,576 at September 30, 2018) |
|
|
5,583,686 |
|
|
|
5,716,825 |
|
|
|
|
|
|
|
|
|
|
Series B
Convertible preferred stock, stated value $1,000 per share, 8,000
shares authorized and 7,003 shares outstanding as of September 30,
2018 (liquidation preference - $7,003,000 at September 30, 2018) No
shares authorized or issued at December 31,2017 |
|
|
6,098,447 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Common
stock par value $0.0001 per share, 250,000,000 shares authorized at
September 30, 2018 and December 31, 2017, respectively; 97,697,243
issued and outstanding as of September 30, 2018; 93,371,129 issued
and outstanding as of December 31, 2017 |
|
|
9,769 |
|
|
|
9,335 |
|
|
|
|
|
|
|
|
|
|
Additional paid in capital |
|
|
60,926,628 |
|
|
|
56,230,347 |
|
|
|
|
|
|
|
|
|
|
Accumulated deficit |
|
|
(62,318,300 |
) |
|
|
(51,274,542 |
) |
|
|
|
|
|
|
|
|
|
Total
stockholders’ equity |
|
|
10,330,230 |
|
|
|
10,681,965 |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
14,411,882 |
|
|
$ |
14,423,692 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Matinas BioPharma Holdings,
Inc.Condensed Consolidated Statements of
Operations(Unaudited)
|
|
Three Months Ended |
|
|
|
September 30, |
|
|
|
2018 |
|
|
2017 |
|
Revenue: |
|
|
|
|
|
|
|
|
Contract
research revenue |
|
$ |
- |
|
|
$ |
44,906 |
|
|
|
|
|
|
|
|
|
|
Costs and
Expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
1,379,525 |
|
|
|
2,013,063 |
|
General
and administrative |
|
|
1,574,712 |
|
|
|
1,440,141 |
|
|
|
|
|
|
|
|
|
|
Total
costs and expenses |
|
|
2,954,237 |
|
|
|
3,453,204 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(2,954,237 |
) |
|
|
(3,408,298 |
) |
|
|
|
|
|
|
|
|
|
Other income/(expense),
net |
|
|
18,660 |
|
|
|
13,584 |
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(2,935,577 |
) |
|
$ |
(3,394,714 |
) |
|
|
|
|
|
|
|
|
|
Preferred stock series
A accumulated dividends |
|
|
(146,786 |
) |
|
|
(150,786 |
) |
|
|
|
|
|
|
|
|
|
Preferred stock series
B accumulated dividends |
|
|
(175,075 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common shareholders |
|
$ |
(3,257,438 |
) |
|
$ |
(3,545,500 |
) |
|
|
|
|
|
|
|
|
|
Net loss available for
common shareholders per share - basic and diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding: |
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
94,697,049 |
|
|
|
92,222,601 |
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2018 |
|
|
2017 |
|
Revenue: |
|
|
|
|
|
|
|
|
Contract
research revenue |
|
$ |
119,750 |
|
|
$ |
104,781 |
|
|
|
|
|
|
|
|
|
|
Costs and
Expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
5,095,110 |
|
|
|
6,711,997 |
|
General
and administrative |
|
|
5,504,559 |
|
|
|
5,264,609 |
|
|
|
|
|
|
|
|
|
|
Total
costs and expenses |
|
|
10,599,669 |
|
|
|
11,976,606 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(10,479,919 |
) |
|
|
(11,871,825 |
) |
|
|
|
|
|
|
|
|
|
Other income/(expense),
net |
|
|
23,304 |
|
|
|
13,354 |
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(10,465,615 |
) |
|
$ |
(11,858,471 |
) |
|
|
|
|
|
|
|
|
|
Preferred stock series
A accumulated dividends |
|
|
(440,857 |
) |
|
|
(462,186 |
) |
|
|
|
|
|
|
|
|
|
Preferred stock series
B accumulated dividends |
|
|
(196,924 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Inducement charge from
exercise of warrants |
|
|
- |
|
|
|
(16,741,356 |
) |
|
|
|
|
|
|
|
|
|
Net loss attributable
to common shareholders |
|
$ |
(11,094,396 |
) |
|
$ |
(29,062,013 |
) |
|
|
|
|
|
|
|
|
|
Net loss available for
common shareholders per share - basic and diluted |
|
$ |
(0.12 |
) |
|
$ |
(0.32 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding: |
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
94,098,372 |
|
|
|
89,468,153 |
|
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 ContactJenene ThomasJenene Thomas
Communications, LLCPhone: +1 (833) 475-8247Email:
mtnb@jtcir.com |
Media
ContactEliza Schleifstein Scient Public RelationsPhone: +
1 (917) 763-8106 Email: eliza@scientpr.com |
Source: Matinas BioPharma Holdings, Inc.
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