Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2024 Financial Results

In This Article:

  • ZTALMY® (ganaxolone) Q3 2024 net product revenue of $8.5 million representing growth of 56% versus Q3 2023

  • Narrowing full year 2024 ZTALMY net product revenue guidance to $33 to $34 million

  • Reported results from Phase 3 TrustTSC trial and commenced process to explore strategic alternatives

  • Marinus continues to support the commercial growth of ZTALMY; further ganaxolone clinical development has been suspended

  • Scheduled to meet with FDA Q4 2024 to discuss a potential path forward for IV ganaxolone in refractory status epilepticus

  • Cost reduction plans implemented with cash runway expected into Q2 2025; cash and cash equivalents of $42.2 million as of September 30, 2024

RADNOR, Pa., November 12, 2024--(BUSINESS WIRE)--Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2024.

"We are pleased to see continued commercial growth of ZTALMY with more than 200 patients active on therapy and a steady increase in demand," said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. "In 2024, our Phase 3 data in status epilepticus and tuberous sclerosis complex showed meaningful clinical activity in certain refractory patients, however, the trials did not meet the thresholds for statistical significance. Given this outcome, we have made the difficult decision to explore strategic alternatives with the goal of maximizing stockholder value while supporting the growth of ZTALMY for patients with CDKL5 deficiency disorder (CDD)."

Dr. Braunstein continued, "I extend my deepest gratitude to our dedicated employees for their significant contributions to our work, and to the patients and clinicians who participated in our trials. We are proud to have delivered the first-and-only FDA-approved treatment for patients with seizures associated with CDD and hope that our research will serve as a foundation for future innovations in areas of high unmet need."

ZTALMY® (ganaxolone) Oral Suspension CV

  • Generated net product revenue of $8.5 million for the third quarter of 2024 representing 56% growth versus the third quarter of 2023.

  • Narrowing full year 2024 net product revenue guidance to $33 to $34 million from a range of $33 to $35 million.

  • Announced issuance of new U.S. patent for ZTALMY oral titration regimens covering the treatment of a range of epilepsies, expiring September 2042.

Clinical Updates

  • The U.S. Food and Drug Administration (FDA) granted Marinus a Type C meeting, scheduled for the fourth quarter of 2024, to discuss a potential path forward for intravenous (IV) ganaxolone in refractory status epilepticus (RSE).

  • Presented data from the Phase 3 RAISE trial evaluating IV ganaxolone for the treatment of RSE at the Neurocritical Care Society Annual Meeting in October 2024.

  • Announced topline results from the Phase 3 TrustTSC trial of oral ganaxolone in tuberous sclerosis complex (TSC) whereby the trial did not achieve statistical significance in the primary endpoint.

  • Marinus will continue to support the commercial growth of ZTALMY and activities required by the FDA and European Medicines Agency specific to post-approval commitments related to the CDD indication.

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