Revenue and Sales Performance - ZTALMY (ganaxolone) net product revenue reached $8.0 million and $15.5 million for the three and six months ended June 30, 2024, respectively, compared to $4.2 million and $7.6 million for the same periods in 2023, indicating a year-over-year increase of 90.5% and 103.9%[116] - ZTALMY net sales were $8.0 million and $15.5 million for the three and six months ended June 30, 2024, respectively, compared to $4.2 million and $7.6 million for the same periods in 2023, representing a year-over-year increase of 90.5% and 103.9%[154] - The addressable patient population for ZTALMY in the U.S. is estimated to be approximately 2,000 pediatric patients[125] - Approximately 50% of the CDD patient population is expected to access primary coverage through Fee-for-Service or Managed Medicaid, with the other 50% through commercial payers[126] Clinical Trials and Approvals - The FDA approved ganaxolone for the treatment of seizures associated with CDKL5 Deficiency Disorder (CDD) in patients aged two years and older on March 18, 2022, with commercial sales beginning in Q3 2022[111] - The European Commission granted marketing authorization for ZTALMY for the adjunctive treatment of epileptic seizures associated with CDD in patients aged two to 17 years on July 28, 2023, with expected commercial launches in select European countries in the second half of 2024[111] - The top-line results from the RAISE trial showed that 80% of patients achieved status epilepticus cessation within 30 minutes of initiating IV ganaxolone compared to 13% for placebo (p < 0.0001)[113] - The company anticipates top-line results from the Phase 3 TSC clinical trial in the first half of Q4 2024[112] - In the Phase 3 Marigold Trial, patients treated with ZTALMY showed a median 30.7% reduction in major motor seizure frequency compared to a 6.9% reduction in the placebo group, achieving statistical significance (p=0.0036)[120] - At two years in the open-label extension phase of the Marigold Trial, patients experienced a median 48.2% reduction in major motor seizure frequency[120] - In an open-label Phase 2 trial for TSC-associated seizures, a median 16.6% reduction in seizure frequency was observed, with 30.4% of patients achieving at least a 50% reduction[137] - The TrustTSC global Phase 3 trial enrolled 129 patients, with a primary endpoint of percent change in 28-day frequency of TSC-associated seizures, and top-line data is expected in Q4 2024[138] Financial Performance and Funding - The company incurred net losses of $35.8 million and $74.5 million for the three and six months ended June 30, 2024, compared to net losses of $31.9 million and $66.7 million for the same periods in 2023, indicating an increase in losses of 12.2% and 11.5%[154] - As of June 30, 2024, the company had cash and cash equivalents of $64.7 million, which is expected to fund operations into the second quarter of 2025[156] - The company has incurred an accumulated deficit of $646.4 million as of June 30, 2024[154] - The company plans to continue incurring substantial losses as it conducts multiple later-stage clinical trials and expands its manufacturing capabilities[155] - The BARDA Contract provides for funding of up to approximately $51 million for the development of IV-administered ganaxolone, with $21 million already recorded as of December 31, 2023[160][162] - The company has entered into collaboration agreements with Orion and Tenacia, receiving an upfront payment of €25 million ($29.6 million) and $10 million, respectively, with potential milestone payments totaling up to €97 million and $256 million[165][169] - The company expects milestone and royalty payments from collaborations for the commercialization of ganaxolone in Europe, Mainland China, Hong Kong, Macau, Taiwan, and the Middle East and North Africa[222] Legal and Regulatory Matters - The company is currently not a party to any material legal proceedings, except for a securities class action lawsuit filed on June 5, 2024, alleging violations related to clinical trials[231] - The company intends to vigorously defend against the securities class action lawsuit and plans to move to dismiss the complaint once a schedule is set[231] - Ovid Therapeutics has filed lawsuits alleging patent infringement, which could divert significant resources and impact commercialization of ganaxolone for RSE[150] - The company is evaluating the implications of Ovid's recent patents and ongoing legal challenges, which may affect the commercialization strategy for ganaxolone[149] Research and Development - Research and development expenses for the three months ended June 30, 2024, were $20.9 million, a decrease from $21.4 million in the same period of 2023, primarily due to decreased clinical trial activity[188] - Total research and development expenses for the six months ended June 30, 2024, were $45.0 million, down from $49.3 million in the same period of 2023, reflecting decreased clinical trial activity[188] - The company is exploring new potential formulations of ganaxolone and expanding its product pipeline through acquisitions that align with its business strategy[108] - A clinical trial for oral ganaxolone targeting LGS and other rare epilepsies is planned to begin in H1 2025, pending results from the TrustTSC trial[139] Operational and Administrative Expenses - Selling, general and administrative expenses increased to $16.7 million for the three months ended June 30, 2024, compared to $15.7 million in the same period of 2023, driven by higher professional fees and stock-based compensation[194] - Interest income decreased to $1.1 million for the three months ended June 30, 2024, from $2.1 million in the same period of 2023, attributed to a decrease in cash and cash equivalents[196] - Interest expense increased to $4.6 million for the three months ended June 30, 2024, compared to $4.2 million in the same period of 2023, reflecting higher debt-related costs[197] - Restructuring costs were approximately $2.0 million for the three and six months ended June 30, 2024, with no comparable costs in 2023, primarily related to severance payments and contract termination costs[195] Corporate Governance and Internal Controls - There were no significant changes to critical accounting policies during the three months ended June 30, 2024, compared to the previous year[225] - Disclosure controls and procedures were evaluated as effective at the reasonable assurance level as of June 30, 2024[227] - There were no changes in internal control over financial reporting that materially affected the company during the quarter ended June 30, 2024[228]

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Marinus Pharmaceuticals, Inc. regarding a class action lawsuit alleging that the company made materially false and misleading statements during the class period from March 17, 2021, to May 7, 2024 [1][2]. Group 1: Allegations - The complaint alleges that Marinus Pharmaceuticals understated the risk of failing to meet early-stopping criteria in the Randomized Therapy in Status Epilepticus Trial (RAISE) [1]. - It is claimed that the company did not disclose that failing to meet the early stopping criteria in the RAISE trial could lead to the cessation of the separate Phase 3 RAISE II trial [1]. - As a result, the statements made by the defendants regarding the company's business, operations, and prospects were materially false and misleading, lacking a reasonable basis [1]. Group 2: Class Action Details - Shareholders who purchased shares of MRNS during the specified class period are encouraged to register for the class action, with a deadline set for August 5, 2024 [2]. - Once registered, shareholders will be enrolled in a portfolio monitoring software to receive updates throughout the lifecycle of the case [2]. - There is no cost or obligation for shareholders to participate in this case [2]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting the rights of investors who have suffered due to deceit, fraud, and illegal business practices [3]. - The firm aims to ensure that companies adhere to responsible business practices and engage in good corporate citizenship [3]. - The firm seeks recovery for investors who incurred losses due to false or misleading statements or omissions of material information that led to artificial inflation of the company's stock [3].

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In Marinus To Contact Him Directly To Discuss Their Options If you suffered losses exceeding $50,000 in Marinus stock or options between March 17, 2021 and May 7, 2024 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247- 4292 or 212-983-9330 (Ext. 1310). You may also click here for additional information: www.faruqilaw.com/MRN ...

NEW YORK, July 31, 2024 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Marinus Pharmaceuticals, Inc. ("Marinus" or the "Company") (NASDAQ: MRNS) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Marinus investors who were adversely affected by alleged securities fraud between March 17, 2021 and May 7, 2024. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/marinus-pharmaceuti ...

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) between March 17, 2021 and May 7, 2024, both dates inclusive (the "Class Period"), of the important August 5, 2024 lead plaintiff deadline in the securities class action first filed by the Firm. WHAT TO DO NEXT: To join the Marinus class action, go to https://rosenlegal.com/submit-form/? case_id=25735 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email case@rosenl ...

Then, on May 8, 2024, before the market opened, the Company filed with the SEC a current report on Form 8- K. Attached to this Form 8-K was a press release in which the Company announced that it would stop clinical trial enrollment in the RAISE and RAISE II trials. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequa ...

The Rosen Law Firm is investigating the Allegations that Marinus Pharmaceuticals, Inc. (MRNS) Misled Investors Regarding its Business Operations. All representation is on a contingency fee basis. Shareholders pay no fees or expenses. To join the Marinus class action, go to https://rosenlegal.com/submit-form/?case_id=25735 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected]. Plaintiff alleges that on May 8, 2024, Fierce Biotech published an article which illustrated the impact on t ...

Core Viewpoint - Marinus Pharmaceuticals is facing a federal securities class action lawsuit due to alleged misleading statements regarding the RAISE trial, which has led to significant stock price declines and investor losses [1][11]. Group 1: Legal Actions and Investor Impact - Faruqi & Faruqi, LLP is investigating claims against Marinus and has set an August 5, 2024 deadline for investors to seek lead plaintiff status in the class action [1]. - The stock price of Marinus fell by $0.14, or 8.91%, closing at $1.43 on May 8, 2024, following the announcement of the class action [2]. - The lawsuit alleges that Marinus executives made false statements regarding the risks associated with the RAISE trial, leading to investor damages when the truth was revealed [11]. Group 2: Stock Performance and Company Announcements - On April 15, 2024, Marinus announced that the RAISE trial did not meet early stopping criteria and would implement cost-saving measures, resulting in a stock price drop of $6.22, or 82.7%, closing at $1.30 [12]. - Following the April announcement, the stock further declined by $0.10, or 7.69%, to close at $1.20 on April 16, 2024 [12]. - On May 8, 2024, Marinus filed a Form 8-K with the SEC, announcing cost-cutting measures and the cessation of the Phase 3 RAISE II trial, which was influenced by the RAISE trial's results [13].

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made materially false and/or misleading statements and/or failed to disclose that: (1) defendants understated the risk of failure to meet the early-stopping criteria in the RAISE trial; (2) defendants did not disclose that a possible consequence of failing to meet the early stopping criteria in the RAISE trial would be that Marinus would stop the separate Phase 3 RAISE II trial; and (3) as a result, defendants' statements ...

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In Marinus To Contact Him Directly To Discuss Their Options If you suffered losses exceeding $50,000 in Marinus stock or options between March 17, 2021 and May 7, 2024 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247- 4292 or 212-983-9330 (Ext. 1310). You may also click here for additional information: www.faruqilaw.com/MRN ...