– Announced positive topline data from initial
study in Phase 1 program for MAT2501 –
Matinas BioPharma Holdings, Inc. (NYSE MKT:MTNB), a clinical-stage
biopharmaceutical company focused on developing innovative
anti-infectives for orphan indications, today announced its
financial results for the quarter ended March 31, 2017.
The Company also reviewed the progress of its
lead anti-infective products in development, MAT2203, an orally
administered, encochleated formulation of amphotericin B (a broad
spectrum fungicidal agent), and MAT2501, an orally administered,
encochleated formulation of the broad spectrum aminoglycoside
antibiotic, amikacin, to treat gram-negative bacterial infections
and other intercellular bacterial infections.
“We have made notable, fundamental progress in
the first quarter of 2017 on the corporate and clinical fronts.
With our recent commencement of trading on the NYSE MKT, the
successful completion of a warrant tender offer that strengthened
our balance sheet, and key appointments of Dr. Ende to our board of
directors and Dominick DiPaolo as SVP of Quality and Regulatory
compliance, I believe that Matinas is positioned for great
advancements this year,” said Roelof Rongen, Chief Executive
Officer. “We remain focused on the progression of our MAT2203 and
MAT2501 clinical programs, and look forward to announcing interim
results and topline data in June, which we believe have the
potential to provide important validation of our cochleate platform
technology broadly.”
Q1 2017 CORPORATE
HIGHLIGHTS
- Commenced trading on the NYSE MKT;
- Successfully completed warrant tender offer with gross proceeds
of $13.5 million from exercise of warrants;
- Bolstered board of directors with the appointment of Eric J.
Ende, MD, MBA;
- Strengthened executive management team with the appointment of
Dominick DiPaolo as Senior Vice President of Quality and Regulatory
Compliance; and
- Opened a Good Laboratory Practice (GLP) lab space/Good
Manufacturing Practice (GMP) commercial scale manufacturing
facility.
Q1 2017 ANTI-INFECTIVE DEVELOPMENT
PROGRAM ACHIEVEMENTS
MAT2203: orally-administered,
encochleated amphotericin B, a broad spectrum fungicidal agent,
currently in Phase 2 clinical studies for the treatment of
refractory mucocutaneous candidiasis and vulvovaginal candidiasis
(VVC)
- Initiated open-label extension to Phase 2a Study of MAT2203 in
chronic mucocutaneous candidiasis.
MAT2501: orally-administered,
encochleated amikacin, a broad spectrum aminoglycoside antibiotic
agent, with a lead chronic indication for treatment of
non-tuberculous mycobacterium (NTM) infections
- Reported positive topline data from the Phase 1
single-ascending dose study of MAT2501 in healthy volunteers;
and
- Reported positive preclinical efficacy results of MAT2501 in an
in vitro Model of Mycobacterium abscessus infection.
EXPECTED NEAR-TERM
MILESTONES
- NIH to report interim results from the open-label,
NIH-sponsored Phase 2a clinical study of MAT2203 in
immunocompromised patients on June 3, 2017 at ASM Microbe 2017 in
New Orleans;
- Report topline results from the ongoing Phase 2 study of
MAT2203 in VVC in June 2017;
- Commence tolerability/PK study of MAT2203 in patients with a
hematologic malignancy in Q3 2017 to position this lead product
candidate for a pivotal study in this population; and
- Commence multiple ascending dose PK/tolerability study of
MAT2501 in healthy volunteers.
Q1 2017 SUMMARY OF FINANCIAL
RESULTS
For the three months ended March 31, 2017, the
Company reported a net loss attributable to common shareholders of
approximately $21.2 million, or a net loss share basic and diluted
of $0.25, compared to a net loss attributable to common
shareholders of approximately $2.2 million, or a net loss per share
basic and diluted of $0.04, for the three months ended March 31,
2016. The net loss for the quarter ended March 31, 2017 is
primarily attributable to an inducement charge from the exercise of
warrants and also includes the ongoing research and development
activities related to the Company’s MAT2203 antifungal and MAT2501
antibacterial product candidates as well as the costs associated
with operating as a public company. The Company ended the quarter
with cash and cash equivalents of approximately $15.8 million.
Based on Management’s current projections, the
Company believes that cash on hand is sufficient to fund operations
into June 2018.
Matinas BioPharma Holdings
Inc.Condensed Consolidated Balance
Sheets |
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2017 (Unaudited) |
|
|
2016 (Audited) |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
15,834,798 |
|
|
$ |
4,105,451 |
|
|
|
|
|
|
|
|
|
|
Restricted cash |
|
|
155,636 |
|
|
|
155,610 |
|
|
|
|
|
|
|
|
|
|
Prepaid
expenses |
|
|
803,039 |
|
|
|
304,427 |
|
|
|
|
|
|
|
|
|
|
Total
current assets |
|
|
16,793,473 |
|
|
|
4,565,488 |
|
|
|
|
|
|
|
|
|
|
Equipment
- net |
|
|
344,158 |
|
|
|
356,143 |
|
|
|
|
|
|
|
|
|
|
In-process research and development |
|
|
3,017,377 |
|
|
|
3,017,377 |
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
|
1,336,488 |
|
|
|
1,336,488 |
|
|
|
|
|
|
|
|
|
|
Other
assets including long term security deposit |
|
|
540,145 |
|
|
|
540,845 |
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS |
|
$ |
22,031,641 |
|
|
$ |
9,816,341 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,247,487 |
|
|
$ |
475,602 |
|
Note
payable |
|
|
47,218 |
|
|
|
118,046 |
|
Accrued
expenses |
|
|
471,501 |
|
|
|
829,724 |
|
Unearned
revenue |
|
|
164,656 |
|
|
|
- |
|
Deferred
rent liability |
|
|
11,744 |
|
|
|
11,485 |
|
Lease
liability |
|
|
10,134 |
|
|
|
9,936 |
|
Total
current liabilities |
|
|
1,952,740 |
|
|
|
1,444,793 |
|
|
|
|
|
|
|
|
|
|
LONG TERM
LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
tax liability |
|
|
1,205,141 |
|
|
|
1,205,141 |
|
Lease
liability - net of current portion |
|
|
13,837 |
|
|
|
16,446 |
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES |
|
|
3,171,718 |
|
|
|
2,666,380 |
|
|
|
|
|
|
|
|
|
|
Commitments |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible preferred stock, stated value $5.00 per share,
1,600,000 shares authorized at March 31, 2017 and December 31,
2016, 1,590,000 and 1,600,0000 shares issued and outstanding as of
March 31, 2017 and December 31, 2016 respectively (liquidation
preference – $7,950,000 at March 31, 2017) |
|
|
6,048,310 |
|
|
|
6,086,350 |
|
|
|
|
|
|
|
|
|
|
Common
stock par value $0.0001 per share, 250,000,000 shares authorized at
March 31, 2017 and December 31, 2016; 90,985,192 issued and
outstanding as of March 31, 2017; 58,159,495 issued and
outstanding as of December 31, 2016 |
|
|
9,098 |
|
|
|
5,817 |
|
|
|
|
|
|
|
|
|
|
Additional paid in capital |
|
|
52,478,342 |
|
|
|
36,237,504 |
|
|
|
|
|
|
|
|
|
|
Accumulated deficit |
|
|
(39,675,827 |
) |
|
|
(35,179,710 |
) |
|
|
|
|
|
|
|
|
|
Total
stockholders' equity |
|
|
18,859,923 |
|
|
|
7,149,961 |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
$ |
22,031,641 |
|
|
$ |
9,816,341 |
|
|
The accompanying notes are an integral part of
these condensed consolidated financial statements. |
Matinas BioPharma Holdings,
Inc.Condensed Consolidated Statements of
Operations(Unaudited) |
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2017 |
|
|
2016 |
|
Revenue: |
|
|
|
|
|
|
|
|
Contract
research revenue |
|
$ |
14,969 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Costs and
Expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
2,384,218 |
|
|
|
921,711 |
|
General
and administrative |
|
|
2,117,975 |
|
|
|
1,315,777 |
|
|
|
|
|
|
|
|
|
|
Total
costs and expenses |
|
|
4,502,193 |
|
|
|
2,237,488 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(4,487,224 |
) |
|
|
(2,237,488 |
) |
|
|
|
|
|
|
|
|
|
Other income/(expense),
net |
|
|
(8,893 |
) |
|
|
(7,122 |
) |
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(4,496,117 |
) |
|
$ |
(2,244,610 |
) |
|
|
|
|
|
|
|
|
|
Inducement charge from
exercise of warrants |
|
|
(16,741,356 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common shareholders |
|
$ |
(21,237,473 |
) |
|
$ |
(2,244,610 |
) |
|
|
|
|
|
|
|
|
|
Net loss
available for common shareholders per share - basic and
diluted |
|
$ |
(0.25 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding: basic and diluted |
|
|
84,595,597 |
|
|
|
57,287,955 |
|
|
The accompanying notes are an integral part of these
condensed consolidated financial statements. |
About MAT2203
MAT2203 is an orally-administered, encochleated
formulation of amphotericin B (a broad spectrum fungicidal agent).
Little to no clinical resistance has been reported to date with
amphotericin B as compared to the rapidly emerging drug resistance
seen in other antifungal therapies. Currently, IV-only administered
amphotericin B is the only broad spectrum fungicidal available but
its IV-delivery results in significant treatment-limiting side
effects, including nephrotoxicity. The ability to provide
amphotericin B orally using our proprietary and novel oral
formulation may offer a new and promising alternative for patients
and doctors. Currently, there are two Phase 2 studies underway with
MAT2203. The first is an open-label Phase 2a
NIH/NIAID-sponsored clinical study with MAT2203 in
immunocompromised patients with refractory mucocutaneous
candidiasis. The second is a Phase 2 study of MAT2203 in patients
with vulvovaginal candidiasis (VVC). Data from both studies is
expected to be announced in June of 2017. The FDA has
designated MAT2203 as a Qualified Infectious Disease Product (QIDP)
for the treatment of invasive candidiasis and the treatment of
aspergillosis, as well as for the prevention of invasive fungal
infections due to immunosuppressive therapy. MAT2203 is also being
explored for treatment of additional anti-fungal indications and
may have the potential for Orphan Drug Designation in certain of
these indications.
About MAT2501
MAT2501 is an orally-administered, encochleated
formulation of the broad spectrum IV-only aminoglycoside antibiotic
agent amikacin, which utilizes the Company’s proprietary,
lipid-crystal, nanoparticle delivery technology. Amikacin is
currently used to treat different types of chronic and acute
bacterial infections, including non-tuberculous mycobacterium (NTM)
infections and various multidrug-resistant gram-negative bacterial
infections. IV-administered amikacin is associated with major side
effects including nephrotoxicity and ototoxicity (permanent loss of
hearing). MAT2501 is specifically designed to provide targeted
delivery of the potent antibiotic amikacin while providing a
significantly improved safety and tolerability profile. In
preclinical studies MAT2501 demonstrated efficacy after oral
bioavailability and targeted delivery of amikacin directly to the
site of infection in murine models of both pulmonary (lung) and
disseminated NTM infections. The FDA has designated MAT2501 as a
QIDP and an Orphan Drug for the treatment of NTM infections. The
Company intends to initially develop MAT2501 for the treatment of
NTM infections and is also exploring the development of MAT2501 for
the treatment of a multi-drug resistant, gram negative bacterial
infections. The Company recently reported positive topline data
from its Phase 1 single ascending dose study in healthy volunteers.
If approved, Matinas believes MAT2501 would become the first orally
bioavailable aminoglycoside and represent a significant improvement
over existing therapies from a treatment and health economic
perspective.
About Matinas BioPharma
Matinas BioPharma is a clinical-stage
biopharmaceutical company focused on developing innovative
anti-infectives for orphan indications. The Company's proprietary,
disruptive technology utilizes lipid-crystal nano-particle
cochleates to nano-encapsulate existing drugs, making them safer,
more tolerable, less toxic and orally bioavailable.
The Company's lead anti-infective product
candidates, MAT2203 and MAT2501, position Matinas BioPharma to
become a leader in the safe and effective delivery of
anti-infective therapies utilizing its proprietary lipid-crystal
nano-particle cochleate formulation technology. For more
information, please visit www.matinasbiopharma.com and connect with
the Company on Twitter, LinkedIn, Facebook, and Google+.
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 strategic focus and the
future development of its product candidates, including MAT2203 and
MAT2501, the anticipated timing of regulatory submissions, the
anticipated timing of clinical studies, 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 maintain and derive benefit from the Qualified
Infectious Disease Product (QIDP), Orphan and/or Fast Track
designations for MAT2203 and MAT2501, which does not change the
standards for regulatory approval or guarantee regulatory approval
on an expedited basis, or at all; 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 Contact
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (908) 938-1475
Email: jenene@jenenethomascommunications.com