06 November 2019
Positive Phase 2 IV ganaxolone data in RSE
Strong enrollment continues in pivotal CDD study
RADNOR, Pa., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical 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, 2019.
“Marinus remains committed to becoming a fully-integrated, CNS-focused player in both orphan epilepsies and hospital-based critical care indications,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus. “The continued efficacy and safety signal seen with IV ganaxolone in two different patient populations, RSE and PPD, strengthens our strategic mission to develop a footprint in the critical care patient population with a hospital-based product. On the orphan epilepsy front, our CDD study is enrolling well and on track for us to announce top-line data in Q3 next year.”
Refractory Status Epilepticus (RSE)
Orphan Pediatric Genetic Epilepsies
CDKL5 Deficiency Disorder (CDD)
PCDH19-Related Epilepsy (PCDH19-RE)
At September 30, 2019, we had cash and cash equivalents of $39.9 million compared to $72.7 million at December 31, 2018. We believe that our cash, cash equivalents and investments as of September 30, 2019 will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2020.
Research and development expenses increased to $11.6 million and $30.5 million for the three and nine months ended September 30, 2019, respectively, as compared to $9.1 million and $20.3 million for the same periods in the prior year. The primary drivers of our research and development expenditures are our clinical and preclinical studies and manufacturing activities.
General and administrative expenses were $2.3 million and $8.5 million for the three and nine months ended September 30, 2019 as compared to $2.1 million and $6.6 million for the same periods in the prior year. The primary drivers of the year-to-date increase were $1.0 million in severance expenses related to the departure of Christopher M. Cashman, our former Chief Executive Officer ($0.4 million of which was non-cash equity compensation expense), and approximately $0.8 million in professional fees and other costs associated with an increased scale of operations.
The Company reported net losses of $13.8 million and $38.7 million for the three and nine months ended September 30, 2019, respectively, compared to $11.1 million and $26.6 million in the same period a year ago. Cash used in operating activities increased to $32.4 million for the nine months ended September 30, 2019 compared to $18.7 million for the same period a year ago.
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, 2019 to be filed with the Securities and Exchange Commission, which includes further detail on the above-referenced transactions and the Company’s business plans, operations, financial condition and results of operations.
About Marinus Pharmaceuticals
Marinus Pharmaceuticals, Inc. is a pharmaceutical 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 depression. 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 IV and oral dose forms intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Marinus is conducting the first ever pivotal studies in children with CDKL5 deficiency disorder and PCDH19-related epilepsy and has recently released top-line data from Phase 2 studies in women with postpartum depression and patients with refractory status epilepticus. For more information visit www.marinuspharma.com. Please follow us on Twitter: @MarinusPharma.
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 study testing schedule and milestones, the ability to complete enrollment in our clinical studies, 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 studies, the timing of the clinical studies, enrollment in clinical studies, availability of data from ongoing clinical studies, expectations for regulatory approvals, the attainment of clinical study 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.
Marinus Pharmaceuticals, Inc.
Selected Financial Data (in thousands, except share and per share amounts)
|Cash and cash equivalents||$37,159||$67,727|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Other long term liabilities||3,158||—|
|Total stockholders’ equity||34,071||68,325|
|Total liabilities and stockholders’ equity||$45,800||$75,234|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||11,572||$||9,148||$||30,454||$||20,307|
|General and administrative||2,327||2,073||8,496||6,599|
|Loss from operations||(13,899||)||(11,221||)||(38,950||)||(26,906||)|
|Per share information:|
|Net loss per share of common stock—basic and diluted||$||(0.26||)||$||(0.27||)||$||(0.74||)||$||(0.66||)|
|Basic and diluted weighted average shares outstanding||52,543,539||40,407,146||52,510,610||40,392,084|
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