Marinus Pharmaceuticals
Mar 7, 2016

Marinus Pharmaceuticals Provides Business Update and 2015 Financial Results

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:


"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:

Pipeline Highlights

Corporate Highlights

Financial Update

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.

Forward-Looking Statements

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)
(unaudited)
   
 December 31,
2015
December 31,
2014
 
   
ASSETS  
Cash and cash equivalents$51,722 $49,720 
Investments 5,962 
Other assets 1,978  493 
Total assets$59,662 $50,213 
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 liabilities 12,741  9,059 
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,  
  2015 2014 2015 2014 
              
Expenses:             
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  
Interest income   20    6    64    12  
Interest expense   (121)   (59)   (475)   (117) 
Other expense   (9)     (7)   
Net loss   (7,607)   (1,668)   (24,850)   (10,833) 
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) 

 

CONTACT: Company:        
Lisa M. Caperelli
Senior Director, Investor Relations & Corporate Communications
Marinus Pharmaceuticals, Inc.
484-801-4674
lcaperelli@marinuspharma.com

Media Contact:
Tiberend Strategic Advisors, Inc.
Amy S. Wheeler
646-362-5750
awheeler@tiberend.com