Matinas BioPharma Reports 2017 Third Quarter Financial Results and Provides Corporate Update
November 15 2017 - 7:35AM
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 September 30, 2017 and
reviewed its operational progress of its lead anti-infective
products in development and expected near-term milestones.
“In the third quarter, our team worked with
leading key opinion leaders and our clinical and regulatory
advisors to analyze in great detail a compilation of very
encouraging preclinical and clinical data generated for MAT2003.
Patients undergoing treatment for acute lymphoblastic leukemia
(ALL), a blood-borne cancer, are at high risk for invasive fungal
infections (IFIs) due to their specific chemotherapy. The profile
of MAT2203 uniquely positions it to significantly reduce the
occurrence of potentially lethal IFIs in these patients. We believe
the compelling MAT2203 data package, combined with the proposed
clinical and regulatory pathway we have established, positions us
to successfully engage with the FDA to move our MAT2203 clinical
development program forward to a pivotal Phase 3 registration study
for the prevention of IFIs,” stated Roelof Rongen, Chief Executive
Officer of Matinas. “Our team continues to work diligently to
establish a clear path forward for our development programs as we
complete the remainder of 2017 and work towards creating
significant value-driving events throughout 2018.”
ANTIFUNGAL MAT2203 RECENT ACHIEVMENTS
- Reported topline data from Phase 2 clinical study of orally
administered MAT2203 in the treatment of vulvovaginal candidiasis
indicating that MAT2203 was safe and well tolerated while
demonstrating signals of efficacy through a mechanism involving
systemic absorption, including a dose response;
- Announced positive interim data from NIH-conducted Phase 2a
clinical study of orally administered MAT2203 for the treatment of
chronic refractory mucocutaneous candidiasis providing for the safe
and efficacious long-term use of MAT2203 (now longer than nine
months without encountering safety issues); and
- Presented positive preclinical efficacy data of MAT2203 in a
mouse model of cryptococcal meningitis demonstrating dramatic
improvement in treatment with MAT2203 and the ability to
systemically cross the blood/brain barrier.
- Mortality results were consistent with what has been seen in
MAT2203 treated models of invasive candidiasis and invasive
aspergillosis and the fluorescence images of brain tissue further
support the unique ability of cochleates to penetrate deep into
infected organs.
MAT2203 NEXT STEPS
- Commence tolerability/PK study of MAT2203 in leukemia patients
as a critical piece of the Phase 2 development program prior to
commencing a pivotal Phase 3 registration trial in prevention of
IFIs in patients with ALL. Initial data expected Q4
2018;
- Conduct Type B Meeting (face-to-face) in early Q1 2018 with FDA
to review overall data package for MAT2203, the Company’s plans to
finalize Phase 2 with data from its tolerability/PK study in
leukemia patients and to position MAT2203 with FDA toward a Phase 3
clinical program in prevention of IFIs in patients with ALL;
and
- Evaluate and commence one or more studies in cryptococcal
meningitis in partnership with the University of Minnesota to
demonstrate patient efficacy in invasive fungal infections as a way
to supplement the overall data package for MAT2203 during
2018.
ANTIBACTERIAL MAT2501 RECENT ACHIEVEMENTS
- Reported positive topline data from the Phase 1
single-ascending dose study of MAT2501 in healthy volunteers.
- No serious adverse events were reported.
- Oral administration of MAT2501 at all tested doses yielded
blood levels that were well below the safety levels recommended for
injected amikacin.
- Data supports further development of MAT2501 for the treatment
of non-tuberculous mycobacterium (NTM) infections.
- Results from Phase 1 study demonstrating systemic absorption
and accumulation in the urine were encouraging toward the potential
for MAT2501 to treat more acute bacterial infections, such as gram
negative urinary tract infections (cUTIs).
MAT2501 NEXT STEPS
- Commence multiple-ascending dose PK/tolerability study of
MAT2501 in healthy volunteers in Q2 2018;
- Announce results of PK/tolerability study in Q4 2018;
and
- Initiate Phase 2 NTM study in Q4 2018.
Q3 2017 SUMMARY OF FINANCIAL RESULTS
For the nine months ended September 30, 2017,
the Company reported a net loss of approximately $11.9 million, or
a net loss share basic and diluted of $0.33, compared to a net loss
of approximately $5.7 million, or a net loss per share basic and
diluted of $0.18, for the nine months ended September 30, 2016. The
net loss for the nine months ended September 30, 2017 is primarily
attributable to ongoing research and development activities related
to MAT2203 and MAT2501 as well as the costs associated with
operating as a public company. The Company ended the quarter with
cash and cash equivalents of approximately $9.0 million.
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. 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. 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.
|
|
|
|
Matinas BioPharma Holdings,
Inc.Condensed Consolidated Statements of
Operations(Unaudited) |
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
|
|
2017 |
|
|
2016 |
|
Revenue: |
|
|
|
|
|
|
Contract
research revenue |
|
$ |
44,906 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Costs and
Expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
2,013,063 |
|
|
|
835,308 |
|
General
and administrative |
|
|
1,440,141 |
|
|
|
999,803 |
|
|
|
|
|
|
|
|
|
|
Total
costs and expenses |
|
|
3,453,204 |
|
|
|
1,835,111 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(3,408,298 |
) |
|
|
(1,835,111 |
) |
|
|
|
|
|
|
|
|
|
Other income/(expense),
net |
|
|
13,584 |
|
|
|
(3,325 |
) |
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(3,394,714 |
) |
|
$ |
(1,838,436 |
) |
|
|
|
|
|
|
|
|
|
Dividend to preferred
shareholders |
|
|
(608,343 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Convertible preferred
stock beneficial conversion feature accreted as a deemed
dividend |
|
|
- |
|
|
|
(4,393,809 |
) |
|
|
|
|
|
|
|
|
|
Net loss attributable
to common shareholders |
|
$ |
(4,003,057 |
) |
|
$ |
(6,232,245 |
) |
|
|
|
|
|
|
|
|
|
Net loss
available for common shareholders per share - basic and
diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding: Basic and diluted |
|
|
92,222,601 |
|
|
|
57,628,917 |
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2017 |
|
|
2016 |
|
Revenue: |
|
|
|
|
|
|
|
|
Contract
research revenue |
|
$ |
104,781 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Costs and
Expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
6,711,997 |
|
|
|
2,399,595 |
|
General
and administrative |
|
|
5,264,609 |
|
|
|
3,293,233 |
|
|
|
|
|
|
|
|
|
|
Total
costs and expenses |
|
|
11,976,606 |
|
|
|
5,692,828 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(11,871,825 |
) |
|
|
(5,692,828 |
) |
|
|
|
|
|
|
|
|
|
Other income/(expense),
net |
|
|
13,354 |
|
|
|
(14,103 |
) |
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(11,858,471 |
) |
|
$ |
(5,706,931 |
) |
|
|
|
|
|
|
|
|
|
Dividend to preferred
shareholders |
|
|
(608,343 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Convertible preferred
stock beneficial conversion feature accreted as a deemed
dividend |
|
|
- |
|
|
|
(4,393,809 |
) |
|
|
|
|
|
|
|
|
|
Inducement charge from
exercise of warrants |
|
|
(16,741,356 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common shareholders |
|
$ |
(29,208,170 |
) |
|
$ |
(10,100,740 |
) |
|
|
|
|
|
|
|
|
|
Net loss
available for common shareholders per share - basic and
diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.18 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding: basic and diluted |
|
|
89,468,153 |
|
|
|
57,505,788 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Matinas BioPharma Holdings
Inc.Consolidated Balance
SheetsUnaudited |
|
|
|
|
|
|
|
|
|
September 30, 2017 |
|
|
December 31, 2016 |
|
|
|
(Unaudited) |
|
|
(Audited) |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
9,000,674 |
|
|
$ |
4,105,451 |
|
Restricted cash |
|
|
155,404 |
|
|
|
155,610 |
|
Prepaid
expenses |
|
|
1,017,372 |
|
|
|
304,427 |
|
Total
current assets |
|
|
10,173,450 |
|
|
|
4,565,488 |
|
|
|
|
|
|
|
|
|
|
Leasehold
improvements and equipment - net |
|
|
1,460,455 |
|
|
|
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 |
|
|
535,999 |
|
|
|
540,845 |
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS |
|
$ |
16,523,769 |
|
|
$ |
9,816,341 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
341,593 |
|
|
$ |
475,602 |
|
Note
payable |
|
|
297,912 |
|
|
|
118,046 |
|
Accrued
expenses |
|
|
753,760 |
|
|
|
829,724 |
|
Deferred
revenue |
|
|
74,844 |
|
|
|
- |
|
Deferred
rent liability |
|
|
395,620 |
|
|
|
11,485 |
|
Lease
liability |
|
|
19,020 |
|
|
|
9,936 |
|
Total
current liabilities |
|
|
1,882,749 |
|
|
|
1,444,793 |
|
|
|
|
|
|
|
|
|
|
LONG TERM
LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
tax liability |
|
|
1,205,141 |
|
|
|
1,205,141 |
|
Lease
liability - net of current portion |
|
|
47,914 |
|
|
|
16,446 |
|
Stock
dividends payable - long term |
|
|
603,143 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES |
|
|
3,738,947 |
|
|
|
2,666,380 |
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A
Convertible preferred stock, stated value $5.00 per share,
1,600,000 shares authorized as of September 30, 2017 and December
31, 2016; 1,507,858 and 1,600,000 shares issued and outstanding as
of September 30, 2017 and December 31, 2016, respectively,
(liquidation preference - $8,142,433 at September 30, 2017) |
|
|
5,735,845 |
|
|
|
6,086,350 |
|
Common
stock par value $0.0001 per share, 250,000,000 and 250,000,000
shares authorized at September 30, 2017 and December 31, 2016,
respectively; 92,950,096 issued and outstanding as of September 30,
2017; 58,159,495 issued and outstanding as of December 31,
2016 |
|
|
9,294 |
|
|
|
5,817 |
|
|
|
|
|
|
|
|
|
|
Additional paid in capital |
|
|
54,686,207 |
|
|
|
36,237,504 |
|
|
|
|
|
|
|
|
|
|
Accumulated deficit |
|
|
(47,646,524 |
) |
|
|
(35,179,710 |
) |
|
|
|
|
|
|
|
|
|
Total
stockholders’ equity |
|
|
12,784,822 |
|
|
|
7,149,961 |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
16,523,769 |
|
|
$ |
9,816,341 |
|
|
|
|
|
|
|
|
|
|
Investor ContactJenene ThomasJenene Thomas
Communications, LLCPhone: +1 (908) 938-1475Email:
jenene@jenenethomascommunications.com
Matinas Biopharma (AMEX:MTNB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Matinas Biopharma (AMEX:MTNB)
Historical Stock Chart
From Apr 2023 to Apr 2024