RADNOR, Pa., March 07, 2016 (GLOBE NEWSWIRE) -- Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical 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, 2015.
Recent Clinical & Corporate Highlights:
- Completed enrollment in pivotal Phase 3 clinical trial in adults with drug-resistant focal onset seizures
- Completed requisite preclinical studies and manufacturing activities in preparation for ganaxolone IV clinical studies
- Expanded clinical and regulatory management team
- Closed public equity financing with gross proceeds of $30.0 million
- Fully enrolled exploratory Phase 2 clinical trial in PCDH19 pediatric epilepsy and completed treatment in exploratory Phase 2 clinical trial in Fragile X Syndrome (FXS)
"During 2015 we made considerable progress in advancing the development of our CNS-selective GABAA modulator, ganaxolone, paving the way for several significant clinical milestones in 2016," said Christopher M. Cashman, Chief Executive Officer of Marinus Pharmaceuticals. "With enrollment complete in our first pivotal Phase 3 clinical trial in drug-resistant focal onset seizures and the addition of our ganaxolone IV dose form, 2016 has the potential to be a transformative year for Marinus. Looking ahead, we believe that the next twelve months offer an opportunity for the company to validate the significant potential of our ganaxolone franchise in treating multiple high-need medical conditions."
During the fourth quarter of 2015, we achieved a number of key milestones that were important in advancing our corporate mission, including:
- Completed patient recruitment in our first pivotal Phase 3 clinical trial of ganaxolone in adults with drug-resistant focal onset seizures. The Company is on-track to announce top-line results in mid-2016.
- Completed treatment in the exploratory Phase 2, investigator-sponsored clinical trial of ganaxolone in children with FXS. The primary objective of the study is to assess the safety, tolerability and efficacy of ganaxolone for treatment of anxiety and attention in subjects with FXS. Nine rating scales are being used to assess outcome measures for specific behaviors associated with childhood FXS. The Company plans to announce top-line results in the first half of 2016.
- Completed patient enrollment in the exploratory Phase 2 clinical trial of ganaxolone in PCDH19 pediatric epilepsy. Patients enrolled in the study are undergoing six-months of treatment following a twelve-week baseline period. The Company plans to announce full data in mid-2016.
- Completed a public equity financing with gross proceeds of $30.0 million. Existing and new healthcare-dedicated institutional investors led the financing, which provides the Company with sufficient capital to evaluate ganaxolone IV in human clinical trials.
- Bolstered clinical and regulatory expertise in preparation of expanding the global Phase 3 programs with the appointment of Jaakko Lappalainen, M.D., Ph.D., as VP of Clinical Operations and Kimberly A. McCormick, PharmD, as Head of Regulatory.
- Hosted a scientific exhibit at the American Epilepsy Society Annual Meeting, which included, presentation of ganaxolone IV preclinical data and clinical development plans, safety, efficacy and a responder analysis of data from the Phase 2 clinical trial in drug resistant focal onset seizures, and PK data of ganaxolone capsule compared to ganaxolone liquid suspension.
At December 31, 2015, the Company had cash, cash equivalents and investments of $57.7 million, compared to $49.7 million at December 31, 2014. The increase was primarily due to $28.1 million in net proceeds received in November 2015 from the closing of a public offering, offset by $20.1 million in cash used in operating activities.
Research and development expenses increased by $10.2 million, to $18.9 million, for the year ended December 31, 2015, compared to the same period of 2014. The increase resulted primarily from an increase in clinical, drug development and consulting costs related to ongoing clinical trials for ganaxolone, as well as increases in compensation-related costs due to hiring additional clinical resources.
General and administrative expenses increased by $2.3 million, to $5.5 million, for the year ended December 31, 2015, compared to the same period of 2014. The increase in general and administrative expenses was primarily due to the addition of new management team members and the upward scaling of our operations in connection with our ongoing Phase 3 clinical trial of ganaxolone in adults with drug-resistant focal onset epileptic seizures.
The Company reported net losses of $24.9 million and $10.8 million for the years ended December 31, 2015 and 2014, respectively. Cash used in operating activities was $20.1 million for the year ended December 31, 2015 compared to $8.6 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, 2015 to be filed with the Securities and Exchange Commission, which includes further detail on the above-referenced transactions and 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 CNS-selective GABAA modulator 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. Ganaxolone IV is planned to enter clinical trials in 2016 and is being developed to treat status epilepticus. Ganaxolone IV is complemented by its oral dose forms, providing the potential for IV-to-oral continuation therapy for patients transitioning from acute care to outpatient settings. Ganaxolone capsule is being evaluated in a Phase 3 multi-national clinical trial as adjunctive treatment of focal onset seizures in adults. Ganaxolone capsule and liquid are being studied in orphan pediatric indications with comorbidities in seizures and behavior disorders — PCDH19 epilepsy and Fragile X Syndrome. 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 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, and other matters, including the development of formulations of ganaxolone, 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, number of shares below per share amounts)|
|Cash and cash equivalents||$||51,722||$||49,720|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||$||7,435||$||2,039|
|Notes payable, long-term portion||5,250||7,000|
|Other long term liabilities||56||20|
|Total stockholders' equity||46,921||41,154|
|Total liabilities and stockholders' equity||$||59,662||$||50,213|
|Three Months Ended December 31,||Year Ended December 31,|
|Research and development||$||6,061||$||2,167||$||18,916||$||8,690|
|General and administrative||1,436||1,387||5,516||3,230|
|Loss from operations||(7,497||)||(3,554||)||(24,432||)||(11,920||)|
|Change in fair value of warrant liability||—||—||—||1,192|
|Cumulative preferred stock dividends||—||—||—||(2,545||)|
|Net loss applicable to common stockholders||$||(7,607||)||$||(3,607||)||$||(24,850||)||$||(13,378||)|
|Per share information:|
|Net loss per share of common stock—basic and diluted||$||(0.45||)||$||(0.26||)||$||(1.67||)||$||(2.17||)|