Marinus Pharmaceuticals, Inc. announced the initiation of the Marinus Access Program, a global managed access program for ZTALMY(R) (ganaxolone) oral suspension CV. The new program enables physicians to request ZTALMY for eligible patients with seizures associated with CDKL5 deficiency disorder (CDD) in geographies where the product is not commercially available and as supported by local regulatory requirements. Examples of forward-looking statements contained in this press release include, among others, statements regarding the potential benefits of the Marinus Access Program and the availability of ZTALMY under the program; commercialization and marketing plans for ZTALMY; the potential benefits ZTALMY will provide for physicians and patients; statements regarding expected clinical development plans, enrollment in clinical trials, regulatory communications and submissions for ganaxolone, and the timing thereof; expectations and beliefs regarding the FDA and EMA with respect to the product candidates; expectations regarding strategic partners; the pl safety and efficacy of ganaxolone, as well as its therapeutic potential in a number of indications; and other statements regarding the company's future operations, financial performance, financial position, prospects, objectives and other future event.

Such risks and uncertainties include, among others, ability to successfully launch the Marinus Access Program; unexpected results or delays in the commercialization of ZTALMY; unexpected market acceptance, payor coverage or future prescriptions and revenue generated by ZTALMY; unexpected actions by the FDA or other regulatory agencies with respect to the 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 varying interpretation of clinical data; ability to comply with the FDA's requirement for additional post-marketing studies in the required timeframes; the timing of regulatory filings for other product candidates; the potential that regulatory authorities, including the FDA and EMA, may not grant or may delay approval for product candidates; 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; ability to obtain and maintain regulatory approval for product candidate; ability to develop new formulations of ganaxolone or prodrugs; ability to obtain, maintain, protect and defend intellectual property for product candidates; the potential negative impact of third party patents on or collaborators' ability to commercialize ganaxolone; delays, interruptions or failures in the manufacture and supply of 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.