Top-line results from the open-label extension of phase 3 monotherapy trial of roluperidone for the treatment of negative symptoms of schizophrenia show continuous improvement in negative symptoms, improved functional ability, favorable safety profile and limited number of psychotic relapses over one year
Pivotal bioequivalence study initiated
WALTHAM, Mass., May 12, 2021 (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, 2020.
Clinical update
On May 11, 2021, the Company announced results of the open-label extension of the phase 3 trial of roluperidone for the treatment of negative symptoms of schizophrenia following the completion of the 40-week open-label extension period. Details are provided in that press release, and key results include:
The Company has initiated subject screening in a pivotal bioequivalence study that will include approximately 48 healthy volunteers. This study will compare the formulations employed in the phase 2b and phase 3 trials of roluperidone, as well as at least one new formulation to facilitate large scale manufacturing.
“The results of the open-label extension of the phase 3 trial with roluperidone provide additional support for the continued development of this agent, particularly in an environment with a continuing significant unmet medical need for schizophrenia treatments with novel mechanisms of action,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.
“In addition, we have initiated the bioequivalence study and are simultaneously moving forward with activities that we believe are necessary to support the submission of a New Drug Application for roluperidone,” said Dr. Luthringer.
First Quarter 2021 Financial Results
Conference Call Information:
Minerva Neurosciences will host a conference call and live audio webcast today at 8:30 a.m. Eastern Time to discuss the quarter and recent business activities. To participate, please dial (877) 312-5845 (domestic) or (765) 507-2618 (international) and refer to conference ID 8981662.
The live webcast can be accessed under “Events and Presentations” in the Investors and Media section of Minerva’s website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
About Minerva Neurosciences
Minerva’s portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia, and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements. 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 statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone (MIN-101); the clinical and therapeutic potential of this compound; the likelihood of successful clinical trials, regulatory review, commercialization, and future sales of and potential royalty stream from seltorexant; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; 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 roluperidone will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic products or seltorexant will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; 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. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed 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, 2021, filed with the Securities and Exchange Commission on May 12, 2021. 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 disclaim any obligation to update any forward-looking statements, except as required by law.
CONDENSED CONSOLIDATED BALANCE SHEET DATA | |||||||
(Unaudited) | |||||||
March 31, | December 31, | ||||||
2021 | 2020 | ||||||
(in thousands) | |||||||
ASSETS | |||||||
Current Assets: | |||||||
Cash and cash equivalents | $ | 80,140 | $ | 25,357 | |||
Restricted cash | 100 | 100 | |||||
Prepaid expenses and other current assets | 1,449 | 1,983 | |||||
Total current assets | 81,689 | 27,440 | |||||
Other noncurrent assets | 15 | 15 | |||||
Operating lease right-of-use assets | 59 | 102 | |||||
In-process research and development | 15,200 | 15,200 | |||||
Goodwill | 14,869 | 14,869 | |||||
Total Assets | $ | 111,832 | $ | 57,626 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current Liabilities: | |||||||
Accounts payable | $ | 1,130 | $ | 996 | |||
Accrued expenses and other current liabilities | 2,165 | 2,053 | |||||
Operating leases | 64 | 111 | |||||
Total current liabilities | 3,359 | 3,160 | |||||
Long-Term Liabilities: | |||||||
Deferred taxes | 1,803 | 1,803 | |||||
Liability related to the sale of future royalties | 61,296 | – | |||||
Total liabilities | 66,458 | 4,963 | |||||
Stockholders’ Equity: | |||||||
Common stock | 4 | 4 | |||||
Additional paid-in capital | 338,970 | 337,454 | |||||
Accumulated deficit | (293,600) | (284,795) | |||||
Total stockholders’ equity | 45,374 | 52,663 | |||||
Total Liabilities and Stockholders’ Equity | $ | 111,832 | $ | 57,626 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
(Unaudited) | |||||||
Three Months Ended March 31, | |||||||
(in thousands, except per share amounts) | |||||||
2021 | 2020 | ||||||
Collaborative revenue | $ | – | $ | – | |||
Operating expenses: | |||||||
Research and development | 3,259 | 8,083 | |||||
General and administrative | 4,249 | 4,189 | |||||
Total operating expenses | 7,508 | 12,272 | |||||
Loss from operations | (7,508) | (12,272) | |||||
Foreign exchange losses | (5) | (9) | |||||
Investment income | 4 | 130 | |||||
Non-cash interest expense for the sale of future royalties | (1,296) | – | |||||
Loss before income taxes | (8,805) | (12,151) | |||||
Benefit for income taxes | – | – | |||||
Net loss | (8,805) | (12,151) | |||||
Net loss per share, basic and diluted | $ | (0.21) | $ | (0.31) | |||
Weighted average shares outstanding, basic and diluted | 42,722 | 39,178 | |||||
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
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