Marinus Cuts 20 percent of Its Staff

Rare Daily Staff

Marinus Pharmaceuticals said it was laying off 20 percent of its staff as part of cost-cutting measures as it prioritizes efforts to continue commercialization of its drug Ztalmy to treat developmental and epileptic encephalopathies.

In March 2022, the U.S. Food and Drug Administration approved Ztalmy oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD), a rare form of genetic epilepsy, in patients two years of age and older. ZTALMY, the first FDA approved treatment specifically in CDD, is a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor.

Cost-cutting efforts include stopping clinical trial enrollment in the RAISE and RAISE II trials, deferred investments in manufacturing IV Ztalmy, and other reductions across research and development and general and administrative functions. RAISE is a phase 3 randomized, placebo-controlled trial to evaluate the safety and efficacy of IV Ztalmy for the treatment of refractory status epilepticus.

The company said the reductions will allow the company to retain the appropriate personnel to assess the topline RAISE results and evaluate potential future development plans for IV Ztalmy. RAISE is a phase 3 randomized, placebo-controlled trial to evaluate the safety and efficacy of IV Ztalmy for the treatment of refractory status epilepticus.

Marinus said it will continue to evaluate additional opportunities to further extend cash runway. The company expects total GAAP operating expenses, inclusive of selling, general and administrative and R&D, in the range of $135 million to $140 million, inclusive of expected stock-based compensation of approximately $20 million. These estimates include the recently initiated cost reduction plans which the company expects to be fully realized in the third and fourth quarters of 2024.

“With continued commercial success in CDD and a significant unmet need in drug-resistant epilepsies, we believe there is a robust market opportunity for the Ztalmy franchise,” said Scott Braunstein, chairman and CEO of Marinus. “We are actively engaged with the tuberous sclerosis complex community, raising awareness and conducting comprehensive market research in preparation for a potential second half 2025 TSC launch.”

Photo: Scott Braunstein, chairman and CEO of Marinus