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Marinus Pharmaceuticals(MRNS) - 2023 Q4 - Annual Report
2024-03-05 21:14
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36576 Marinus Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction ...
Marinus Pharmaceuticals(MRNS) - 2023 Q4 - Annual Results
2024-03-05 21:05
Exhibit 99.1 "We are thrilled to announce we have exceeded the enrollment threshold required to conduct an interim analysis in the Phase 3 RAISE trial in refractory status epilepticus, a life-threatening condition," said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. "With over 90 patients now randomized following several months of increasingly strong enrollment trends, we are on track to announce topline data in the second quarter, assuming efficacy criteria for the interim analys ...
Marinus Pharmaceuticals(MRNS) - 2023 Q3 - Earnings Call Transcript
2023-11-07 19:00
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS) Q3 2023 Earnings Conference Call November 7, 2023 8:30 AM ET Company Participants Sonya Weigle - SVP, IR Scott Braunstein - CEO, President & Chairman Christina Shafer - Chief Commercial Officer Joseph Hulihan - Chief Medical Officer Steven Pfanstiel - COO, CFO & Treasurer Thomas Lyons - Chief Business Officer Conference Call Participants Brian Abrahams - RBC Capital Markets Joseph Thome - TD Cowen Joon Lee - Truist Securities Andrew Tsai - Jefferies Marc Goodman - ...
Marinus Pharmaceuticals(MRNS) - 2023 Q3 - Quarterly Report
2023-11-07 12:31
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-36576 Registrant's telephone number, including area code: (484) 801-4670 Securities registered pursuant to Section 12 ...
Marinus Pharmaceuticals(MRNS) - 2023 Q2 - Earnings Call Transcript
2023-08-10 16:20
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS) Q2 2023 Earnings Conference Call August 10, 2023 8:30 AM ET Company Participants Sonia Weigle - SVP, IR, HR, and Corporate Affairs Scott Braunstein - Chairman and CEO Christy Shafer - CCO Joseph Hulihan - CMO Steven E. Pfanstiel - CFO and COO Conference Call Participants Brian Abrahams - RBC Capital Markets Joseph Thome - TD Cowen Andrew Tsai - Jefferies Charles Duncan - Cantor Fitzgerald Joon Lee - Truist Securities Marc Goodman - Leerink Partners Douglas Tsao - ...
Marinus Pharmaceuticals(MRNS) - 2023 Q2 - Earnings Call Presentation
2023-08-10 12:01
Corporate Presentation August 2023 Safe Harbor Statement To the extent that statements contained in this presentation 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 o ...
Marinus Pharmaceuticals(MRNS) - 2023 Q2 - Quarterly Report
2023-08-10 11:55
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-36576 MARINUS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 20-0198082 (State or o ...
Marinus Pharmaceuticals(MRNS) - 2023 Q1 - Quarterly Report
2023-05-11 12:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-36576 MARINUS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 20-0198082 (State or ...
Marinus Pharmaceuticals(MRNS) - 2022 Q4 - Annual Report
2023-03-09 21:03
Financial Viability and Profitability - The company may never achieve or sustain profitability, which could depress the market price of its common stock[19] - Additional capital will be required to fund operations, and failure to obtain necessary financing may hinder the commercialization of ZTALMY and the development of ganaxolone[19] - The future success of the company is dependent on the successful clinical development, regulatory approval, and commercialization of ganaxolone, which requires significant capital resources and time[19] Product Development and Commercialization - ZTALMY is the company's first commercial product, and there is a limited history of successfully commercializing drugs, making it difficult to evaluate future viability[19] - Regulatory approval for ZTALMY has been obtained in the U.S., but extensive FDA regulatory requirements remain, which may pose challenges[19] - The commercial success of ZTALMY depends on significant market access and acceptance among physicians, patients, and payers, as well as sufficient reimbursement for ganaxolone[19] - The company may face difficulties in differentiating ZTALMY from existing treatments, which could adversely affect commercialization efforts[19] - Failure to obtain regulatory approval in international jurisdictions would prevent ganaxolone from being marketed outside the U.S.[19] - Ganaxolone's clinical development may not yield favorable results, impacting regulatory approval across multiple indications[25] - The therapeutic efficacy and safety of ganaxolone in indications other than CDD have not been established, posing risks for future commercialization[25] - The company has limited experience in commercial-scale manufacturing of ganaxolone, relying on third parties[25] Market Competition and Challenges - The company operates in a competitive market, which may result in others commercializing products before or more successfully than it does[19] - Favorable reimbursement determinations have been received for ZTALMY, but adverse changes in reimbursement could harm the business[19] - Collaboration or out-license agreements for ganaxolone outside the U.S. may not be successful, limiting market potential[25] Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for ganaxolone production, which may lead to delays if issues arise[25] - The COVID-19 pandemic could adversely affect the company's ability to conduct and complete clinical trials[26] Intellectual Property and Legal Risks - Intellectual property rights protection may be inadequate, potentially harming the company's competitive position[25] - The company may face legal challenges regarding intellectual property rights from third parties, which could impact business operations[25] - Patent terms may not sufficiently protect the company's competitive position for an adequate duration[25] Government and Funding Risks - Government funding for research may impose additional costs and requirements, affecting commercialization efforts[25]
Marinus Pharmaceuticals(MRNS) - 2022 Q3 - Quarterly Report
2022-11-07 21:04
Table of Contents For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION COMMISSION FILE NUMBER 001-36576 WASHINGTON, D.C. 20549 MARINUS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 20-0198082 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2022 ...