11 March 2019
RADNOR, Pa., March 11, 2019 -- 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 year ended December 31, 2018.
First Half 2019 Clinical Milestones
“2018 was a pivotal year for Marinus, kicking off the first-ever single pivotal Phase 3 study in children with CDKL5 deficiency disorder, and reporting positive results from Part 1 of our Magnolia Study with IV ganaxolone in women with postpartum depression,” said Christopher M. Cashman, CEO of Marinus. “As my tenure at Marinus comes to a close, I feel confident that the company is well positioned to further advance ganaxolone into additional late-stage studies and prepare for commercialization.”
Dr. Scott Braunstein, Executive Chairman of Marinus commented, “Through the multiple clinical studies conducted to date, we have shown that ganaxolone is safe, well-tolerated and effective in reducing seizures, anxiety and depression. I look forward to working with the Marinus team to unlock the value of ganaxolone, not only in the indications under development, but also into other refractory epilepsy and neuropsychiatric disorders. I look forward to keeping shareholders apprised of our developments in the upcoming months.”
Postpartum Depression (PPD)
Orphan Pediatric Genetic Epilepsy Programs
CDKL5 Deficiency Disorder (CDD):
PCDH19-Related Epilepsy (PCDH19-RE):
Refractory Status Epilepticus (RSE)
At December 31, 2018, the Company had cash, cash equivalents and investments of $72.7 million, compared to $58.4 million at December 31, 2017. We believe that our cash, cash equivalents and investments as of December 31, 2018 will enable us to fund our current scale of operating expenses and capital expenditure requirements into 2021.
Research and development expenses increased to $28.4 million for the year ended December 31, 2018, as compared to $12.4 million in the prior year. The increase for the year ended December 31, 2018 compared to 2017 was due primarily to increased patient enrollment of the Magnolia study, expansion of the Amaryllis Phase 2 study, and additional preclinical studies and manufacturing activities, in support of all formulations and indications.
General and administrative expenses increased $2.1 million for the year ended December 31, 2018 compared to 2017, primarily due to an increase in noncash, stock-based compensation expense.
The Company reported net losses of $36.7 million and $18.9 million for the years ended December 31, 2018 and 2017, respectively. Cash used in operating activities increased to $27.8 million for the year ended December 31, 2018 compared to $18.8 million for the same period a year ago.
Readers are referred to, and encouraged to read in its entirety, the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 to be filed with the Securities and Exchange Commission, which includes further detail on the above-referenced transactions and the Company’s business plans, operations, financial condition and results of operations.
Marinus Pharmaceuticals, Inc.
Selected Financial Data (in thousands, except share and per share amounts)
|Cash and cash equivalents||$||67,727||$||33,531|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Total current liabilities||6,909||2,544|
|Other long-term liabilities||—||120|
|Total stockholders’ equity||68,325||58,008|
|Total liabilities and stockholders’ equity||$||75,234||$||60,672|
|Year Ended December 31,|
|Research and development||$||28,394||$||12,376|
|General and administrative||8,785||6,667|
|Loss from operations||(37,179||)||(19,043||)|
|Per share information:|
|Net loss per share of common stock—basic and diluted||$||(0.90||)||$||(0.80||)|
|Basic and diluted weighted average shares outstanding||40,895,406||23,540,738|
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 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 studies in children with CDKL5 deficiency disorder and PCDH19-related epilepsy, and is currently conducting studies in patients with postpartum depression and refractory status epilepticus. For more information visit www.marinuspharma.com.
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.
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