Company Announcements

New U.S. patent issued for ZTALMY^® (ganaxolone) oral titration regimens cover the treatment of a range of epilepsy disorders, expiring September 2042

Marinus continues to grow its IP portfolio to protect its scientific innovation

RADNOR, Pa.--(BUSINESS WIRE)--Oct. 15, 2024-- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced it has added to its intellectual property (IP) estate with a new patent issued by the United States Patent and Trademark Office (USPTO) for ZTALMY^® (ganaxolone) oral titration regimens covering the treatment of a range of epilepsy disorders, including CDKL5 deficiency disorder, tuberous sclerosis complex (TSC) and Lennox-Gastaut syndrome (LGS). The U.S. patent No. 12,115,169 expires in September 2042.

“The new patent granted to Marinus further strengthens the IP protection of ZTALMY and supports our development and commercialization plans for ganaxolone in TSC and other areas of high unmet need, such as LGS,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. “Our patent portfolio is the result of decades of research and scientific innovation, fortified by robust data on the pharmacology and effective clinical dosing of ganaxolone. We are pleased that the USPTO recognized that the claimed titration regimens are markedly different from prior titration regimens. We believe that this revised ganaxolone titration schedule has the potential to have a meaningful impact on tolerability, compliance, and lead to improved patient outcomes in a range of epilepsy disorders.”

About Marinus Pharmaceuticals

Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company’s product, ZTALMY^® (ganaxolone) oral suspension CV, is an FDA-approved prescription medication introduced in the U.S. in 2022. For more information, please visit www.marinuspharma.com and follow us on Facebook, LinkedIn and X.

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, our expectation that the new intellectual property for ganaxolone that covers the titration regimen will support development of additional indications for use of ZTALMY and has the potential to have a meaningful impact on tolerability, compliance, and lead to improved patient outcomes in a range of epilepsy disorders, as well as other statements regarding our strategy, development plans and timelines and other future events.

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 company’s ability to protect its intellectual property; unexpected actions by the FDA or other regulatory agencies with respect to our product candidates or products; competitive conditions and unexpected adverse events or patient outcomes from being treated with ZTALMY, uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the timing of regulatory filings for our product candidates; 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; the size and growth potential of the markets for the company’s product candidates, and the company’s ability to service those markets; delays, interruptions or failures in the manufacture and supply of our product candidates; and the company’s ability to obtain additional funding to support its clinical development and commercial programs. This list is not exhaustive and these and other risks are described in our periodic reports, including our annual reports 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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Investors
Sonya Weigle
Chief People and Investor Relations Officer
Marinus Pharmaceuticals, Inc.
sweigle@marinuspharma.com

Media
Molly Cameron
Director, Corporate Communications & Investor Relations
Marinus Pharmaceuticals, Inc.
mcameron@marinuspharma.com

Source: Marinus Pharmaceuticals