NERV Minerva Neurosciences Inc

3.5
-0.14  -4%
Previous Close 3.65
Open 3.62
52 Week Low 1.81
52 Week High 15.215
Market Cap $137,463,065
Shares 39,219,134
Float 26,741,124
Enterprise Value $105,878,620
Volume 1,424,515
Av. Daily Volume 4,152,213
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Drug Pipeline

Drug Stage Notes
Roluperidone (MIN-101)
Schizophrenia
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - May 29, 2020.
MIN-117
Major Depressive Disorder
Phase 2b
Phase 2b
Phase 2b data failed to meet endpoints - December 18, 2019. Development to be discontinued in MDD.
MIN-202 (seltorexant) vs quetiapine
Major Depressive Disorder
Phase 2
Phase 2
Phase 2b data noted quantitative advantage but no statistical separation between two arms. Company noted trial was not designed to detect statistical significance.
MIN-202 (seltorexant)
Primary insomnia
Phase 2b
Phase 2b
Phase 2b data June 24, 2019 met primary endpoint.
MIN-202 (seltorexant)
Major Depressive Disorder
Phase 2
Phase 2
Phase 2b data May 13, 2019 noted p-value was 0.083.

Latest News

    • Preserves royalties payable to Minerva on worldwide sales of seltorexant
    • Eliminates all financial obligations with respect to the clinical development and commercialization of seltorexant
    • Corporate focus now on lead product, roluperidone, in Phase 3 development

    WALTHAM, Mass., July 01, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that it has exercised its right to opt out of its agreement with Janssen Pharmaceutica NV (Janssen) for the future development of seltorexant (MIN-202).

    As a result, Minerva will now collect a royalty on worldwide sales of seltorexant in all indications…

    • Preserves royalties payable to Minerva on worldwide sales of seltorexant
    • Eliminates all financial obligations with respect to the clinical development and commercialization of seltorexant
    • Corporate focus now on lead product, roluperidone, in Phase 3 development

    WALTHAM, Mass., July 01, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that it has exercised its right to opt out of its agreement with Janssen Pharmaceutica NV (Janssen) for the future development of seltorexant (MIN-202).

    As a result, Minerva will now collect a royalty on worldwide sales of seltorexant in all indications in the mid-single digits, with no financial obligations to Janssen. 

    "We believe opting out of our agreement with Janssen at this stage of the program creates real value for Minerva," said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.  "This decision enables us to retain a meaningful financial interest in the future revenue stream of a compound with significant commercial potential while eliminating the Company's financial obligations to a substantial Phase 3 program encompassing major depressive disorder and insomnia.  Furthermore, opting out will help align our human and financial resources with our focus on establishing a path to approval of our lead compound, roluperidone, in Phase 3 development." 

    About Minerva Neurosciences

    Minerva's portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia; a potential royalty stream from seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; 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 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 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 future sales and a 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 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, 2020, filed with the Securities and Exchange Commission on May 4, 2020. 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.

    Contact:

    William B. Boni

    VP, Investor Relations/

    Corp. Communications

    Minerva Neurosciences, Inc.

    (617) 600-7376

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  1. WALTHAM, Mass., June 01, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the company will hold a webcast on Friday, June 5, 2020 at 8.30 a.m. to present additional results and analyses from its Phase 3 trial in negative symptoms. This webcast replaces that previously scheduled for today (June 1, 2020) announced by the Company on May 29, 2020. 

    Minerva management will be joined on the webcast by key opinion leaders Philip Harvey, Ph.D. and Brian Kirkpatrick, M.D. who will discuss these findings.

    Philip D. Harvey, Ph.D. is Leonard M. Miller Professor of Psychiatry and director…

    WALTHAM, Mass., June 01, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the company will hold a webcast on Friday, June 5, 2020 at 8.30 a.m. to present additional results and analyses from its Phase 3 trial in negative symptoms. This webcast replaces that previously scheduled for today (June 1, 2020) announced by the Company on May 29, 2020. 

    Minerva management will be joined on the webcast by key opinion leaders Philip Harvey, Ph.D. and Brian Kirkpatrick, M.D. who will discuss these findings.

    Philip D. Harvey, Ph.D. is Leonard M. Miller Professor of Psychiatry and director of the Division of Psychology at the University of Miami Miller School of Medicine and a VA Senior Health Scientist. Dr. Harvey's research has focused on cognition and functioning, and he has written extensively on aging in schizophrenia, negative symptoms in schizophrenia, functional impairments in severe mental illness, the cognitive effects of typical and atypical antipsychotics, and the effects of cognitive enhancing agents and cognitive training in various conditions. He is the author of over 1,000 scientific papers and abstracts, and he has written over 60 book chapters. Dr. Harvey is a widely cited author who was repeatedly designated by Thompson-Reuters as being in the top 1% of all researchers in citations in mental health each year since 2010. He has received numerous awards for his research in schizophrenia.

    Brian Kirkpatrick, M.D. is a professor and department chair at the University of Nevada, Reno School of Medicine Department of Psychiatry and Behavioral Sciences. He received his M.D. from the University of Texas Medical School at Houston. He completed his psychiatry residency at the University of North Carolina, where he also received a master's in epidemiology. He was on the faculty of Maryland Psychiatric Research Center at the University of Maryland, and was Vice Chair of the Department of Psychiatry at the Medical College of Georgia. He was Chair of the Department of Psychiatry at Scott & White Healthcare and Texas A&M University College of Medicine before coming to Nevada.  Dr. Kirkpatrick is an associate editor of Clinical Schizophrenia and Related Psychoses, serves on the editorial board of Schizophrenia Bulletin and was co-chair of the National Institute of Mental Health-sponsored Consensus Development Conference on Negative Symptoms.

    Conference Call Information:

    Minerva Neurosciences will host a conference call and live audio webcast on Friday, June 5, 2020 at 8:30 a.m. Eastern Time to discuss the Phase 3 trial of roluperidone. To participate, please dial 1-877-425-9470 (toll free) or 1-201-389-0878 (toll/international), and refer to conference ID 13703481.

    To participate in the webcast, please link to: http://public.viavid.com/index.php?id=139821. 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 proprietary compounds include: roluperidone (MIN-101), in clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; 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 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 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 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 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, 2020, filed with the Securities and Exchange Commission on May 4, 2020. 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.

    Contact:
    William B. Boni
    VP, Investor Relations/
    Corp. Communications
    Minerva Neurosciences, Inc.
    (617) 600-7376

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    • The 64 mg and 32 mg doses were not statistically significantly different from placebo at Week 12 on the primary endpoint, the PANSS Marder Negative Symptoms Factor Score (p ≤0.064 and 0.259, respectively), or the key secondary endpoint, the Personal and Social Performance Scale Total Score (p ≤0.021 and p ≤0.542, respectively)
    • Roluperidone separated from placebo on both primary and key secondary endpoints at Weeks 4, 8 and 12
    • Roluperidone was generally well tolerated with a safety profile comparable to placebo

    WALTHAM, Mass., May 29, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today…

    • The 64 mg and 32 mg doses were not statistically significantly different from placebo at Week 12 on the primary endpoint, the PANSS Marder Negative Symptoms Factor Score (p ≤0.064 and 0.259, respectively), or the key secondary endpoint, the Personal and Social Performance Scale Total Score (p ≤0.021 and p ≤0.542, respectively)
    • Roluperidone separated from placebo on both primary and key secondary endpoints at Weeks 4, 8 and 12
    • Roluperidone was generally well tolerated with a safety profile comparable to placebo

    WALTHAM, Mass., May 29, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the Phase 3 trial of roluperidone to treat negative symptoms in schizophrenia did not meet its primary (reduction in PANSS Marder Negative Symptoms Factor Score or NSFS) and key secondary (improvement in the Personal and Social Performance Scale Total Score or PSP) endpoints.

    Trial parameters and top-line results

    In total, 515 patients were enrolled into the trial, and 513 patients received treatment and were included in the safety and Intent-To-Treat population. The trial was conducted in the USA, Europe and Israel. There were 172 patients who received placebo, 172 patients who received roluperidone 32 mg, and 171 patients who received roluperidone 64 mg. Demographic and baseline disease characteristics were comparable across all treatment arms.

    The results for both roluperidone doses versus placebo across both the primary and the key secondary endpoints to Week 12 were corrected for multiplicity using the truncated Hochberg procedure.

    The primary objective of the trial was to evaluate the change from baseline to Week 12 of NSFS with 32 mg and 64 mg doses of roluperidone compared to placebo in patients diagnosed with schizophrenia presenting with moderate to severe negative symptoms. Neither the 32 mg nor 64 mg dose of roluperidone showed a statistically significant separation from placebo (32 mg: p ≤0.256, effect size [ES]=0.1; 64 mg: p ≤0.064, ES=0.2).

    Furthermore, neither dose showed a statistically significant separation from placebo on the key secondary endpoint, the change from baseline to Week 12 in PSP (32 mg: p ≤0.542, ES=0.1; 64 mg: nominal p ≤0.021, ES=0.3).

    Although limited inferences can be drawn from this data, unadjusted statistically significant separations from placebo were observed in NSFS at Week 4 for both doses (32 mg: nominal p ≤0.036, ES=0.2; 64 mg: nominal p ≤0.007, ES=0.3), and at Week 8 for the 64 mg dose (nominal p ≤0.027, ES=0.3), and the 64 mg dose was statistically significantly different from placebo as measured by change in PSP at all other assessment timepoints (Week 4, nominal p ≤0.005, ES=0.3; Week 8: nominal p ≤0.018, ES=0.3).

    Photos accompanying this announcement are available at

    https://www.globenewswire.com/NewsRoom/AttachmentNg/55de50fe-e501-4ef7-a1af-c2a72c8ddc54

    https://www.globenewswire.com/NewsRoom/AttachmentNg/ad64a83c-09ed-4727-919a-cf137154cda1

    Overall, subgroup analyses by region (USA and rest of the world) and by age groups were similar.

    Roluperidone was generally well tolerated, and the incidences of patients who reported treatment‑emergent adverse events over the duration of 12 weeks of treatment were 37% for the 64 mg group, 42% for the 32 mg group, and 33% for placebo. Only 42 patients discontinued from the study due to adverse events, 16 (9%) in 64 mg arm, 18 (10%) in 32 mg arm, and 8 (5%) in placebo arm. Two treatment-unrelated deaths were reported in the 32 mg treatment arm.

    "As someone who has spent his career studying everyday functioning in schizophrenia, I see disability as the most important treatment target for people with schizophrenia," stated Philip Harvey, Ph.D., Leonard M. Miller Professor of Psychiatry and Director of the Division of Psychology at the University of Miami Miller School of Medicine. "The substantial improvements in the PSP scale with the 64 mg dose are tremendously encouraging. These study results represent a very important outcome in a study of a potential treatment of negative symptoms, one of the most important drivers of everyday disability and a critical unmet medical need for patients with schizophrenia. The consistency in treatment effects, in terms of overall negative symptoms and of the most important subtype, reduced emotional experience, between the previous Phase 2b study and the current one is encouraging. The increased placebo effect from the first to second study seems to be the only reason that the study did not meet its primary endpoint."

    "We are encouraged by the results obtained in this study which expand upon the outcome of the Phase 2b study that showed improvements in the primary endpoint and in multiple secondary endpoints," said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. "Even though this study didn't achieve its primary and key secondary endpoints, primarily due to a larger than expected placebo effect at Week 12, results obtained with the 64 mg dose including the early onset of effect and functional improvement as measured by PSP suggest roluperidone merits continued investigation for the treatment of primary negative symptoms. We intend to consult with the US FDA about the next steps in the development of roluperidone for this indication after we complete the analysis of the study data. I would like to express our sincere appreciation to all of the patients, caregivers, the investigators and their staff who participated in this trial."

    The company will hold a webcast event on Monday, June 1, 2020 at 8:30 a.m. to discuss additional data from this study and to provide further insight into the roluperidone Phase 3 trial.

    About Minerva Neurosciences

    Minerva's proprietary compounds include: roluperidone (MIN-101), in clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; 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 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 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 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 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, 2020, filed with the Securities and Exchange Commission on May 4, 2020. 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.

    Contact:
    William B. Boni
    VP, Investor Relations/
    Corp. Communications
    Minerva Neurosciences, Inc.
    (617) 600-7376 

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  2. WALTHAM, Mass., May 04, 2020 (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.

    "We are pleased to report that we are approaching the conclusion of the double-blind, 12-week phase of our pivotal Phase 3 trial with roluperidone and reiterate our previous guidance that we expect to report top line results in the second quarter," said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. "Progress in this trial has been unaffected to date by the coronavirus pandemic and we are continually…

    WALTHAM, Mass., May 04, 2020 (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.

    "We are pleased to report that we are approaching the conclusion of the double-blind, 12-week phase of our pivotal Phase 3 trial with roluperidone and reiterate our previous guidance that we expect to report top line results in the second quarter," said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. "Progress in this trial has been unaffected to date by the coronavirus pandemic and we are continually monitoring each trial site and our contract research organizations to ensure the safety of all patients and their access to study drug," said Dr. Luthringer.  "The last patient visit has taken place in the double-blind phase of the trial, in which a total of 515 patients were enrolled.  In total, 362 patients have completed the double-blind phase, 333 patients from the double-blind phase have elected to transition into the open-label extension period, and 92 patients have completed the extension phase as of April 30, 2020.

    "Finally, the prominent role of negative symptoms in schizophrenia has been increasingly highlighted by the key opinion leader (KOL) community since we initiated the Phase 3 trial," said Dr. Luthringer.  "Our recent KOL webcast, which included the participation of Dr. Stephen Marder, Dr. William Carpenter, Dr. Ofer Agid and Dr. John Kane, discussed how roluperidone may play an important role in treating the negative symptoms of schizophrenia, which persist and worsen over the lifetimes of the majority of patients, accounting for their functional disability and severely limiting their social and vocational reintegration over the long term." 

    Clinical Development Updates

    Roluperidone (MIN-101):

    Following the completion of enrollment in a pivotal Phase 3 trial with roluperidone (clinicaltrials.gov identifier: NCT033971340) to treat negative symptoms in schizophrenia in February 2020, top-line results from this trial are expected in the second quarter of 2020, consistent with previous guidance.  In parallel with completing this trial, the Company is advancing preparatory work for regulatory filing and commercialization, including clinical pharmacology studies, manufacturing of registration batches of the drug, medical affairs, commercialization strategy and product launch planning.

    Seltorexant (MIN-202)

    The Company and its co-development and co-commercialization partner, Janssen Pharmaceutica NV, met recently with the U.S. Food and Drug Administration (FDA) to discuss the Phase 3 program for seltorexant based on findings from trials with seltorexant completed in 2019.  The two companies are consulting with each other and with the FDA and the European Medicines Agency/ Committee for Medicinal Products for Human Use about a target indication of adjunctive Major Depressive Disorder (aMDD) in patients with insomnia symptoms and clinical trials to support that target indication.

    First Quarter 2020 Financial Results

    • Net Loss:  Net loss was $12.2 million for the first quarter of 2020, or a loss per share of $0.31 (basic and diluted), compared to a net loss of $15.8 million for the first quarter of 2019, or a loss per share of $0.41 (basic and diluted).
       
    • R&D Expenses: Research and development (R&D) expenses were $8.1 million in the first quarter of 2020, compared to $11.6 million in the first quarter of 2019.  The decrease in R&D expenses primarily reflects lower development expenses for the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117. R&D expenses are expected to decrease during 2020 with the completion of the Phase 2b trial of MIN-117 and the 12-week, double-blind portion of the Phase 3 clinical trial of roluperidone.
       
    • G&A Expenses: General and administrative (G&A) expenses were $4.2 million in the first quarter of 2020, compared to $4.7 million in the first quarter of 2019. This decrease in G&A expenses was primarily due to a decrease in non-cash stock-based compensation expenses and a decrease in professional fees.
       
    • Cash Position: Cash, cash equivalents, restricted cash and marketable securities as of March 31, 2020 were approximately $37.6 million. 

    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 3969525.

    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 proprietary compounds include: roluperidone (MIN-101), in clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; 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 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 statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone (MIN-101) and seltorexant (MIN-202); the clinical and therapeutic potential of these compounds; 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; management's ability to successfully achieve its goals; and the impact of the coronavirus (COVID-19) pandemic.  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, seltorexant and MIN-301 will advance further in the clinical trials process and whether and when, if at all, they 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 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, 2020, filed with the Securities and Exchange Commission on May 4, 2020.  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,
        2020     2019  
      (in thousands)
    ASSETS
    Current Assets:    
    Cash and cash equivalents $ 30,036   $ 21,413  
    Marketable securities   7,478     24,442  
    Restricted cash   100     100  
    Prepaid expenses and other current assets   852     1,182  
    Total current assets   38,466     47,137  
    Equipment, net   12     16  
    Other noncurrent assets   15     15  
    Operating lease right-of-use assets   224     262  
    In-process research and development   15,200     15,200  
    Goodwill   14,869     14,869  
    Total Assets $ 68,786   $ 77,499  
         
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current Liabilities:    
    Accounts payable $ 3,003   $ 2,317  
    Accrued expenses and other current liabilities   3,936     4,139  
    Operating leases   179     173  
    Total current liabilities   7,118     6,629  
    Long-Term Liabilities:    
    Deferred taxes   1,803     1,803  
    Deferred revenue   41,176     41,176  
    Noncurrent operating leases   64     111  
    Total liabilities   50,161     49,719  
    Stockholders' Equity:    
    Common stock   4     4  
    Additional paid-in capital   317,508     314,512  
    Accumulated deficit   (298,887 )   (286,736 )
    Total stockholders' equity   18,625     27,780  
    Total Liabilities and Stockholders' Equity $ 68,786   $ 77,499  
         


    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)      
        Three Months Ended March 31,
        (in thousands, except per share amounts)
          2020     2019  
           
    Revenues   $ -   $ -  
    Operating expenses:      
    Research and development     8,083     11,606  
    General and administrative     4,189     4,706  
    Total operating expenses     12,272     16,312  
           
    Foreign exchange losses     (9 )   (6 )
    Investment income     130     491  
    Net (loss) income   $ (12,151 ) $ (15,827 )
    Loss per share:      
    Basic and diluted   $ (0.31 ) $ (0.41 )
    Weighted average shares:      
    Basic and diluted     39,178     38,968  
           

    Contact:
    William B. Boni
    VP, Investor Relations/
    Corp. Communications
    Minerva Neurosciences, Inc.
    (617) 600-7376

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  3. WALTHAM, Mass., April 27, 2020 (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 announced that it will release financial results and business updates for the first quarter of 2020 on Monday, May 4, 2020.  The Company will host a webcast and conference call that day at 8:30 a.m. Eastern Time to discuss these results and updates. 

    The live call may be accessed by dialing (877) 312-5845 (domestic) or (765) 507-2618 (international) and referring to conference ID number 3969525.  A live webcast of the conference call will be available online in the Investors and Media section of the Company's website…

    WALTHAM, Mass., April 27, 2020 (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 announced that it will release financial results and business updates for the first quarter of 2020 on Monday, May 4, 2020.  The Company will host a webcast and conference call that day at 8:30 a.m. Eastern Time to discuss these results and updates. 

    The live call may be accessed by dialing (877) 312-5845 (domestic) or (765) 507-2618 (international) and referring to conference ID number 3969525.  A live webcast of the conference call will be available online in the Investors and Media section of the Company's website at ir.minervaneurosciences.com.  The archived webcast will be available on the Company's website beginning approximately two hours after the event for 30 days.

    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 proprietary compounds include: roluperidone (MIN-101), in clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and major depressive disorder (MDD); 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

    Contact:

    William B. Boni
    VP, Investor Relations/
    Corp. Communications
    Minerva Neurosciences, Inc.
    (617) 600-7376

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