Marinus Pharmaceuticals Provides Business Update and Reports Second Quarter 2021 Financial Results

06 August 2021

RADNOR, Pa.--(BUSINESS WIRE)-- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today provided an update on its clinical and regulatory development activities and reported its financial results for the second quarter ended June 30, 2021.

“We have seen tremendous progress over the past few months, including the recent announcements of our European collaboration with Orion Corporation and the submission of our NDA for ganaxolone in CDKL5 deficiency disorder,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus Pharmaceuticals. “Orion’s leadership in the European rare orphan disease market and its ability to commercialize both oral and IV ganaxolone makes them a strong partner.”

Dr. Braunstein added, “We are also pleased to report that the FDA indicated they are in overall alignment with the design of our TSC Phase 3 clinical trial, which we expect to initiate in the fourth quarter of the year. We anticipate the remainder of 2021 to be equally eventful.”

Pipeline Update

CDKL5 Deficiency Disorder (CDD)

Tuberous Sclerosis Complex (TSC)

Status Epilepticus

Corporate Update

Financial Update

Corporate Guidance

Marinus Pharmaceuticals, Inc.

Selected Financial Data (in thousands, except share and per share amounts)

June 30,

December 31,

2021

2020

ASSETS

Cash and cash equivalents

$112,493

$138,509

Investments

1,474

Other assets

12,496

10,479

Total assets

$124,989

$150,462

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities

$16,694

$10,729

Long Term Debt, Net

$10,970

$0

Other long-term liabilities

2,266

2,534

Total liabilities

29,930

13,263

Total stockholders’ equity

95,059

137,199

Total liabilities and stockholders’ equity

$124,989

$150,462

Three Months Ended June 30,

Six Months Ended June 30,

2021

2020

2021

2020

Federal contract revenue

$

1,905

$

$

3,711

$

Expenses:

Research and development

$

18,562

$

11,752

$

37,153

$

26,756

General and administrative

6,828

4,130

17,204

7,980

Loss from operations

(23,485)

(15,882)

(50,646)

(34,736)

Interest income

16

212

40

398

Interest expense

(351)

(351)

Other expense, net

(3)

(5)

(7)

(9)

Net loss and comprehensive loss

$

(23,823)

$

(15,675)

$

(50,964)

$

(34,347)

Deemed dividends on convertible preferred stock

(8,880)

Net loss applicable to common shareholders

$

(23,823)

$

(15,675)

$

(50,964)

$

(43,227)

Per share information:

Net loss per share of common stock—basic and diluted

$

(0.65)

$

(0.63)

$

(1.39)

$

(1.86)

Basic and diluted weighted average shares outstanding

36,659,615

24,942,624

36,629,823

23,295,199

About Ganaxolone

Ganaxolone, a positive allosteric modulator of GABAA receptors, is an investigational product being developed in intravenous and oral formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Ganaxolone exhibits anti-seizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors. Ganaxolone has been studied in more than 1,800 pediatric and adult subjects across various indications at therapeutically relevant dose levels and treatment regimens for up to more than two years.

Ganaxolone development for RSE is being funded, in part, by the Biomedical Advanced Research and Development Authority (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.

About Marinus Pharmaceuticals

Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects. Ganaxolone 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. Marinus completed the first ever Phase 3 pivotal trial in children with CDKL5 deficiency disorder last year and is conducting a Phase 2 trial in tuberous sclerosis complex and a Phase 3 trial in refractory status epilepticus. 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 and beliefs regarding the FDA and EMA with respect to our product candidates; our expectations regarding the Orion collaboration, including the expected benefits of such collaboration and receipt of an upfront fee and potential R&D reimbursement and milestone and royalty payments thereunder; our expectation regarding the impact of the COVID-19 pandemic on our business and clinical development plans; our expectations regarding our reformulation efforts; our expectations regarding the announcement of a European expanded access program; our expectations regarding the Oaktree credit facility; and the potential safety and efficacy of ganaxolone, as well as its therapeutic potential in a number of indications.

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, the risk that the timing of FDA’s review of the NDA will be delayed or that the NDA is not accepted for filing by the FDA; the risk that the FDA will require additional clinical trials or data; any delays in acceptance and review of the NDA submission by the FDA for any reason, including the COVID-19 pandemic; the timing of regulatory filings, including the timing of filing the ganaxolone MAA with the EMA; the potential that regulatory authorities, including the FDA and EMA, may not grant or may delay approval for our product candidate; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; early clinical trials may not be indicative of the results in later clinical trials; 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; our ability to obtain and maintain regulatory approval for our product candidate; our ability to obtain, maintain, protect and defend intellectual property for our product candidates; the potential negative impact of third party patents on our or our collaborators’ ability to commercialize ganaxolone; delays, interruptions or failures in the manufacture and supply of our product candidate; the size and growth potential of the markets for the company’s product candidates, and the company’s ability to service those markets; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development programs; the company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the company’s product candidates; the potential for Orion to breach the collaboration or terminate the agreement in accordance with its terms; the potential for Orion to recoup a percentage of the upfront fee depending on the additional pre-clinical testing expected to be completed in Q1 2022; the effect of the COVID-19 pandemic on our business, the medical community, regulators and the global economy; and the availability or potential availability of alternative products or treatments for conditions targeted by us that could affect the availability or commercial potential of our product candidate. This list is not exhaustive and these and other risks are described in the company’s periodic reports, including the annual report 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 the company makes in this press release speak only as of the date of this press release. The company assumes 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.

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