0001104659-22-095632.txt : 20220829 0001104659-22-095632.hdr.sgml : 20220829 20220829160842 ACCESSION NUMBER: 0001104659-22-095632 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220829 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220829 DATE AS OF CHANGE: 20220829 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MARINUS PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0001267813 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36576 FILM NUMBER: 221211337 BUSINESS ADDRESS: STREET 1: 5 RADNOR CORPORATE CENTER SUITE 500 STREET 2: 100 MATSONFORD RD CITY: RADNOR STATE: PA ZIP: 19087 BUSINESS PHONE: 484-801-4670 MAIL ADDRESS: STREET 1: 5 RADNOR CORPORATE CENTER SUITE 500 STREET 2: 100 MATSONFORD RD CITY: RADNOR STATE: PA ZIP: 19087 FORMER COMPANY: FORMER CONFORMED NAME: MARINUS PHARMACEUTICALS INC DATE OF NAME CHANGE: 20031022 8-K 1 tm2224596d1_8k.htm FORM 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): August 29, 2022

 

Marinus Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware 001-36576 20-0198082

(State or other jurisdiction of

incorporation)

 (Commission File Number)

(IRS Employer Identification

No.)

 

5 Radnor Corporate Center, Suite 500

100 Matsonford Rd, Radnor, PA

 

19087

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (484) 801-4670

 

__________________________________________________________________

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.001 MRNS Nasdaq Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

 

 

 

 

 

Item 8.01.Other Events.

 

On August 29, 2022, Marinus Pharmaceuticals, Inc. (the “Company”) announced that it closed the sale of its Rare Pediatric Disease Priority Review Voucher (the “PRV”) for $110.0 million to Novo Nordisk Inc.. The United States Secretary of Health and Human Services, Food and Drug Administration, issued the PRV to the Company on March 18, 2022 in connection with the approval of the use of ZTALMY® (ganaxolone) oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. A copy of the press release announcing the closing of the sale of the PRV 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
99.1   Press Release issued by Marinus Pharmaceuticals, Inc., dated August 29, 2022.
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: August 29, 2022 /s/ Steven Pfanstiel
  Steven Pfanstiel
  Chief Financial Officer

 

 

 

 EX-99.1 2 tm2224596d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

Marinus Pharmaceuticals Announces Closing of Sale of Priority Review Voucher for $110 Million

 

RADNOR, Pa. – August 29, 2022 – Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it has closed on the sale of its Rare Pediatric Disease Priority Review Voucher for $110 million. The $110 million of gross funds have been received and are in addition to the $92.3 million in cash and cash equivalents reported as of June 30, 2022.

 

Marinus anticipates using the proceeds for the ZTALMY® commercial launch, execution of its Phase 3 clinical programs in refractory status epilepticus and tuberous sclerosis complex, and other general expenditures. With the addition of this funding, Marinus expects cash and cash equivalents are sufficient to fund its operating expenses, capital expenditure requirements and maintain the minimum cash balance required under its debt facility into the fourth quarter of 2023.

 

Jefferies LLC acted as the exclusive financial advisor to Marinus for this transaction.

 

About the Rare Pediatric Disease Priority Review Voucher (PRV) Program

 

The U.S. Food and Drug Administration Rare Pediatric Disease Priority Review Program is intended to encourage the development of new drug and biological products for the prevention and treatment of certain rare pediatric diseases. Under this program, a PRV is issued to the sponsor of a rare pediatric disease product application and entitles the holder to priority review of a single New Drug Application or Biologics License Application. The sponsor may choose to sell or transfer the voucher upon approval of the rare pediatric disease product application.

 

About Marinus Pharmaceuticals

 

Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company’s commercial product, ZTALMY® (ganaxolone) oral suspension CV, has been approved by the U.S. FDA for the treatment of seizures associated with CDKL5 deficiency disorder in patients two years of age and older. The potential of ganaxolone is also being studied in other rare seizure disorders, including in Phase 3 trials in tuberous sclerosis complex and refractory status epilepticus. Ganaxolone is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects. It is being developed in IV and oral formulations to maximize therapeutic reach for adult and pediatric patients in acute and chronic care settings. For more information visit www.marinuspharma.com.

 

 

 

 

 

 

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, statements regarding the our plans with respect to the use of the PRV sale proceeds; our expected cash runway with the PRV sale proceeds; our commercialization plans with respect to ZTALMY and the expected timing thereof; our expected clinical development plans, enrollment in our clinical trials, regulatory communications and submissions for ganaxolone, and the timing thereof; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives and other future event.

 

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, 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; 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; delays, interruptions or failures in the manufacture and supply of our product candidates; the company’s ability to obtain additional funding to support its clinical development and commercial programs; and the effect of the COVID-19 pandemic on our business, the medical community, regulators and the global economy. 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.

 

Company Contact

 

Sasha Damouni Ellis
Vice President, Corporate Affairs & Investor Relations
Marinus Pharmaceuticals, Inc.
sdamouni@marinuspharma.com

 

 

 

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