Minerva Neurosciences Reports 2023 Third Quarter Financial Results and Business Updates
Minerva Neurosciences, Inc. reports business updates, focusing on the FDA review of its New Drug Application for roluperidone to treat negative symptoms of schizophrenia, with R&D expenses increasing and a net loss of $7.8 million for the third quarter of 2023.
11/07/2023 - 07:30 AM
BURLINGTON, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the third quarter ended September 30, 2023.
The Company continues to work with the U.S. Food and Drug Administration (FDA) during its review of its New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia, in advance of the February 26, 2024 PDUFA date.
“We remain committed to bringing roluperidone to patients and physicians as we believe it addresses a significant unmet clinical need and has the potential to improve patients’ quality of life and expand treatment options available to physicians. If approved, roluperidone would be the first medication for negative symptoms of schizophrenia to receive regulatory approval,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.
Third Quarter 2023 Financial Results
Research and development (R&D) expense : For the three months ended September 30, 2023 and 2022, R&D expense was $3.4 million and $2.4 million , respectively. R&D expense was higher versus the prior year primarily due to costs associated with the FDA’s review of the Company’s NDA. For the nine months ended September 30, 2023 and 2022, R&D expense was $8.0 million and $11.5 million , respectively. The decrease in R&D expense versus the prior year was primarily due to higher costs in 2022 related to the preparation of the NDA for roluperidone, which was submitted in August 2022.General and administrative (G&A) expense: For the three months ended September 30, 2023 and 2022, G&A expense was $2.6 million and $2.8 million , respectively. For the nine months ended September 30, 2023 and 2022, G&A expense was $8.0 million and $8.7 million , respectively. The decrease in G&A expense for the three and nine-months ended September 30, 2023 versus the prior year was primarily due to lower non-cash stock compensation costs.Non-cash interest expense : For the three months ended September 30, 2023 and 2022, non-cash interest expense for the sale of future royalties was $2.1 million and $1.9 million , respectively. For the nine months ended September 30, 2023 and 2022, non-cash interest expense was $6.1 million and $5.5 million , respectively. The Company amortizes non-cash interest expense for the difference between the balance of the liability related to the sale of future royalties and the estimated amount future royalties to be received over the royalty period. Net loss: Net loss was $7.8 million for the three months ended September 30, 2023, or net loss per share of $1.03 b asic and diluted, as compared to net loss of $6.9 million , or net loss per share of $1.29 b asic and diluted, for the three months ended September 30, 2022. Net loss was $21.0 million for the nine months ended September 30, 2023, or net loss per share of $3.41 b asic and diluted, as compared to net loss of $25.4 million , or net loss per share of $4.75 b asic and diluted for the nine months ended September 30, 2022.Cash Position : Cash, cash equivalents and restricted cash at September 30, 2023, were approximately $47.0 million , as compared to $36.2 million at December 31, 2022. 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 (f/k/a 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 September 30, 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 Ahlholm Chief Financial Officer Minerva Neurosciences, Inc.info@minervaneurosciences.com
Media inquiries: Helen Shik Principal Shik Communications LLChelen@shikcommunications.com
CONDENSED CONSOLIDATED BALANCE SHEET DATA (Unaudited) September 30, 2023 December 31, 2022 (in thousands) ASSETS Current Assets: Cash and cash equivalents $ 46,904 $ 36,094 Restricted cash 100 100 Refundable regulatory fee - 3,117 Prepaid expenses and other current assets 1,221 848 Total current assets 48,225 40,159 Equipment & capitalized software, net 36 59 Goodwill 14,869 14,869 Total Assets $ 63,130 $ 55,087 LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY Current Liabilities: Accounts payable $ 1,395 $ 969 Accrued expenses and other current liabilities 1,955 408 Total current liabilities 3,350 1,377 Long-Term Liabilities: Liability related to the sale of future royalties 79,826 73,734 Total liabilities 83,176 75,111 Stockholders' (Deficit) Equity: Common stock 1 1 Additional paid-in capital 367,746 346,785 Accumulated deficit (387,793 ) (366,810 ) Total stockholders' (deficit) equity (20,046 ) (20,024 ) Total Liabilities and Stockholders' (Deficit) Equity $ 63,130 $ 55,087
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three Months Ended September 30, (in thousands, except per share amounts) Nine Months Ended September 30 (in thousands, except per share amounts) 2023 2022 2023 2022 Operating expenses: Research and development $ 3,444 $ 2,367 $ 7,985 $ 11,459 General and administrative 2,635 2,840 7,963 8,703 Total operating expenses 6,079 5,207 15,948 20,162 Loss from operations (6,079 ) (5,207 ) (15,948 ) (20,162 ) Foreign exchange (losses) gains (5 ) 2 (21 ) - Investment income 349 180 1,079 260 Non-cash interest expense for the sale of future royalties (2,085 ) (1,875 ) (6,093 ) (5,481 ) Net loss $ (7,820 ) $ (6,900 ) $ (20,983 ) $ (25,383 ) Net loss per share, basic and diluted $ (1.03 ) $ (1.29 ) $ (3.41 ) $ (4.75 ) Weighted average shares outstanding, basic and diluted 7,569 5,340 6,148 5,340
What is Minerva Neurosciences, Inc. focused on?
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies to treat central nervous system disorders.
What is the PDUFA date for roluperidone?
The PDUFA date for roluperidone is February 26, 2024.
How did R&D expenses change from 2022 to 2023?
R&D expenses increased from $2.4 million to $3.4 million for the third quarter of 2022 and 2023, respectively.
What was the net loss for the third quarter of 2023?
The net loss for the third quarter of 2023 was $7.8 million.
What was the cash position at September 30, 2023?
Cash, cash equivalents, and restricted cash at September 30, 2023, were approximately $47.0 million.
Minerva Neurosciences Inc
NERV Rankings
#321 Ranked by Stock Gains
NERV Stock Data
Industry
Pharmaceutical Preparation Manufacturing
Sector
Manufacturing
Tags
Health Technology, Biotechnology, Manufacturing, Pharmaceutical Preparation Manufacturing
Country
US
City
Waltham
About NERV
minerva neurosciences, inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of a portfolio of product candidates for the treatment of central nervous system diseases. its lead product candidate is roluperidone, which is in phase iii clinical trial, a compound for the treatment of schizophrenia. the company is also developing seltorexant that has completed phase iib clinical trial for treating insomnia and major depressive disorders; and min-301, which is in pre-clinical trial, a soluble recombinant form of the neuregulin-1b1 protein for the treatment of parkinson's disease. minerva neurosciences, inc. has a license agreement with mitsubishi tanabe pharma corporation for the development and commercialization of the roluperidone worldwide, excluding asia; and co-development and license agreement with janssen pharmaceutica, n.v. for the development of seltorexant. the company was formerly known as cyrenaic pharmaceuticals, inc. and changed its