MRNS
Third and fourth quarters going to be a thing of beauty for this solid biotech company.
Marinus Pharmaceuticals Provides Business Update And Reports Second Quarter 2017 Financial Results
GlobeNewswire - Tue Aug 1, 6:31AM CDT
Data from Studies in Rare Pediatric Epilepsies and Severe Postpartum Depression Expected in 2 Half
On-track to Initiate Two Additional Phase 2 Trials Later This Year in Status Epilepticus and Moderate Postpartum Depression
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 June 30, 2017.
"This quarter Marinus significantly advanced the development of ganaxolone, which positions us to achieve several value-creating milestones in the second half of this year," said Christopher M. Cashman, Chief Executive Officer of Marinus Pharmaceuticals. "With intravenous dosing occurring in our Magnolia study and plans to initiate the Amaryllis study with ganaxolone capsules, we are well positioned to evaluate inpatient and outpatient treatments with ganaxolone in women diagnosed with both severe and moderate PPD.
We expect to announce top-line data from our Phase 2 trial evaluating children with CDKL5 disorder this quarter. We are interested in ganaxolone's anti-seizure and anti-anxiety activity in improving the quality of life for these children and their families who suffer from seizure and behavioral co-morbidities."
Second Quarter Clinical Highlights and Updates
-- Initiated 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 greater-than or equal to26. Patients randomized to the first study cohort will undergo an infusion of either ganaxolone or placebo and will be followed for at least 30 days. Subsequent cohorts could include shorter- or higher-dose IV regimens alone, or in sequential administration with ganaxolone capsules.
-- Received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for ganaxolone for the treatment of CDKL5 disorder. CDKL5 disorder is a severe, rare genetic disorder with no approved therapies that affects children at an early age and causes difficult-to-control seizures and neuro-developmental impairment.
-- Preparations are underway to initiate the Amaryllis Study later this year. This Phase 2 study will evaluate ganaxolone capsules in women with moderate PPD. Ganaxolone capsules have the potential to provide the largest segment of the PPD patient population with access to convenient, oral outpatient therapy. The Company plans to leverage the extensive safety profile associated with ganaxolone capsules to advance the regulatory path of this program. The specific details of the trial design and estimated completion timing will be announced at the time of study initiation.
-- Preparations are underway to initiate a Phase 2 study in patients with SE later this year. If SE is not treated immediately, permanent neuronal damage may occur, which contributes to high rates of morbidity and mortality. The Company's approach to address SE is differentiated from other drugs in development. The ganaxolone treatment regimen will target refractory patients with the goal of stopping the seizures earlier and preventing the need for medically-induced coma, which should result in better outcomes for these patients. The specific details of the trial design and estimated completion timing will be announced at the time of study initiation.
Financial Update
At June 30, 2017, the Company had cash, cash equivalents and investment balances of $20.3 million. The Company believes that its cash, cash equivalents and investments, as of June 30, 2017, inclusive of subsequent financing activities, are adequate to fund operations into the fourth quarter of 2018.
Research and development expenses were $2.8 million and $6.4 million for the three and six months ended June 30, 2017, respectively, a decrease of $4.4 million and $6.4 million for the three and six month periods ended June 30, respectively. The decrease was primarily associated with our drug-resistant focal onset seizures program, which discontinued in June 2016, and partially offset by an increase of $0.3 million and $1.0 million for the three and six month periods ended June 30, respectively, associated with our IV programs in PPD and SE.
General and administrative expenses were $1.7 million and $3.5 million for the three and six months ended June 30, 2017, respectively, as compared to similar expense amounts of $1.6 million and $3.2 million for the same periods in the prior year.
Cash used in operating activities $11.2 million for the six months ended June 30, 2017, a decrease of $1.0 million from the same period a year ago. The change in operating activities was driven primarily by a decrease in net loss of $6.2 million, partially offset by a decrease in the change in operating assets and liabilities of $5.2 million.
