MARINUS PHARMACEUTICALS INC (Form: 8-K, Received: 03/31/2022 16:30:54)

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): March 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.)

, Radnor, PA

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 1.01.

Entry into a Material Definitive Agreement.

On March 29, 2022, Marinus Pharmaceuticals, Inc. (the “Company”) entered into an amendment (the “Amendment”) 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 the Amendment, the “BARDA Contract”). The Amendment extends the end date of the Company’s performance period for funding under the BARDA Contract from September 1, 2022 to December 31, 2023.

This description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, which is attached hereto as Exhibit 10.1 and is incorporated by reference herein.

Item 2.03.

Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

On March 30, 2022, the Company, pursuant to its option under its previously disclosed Credit Agreement and Guaranty dated as of May 11, 2021 (the “Closing Date”) with Oaktree Fund Administration, LLC, as the Administrative Agent, and the lenders party thereto (as amended by that certain Letter Agreement dated May 17, 2021, the “Credit Agreement”), consummated a drawdown of $30.0 million of tranche B term loans from the Credit Agreement (the “Tranche B Term Loan”). As previously disclosed, the Credit Agreement provides for up to a $125.0 million term loan facility, $15.0 million of which was borrowed on the Closing Date and $30.0 million of which was borrowed in September 2021. The Tranche B Term Loan became available as a result of the approval by the U.S. Food and Drug Administration (FDA) of ZTALMY® (ganaxolone) oral suspension for the treatment of seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older. The Tranche B Term Loan is scheduled to mature on May 11, 2026, unless earlier prepaid.

Pursuant to the Credit Agreement, and subject to the Company’s achievement of certain financing, product development and product revenue milestones, and satisfaction of certain other conditions specified in the Credit Agreement, the Company would have the right to draw down two additional tranches in amounts up to $25.0 million in each tranche.

The Company intends to use the proceeds of the Tranche B Term Loan to continue clinical development activities and commercialization efforts for ganaxolone and for other working capital and general corporate purposes.

The description of the Credit Agreement is not complete and is qualified in its entirety by reference to the complete text of the Credit Agreement. A copy of the Credit Agreement is filed as Exhibits 10.1 and 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 17, 2021.

Item 8.01.

Other Events.

A copy of the press release announcing certain of the matters described under Items 1.01 and 2.03 of this Current Report on Form 8-K 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		Amendment, dated March 29, 2022, by and between Marinus Pharmaceuticals, Inc. and the Biomedical Advanced Research and Development Authority, a division of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
99.1		Press Release issued by Marinus Pharmaceuticals, Inc., dated March 31, 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: March 31, 2022/s/ Steven Pfanstiel

Steven Pfanstiel

Chief Financial Officer

Exhibit 10.1

10_1_exhibit 10_1.gif

MARINUS PHARMACEUTICALS INC 1564975 Attn: MICHAEL MCNAMARA MARINUS PHARMACEUTICALS, INC. 100 MATSONFORD RD STE 304 RADNOR PA 190874558 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) See Schedule 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. ORDER NO. IN ITEM 10A. appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). 1 is required to sign this document and return copies to the issuing office . E. IMPORTANT: Contractor is not 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) Tax ID Number: 20-0198082 DUNS Number: 141007232 The purpose of this 00001 modification is to change the Period of Performance for Base Year CLIN FROM: 9/15/2020 to 9/1/2022 12/31/2023 TO: 9/15/2020 to Accordingly, Article B.2. is modified herein. Period of Performance: 09/15/2020 to 12/31/2023 Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect . Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243 15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) JILL M. JOHNSON 15B. CONTRACTOR/OFFEROR /s/ Debra Mohollen (Signature of person authorized to sign) 15C. DATE SIGNED 03/29/2022 16B. UNITED STATES OF AMERICA /s/ Jill M. Johnson (Signature of Contracting Officer) 16C. DATE SIGNED 03/29/2022 x CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: X D. OTHER (Specify type of modification and authority) FAR Part 43.103(a) - Bilateral Modifications. AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES 1 2 2. AMENDMENT/MODIFICATION NO. P00001 3. EFFECTIVE DATE See Block 16C 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE ASPR-BARDA 7. ADMINISTERED BY (If other than Item 6) CODE ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (x) 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) x 10A. MODIFICATION OF CONTRACT/ORDER NO. 75A50120C00159 10B. DATED (SEE ITEM 13) 09/08/2020 CODE 1564975 FACILITY CODE

Marinus Ex10_exhibit 10_1.gif

Beginning with the effective date of this modification, the contract is modified as follows: 1. B.2 BASE PERIOD Clinical Trial; Pre-CONTRACTOR’S STATEMENT OF RELEASE IN CONSIDERATION OF THE MODIFICATION(S) AGREED TO HEREIN, BY SIGNING THIS MODIFICATION, THE CONTRACTOR HEREBY RELEASES THE GOVERNMENT FORM ANY AND ALL LIABILITY UNDER THE CONTRACT FOR FURTHER EQUITABLE ADJUSTMENTS ATTRIBUTABLE TO SUCH FACTS OR CIRCUMSTANCES GIVING RISE TO THIS MODIFICATION TO EXTEND THE PERIOD OF PERFORMANCE OF CLIN 0001. ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED. END OF MODIFICATION NO. P00001 CLIN Period of Performance Supplies/Services Government Share Contractor Share Total Estimated Cost 0001 9/15/2020 to 12/31/2023 Pre-clinical Efficacy in a nerve agent model; Phase 3 NDA Meeting $21,338,880 (52%) $19,455,822 (48%) $40,794,702 Contract No. 75A50120C00159 Modification No. P00001 Continuation Sheet Block 14 Page 2 of 2

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Exhibit 99.1

Marinus Pharmaceuticals Bolsters Financial Position With Drawdown of $30 Million Under Oaktree Capital Credit Facility

BARDA research contract extended through 2023

RADNOR, Pa. – March 31, 2022 – Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced it has received $30 million in funding under the existing Oaktree Capital Management, L.P. (Oaktree) credit agreement. This additional funding became available as a result of the U.S. Food and Drug Administration’s (FDA) recent approval of the company’s New Drug Application (NDA) for ZTALMY^® (ganaxolone) oral suspension for the treatment of seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older.

In May 2021, Marinus signed a credit financing agreement with Oaktree, a leader among global investment managers specializing in alternative investments. Together with this $30 million drawdown, Marinus has drawn a total of $75 million in funding, including $15 million at signing of the credit financing agreement and $30 million upon the FDA’s acceptance of the CDD NDA filing in September 2021.

In addition, Marinus entered into an amendment to its previously disclosed agreement with the Biomedical Advanced Research and Development Authority (BARDA) to extend Marinus’ performance period for funding through the end of 2023 to align with updated timeline expectations for the Phase 3 RAISE trial in refractory status epilepticus (RSE). The base contract provides up to $21 million of research funding from BARDA for the ongoing RAISE trial, with potential for total BARDA research funding of up to $51 million based on success-based milestones. Ganaxolone development for RSE is being funded in part by BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, under contract number 75A50120C00159.

Indication and Usage

ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.

Important Safety Information

Warnings and Precautions

Somnolence and Sedation: ZTALMY can cause somnolence and sedation. In a clinical study somnolence and sedation appeared early during treatment and were generally dose related. Other CNS depressants, including opioids, antidepressants, and alcohol, could potentiate these effects. Monitor patients for these effects and advise them not to drive or operate machinery until they have gained sufficient experience on ZTALMY to gauge whether it adversely affects their ability to drive or operate machinery.

Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including ZTALMY, increase the risk of suicidal thoughts or behavior. Monitor patients taking ZTALMY for the emergence or

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worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. Advise patients, caregivers, and their families to be alert for these behavioral changes and report behaviors of concern immediately to healthcare providers. When considering ZTALMY, or any other AED, balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. If these symptoms emerge during treatment, consider whether it may be related to the AED or the underlying illness.

Withdrawal of Antiepileptic Drugs: As with most AEDs, withdraw ZTALMY gradually to minimize the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered.

Adverse Reactions

The most common adverse reactions (incidence of at least 5% and at least twice the rate of placebo) were somnolence, pyrexia, salivary hypersecretion, and seasonal allergy.

Full Prescribing Information for ZTALMY^®is available here.

About Marinus Pharmaceuticals

Marinus is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Ganaxolone is a neuroactive steroid GABA_A 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 dose formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both 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 our expected clinical development plans, enrollment in our clinical trials, regulatory communications and submissions and product launches for ganaxolone, and the timing thereof; our expectations regarding BARDA funding; our expectations regarding the timing of the RAISE trial; 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; and the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated. This list is not exhaustive and these and other risks are described in our

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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.
484-253-6792
sdamouni@marinuspharma.com