Marinus Pharmaceuticals Announces Nine Presentations and Virtual Investor Event at American Epilepsy Society 2021 Annual Meeting

RADNOR, Pa.--(BUSINESS WIRE)-- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced that nine abstracts highlighting clinical trial and research data have been accepted for poster presentation at the American Epilepsy Society (AES) Annual Meeting being held in Chicago, Illinois, from December 3 through 7, 2021.

“Alongside new quality of life and extended safety and efficacy data of ganaxolone in CDKL5 deficiency disorder—our lead indication currently under FDA review—we look forward to highlighting data in tuberous sclerosis complex and Lennox-Gastaut syndrome that we believe support our clinical development plans in both indications,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus Pharmaceuticals. “In addition, we’re pleased to share new data from the growing body of evidence supporting the use of IV ganaxolone in the acute care setting, with a quantitative EEG analysis and case studies of patients in super-refractory status epilepticus that further demonstrate the potential of ganaxolone in treating seizure disorders.”

AES is the premier event for epilepsy professionals in academia, clinical practice, industry and patient advocacy. The Annual Meeting is also available virtually through AES 2021 Digital Select.

Marinus poster presentations include:

Longitudinal Relationship Between Seizure Burden and Developmental Progression and the Implications on Quality of Life in Children with CDKL5 Deficiency Disorder
Poster Session Number: 1.277
Date/Time: Saturday Dec. 4th; 1:00-3:00 p.m. ET (12:00-2:00 p.m. CT)

Aggregated Safety and Tolerability Experience from the Ganaxolone Development Program
Poster Session Number: 2.205
Date/Time: Sunday Dec. 5th; 1:00-3:00 p.m. ET (12:00-2:00 p.m. CT)

Extended Duration Safety and Efficacy of Adjunctive Ganaxolone Treatment in Patients with CDKL5 Deficiency Disorder: 8-Month Minimum Open-Label Extension Follow-up
Poster Session Number: 2.217
Date/Time: Sunday Dec. 5th; 1:00-3:00 p.m. ET (12:00-2:00 p.m. CT)

Ganaxolone Treatment in Patients with CDKL5 Deficiency Disorder with Comorbid Lennox-Gastaut Syndrome: A Post-hoc Analysis from the Marigold Study
Poster Session Number: 2.098
Date/Time: Sunday Dec. 5th; 1:00-3:00 p.m. ET (12:00-2:00 p.m. CT)

Utilization of Quantitative EEG Spectral Analysis to Characterize IV Ganaxolone PK/PD Properties in Refractory Status Epilepticus (RSE) (Epilog)
Poster Session Number: 2.1
Date/Time: Sunday Dec. 5th; 1:00-3:00 p.m. ET (12:00-2:00 p.m. CT)

Phase 2 Open-Label Clinical Study Evaluating Oral Ganaxolone for the Treatment of Seizures Associated with Tuberous Sclerosis Complex
Poster Session Number: 2.412
Date/Time: Sunday Dec. 5th; 1:00-3:00 p.m. ET (12:00-2:00 p.m. CT)

Effect of Ganaxolone on Quality of Life in Children with CDKL5 Deficiency Disorder
Poster Session Number: 3.279
Date/Time: Monday Dec. 6th; 1:00-2:45 p.m. ET (12:00-1:45 p.m. CT)

IV Ganaxolone in Pediatric Super-Refractory Status Epilepticus: Two Case Presentations
Poster Session Number: 3.382
Date/Time: Monday Dec. 6th; 1:00-2:45 p.m. ET (12:00-1:45 p.m. CT)

Phase 2, Placebo-Controlled Clinical Study of Oral Ganaxolone in PCDH19-Clustering Epilepsy (the Violet Study)
Poster Session Number: 3.281
Date/Time: Monday Dec. 6th; 1:00-2:45 p.m. ET (12:00-1:45 p.m. CT)

Marinus investor event:

Marinus will also host a virtual investor event in parallel to its activities at AES, featuring a clinical update and commercial overview on its pipeline programs from company scientific and medical leadership. Dr. Rani K. Singh, clinical associate professor, Department of Pediatrics, Atrium Health / Levine Children’s Hospital in North Carolina, will also be presenting emergency Investigational New Drug (eIND) ganaxolone data in super refractory status epilepticus.

Marinus Pharmaceuticals Virtual Investor Event at American Epilepsy Society 2021 Annual Meeting
Date and Time: Monday, Dec. 6th, 1:00-2:30 p.m. ET (12:00-1:30 p.m. CT)
Webcast Link: https://wsw.com/webcast/cc/mrns4/1448568

About Ganaxolone
Ganaxolone, a positive allosteric modulator of GABA_A receptors, is an investigational product being developed in intravenous and oral formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Ganaxolone exhibits anti-seizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABA_A receptors. Ganaxolone has been studied in more than 1,900 pediatric and adult subjects across various indications at therapeutically relevant dose levels and treatment regimens for up to more than two years.

About Marinus Pharmaceuticals
Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Ganaxolone is a positive allosteric modulator of GABA_A receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects. Ganaxolone is being developed in IV and oral dose formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Marinus completed the first ever Phase 3 pivotal trial in children with CDKL5 deficiency disorder last year, is planning to conduct a Phase 3 trial in tuberous sclerosis complex, and a Phase 3 trial in refractory status epilepticus is ongoing. 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 expected clinical development plans, enrollment in our clinical trials, regulatory communications and submissions and product launches for ganaxolone, and the timing thereof; our expectations and beliefs regarding the FDA and EMA with respect to our product candidates; our expectations regarding the Orion Corporation collaboration; our expectation regarding the impact of the COVID-19 pandemic on our business and clinical development plans; our financial projections; and the potential safety and efficacy of ganaxolone, as well as its therapeutic potential in a number of indications.

Forward-looking statements in this press 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 risk that the FDA will require additional clinical trials or data; any delays in review of the NDA submission by the FDA for any reason, including the COVID-19 pandemic; the timing of regulatory filings for our product candidates; the potential that regulatory authorities, including the FDA and EMA, may not grant or may delay approval for our product candidate; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; early clinical trials may not be indicative of the results in later clinical trials; clinical trial results may not support regulatory approval or further development in a specified indication or at all; actions or advice of the FDA or EMA 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; our ability to obtain, maintain, protect and defend intellectual property for our product candidates; the potential negative impact of third party patents on our or our collaborators’ ability to commercialize ganaxolone; delays, interruptions or failures in the manufacture and supply of our product candidate; the size and growth potential of the markets for the company’s product candidates, and the company’s ability to service those markets; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development programs; the company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the company’s product candidates; the potential for Orion to breach the collaboration or terminate the agreement in accordance with its terms; the potential for Orion to recoup a percentage of the upfront fee depending on the additional pre-clinical testing; the effect of the COVID-19 pandemic on our business, the medical community, regulators 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. This list is not exhaustive and these and other risks are described in our periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

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