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

09 November 2021

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

“The third quarter provided steady progress across the wide breadth of our clinical programs and commercialization planning efforts. Our goal is to have ganaxolone available commercially, both in the U.S. and Europe, by the middle of next year following regulatory approvals,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus Pharmaceuticals. “We also made significant advancements on the regulatory and patent exclusivity front, continued to build our commercial leadership team and expanded our patient-centric advocacy framework. In addition, we have prioritized second generation ganaxolone with a goal of beginning Phase 1 clinical trials early next year.”

Joseph Hulihan, M.D., Chief Medical Officer of Marinus, added, “Clinical trials in both our oral and IV franchises remain on track. We have advanced ganaxolone across multiple indications where there is high unmet medical need in the U.S. and in Europe. In particular, we are pleased that the European Medicines Agency has accepted our Marketing Authorization Application for review. We plan to have a significant presence at the American Epilepsy Society’s 2021 Annual Meeting where we will further detail the potential of ganaxolone with nine abstracts accepted for presentation.”

Pipeline Update

CDKL5 Deficiency Disorder (CDD)

Tuberous Sclerosis Complex (TSC)

Status Epilepticus*

Second Generation Formulation and Lennox-Gastaut Syndrome (LGS)

*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

Financial Update

Corporate Guidance

September 30,

December 31,

2021

2020

ASSETS

Cash and cash equivalents

145,101

138,509

Investments

1,474

Other assets

13,772

10,479

Total assets

158,873

150,462

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities

37,676

10,729

Long Term Debt, Net

40,579

-

Other long-term liabilities

2,124

2,534

Total liabilities

80,379

13,263

Total stockholders’ equity

78,494

137,199

Total liabilities and stockholders’ equity

158,873

150,462

Three Months Ended September 30,

Nine Months Ended September 30,

2021

2020

2021

2020

Revenue:

Federal contract revenue

1,127

171

4,838

171

Collaboration revenue

8,987

8,987

Total revenue

10,114

171

13,825

171

Expenses:

Research and development

18,353

11,306

55,506

38,062

General and administrative

9,452

4,564

26,656

12,543

Cost of collaboration revenue

1,478

1,478

Loss from operations

-19,169

-15,699

-69,815

-50,434

Interest income

17

79

57

459

Interest expense

-678

-1,029

Currency translation and other expense, net

323

-39

316

-31

Net loss and comprehensive loss

-19,507

-15,659

-70,471

-50,006

Deemed dividends on convertible preferred stock

-8,880

Net loss applicable to common shareholders

-19,507

-15,659

-70,471

-58,886

Per share information:

Net loss per share of common stock—basic and diluted

-0.53

-0.51

-1.92

-2.29

Basic and diluted weighted average shares outstanding

36,744,591

30,552,947

36,667,472

25,737,981

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 1,900 pediatric and adult subjects across various indications at therapeutically relevant dose levels and treatment regimens for up to more than two years.

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, is planning to conduct a Phase 3 trial in tuberous sclerosis complex, and a Phase 3 trial in refractory status epilepticus is ongoing. 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 Corporation collaboration; our expectation regarding the impact of the COVID-19 pandemic on our business and clinical development plans; our financial projections; 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 FDA will require additional clinical trials or data; any delays in review of the NDA submission by the FDA for any reason, including the COVID-19 pandemic; the timing of regulatory filings for our product candidates; 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; 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 our 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 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.

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