17 May 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 first quarter ended March 31, 2021.
“I am pleased to announce that we have reached agreement with Oaktree to secure up to $125 million in credit financing,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus Pharmaceuticals. “This new credit facility provides a potentially meaningful extension of our cash runway, allowing for continued support of our commercial, clinical, and next-generation formulations, and reflects Oaktree’s confidence in our anticipated NDA submission, strategy, and science. We believe this credit agreement will be a valuable financial enabler of our roadmap to further unlock ganaxolone’s potential.”
Aman Kumar, Co-Portfolio Manager of Life Sciences Lending at Oaktree, commented, “Oaktree is pleased to partner with Marinus and provide financial support for its upcoming clinical and commercialization activities at this inflection point in its evolution as a company. With a strong management team in place, compelling clinical data and a well-defined long-term strategic growth plan, we believe Marinus is well-positioned to capture significant value in treating seizures and epilepsy.”
“Building on the momentum we have established in early 2021, we are making progress in our clinical programs, business operations, and in growing and diversifying our talent pool. We continue to target the submission of a new drug application to the FDA for the use of ganaxolone in CDKL5 deficiency disorder by mid-2021, completion of our Phase 2 clinical trial in tuberous sclerosis complex this summer, and expect top-line data for the ongoing Phase 3 RAISE trial in refractory status epilepticus in the first half of 2022,” Dr. Braunstein said. “We are equally focused on providing access to ganaxolone globally as evidenced by our recent successful regulatory meetings with the EMA discussing the IV and oral programs. Looking toward the second half of 2021, we are focused on commercial preparedness for our first potential product launch in the U.S., continued enrollment of our Phase 3 trial in RSE, and the planned initiation of a Phase 3 trial in TSC.”
“We are also pleased to have recently appointed three leading experts in clinical neurology and pediatric epilepsy to the Marinus Scientific Advisory Board,” continued Dr. Braunstein. “Dr. Elizabeth Thiele, Dr. Elia Pestana Knight and Dr. Nicola Specchio join us at an exciting and pivotal time as we prepare for our next phase of investment. They will serve as invaluable resources for our oral pipeline as we work to realize the full potential of ganaxolone as a treatment for epilepsy.”
Marinus has decided to pursue ganaxolone development for LGS, given the overlap in seizure types and etiologies with other disorders where ganaxolone has shown potential, such as CDD and TSC
The company will present additional details on clinical development plans this fall, targeting initiation of a Phase 2 clinical trial in mid-2022
Marinus Pharmaceuticals, Inc. |
||||||
March 31, |
December 31, |
|||||
ASSETS |
||||||
Cash and cash equivalents |
$ |
123,472 |
$ |
138,509 |
||
Investments |
— |
1,474 |
||||
Other assets |
10,387 |
10,479 |
||||
Total assets |
$ |
133,859 |
$ |
150,462 |
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||
Current liabilities |
$ |
16,121 |
$ |
10,729 |
||
Other long term liabilities |
2,404 |
2,534 |
||||
Total liabilities |
18,525 |
13,263 |
||||
Total stockholders’ equity |
115,334 |
137,199 |
||||
Total liabilities and stockholders’ equity |
$ |
133,859 |
$ |
150,462 |
Three Months Ended |
||||||||
2021 |
2020 |
|||||||
Federal contract revenue |
$ |
1,806 |
$ |
— |
||||
Expenses: |
||||||||
Research and development |
$ |
18,591 |
$ |
15,004 |
||||
General and administrative |
10,376 |
3,850 |
||||||
Loss from operations |
(27,161 |
) |
(18,854 |
) |
||||
Interest income |
24 |
222 |
||||||
Other expense, net |
(4 |
) |
(40 |
) |
||||
Net loss |
$ |
(27,141 |
) |
$ |
(18,672 |
) |
||
Deemed dividends on convertible preferred stock |
— |
(8,880 |
) |
|||||
Net loss applicable to common shareholders |
$ |
(27,141 |
) |
$ |
(27,552 |
) |
||
Per share information: |
||||||||
Net loss per share of common stock—basic and diluted |
$ |
(0.74 |
) |
$ |
(1.27 |
) |
||
Basic and diluted weighted average shares outstanding |
36,592,394 |
21,665,461 |
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 recently completed the first ever Phase 3 pivotal trial in children with CDKL5 deficiency disorder, is conducting a Phase 2 trial in tuberous sclerosis complex and has recently disclosed top-line results from its Phase 2 proof-of-concept trial in PCDH19-related epilepsy. The company has initiated a Phase 3 trial in refractory status epilepticus. For more information visit www.marinuspharma.com.
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
Oaktree is a leader among global investment managers specializing in alternative investments,
with $153 billion in assets under management as of March 31, 2021. The firm emphasizes an opportunistic, value-oriented and risk-controlled approach to investments in credit, private equity, real assets and listed equities. The firm has over 1,000 employees and offices in 19 cities worldwide. For additional information, please visit Oaktree’s website at http://www.oaktreecapital.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 the Oaktree credit facility and its effects on our cash runway and business plans; our expectations that our cash and cash equivalents combined with the net upfront proceeds of the Oaktree credit facility will be sufficient to fund our operating expenses and capital expenditures through the second quarter of 2022; 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, 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 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 effect of the COVID-19 pandemic on our business, the medical community 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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