Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2017 Financial Results
October 31 2017 - 6:30AM
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 September 30, 2017.
“We achieved an important milestone this quarter
as we announced successful results from our clinical study in
children with CDKL5 deficiency disorder, a rare, genetic epilepsy
with no approved therapies,” said Christopher M. Cashman, Chief
Executive Officer of Marinus Pharmaceuticals. “On the heels
of this data, we raised capital to advance the development of
ganaxolone into CDKL5 patients and extend our cash runway.
With a strong balance sheet in place, we are focused on quality
execution of our clinical studies in postpartum depression, which
will inform our later stage clinical development plans for this
important underserved patient population.”
Clinical Programs Update
CDKL5 Deficiency Disorder (CDD)
- In September, the Company announced successful results from a
Phase 2 open-label study evaluating the safety and efficacy of
ganaxolone in children with CDD. The data showed that ganaxolone
provided substantial and durable anti-seizure efficacy in children
with CDD. Ganaxolone was generally safe and well-tolerated with no
serious adverse events. Four patients continue to receive
ganaxolone; three of which have entered the one-year extension of
the study and one of which is still receiving treatment within the
26-week treatment period. Based on the data, the Company is
planning to meet with regulatory agencies to discuss the clinical
development plan with the goal of commencing a clinical study in
2018.
- The Phase 2 data in patients with CDD was presented at the 2017
Child Neurology Society Annual Meeting in October. The Child
Neurology Society is the preeminent professional association of
pediatric neurologists worldwide devoted to fostering the
discipline of child neurology and promoting the optimal care and
welfare of children with neurological and neuro developmental
disorders.
Postpartum Depression (PPD)
- Enrollment is on-going in the Magnolia Study, a Phase 2
double-blind, placebo-controlled clinical trial to evaluate the
safety, efficacy and pharmacokinetics of intravenous (IV)
ganaxolone in women diagnosed with severe PPD. The study consists
of multiple cohorts of women with a Hamilton Depression Rating
Scale (HAMD17) score ≥ 26. Patients randomized in the initial
cohort(s) will undergo an infusion of either ganaxolone or placebo
and will be followed for 30 days, with data expected in early 2018.
Subsequent cohorts could include shorter- or higher-dose IV
regimens alone, or in sequential administration with ganaxolone
capsules.
- The Company is initiating its Amaryllis Study, a Phase 2
clinical trial to evaluate the safety, tolerability and efficacy of
oral ganaxolone in women with moderate PPD (HAMD17 score > 20
and < 26). The goal of this study is to determine the oral
dosing regimen for future studies. Oral ganaxolone has the
potential to provide the largest segment of the PPD patient
population with access to convenient, oral outpatient therapy. Data
from this study is expected in 2018.
Status Epilepticus (SE)
- The Company is initiating its Phase 2 feasibility study with
ganaxolone IV in patients with refractory status epilepticus (RSE).
The Phase 2 trial is designed to treat patients in the SE treatment
paradigm as second-line, when they have active brain function and
potential for better outcomes. Data from this feasibility study is
expected in 2018.
Financial Update
At September 30, 2017, the Company had cash,
cash equivalents and investment balances of $62.9 million.
The Company believes that its cash, cash equivalents and
investments as of September 30, 2017 are adequate to fund
operations into 2020.
Research and development expenses decreased to
$2.6 million and $9.0 million for the three and nine months ended
September 30, 2017, respectively, as compared to $4.8 million
and $17.6 million for the same periods in the prior year. The
decreases were primarily due to a decrease of $1.8 million and $9.3
million for the three- and nine-month periods ended September 30,
respectively, associated with our drug-resistant focal onset
seizures program, which discontinued in June 2016.
Additionally, we sold $0.4 million in state research and
development tax credits which we used to offset research and
development expenses. The decrease was partially offset by an
increase of $0.9 million for the nine-month period ended September
30, associated with our IV programs in PPD, for which a Phase 2
clinical trial was initiated in June 2017, and SE, for which we are
initiating a Phase 2 clinical trial.
General and administrative expenses were $1.6
million and $5.1 million for the three and nine months ended
September 30, 2017 as compared to similar expense amounts of
$1.5 million and $4.7 million for the same periods in the
prior year.
Cash used in operating activities decreased to
$14.3 million for the nine months ended September 30, 2017
compared to $18.7 million for the same period a year ago. The
decrease was driven primarily by a decrease in our net loss of $8.5
million, partially offset by a decrease in the change in operating
assets and liabilities of $4.1 million. The net decrease in
the change in operating assets and liabilities was primarily due to
upfront payments for planned clinical trials in our IV program,
payment of corporate insurance premiums and the timing of payment
obligations related to our drug supply in 2016.
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, 2017 to be 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
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 currently evaluating ganaxolone in women with postpartum
depression and preparing to initiate studies in children with CDKL5
deficiency disorder and patients with status epilepticus, both of
which are orphan indications. 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
Marinus Pharmaceuticals,
Inc.Selected Financial Data (in thousands, except
share and per share amounts)
(unaudited) |
|
|
|
|
|
September 30,2017 |
|
December 31,2016 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
Cash and cash
equivalents |
$ |
37,530 |
$ |
26,178 |
Investments |
|
25,373 |
|
3,922 |
Other assets |
|
1,754 |
|
1,347 |
Total
assets |
$ |
64,657 |
$ |
31,447 |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
Total current
liabilities |
$ |
2,430 |
$ |
8,084 |
Notes payable,
long-term portion |
|
— |
|
1,743 |
Other long term
liabilities |
|
127 |
|
141 |
Total
liabilities |
|
2,557 |
|
9,968 |
Total
stockholders’ equity |
|
62,100 |
|
21,479 |
Total
liabilities and stockholders’ equity |
$ |
64,657 |
$ |
31,447 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
2,642 |
|
|
$ |
4,840 |
|
|
$ |
9,032 |
|
|
$ |
17,593 |
|
|
General
and administrative |
|
|
1,571 |
|
|
|
1,529 |
|
|
|
5,074 |
|
|
|
4,719 |
|
|
Loss from
operations |
|
|
(4,213 |
) |
|
|
(6,369 |
) |
|
|
(14,106 |
) |
|
|
(22,312 |
) |
|
Interest income |
|
|
45 |
|
|
|
36 |
|
|
|
116 |
|
|
|
93 |
|
|
Interest expense |
|
|
(3 |
) |
|
|
(118 |
) |
|
|
(159 |
) |
|
|
(365 |
) |
|
Other income
(expense) |
|
|
1 |
|
|
|
(13 |
) |
|
|
(11 |
) |
|
|
(44 |
) |
|
Net loss |
|
$ |
(4,170 |
) |
|
$ |
(6,464 |
) |
|
$ |
(14,160 |
) |
|
$ |
(22,628 |
) |
|
Per share
information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share of common stock—basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.60 |
) |
|
$ |
(1.16 |
) |
|
Basic and
diluted weighted average shares outstanding |
|
|
28,666,656 |
|
|
|
19,509,220 |
|
|
|
23,531,745 |
|
|
|
19,494,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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