Marinus Pharmaceuticals Provides Business Update and Third Quarter 2018 Financial Results
October 29 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 third quarter ended September 30, 2018.
“This is an exciting time for Marinus,”
commented Christopher M. Cashman, chairman and chief executive
officer of Marinus. “With enrollment complete in our Magnolia study
last quarter, we are on-track to report data shortly. This is our
first data readout for ganaxolone in women suffering from
postpartum depression, a devastating condition with few treatment
options. We will learn how ganaxolone performs in this patient
population at various doses and apply these learnings to ongoing
and future development as we lay the foundation for later-stage
studies.”
CDKL5 Deficiency Disorder (CDD)
- The Company is enrolling patients in its pivotal Phase 3
clinical trial (Marigold Study) evaluating the use of oral
ganaxolone in children and young adults with CDD. The Marigold
Study is a global, double-blind, placebo-controlled, trial that
will enroll approximately 70 patients between the ages of 2 and 21
with a confirmed disease-related CDKL5 gene variant. Patients will
undergo an 8-week baseline period before being randomized to
receive either ganaxolone (up to 1,800 mg/day) or placebo for 17
weeks, in addition to their existing anti-seizure treatment.
Following the double-blind treatment period, all patients that meet
certain eligibility requirements will have the opportunity to
receive ganaxolone in the open label phase of the study. The
study’s primary efficacy endpoint is percent reduction in seizures.
Secondary outcome measures will include non-seizure-related
endpoints to capture certain changes in behavior and sleep. There
are currently no approved treatments for CDD.
Postpartum Depression (PPD)
- The Company has completed enrollment in the IV only portion of
the Magnolia study, a Phase 2 double-blind, placebo-controlled,
dose-optimization clinical trial to evaluate ganaxolone in women
diagnosed with PPD. The efficacy endpoint is change from baseline
in the Hamilton Depression Rating Scale (HAMD17) score. The Company
expects to provide top-line data this quarter and announce next
steps in our PPD program.
- Enrollment is on-going in the Company’s Amaryllis study, a
Phase 2 clinical trial to evaluate the safety, tolerability and
efficacy of oral ganaxolone in women with PPD. Patients enrolled in
the initial open label phase of the study receive one of multiple
treatment regimens with oral ganaxolone. The efficacy endpoint is
change from baseline in the HAMD17 score. The Company will provide
an update on timing for data from the open label phase of the
Amaryllis study after release of data from the Magnolia study, as
the Magnolia study data may provide dosing insights that inform
further oral dose optimization. Upon successful completion of the
open label phase, the Amaryllis study is planned to continue as a
double-blind placebo-controlled trial.
Status Epilepticus (SE)
- The Company is enrolling patients with refractory status
epilepticus (RSE) in its Phase 2 study with ganaxolone IV. Initial
data from this proof-of-concept study are expected in the fourth
quarter of 2018.
Financial Update
At September 30, 2018, the Company had cash,
cash equivalents and investments of $39.6 million. The Company
believes that its cash, cash equivalents and investments, as of
September 30, 2018, are adequate to fund its operations into
2020.
Research and development expenses increased to
$9.1 million and $20.3 million for the three and nine months ended
September 30, 2018, respectively, as compared to $2.6 million
and $9.0 million for the same periods 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
Phase 3 trial in CDD.
General and administrative expenses were $2.1
million and $6.6 million for the three and nine months ended
September 30, 2018, respectively, as compared to $1.6 million
and $5.1 million for the same periods in the prior year. The
increase was driven primarily by an increase in non-cash
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 September 30, 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) |
|
|
|
September
30, |
|
December
31, |
|
|
2018 |
|
2017 |
|
|
|
|
|
ASSETS |
|
|
|
|
Cash and cash
equivalents |
|
$19,662 |
|
$33,531 |
Investments |
|
19,967 |
|
24,825 |
Other assets |
|
2,470 |
|
2,316 |
Total
assets |
|
$42,099 |
|
$60,672 |
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current
liabilities |
|
$6,877 |
|
$2,544 |
Other long term
liabilities |
|
100 |
|
120 |
Total
liabilities |
|
6,977 |
|
2,664 |
Total
stockholders' equity |
|
35,122 |
|
58,008 |
Total
liabilities and stockholders' equity |
|
$42,099 |
|
$60,072 |
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
9,148 |
|
|
$ |
2,642 |
|
|
$ |
20,307 |
|
|
$ |
9,032 |
|
General
and administrative |
|
|
2,073 |
|
|
|
1,571 |
|
|
|
6,599 |
|
|
|
5,074 |
|
Loss from
operations |
|
|
(11,221 |
) |
|
|
(4,213 |
) |
|
|
(26,906 |
) |
|
|
(14,106 |
) |
Interest income |
|
|
111 |
|
|
|
45 |
|
|
|
292 |
|
|
|
116 |
|
Interest expense |
|
|
— |
|
|
|
(3 |
) |
|
|
— |
|
|
|
(159 |
) |
Other income
(expense) |
|
|
— |
|
|
|
1 |
|
|
|
— |
|
|
|
(11 |
) |
Net loss |
|
$ |
(11,110 |
) |
|
$ |
(4,170 |
) |
|
$ |
(26,614 |
) |
|
$ |
(14,160 |
) |
Per share
information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share of common stock—basic and diluted |
|
$ |
(0.27 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.66 |
) |
|
$ |
(0.60 |
) |
Basic and
diluted weighted average shares outstanding |
|
|
40,407,146 |
|
|
|
28,666,656 |
|
|
|
40,392,084 |
|
|
|
23,531,745 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
anti-seizure, anti-depressant 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 has initiated the first ever pivotal study in
children with CDKL5 deficiency disorder, a rare form of epilepsy,
and is 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. Caperelli |
|
|
Executive Director,
Investor & Strategic Relations |
|
|
Marinus
Pharmaceuticals, Inc. |
|
|
484-801-4674 |
|
|
lcaperelli@marinuspharma.com |
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