Marinus Pharmaceuticals Provides Business Update and First Quarter 2018 Financial Results
May 02 2018 - 7:30AM
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS) (“Marinus” or
“Company”), a biopharmaceutical company dedicated to the
development of innovative therapeutics to treat epilepsy and
neuropsychiatric disorders, today provided a business update on its
clinical development activities and reported its financial results
for the first quarter ended March 31, 2018.
Near-term Clinical Value Catalysts
(unchanged)
- Initiate Phase 3 Marigold pivotal study with oral ganaxolone in
children with CDKL5 deficiency disorder (CDD) mid-2018
- Report top-line intravenous (IV) ganaxolone data from Phase 2
Magnolia study in women with severe postpartum depression (PPD)
third quarter 2018
- Report top-line oral ganaxolone data from Amaryllis study in
women with moderate PPD fourth quarter 2018
“Our team is laser-focused on enrolling our
studies in women with postpartum depression and preparing the
medical community for a soon-to-initiate global phase 3 pivotal
study in children with CDKL5 deficiency disorder,” commented
Christopher M. Cashman, chairman and chief executive officer of
Marinus. “We expect our PPD studies to generate data this year that
will inform our Phase 3 program. We look forward to providing
updates on our progress in these areas in the upcoming months.”
CDKL5 Deficiency Disorder (CDD)
- The Company expects to begin enrolling CDD patients in its
Marigold study in mid-2018. The Marigold study will be a global,
double-blind, placebo-controlled, Phase 3 clinical trial in which
patients will undergo a baseline period followed by a treatment
period. The study’s primary efficacy endpoint will be percent
reduction in seizures. Further study details will be released
once the study has been initiated.
Postpartum Depression (PPD)
- Enrollment is ongoing in the Company’s Magnolia study, a Phase
2 double-blind, placebo-controlled, dose-optimization clinical
trial to evaluate ganaxolone in women diagnosed with severe PPD
(Hamilton Depression Rating Scale (HAMD17) score ≥26). The
primary efficacy endpoint in the Magnolia study is change from
baseline in the HAMD17 score. Patients randomized into the first
part of the study will undergo a 60-hour infusion of either
ganaxolone or placebo and will be followed for 30 days. The Company
expects to complete the IV portion (part one) of the study in the
third quarter of 2018. These data will be used to inform dosing for
part two of the study, which is planned to evaluate regimens that
include both IV and oral formulations of ganaxolone.
- Enrollment is also on-going in the Company’s Amaryllis study, a
Phase 2 double-blind, placebo-controlled clinical trial to evaluate
the safety, tolerability and efficacy of oral ganaxolone in women
with moderate PPD (HAMD17 score between 20 and 25). Patients
enrolled in the study will receive up to two weeks of treatment
with ganaxolone capsules and will be followed for 14 days. The
primary efficacy endpoint is change from baseline in the HAMD17
score. Data from this study are expected fourth quarter of
2018.
Status Epilepticus (SE)
- The Company has initiated its Phase 2 study with ganaxolone IV
in patients with refractory status epilepticus (RSE). Ganaxolone IV
will be added to standard of care and administered for up to five
days. The primary endpoint of the study is the number of
subjects who do not require IV anesthetic for status epilepticus
treatment within the first 24 hours after study drug initiation.
Initial data from this proof-of-concept study are expected fourth
quarter of 2018.
Financial Update
At March 31, 2018, the Company had cash, cash
equivalents and investments of $52.0 million, compared to $58.4
million at December 31, 2017. The Company believes that its
cash, cash equivalents and investments, as of March 31, 2018, are
adequate to fund its operations into 2020.
Research and development expenses increased to $3.9 million for
the three months ended March 31, 2018, as compared to
$3.6 million for the same period in the prior year. The
increase was related to preclinical and clinical expenses
associated with our Phase 2 clinical trials in PPD and RSE and
planned Phase 3 trial in CDD.
General and administrative expenses were $2.2 million for the
three months ended March 31, 2018 as compared to $1.8 million
for the same period in the prior year. The expense increase
was driven primarily by an increase in stock-based compensation
expense.
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, 2018 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.
Marinus Pharmaceuticals,
Inc.Selected Financial Data (in thousands, except
share and per share amounts)
(unaudited)
|
March
31,2018 |
|
December 31,2017 |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Cash and cash
equivalents |
$27,181 |
|
$33,531 |
Investments |
|
24,839 |
|
|
24,825 |
Other assets |
|
3,013 |
|
|
2,316 |
Total
assets |
$55,033 |
|
$60,672 |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
Current
liabilities |
|
1,794 |
|
|
2,544 |
Other long term
liabilities |
|
114 |
|
|
120 |
Total
liabilities |
|
1,908 |
|
|
2,664 |
Total
stockholders’ equity |
|
53,125 |
|
|
58,008 |
Total liabilities and stockholders’ equity |
$55,033 |
|
$60,672 |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2018 |
|
2017 |
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
Research
and development |
|
$ |
3,927 |
|
|
$ |
3,573 |
|
General
and administrative |
|
|
2,187 |
|
|
|
1,812 |
|
Loss from
operations |
|
|
(6,114 |
) |
|
|
(5,385 |
) |
Interest income |
|
|
116 |
|
|
|
40 |
|
Interest expense |
|
|
— |
|
|
|
(84 |
) |
Other income
(expense) |
|
|
(1 |
) |
|
|
(9 |
) |
Net loss |
|
$ |
(5,999 |
) |
|
$ |
(5,438 |
) |
Per share
information: |
|
|
|
|
|
|
Net loss
per share of common stock—basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.26 |
) |
Basic and
diluted weighted average shares outstanding
|
|
|
40,373,083 |
|
|
|
20,580,558 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
anti-seizure and anti-anxiety 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 preparing to initiate a pivotal study in children
with CDKL5 deficiency disorder, a rare form of epilepsy, and
currently conducting studies in patients with postpartum depression
and refractory status epilepticus. 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”, 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, the attainment of clinical trial results that will be
supportive of regulatory approvals, and other matters, including
the development of formulations of ganaxolone, and the availability
or potential availability of alternative products or treatments for
conditions targeted by the Company 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.
CONTACT: Lisa M. CaperelliExecutive Director,
Investor & Strategic RelationsMarinus Pharmaceuticals,
Inc.484-801-4674lcaperelli@marinuspharma.com
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