Company Expects to Submit an NDA for Roluperidone, Subject to FDA Guidance, in the Third Quarter of 2022
WALTHAM, Mass., May 04, 2022 (GLOBE NEWSWIRE) — Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported key business updates and financial results for the quarter ended March 31, 2022.
Roluperidone Update
On April 7, 2022, the Company issued a press release providing an update from the March 2, 2022 Type C Meeting with the Food and Drug Administration (FDA) and next steps in preparation for submission of a New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in schizophrenia. Following the update, the Company hosted a webcast on April 13, 2022, which is archived and can be accessed under “Events and Presentations” in the Investors and Media section of the Company’s website.
Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva Neurosciences said, “We had a constructive Type C meeting with the FDA who confirmed that there is a significant unmet need for treatments for negative symptoms of schizophrenia. Patients and medical communities have long recognized the need for a new treatment paradigm to address the debilitating effects of negative symptoms. We are encouraged by the recent meeting with the FDA and we continue to believe that roluperidone has the potential to transform the lives of people who are unable to enjoy everyday activities due to their negative symptoms.”
Minerva has conducted two adequate and well controlled studies for the intended indication and are of the opinion that the data from these studies are sufficient to support a marketing application. Following the meeting, the Company submitted additional data to the FDA to address matters discussed at the meeting. The Company is preparing an NDA for roluperidone which, subject to FDA guidance, is currently expected to be submitted in the third quarter of 2022.
First Quarter 2022 Financial Results
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), in clinical development 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 not limited to, statements herein with respect to the clinical development of roluperidone as monotherapy for the treatment of negative symptoms of schizophrenia; the potential benefits of roluperidone; the adequacy and efficacy of our clinical trials and studies with roluperidone, and the sufficiency of the data from such trials and studies to support marketing application; our interpretation of the feedback from the U.S. Food and Drug Administration (FDA); the anticipated timing of New Drug Application (NDA) submission; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA; and management’s ability to successfully achieve its goals. 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 we will be able to successfully address the FDA’s concerns discussed herein and whether our future interactions with the FDA will have satisfactory outcomes; whether the FDA will support and accept an NDA submission for roluperidone; whether and when, if at all, our NDA for roluperidone, if successfully submitted, will be approved by the FDA; 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 on terms acceptable to us; and general economic conditions. Other factors that may cause our actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the Securities and Exchange Commission on May 4, 2022. Copies of reports filed with the SEC are posted on our website at www.minervaneurosciences.com. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we expressly disclaim any obligation to update any forward-looking statements, except as required by law.
For more information: | ||
Investor inquiries: Fred Ahlholm CFO, Minerva Neurosciences info@minervaneurosciences.com |
Media Inquiries: Helen Shik Principal, Shik Communications LLC helen@shikcommunications.com |
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CONDENSED CONSOLIDATED BALANCE SHEET DATA | |||||||
(Unaudited) | |||||||
March 31, 2022 |
December 31, 2021 | ||||||
(in thousands) | |||||||
ASSETS | |||||||
Current Assets: | |||||||
Cash and cash equivalents | $ | 54,947 | $ | 60,755 | |||
Restricted cash | 100 | 100 | |||||
Prepaid expenses and other current assets | 650 | 1,346 | |||||
Total current assets | 55,697 | 62,201 | |||||
Capitalized software, net | 52 | 52 | |||||
Goodwill | 14,869 | 14,869 | |||||
Total Assets | $ | 70,618 | $ | 77,122 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current Liabilities: | |||||||
Accounts payable | $ | 1,586 | $ | 1,853 | |||
Accrued expenses and other current liabilities | 1,662 | 966 | |||||
Total current liabilities | 3,248 | 2,819 | |||||
Long-Term Liabilities: | |||||||
Liability related to the sale of future royalties | 68,106 | 66,327 | |||||
Total liabilities | 71,354 | 69,146 | |||||
Stockholders’ Equity: | |||||||
Common stock | 4 | 4 | |||||
Additional paid-in capital | 343,725 | 342,673 | |||||
Accumulated deficit | (344,465 | ) | (334,701 | ) | |||
Total stockholders’ equity | (736 | ) | 7,976 | ||||
Total Liabilities and Stockholders’ Equity | $ | 70,618 | $ | 77,122 | |||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
(Unaudited) | |||||||
Three Months Ended March 31, (in thousands, except per share amounts) |
|||||||
2022 | 2021 | ||||||
Operating expenses: | |||||||
Research and development | $ | 4,960 | $ | 3,259 | |||
General and administrative | 3,029 | 4,249 | |||||
Total operating expenses | 7,989 | 7,508 | |||||
Loss from operations | (7,989 | ) | (7,508 | ) | |||
Foreign exchange losses | (4 | ) | (5 | ) | |||
Investment income | 8 | 4 | |||||
Non-cash interest expense for the sale of future royalties | (1,779 | ) | (1,296 | ) | |||
Net loss | $ | (9,764 | ) | $ | (8,805 | ) | |
Net loss per share, basic and diluted | $ | (0.23 | ) | $ | (0.21 | ) | |
Weighted average shares outstanding, basic and diluted | 42,722 | 42,722 | |||||
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