Minerva Neurosciences Reports 2023 Second Quarter Financial Results and Business Updates
08/01/2023 - 07:30 AM
BURLINGTON, Mass., Aug. 01, 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 second quarter ended June 30, 2023.
“In the second quarter, we completed an equity financing of $20.0 million , further strengthening our cash position. This investment from Boehringer Ingelheim and Federated Hermes Kaufman Funds comes as we continue to interact with the FDA in support of their review of our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia.”
“We remain committed to bringing roluperidone to patients and physicians, as we believe it has the potential to improve patients’ quality of life and expand the treatment options physicians can offer their patients. Roluperidone, if approved, would be the first medication for negative symptoms of schizophrenia, a recognized unmet clinical need,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.
Q2 2023 Business Highlights
On June 30, 2023 , the Company completed a private investment in public equity financing of $20 million in gross proceeds from Boehringer Ingelheim, a global biopharmaceutical company with a growing mental health pipeline that includes schizophrenia, and Federated Hermes Kaufmann Funds. On May 8, 2023 , the FDA confirmed that they had assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024. On April 27, 2023 , the FDA confirmed the filing of Minerva’s NDA for roluperidone for the treatment of negative symptoms in patients with schizophrenia. Second Quarter 2023 Financial Results
Research and development (“R&D”) expense : R&D expense was $1.9 million and $4.5 million for the three and six months ended June 30, 2023, respectively, as compared to $4.1 million and $9.1 million for the three and six months ended June 30, 2022, respectively. The decrease of $2.2 million and $4.6 million in R&D expense for the three and six months ended June 30, 2023 versus the prior year periods was primarily due to lower non-cash stock compensation costs and lower consultant fees related to the preparation of the Company’s NDA for roluperidone, which was submitted during 2022, partially offset by higher professional service fees and staffing related expenses during 2023. Non-cash stock compensation costs included in R&D expense was $0.3 million and $0.5 million for the three and six months ended June 30, 2023, respectively, as compared to $0.5 million and $1.0 million for the three and six months ended June 30, 2022, respectively.General and administrative (G&A) expense: G&A expense was $2.6 million and $5.3 million for the three and six months ended June 30, 2023, respectively, as compared to $2.8 million and $5.9 million for the three and six months ended June 30, 2022, respectively. The decrease of approximately $0.2 million and $0.6 million for the three and six months ended June 30, 2023 versus the prior year periods was primarily due to lower non-cash stock compensation expense and insurance costs, partially offset by higher staffing related expenses during 2023. Non-cash stock compensation costs included in G&A expense was $0.3 million and $0.5 million for the three and six months ended June 30, 2023, respectively, as compared to $0.6 million and $1.1 million for the three and six month periods ended June 30, 2022, respectively.Non-cash interest expense : For the three and six months ended June 30, 2023, we recognized non-cash interest expense of $2.0 million and $4.0 million , respectively, as compared to $1.8 million and $3.6 million for the three and six months ended June 30, 2022, respectively. The increase in non-cash interest expense for both periods was primarily due to an increase in the carrying value of the liability related to the sale of future royalties for seltorexant to Royalty Pharma, for which upfront milestone payments are being amortized under the interest method over the estimated life of the agreement.Net loss: Basic and diluted net loss for the three and six months ended June 30, 2023 was $6.2 million and $13.2 million , or a loss per share of $1.12 and $2.43 , respectively, as compared to a net loss for the three and six months ended June 30, 2022 of $8.7 million and $18.5 million or a loss per share of $1.63 and $3.46 , respectively.Cash Position : Cash, cash equivalents, and restricted cash as of June 30, 2023, were approximately $51.9 million , as compared to $36.2 million as of December 31, 2022. In June 2023, we issued approximately 1.4 million shares of common stock and approximately 0.6 million pre-funded warrants to purchase common shares to two investors for gross proceeds to the Company of $20.0 million . 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 June 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, in thousands) June 30, 2023 December 31, 2022 ASSETS Current Assets: Cash and cash equivalents $ 51,797 $ 36,094 Restricted cash 100 100 Refundable regulatory fee - 3,117 Prepaid expenses and other current assets 329 848 Total current assets 52,226 40,159 Equipment & capitalized software, net 44 59 Goodwill 14,869 14,869 Total Assets $ 67,139 $ 55,087 LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY Current Liabilities: Accounts payable $ 298 $ 969 Accrued expenses and other current liabilities 1,610 408 Total current liabilities 1,908 1,377 Long-Term Liabilities: Liability related to the sale of future royalties 77,742 73,734 Total liabilities 79,650 75,111 Stockholders' (Deficit) Equity: Common stock 1 1 Additional paid-in capital 367,461 346,785 Accumulated deficit (379,973 ) (366,810 ) Total stockholders' (deficit) equity (12,511 ) (20,024 ) Total Liabilities and Stockholders' (Deficit) Equity $ 67,139 $ 55,087
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three Months Ended June 30, (in thousands, except per share amounts) Six Months Ended June 30 (in thousands, except per share amounts) 2023 2022 2023 2022 Operating expenses: Research and development $ 1,887 $ 4,132 $ 4,541 $ 9,092 General and administrative 2,633 2,833 5,327 5,862 Total operating expenses 4,520 6,965 9,868 14,954 Loss from operations (4,520 ) (6,965 ) (9,868 ) (14,954 ) Foreign exchange (losses) gains (7 ) 2 (16 ) (2 ) Investment income 365 72 730 80 Non-cash interest expense for the sale of future royalties (2,030 ) (1,827 ) (4,008 ) (3,606 ) Net loss $ (6,192 ) $ (8,718 ) $ (13,162 ) $ (18,482 ) Net loss per share, basic and diluted $ (1.12 ) $ (1.63 ) $ (2.43 ) $ (3.46 ) Weighted average shares outstanding, basic and diluted 5,511 5,340 5,426 5,340
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