Marinus Pharmaceuticals Provides Business Update and Reports First Quarter 2017 Financial Results
May 01 2017 - 7:30AM
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS) (the “Company”), a
biopharmaceutical company dedicated to the development of
innovative therapeutics to treat epilepsy and neuropsychiatric
disorders, today provided a business update and reported its
financial results for the quarter ended March 31, 2017.
Near-term Clinical Value Catalysts
(unchanged)
- Initiate Phase 2 study in women with postpartum depression
(PPD) in 1H 2017
- Report top-line data from children with genetic seizure
disorders in mid-2017
- Initiate Phase 2 study in patients with status epilepticus (SE)
in 2H 2017
“We have directed our strategy towards
indications where we believe there is both a significant unmet
medical need and expected therapeutic benefit from ganaxolone’s
GABAA modulation mechanism,” said Christopher M. Cashman, chief
executive officer of Marinus Pharmaceuticals. “With the
recent addition of Dr. Lorianne Masuoka as chief medical officer,
our clinical leadership is in place to execute on our strategy and
vision to improve the lives of patients and their families
suffering from seizures, depression and anxiety disorders.”
Recent Publications and
Presentations
- Publication of ganaxolone data in the January issue of
Neuropharmacology showing reduction in seizures and improvement in
behaviors in a preclinical model of Angelman syndrome.
- Platform presentation at the American Academy of Neurology
annual meeting of the clinical data from the double-blind,
placebo-controlled, cross-over trial evaluating ganaxolone in
children and adolescents with Fragile X Syndrome (FXS). Patients
enrolled in the study with a higher level of anxiety at baseline
showed separation between ganaxolone and placebo in anxiety and
positive trends in improvement in attention and hyperactivity.
- Presentation of ganaxolone Phase 1 data at the biannual
London-Innsbruck Colloquium on Status Epilepticus and Acute
Seizures and selection as a Best Poster for publication in
Epilepsia. The phase 1 clinical data showed that ganaxolone IV was
generally safe, well-tolerated and reached targeted dose levels in
a short period of time.
Financial Update
At March 31, 2017, the Company had cash, cash
equivalents and investments of $24.8 million, compared to $30.1
million at December 31, 2016. The Company believes that its
cash, cash equivalents and investments, as of March 31, 2017, are
adequate to fund operations into the second half of 2018.
Research and development expenses decreased to
$3.6 million for the three months ended March 31, 2017, as compared
to $5.5 million for the same period in the prior year.
The decrease was primarily due to a decrease of $2.9 million
associated with our drug-resistant focal onset seizures program,
which discontinued in June 2016. The decrease was partially
offset by an increase of $0.7 million associated with our IV
programs in PPD and SE.
General and administrative expenses increased to
$1.8 million for the three months ended March 31, 2017, as compared
to $1.6 million for the same period in the prior year.
Cash used in operating activities increased to
$6.8 million for the three months ended March 31, 2017
compared to $6.1 million for the same period in the prior
year. The increase was driven primarily by a net increase in the
change in operating assets and liabilities of $2.6 million,
partially offset by a decrease in net loss of $1.8
million.
Readers are referred to, and encouraged to read
in its entirety, the Company’s Quarterly Report on Form 10-Q for
the quarter ended March 31, 2017 filed with the Securities and
Exchange Commission, which includes further detail on the Company’s
business plans and operations, financial condition and results of
operations.
About Marinus
Pharmaceuticals
Marinus Pharmaceuticals, Inc. is a
biopharmaceutical company dedicated to the development of
ganaxolone, which offers a new mechanism of action, demonstrated
efficacy and safety, and convenient dosing to improve the lives of
patients suffering from epilepsy and neuropsychiatric disorders.
Ganaxolone is a positive allosteric modulator of GABAA that acts on
a well-characterized target in the brain known to have both
antiseizure and antianxiety effects. Ganaxolone is being developed
in three different dose forms (IV, capsule and liquid) intended to
maximize therapeutic reach to adult and pediatric patient
populations in both acute and chronic care settings. Marinus is
currently evaluating ganaxolone in orphan pediatric indications for
the treatment of genetic seizure and behavior disorders, and
preparing to initiate Phase 2 studies in status epilepticus, an
orphan indication, and postpartum depression. For more information
visit www.marinuspharma.com. Please follow us on Twitter:
@MarinusPharma.
Forward-Looking Statements
To the extent that statements contained in this
press release are not descriptions of historical facts regarding
Marinus, they are forward-looking statements reflecting the current
beliefs and expectations of management made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. Words such as “may”, “will”, “expect”, “anticipate”,
“estimate”, “intend”, “believe”, “on-track”, and similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. Examples of
forward-looking statements contained in this press release include,
among others, statements regarding our interpretation of
preclinical studies, development plans for our product candidate,
including the development of dose forms, the clinical trial testing
schedule and milestones, the ability to complete enrollment in our
clinical trials, interpretation of scientific basis for ganaxolone
use, timing for availability and release of data, the safety,
potential efficacy and therapeutic potential of our product
candidate and our expectation regarding the sufficiency of our
working capital. Forward-looking statements in this release involve
substantial risks and uncertainties that could cause our clinical
development programs, future results, performance or achievements
to differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties
include, among others, the uncertainties inherent in the conduct of
future clinical trials, the timing of the clinical trials,
enrollment in clinical trials, availability of data from ongoing
clinical trials, expectations for regulatory approvals, and other
matters, including the development of formulations of ganaxolone,
that could affect the availability or commercial potential of our
drug candidates. Marinus undertakes no obligation to update
or revise any forward-looking statements. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to the business of the
Company in general, see filings Marinus has made with the
Securities and Exchange Commission.
|
Marinus Pharmaceuticals, Inc. |
Selected Financial Data (in thousands, except
share and per share amounts) |
(unaudited) |
|
|
March 31,2017 |
|
December 31,2016 |
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
Cash and cash
equivalents |
$22,576 |
|
$26,178 |
Investments |
|
2,184 |
|
|
3,922 |
Other assets |
|
2,064 |
|
|
1,347 |
Total
assets |
$26,824 |
|
$31,447 |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Total current
liabilities |
$6,569 |
|
$8,084 |
Notes payable,
long-term portion |
|
870 |
|
|
1,743 |
Other long term
liabilities |
|
137 |
|
|
141 |
Total
liabilities |
|
7,576 |
|
|
9,968 |
Total
stockholders’ equity |
|
19,248 |
|
|
21,479 |
Total
liabilities and stockholders’ equity |
$26,824 |
|
$31,447 |
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
Research
and development |
|
$ |
3,573 |
|
|
$ |
5,494 |
|
|
General
and administrative |
|
|
1,812 |
|
|
|
1,604 |
|
|
Loss from
operations |
|
|
(5,385 |
) |
|
|
(7,098 |
) |
|
Interest income |
|
|
40 |
|
|
|
22 |
|
|
Interest expense |
|
|
(84 |
) |
|
|
(124 |
) |
|
Other expense |
|
|
(9 |
) |
|
|
(16 |
) |
|
Net loss |
|
$ |
(5,438 |
) |
|
$ |
(7,216 |
) |
|
Per share
information: |
|
|
|
|
|
|
|
Net loss
per share of common stock—basic and diluted |
|
$ |
(0.26 |
) |
|
$ |
(0.37 |
) |
|
Basic and
diluted weighted average shares outstanding |
|
|
20,580,558 |
|
|
|
19,464,669 |
|
|
|
|
|
|
|
|
|
|
|
|
CONTACT:
Lisa M. Caperelli
Executive Director, Investor & Strategic Relations
Marinus Pharmaceuticals, Inc.
484-801-4674
lcaperelli@marinuspharma.com
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