Marinus Pharmaceuticals Provides Business Update and Second Quarter 2018 Financial Results
August 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 second quarter ended June 30, 2018.
Near-term Clinical Value
Catalysts
- Complete enrollment of patients in
ganaxolone intravenous (IV) portion of the Phase 2 Magnolia study
in women with severe postpartum depression (PPD) in third quarter
2018
- Report top-line data from
ganaxolone IV portion of the Magnolia study in fourth quarter
2018
- Report top-line oral ganaxolone
data from Amaryllis study in women with PPD in fourth quarter
2018
“We achieved an important milestone in the
second quarter with the initiation of a pivotal Phase 3 clinical
trial evaluating the use of oral ganaxolone in children and young
adults with CDKL5 Deficiency Disorder (CDD),” commented Christopher
M. Cashman, chairman and chief executive officer of Marinus. “This
is the first-ever phase 3 clinical trial for CDD, and the CDD
community is awaiting treatment options to reduce the seizure
burden of this disease. We are hopeful that ganaxolone may provide
a benefit to this underserved patient population.”
Mr. Cashman continued, “We are continuing to
enroll patients with postpartum depression in both our Magnolia and
Amaryllis studies and look forward to reporting top-line data from
both studies in the coming months.”
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 a 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 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 behavioral and sleep
disturbances that were reported in previous clinical studies with
ganaxolone. There are currently no approved treatments for
CDD.
Postpartum Depression (PPD)
- The Company is in the process of
completing 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
severe PPD (Hamilton Depression Rating Scale (HAMD17) score ≥26).
The efficacy endpoint is change from baseline in the HAMD17
score. The Company expects to provide top-line data in the
fourth quarter and discuss next steps in our PPD program, which
include evaluating an IV followed by oral formulations of
ganaxolone.
- 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
moderate PPD (HAMD17 score of ≥ 20, but < 26). Patients enrolled
in the initial open label phase of the study receive one of
multiple treatment regimens with ganaxolone capsules which include
once-daily dosing. The efficacy endpoint is change from baseline in
the HAMD17 score. Data from the open label phase are expected in
the fourth quarter of 2018 and will inform later stage development
of novel treatment paradigms that may include an IV followed by
oral ganaxolone pivotal program. Upon successful completion of the
open label phase, the study will 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 June 30, 2018, the Company had cash, cash
equivalents and investments of $46.4 million. The Company
believes that its cash, cash equivalents and investments, as of
June 30, 2018, are adequate to fund its operations into 2020.
Research and development expenses increased to
$7.2 million and $11.2 million for the three and six months ended
June 30, 2018, respectively, as compared to $2.8 million and
$6.4 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 $2.3
million and $4.5 million for the three and six months ended June
30, 2018, respectively, as compared to $1.7 million and $3.5
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 June 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)
|
June 30, 2018 |
|
December 31, 2017 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
Cash and cash
equivalents |
$21,467 |
|
$33,531 |
Investments |
24,902 |
|
24,825 |
Other assets |
2,318 |
|
2,316 |
Total
assets |
$48,687 |
|
$60,672 |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities |
$3,560 |
|
$2,544 |
Other long term
liabilities |
107 |
|
120 |
Total
liabilities |
3,667 |
|
2,664 |
Total
stockholders’ equity |
45,020 |
|
58,008 |
Total
liabilities and stockholders’ equity |
$48,687 |
|
$60,672 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
7,232 |
|
|
$ |
2,817 |
|
|
$ |
11,159 |
|
|
$ |
6,390 |
|
|
General
and administrative |
|
|
2,338 |
|
|
|
1,691 |
|
|
|
4,526 |
|
|
|
3,503 |
|
|
Loss from
operations |
|
|
(9,570 |
) |
|
|
(4,508 |
) |
|
|
(15,685 |
) |
|
|
(9,893 |
) |
|
Interest income |
|
|
65 |
|
|
|
31 |
|
|
|
181 |
|
|
|
71 |
|
|
Interest expense |
|
|
— |
|
|
|
(72 |
) |
|
|
— |
|
|
|
(156 |
) |
|
Other income
(expense) |
|
|
1 |
|
|
|
(3 |
) |
|
|
— |
|
|
|
(12 |
) |
|
Net loss |
|
$ |
(9,504 |
) |
|
$ |
(4,552 |
) |
|
$ |
(15,504 |
) |
|
$ |
(9,990 |
) |
|
Per share
information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share of common stock—basic and diluted |
|
$ |
(0.24 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.47 |
) |
|
Basic and
diluted weighted average shares outstanding |
|
|
40,395,650 |
|
|
|
21,985,213 |
|
|
|
40,384,429 |
|
|
|
21,288,545 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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. CaperelliExecutive Director,
Investor & Strategic RelationsMarinus Pharmaceuticals,
Inc.484-801-4674lcaperelli@marinuspharma.com
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