04 May 2020
Constructive End of Phase 2 Meeting with FDA for Status Epilepticus Completed in March; Pivotal Phase 3 Clinical Trial Expected to Begin Next Quarter
Topline Data on Track for Q3 2020 from Pivotal Phase 3 Marigold Study in CDKL5 Deficiency Disorder and Preparations Continue for Potential NDA Filing
First Patients to be Screened this Quarter for Phase 2 Tuberous Sclerosis Complex Clinical Trial
RADNOR, Pa., May 04, 2020 (GLOBE NEWSWIRE) -- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today provided an update on its clinical development activities and reported its financial results for the first quarter ended March 31, 2020.
“We are proud to have made real progress across all of our clinical programs prior to and during the unprecedented and challenging global impact of the COVID-19 pandemic,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus. “We remain confident that our key milestones are still on track, including the topline data from our pivotal Phase 3 clinical trial in CDKL5 deficiency disorder in Q3 2020. With positive topline data, we intend to continue preparations for both our first NDA submission and the commercial launch of ganaxolone.”
Dr. Braunstein added, “We had a highly constructive end-of-Phase 2 meeting with the FDA for our status epilepticus program and anticipate enrolling the first patient in the Phase 3 trial later this year. In addition, we have made significant headway in expanding our biomarker-informed trial for tuberous sclerosis complex, as our first site has been activated for patient enrollment. This will be a year of noteworthy milestones for the organization, and we are confident that we are just beginning to unlock ganaxolone’s potential to improve the lives of patients and families affected by rare and severe epilepsies.”
Status Epilepticus (SE)
CDKL5 Deficiency Disorder (CDD)
Tuberous Sclerosis Complex (TSC)
PCDH19 Related Epilepsy (PCDH19-RE)
On March 31, 2020, the Company had cash and cash equivalents and investments totaling $77.8 million compared to $91.7 million on December 31, 2019. Marinus believes that its cash, cash equivalents and investments as of March 31, 2020 will enable the Company to fund operating expenses and capital expenditure requirements into the third quarter of 2021.
Research and development expenses increased to $15.0 million for the three months ended March 31, 2020, as compared to $8.9 million for the three months ended March 31, 2019. The primary drivers for the increase to our research and development expenditures are clinical and manufacturing activities in support of our Phase 3 trial in CDD and preparations for a Phase 3 trial in SE, partially offset by decreased costs for non-seizure disorder indications.
General and administrative expenses were $3.9 million for the three months ended March 31, 2020 as compared to $3.7 million in the prior year. The primary drivers of the increase were professional fees and other costs associated with an increased scale of operations.
The Company reported a net loss of $18.7 million for the three months ended March 31, 2020, compared to $12.5 million for the three months ended March 31, 2019. Cash used in operating activities increased to $14.0 million for the three months ended March 31, 2020 compared to $11.7 million for the three months ended March 31, 2019.
Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 to be filed with the Securities and Exchange Commission, which includes further detail on the Company’s business plans, operations, financial condition and results of operations.
Marinus Pharmaceuticals, Inc.
Selected Financial Data (in thousands, except share and per share amounts)
|March 31,||December 31,|
|Cash and cash equivalents||$||70,326||$||90,943|
|Liabilities and stockholders’ equity:|
|Accounts payable and accrued expenses||$||10,325||$||8,031|
|Series A preferred stock||28,200||28,200|
|Total stockholders’ equity||43,113||59,569|
|Total liabilities and stockholders’ equity||$||84,558||$||98,842|
|Three Months Ended March 31,|
|Research and development||$||15,004||$||8,872|
|General and administrative||3,850||3,667|
|Loss from operations||(18,854||)||(12,539||)|
|Deemed dividends on convertible preferred stock||(8,880||)||—|
|Net loss applicable to common shareholders||$||(27,552||)||$||(12,483||)|
|Per share information:|
|Net loss per share of common stock—basic and diluted||$||(0.32||)||$||(0.24||)|
|Basic and diluted weighted average shares outstanding||86,661,845||52,465,207|
About Marinus Pharmaceuticals
Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders. Ganaxolone is a positive allosteric modulator of GABAA receptors 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 Phase 3 pivotal trial in children with CDKL5 deficiency disorder, along with a Phase 2 trial in Tuberous Sclerosis Complex, and a Phase 2 biomarker driven proof of concept trial in PCDH19-related epilepsy. The Company intends to initiate a Phase 3 trial in 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 clinical development plans for ganaxolone, expected dosing in our clinical trials, the clinical development schedule and milestones, our expected timing to begin and complete enrollment in our clinical trials, the expected protocols for our clinical trials, interpretation of scientific basis for ganaxolone use, timing for availability and release of data, the potential safety and efficacy of ganaxolone, the therapeutic potential of ganaxolone, our expectations regarding the effect of the COVID-19 pandemic on our business and clinical development plans, and our expectations 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, uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; clinical trial results may not support further development in a specified indication or at all; actions or advice of the U.S. Food and Drug Administration may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; our ability to obtain and maintain regulatory approval for our product candidate; delays, interruptions or failures in the manufacture and supply of our product candidate; our ability to raise additional capital; the effect of the COVID-19 pandemic on our business, the medical community and the global economy; and the availability or potential availability of alternative products or treatments for conditions targeted by us that could affect the availability or commercial potential of our product candidate. 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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