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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Marinus Pharmaceuticals Inc | NASDAQ:MRNS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.0506 | 3.37% | 1.5506 | 1.55 | 1.56 | 1.585 | 1.4705 | 1.49 | 258,416 | 16:56:39 |
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the first quarter ended March 31, 2024.
“Our unwavering commitment is to develop innovative treatment options for individuals with seizure disorders,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. “With continued commercial success in CDD and a significant unmet need in drug-resistant epilepsies, we believe there is a robust market opportunity for the ZTALMY franchise. We are actively engaged with the tuberous sclerosis complex community, raising awareness and conducting comprehensive market research in preparation for a potential second half 2025 TSC launch.”
Dr. Braunstein continued, “We plan to announce the RAISE trial topline results this summer and to then engage the FDA to discuss a potential filing strategy. Additionally, we have been prudent in our spend and have implemented cost-reduction measures to extend our cash runway beyond the two upcoming topline data readouts.”
ZTALMY® (ganaxolone) Oral Suspension CV
Clinical Pipeline
“We are optimistic that we can replicate the success of our pivotal CDD trial of ZTALMY in the TrustTSC study, where we believe refinements made to the Phase 3 titration schedule and low discontinuation rates throughout the trial suggest improved tolerability,” said Joseph Hulihan, M.D., Chief Medical Officer. “Our pipeline is supported by clinical and preclinical data which has demonstrated ganaxolone’s potential in treating seizures resistant to other medications, attributed to its unique ability to modulate both synaptic and extrasynaptic GABAA receptors. This is particularly valuable in indications such as TSC, where approximately 25% of patients suffer from highly refractory epilepsy.”
Dr. Hulihan added, “We have enrolled 100 patients in the RAISE trial and are preparing for topline results from the full dataset. We then plan to engage with regulatory authorities and RSE stakeholders to discuss the results and potential future development plans for IV ganaxolone.”
Tuberous Sclerosis Complex
Other Rare Genetic Epilepsies
Status Epilepticus
Ganaxolone development in the RAISE trial is being supported in part by the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00159.
General Business and Financial Update
Financial Results
Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, to be filed with the Securities and Exchange Commission, which includes further detail on the Company’s business plans, operations, financial condition, and results of operations.
Selected Financial Data (in thousands, except share and per share amounts)
March 31, 2024 (unaudited)
December 31, 2023
ASSETS
Cash and cash equivalents
$
104,253
$
120,572
Short-term investments
9,000
29,716
Other assets
24,097
20,620
Total assets
$
137,350
$
170,908
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY
Current liabilities
$
42,758
$
40,624
Long term debt, net
58,072
61,423
Revenue interest financing payable, net
34,642
33,766
Other long-term liabilities
18,312
18,330
Total liabilities
153,784
154,143
Total stockholders’ (deficit) equity
(16,434)
16,765
Total liabilities and stockholders’ (deficit) equity
$
137,350
$
170,908
Three Months Ended March 31,
2024 (unaudited)
2023 (unaudited)
Revenue:
Product revenue, net
$
7,509
$
3,332
Federal contract revenue
152
7,048
Collaboration revenue
18
-
Total revenue
$
7,679
$
10,380
Expenses:
Research and development
$
24,118
$
27,933
Selling, general and administrative
18,626
15,204
Cost of product revenue
756
206
Total expenses:
$
43,500
$
43,343
Loss from operations
(35,821
)
(32,963
)
Interest income
1,462
2,343
Interest expense
(4,346
)
(4,147
)
Other income, net
36
37
Net loss applicable to common shareholders
$
(38,669
)
$
(34,730
)
Per share information:
Net loss per share of common stock—basic and diluted
$
(0.68
)
$
(0.67
)
Basic and diluted weighted average shares outstanding
56,851,811
51,769,685
Other comprehensive income (loss)
Unrealized gain on available-for-sale securities
20
74
Total comprehensive loss
$
(38,649
)
$
(34,656
)
About Marinus Pharmaceuticals
Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company first introduced FDA-approved prescription medication ZTALMY® (ganaxolone) oral suspension CV in the U.S. in 2022 and continues to invest in the potential of ganaxolone 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 our commercialization and marketing plans for ZTALMY; our net product revenue guidance; the potential benefits ZTALMY will provide for physicians and patients; statements regarding our expected clinical development plans, enrollment in our clinical trials, regulatory communications and submissions for ganaxolone, and the timing thereof; our expected data readouts; our expected cash runway; our expectations and beliefs regarding the FDA and EMA with respect to our product candidates; our expectations regarding the development of new formulations and prodrug candidates; our expectations regarding our strategic partners; the expectation that the results from the RAISE trial will be used to determine whether to continue development of IV ganaxolone; expectation that the implemented cost reduction plans will reduce operating costs while prioritizing advancement towards the Company's near-term goals; our financial projections; the potential safety and efficacy of ganaxolone, as well as its therapeutic potential in a number of indications; 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, the Company’s ability to continue as a going concern; unexpected market acceptance, payor coverage or future prescriptions and revenue generated by ZTALMY; unexpected actions by the FDA or other regulatory agencies with respect to our products; competitive conditions and unexpected adverse events or patient outcomes from being treated with ZTALMY, 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 our operating plan for as long as anticipated; our ability to comply with the FDA’s requirement for additional post-marketing studies in the required time frames; the timing of regulatory filings for our other product candidates; 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; the size and growth potential of the markets for the company’s product candidates, and the company’s ability to service those markets; our ability to develop new formulations of ganaxolone or prodrugs; 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 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 and commercial programs; the potential for our ex-US partners to breach their obligations under their respective agreements with us or terminate such agreements in accordance with their respective terms; the risk that drug product quality requirements may not support continued clinical investigation of our product candidates and result in delays or termination of such clinical trials and product approvals; 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 candidates. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240508849271/en/
Company Contacts
Investors Sonya Weigle SVP, IR, HR & Corporate Affairs Marinus Pharmaceuticals, Inc. sweigle@marinuspharma.com
Media Molly Cameron Director, Corporate Communications & Investor Relations Marinus Pharmaceuticals, Inc. mcameron@marinuspharma.com
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