We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Minerva Neurosciences Inc | NASDAQ:NERV | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.12 | -4.78% | 2.39 | 2.31 | 2.95 | 2.5114 | 2.3501 | 2.51 | 20,962 | 05:00:06 |
“The first quarter saw the achievement of a significant milestone for our investigational drug, roluperidone, and for Minerva, as the U.S. Food and Drug Administration (FDA) filed our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia on April 27, 2023. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024. We believe roluperidone has a unique mechanism of action and is intended to treat a group of patients that, to date, have not had an approved treatment. This is a completely new approach to treating negative symptoms of schizophrenia and we look forward to continuing to work with the FDA as they undertake their review.
“Successfully treating the negative symptoms of schizophrenia has historically been a significant challenge. If approved, roluperidone will be the first approved treatment for negative symptoms of schizophrenia in the U.S. We believe it has the potential to beneficially impact patients’ quality of life, reduce the burden on families and caregivers and provide physicians with a new treatment option,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.
Recent Business Highlights
First Quarter 2023 Financial Results
Conference Call Information:
The live conference call will begin this morning at 8:30 a.m. ET and may be accessed here and on the Company’s website under Events and Presentations.
The archived webcast will be available on the Company’s website beginning approximately two hours after the event for 90 days.
About Minerva Neurosciences
Minerva Neurosciences, Inc. (Nasdaq: NERV) is a clinical-stage biopharmaceutical company focused on developing product candidates to treat central nervous system (CNS) diseases. Our goal is to transform the lives of patients with improved therapeutic options. Minerva’s portfolio of compounds includes roluperidone (MIN-101), for negative symptoms of schizophrenia, and MIN-301, for Parkinson’s disease. For more information, please visit our website.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include, but are not limited to, statements herein with respect to the regulatory progress and therapeutic potential of roluperidone for the treatment of negative symptoms in patients with schizophrenia. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether the FDA will require additional trials or data which may significantly delay and put at risk our efforts to obtain regulatory approval; whether the FDA may meet expected review timelines for our NDA; whether roluperidone will be successfully marketed if approved; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations and corporate objectives on terms acceptable to us; general economic conditions; and other factors that are described under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 8, 2023, as updated by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023. Copies of reports filed with the SEC are posted on our website at http://ir.minervaneurosciences.com/. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.
Contact:
Investor inquiries:Frederick AhlholmChief Financial OfficerMinerva Neurosciences, Inc.info@minervaneurosciences.com
Media inquiries: Helen ShikPrincipalShik Communications LLChelen@shikcommunications.com
CONDENSED CONSOLIDATED BALANCE SHEET DATA | ||||||
(Unaudited, in thousands) | ||||||
March 31, 2023 | December 31, 2022 | |||||
ASSETS | ||||||
Current Assets: | ||||||
Cash and cash equivalents | $ | 35,978 | $ | 36,094 | ||
Restricted cash | 100 | 100 | ||||
Refundable regulatory fee | - | 3,117 | ||||
Prepaid expenses and other current assets | 596 | 848 | ||||
Total current assets | 36,674 | 40,159 | ||||
Equipment & capitalized software, net | 52 | 59 | ||||
Goodwill | 14,869 | 14,869 | ||||
Total Assets | $ | 51,595 | $ | 55,087 | ||
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | ||||||
Current Liabilities: | ||||||
Accounts payable | $ | 961 | $ | 969 | ||
Accrued expenses and other current liabilities | 1,541 | 408 | ||||
Total current liabilities | 2,502 | 1,377 | ||||
Long-Term Liabilities: | ||||||
Liability related to the sale of future royalties | 75,711 | 73,734 | ||||
Total liabilities | 78,213 | 75,111 | ||||
Stockholders' (Deficit) Equity: | ||||||
Common stock | 1 | 1 | ||||
Additional paid-in capital | 347,161 | 346,785 | ||||
Accumulated deficit | (373,780 | ) | (366,810 | ) | ||
Total stockholders' (deficit) equity | (26,618 | ) | (20,024 | ) | ||
Total Liabilities and Stockholders' (Deficit) Equity | $ | 51,595 | $ | 55,087 | ||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) | |||||||
Three Months Ended December 31,(in thousands, except per share amounts) | |||||||
2023 | 2022 | ||||||
Operating expenses: | |||||||
Research and development | $ | 2,653 | $ | 4,960 | |||
General and administrative | 2,695 | 3,029 | |||||
Total operating expenses | 5,348 | 7,989 | |||||
Loss from operations | (5,348 | ) | (7,989 | ) | |||
Foreign exchange loss | (9 | ) | (4 | ) | |||
Investment income | 364 | 8 | |||||
Non-cash interest expense for the sale of future royalties | (1,977 | ) | (1,779 | ) | |||
Net loss | (6,970 | ) | (9,764 | ) | |||
Net loss per share, basic and diluted | $ | (1.31 | ) | $ | (1.83 | ) | |
Weighted average shares outstanding, basic and diluted | 5,340 | 5,340 |
1 Year Minerva Neurosciences Chart |
1 Month Minerva Neurosciences Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions