18 March 2020
RADNOR, Pa., March 16, 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 a business update on its clinical development activities and reported its financial results for the year ended December 31, 2019.
Key 2020 Planned Milestones:
“We have started 2020 in a strong position, with recent accomplishments in the clinic that support our strategy to develop ganaxolone in mechanistically relevant disease states where we have the potential to significantly improve patient outcomes,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus. “We have recently announced enrollment completion for our Phase 3 trial in CDD and remain on track for topline data later this year. Preparations are underway for our first potential NDA filing and commercial launch with oral ganaxolone. Our team continues to build momentum in the status epilepticus program and we are on track for the initiation later this year of our pivotal Phase 3 trial. Taken together, we believe we have developed thoughtful, data-driven clinical programs designed to provide new treatments to patients suffering from severe and rare seizure disorders.”
Clinical Development Overview and Highlights
Marinus is developing oral and intravenous (IV) ganaxolone formulations to treat adults and children suffering from acute and chronic rare seizure disorders where there is a mechanistic rationale for ganaxolone to provide a therapeutic benefit to patients with unmet or underserved medical needs.
Status Epilepticus (SE)
CDKL5 Deficiency Disorder (CDD)
PCDH19-related Epilepsy (PCDH19-RE)
Tuberous Sclerosis Complex (TSC)
At December 31, 2019, we had cash and cash equivalents of $90.9 million compared to $67.7 million at December 31, 2018. We believe that our cash, cash equivalents and investments as of December 31, 2019 will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2021.
Research and development expenses increased to $43.0 million for the year ended December 31, 2019, as compared to $28.4 million in the year ended December 31, 2018. The primary drivers for the increase to our research and development expenditures were clinical and manufacturing activities in support of our Phase 3 trials in CDD and PCDH19-RE, partially offset by decreased costs for non-seizure disorder indications.
General and administrative expenses were $11.5 million for the year ended December 31, 2019 as compared to $8.8 million in the prior year. The primary drivers of this increase were $1.3 million in severance expenses related to the departure of former executive officers ($0.4 million of which was non-cash equity compensation expense), and approximately $1.2 million in professional fees and other costs associated with an increased scale of operations.
The Company reported a net loss of $54.1 million for the year ended December 31, 2019, compared to $36.7 million for the year ended December 31, 2018. Cash used in operating activities increased to $48.6 million for the year ended December 31, 2019 compared to $27.8 million for the year ended December 31, 2018.
Readers are referred to, and encouraged to read in its entirety, the Company’s Annual Report on Form 10-K for the quarter ended December 31, 2019 to be filed with the Securities and Exchange Commission, which includes further detail on the Company’s business plans, operations, financial condition and results of operations.
Marinus Pharmaceuticals, Inc.
Selected Financial Data (in thousands, except share and per share amounts)
|Cash and cash equivalents||$||90,943||$||67,727|
|Liabilities and stockholders’ equity:|
|Series A convertible preferred stock||28,200||—|
|Total stockholders’ equity||59,569||68,325|
|Total liabilities and stockholders’ equity||$||98,842||$||75,234|
|Year Ended December 31,|
|Research and development||$||42,966||$||28,394|
|General and administrative||11,456||8,785|
|Loss from operations||(54,422||)||(37,179||)|
|Per share information:|
|Net loss per share of common stock—basic and diluted||$||(0.99||)||$||(0.90||)|
|Basic and diluted weighted average shares outstanding||54,512,778||40,895,406|
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 pivotal trials in children with CDKL5 deficiency disorder and PCDH19-related epilepsy. Later this year, the company intends to initiate a Phase 3 trial in SE and a Phase 2 trial in Tuberous Sclerosis Complex (TSC).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 development 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 clinical trials, the timing of clinical trials, enrollment in clinical trials, availability of data from clinical trials, expectations for regulatory approvals, the attainment of clinical trial results that will be supportive of regulatory approvals, and other matters, including the development of formulations of ganaxolone, unanticipated costs and expenses, our ability to raise additional capital 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.
26 October 2021
26 October 2021
25 October 2021
25 October 2021