Marinus Pharmaceuticals presents clinical progress and preparations for launch of ZTALMY in TSC at Investor and Analyst Day Page 1

Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company focused on developing innovative therapeutics to treat seizure disorders, will host an Investor and Analyst Day today and will provide a detailed overview of the Company’s ZTALMY (ganaxolone) CV oral suspension development program in tuberous sclerosis (TSC), in advance of the release of topline data from the Phase 3 TrustTSC trial, expected in the first half of the fourth quarter of 2024. The event will begin at 9:00 a.m. ET and will be available via webcast here.

“Today, we are highlighting exciting clinical and commercial advances as we prepare to release topline data from our global Phase 3 TrustTSC trial,” said Scott Braunstein, MD, Chairman and Chief Executive Officer of Marinus. “Newly reported data from our patients in the Phase 2 TSC trial demonstrated durable and increasing reductions in seizure frequency over the long-term follow-up period. These data, along with a low discontinuation rate in the TrustTSC trial and a high proportion of patients crossing over into the open-label extension, increase our confidence that ZTALMY has the potential to be a meaningful treatment option for TSC patients with refractory epilepsy.”

“Patients with TSC face significant challenges due to the complex nature of their disease, which is often characterized by severe neurologic symptoms, including intractable seizures and neurodevelopmental delays. Despite advances in treatment, there remains a significant unmet need for therapies that can reduce the frequency of seizures in children and adults,” said Mary Kay Koenig, MD, director of the Center for Treatment of Pediatric Neurodegenerative Disease (CTPND), director of research in the Division of Pediatric and Adolescent Neurology at the University of Texas McGovern Medical School, and investigator in the TrustTSC trial.

Dr. Braunstein added, “In addition to our clinical momentum, we are poised for a rapid and efficient launch in the U.S. in TSC, subject to FDA approval, based on our established commercial infrastructure, lessons learned from our successful launch in CDD, and our extensive understanding of the market. In addition, we are pleased to share that we expect the Patent Office to grant new intellectual property for ganaxolone covering the titration regimen used in the TrustTSC study. With a U.S. market potential of approximately $2.5 billion in CDD and TSC, we believe our differentiated approach and ganaxolone’s unique mechanism of action, combined with expected favorable reimbursement dynamics, can enable broader patient access and address critical unmet needs in these challenging therapeutic areas.”