UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Item 1.01. Entry into a Material Definitive Agreement.
Effective September 21, 2022, Marinus Pharmaceuticals, Inc. (the “Company”) entered into a contract modification (“Amendment No. 2”) to its previously disclosed agreement with the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, dated as of September 8, 2020 (as amended by Amendment No. 1, dated March 29, 2022, and Amendment No. 2, the “BARDA Contract”). Amendment No. 2, among other things, (i) provides for the exercise of BARDA’s option under the BARDA Contract to support U.S. onshoring of the manufacturing capabilities for ganaxolone active pharmaceutical ingredient (“Option 2”); (ii) changes the end date of the Company’s performance period under Option 2 from December 31, 2026 to July 31, 2025; (iii) increases the government cost share amount under Option 2 from approximately $11.5 million to approximately $12.3 million; and (iv) increases the Company’s cost share amount under Option 2 from approximately $4.9 million to approximately $5.3 million.
This description of Amendment No. 2 does not purport to be complete and is qualified in its entirety by reference to Amendment No. 2, which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference to this Item 1.01.
Item 8.01. Other Events.
On September 22, 2022, the Company issued a press release announcing that BARDA exercised its first contract option, valued at approximately $12.3 million, to support U.S. onshoring of the manufacturing capabilities for ganaxolone active pharmaceutical ingredient. A copy of the press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference to this Item 8.01.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits
Exhibit No. |
| Description |
10.1 |
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99.1 | Press Release, dated September 22, 2022, of Marinus Pharmaceuticals, Inc. | |
104 | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
MARINUS PHARMACEUTICALS, INC. | |
Date: September 23, 2022 | /s/ Steven Pfanstiel |
Steven Pfanstiel | |
Chief Financial Officer and Treasurer |