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Marinus Pharmaceuticals Provides Business Update and Reports First Quarter 2016 Financial Results

(MRNS), 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 March 31, 2016.

“This is a very important year for Marinus,” commented Christopher M. Cashman, Chief Executive Officer of Marinus Pharmaceuticals. “All three of our ongoing ganaxolone clinical studies are fully enrolled with data on track for release over the next few months. The outcomes from these studies will determine our future development and commercial plans for our ganaxolone franchise.”

Upcoming Milestones for 2016 & Recent Highlights

  • The Company is on-track to report top-line data in the upcoming weeks from the Phase 2 proof-of-concept, investigator-sponsored clinical study in patients with Fragile X syndrome. The study incorporates several clinician- and parental-validated scales to evaluate the effect of ganaxolone on anxiety, attention, social behavior, aggression, hyperactivity, and language.
  • The Company is on-track to report top-line data in the middle of 2016 from the Phase 3 clinical trial evaluating ganaxolone in adults with focal onset seizures.
  • The Company is on-track to report top-line data in the middle of 2016 from the Phase 2, proof-of-concept clinical trial evaluating ganaxolone in pediatrics with PCDH19.
  • In April, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to ganaxolone intravenous (IV) for the treatment of status epilepticus (SE). A Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of ganaxolone IV is on-track to initiate this quarter.
  • In April, preclinical data of ganaxolone IV showing robust activity in a well-accepted and clinically-translatable animal model of SE were presented by Dr. Michael Saporito at the 68th American Academy of Neurology (AAN) Annual Meeting. The data from two separate studies showed that ganaxolone IV attenuates electroencephalographic seizures and prevents behavioral seizures and promotes survival in a benzodiazepine-resistant model of SE.

Financial Update
At March 31, 2016, the Company had cash, cash equivalents and investments of $51.4 million, compared to $57.7 million at December 31, 2015. The Company believes that its cash, cash equivalents and investments, as of March 31, 2016, are adequate to fund operations into the second half of 2017.

Research and development expenses remained flat at $5.5 million for the three months ended March 31, 2016 and for...