SEC 8-K filings with transcript text
Nov 6, 2026
2 d192598dex991.htm
Exhibit 99.1
Minerva Neurosciences Provides Third Quarter 2026 Financial Results
and Business Updates
Confirmatory Phase 3 trial of roluperidone (MIN-101C19) ongoing with topline efficacy data expected
Recent Schizophrenia Research article describes need to expand basic science beyond dopaminergic mechanisms and to improve clinical trial methodology for negative symptoms
Roluperidone remains the only late-stage drug candidate for this high-need
population
Company to host in-person and virtual KOL event on November 12, 2026 at
BURLINGTON, Mass., November 6, 2026 (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 financial and business updates for the third quarter ended September 30, 2026.
“The recent publication in Schizophrenia Research lays out the approach we are taking at Minerva: developing treatments for negative symptoms beyond dopaminergic mechanisms and testing them in trials designed to separate signal from noise,” said Remy Luthringer, Ph.D., Chief Executive Officer of Minerva Neurosciences. “The psychiatry field has increasingly recognized the importance of finding non-dopaminergic mechanisms in the treatment of schizophrenia, particularly for negative symptoms. Roluperidone is the only late-stage candidate targeting negative symptoms directly. The C19 study, our ongoing Phase 3 trial, is designed to confirm the effect we saw in our prior trials. We remain focused on execution and on track for topline efficacy data in the second half of 2027.”
In-Person and Virtual KOL Event
The Company will host a KOL event in New York on Thursday, November 12, 2026, at 10:00 AM ET featuring several key opinion leaders and company management focused on the opportunity for roluperidone in treating the negative symptoms of schizophrenia.
For more details and to register for the event, click here.
Corporate Updates
Roluperidone - potentially the first treatment for negative symptoms of schizophrenia
•
Minerva’s ongoing global Phase 3 clinical trial of roluperidone for the treatment of negative symptoms of schizophrenia (the C19 Study) is designed to enroll 380 patients across approximately 40 clinical sites worldwide, including the United States (US) and multiple European countries.
•
The C19 Study follows discussions with the FDA on the overall design and efficacy assessments and builds directly on Minerva’s prior Phase 2b and Phase 3 trials (C03 and C07).
•
Phase A of the C19 Study is evaluating roluperidone 64 mg versus placebo to confirm the effect of roluperidone on primary negative symptoms at 12 weeks. The topline data from Phase A is expected in 2H 2027.
•
Phase B of the C19 Study is evaluating longer-term relapse of positive symptoms for roluperidone versus commonly prescribed antipsychotic medications for an additional 52-week period. The topline data from Phase B is expected in 2H 2028.
•
See “About the Phase 3 MIN-101C19 Trial” below for more information.
•
Roluperidone remains the only late-stage drug candidate for this high-need population.
Scientific Publication – development of non-dopamine active drugs for negative symptoms
•
Remy Luthringer, Ph.D. (Chief Executive Officer) and Michael Davidson, MD (Chief Medical Officer) published “Development of non-dopamine active drugs for negative symptoms” in Schizophrenia Research.
•
The article describes the need for basic science to expand beyond attempts to interfere with brain dopaminergic activity and for clinical science to improve trial methodology in negative symptoms of schizophrenia.
•
The article describes roluperidone as an antagonist with high affinity for s-2, 5-HT2A and α1A receptors and very weak affinity for dopamine receptors.
•
The article also discusses trial design considerations for negative symptoms, including the distinction between primary and secondary negative symptoms, patient selection, placebo response, add-on and targeted treatment designs, assessment instruments, and Bayesian analysis.
Third Quarter and Nine Months 2026 Financial Results
Research and development (R&D) expense: For the three months ended September 30, 2026 and 2025, R&D expense was $5.2 million and $0.9 million, respectively. For the nine months ended September 30, 2026 and 2025, R&D expense was $17.6 million and $3.6 million, respectively. R&D expense was higher versus the prior year period in both the three and nine months ended September 30 primarily due to expenses related to the C19 trial as well as higher compensation costs.
General and administrative (G&A) expense: For the three months ended September 30, 2026 and 2025, G&A expense was $4.3 million and $1.9 million, respectively. G&A expense was higher versus the prior year period primarily due to higher professional service fees and compensation
Aug 7, 2026
2 d22348dex991.htm
Exhibit 99.1
Minerva Neurosciences Provides Second Quarter 2026 Financial Results and Business Updates
Confirmatory Phase 3 trial of roluperidone (MIN-101C19) ongoing with topline efficacy data expected
Scientific Advisory Board of leading experts in psychiatry and neuroscience established to guide the confirmatory Phase 3 trial of roluperidone
Roluperidone remains the only late-stage drug candidate for this high-need population
BURLINGTON, Mass.– August 7, 2026 (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 financial and business updates for the second quarter ended June 30, 2026.
“The psychiatry field has increasingly recognized negative symptoms as a distinct, undertreated driver of disability in schizophrenia, separate from the positive symptoms that current antipsychotics are designed to address,” said Remy Luthringer, Ph.D., Chief Executive Officer of Minerva Neurosciences. “Roluperidone is the only late-stage candidate targeting negative symptoms directly. The C19 study, our ongoing confirmatory Phase 3 trial, is designed to confirm the effect we saw in our prior studies. We remain focused on execution and on track for topline efficacy data in the second half of 2027.”
Corporate Updates
Roluperidone - potentially the First Treatment for Negative Symptoms of Schizophrenia
•
Minerva’s global confirmatory Phase 3 clinical trial of roluperidone for the treatment of negative symptoms of schizophrenia (the C19 Study) is designed to enroll 380 patients across approximately 40 clinical sites worldwide, including the United States (US) and multiple European countries.
•
The C19 Study follows productive discussions with the FDA on the overall design and efficacy assessments and builds directly on Minerva’s clinical success in the prior pivotal Phase 2b and Phase 3 trials (C03 and C07).
•
Phase A of the C19 Study will evaluate roluperidone 64 mg versus placebo to confirm the effect of roluperidone on primary negative symptoms at 12 weeks.
•
Phase B of the C19 Study will evaluate longer-term relapse of positive symptoms for roluperidone versus commonly prescribed antipsychotic medications for an additional 52-week period. The topline data from Phase B is expected in 2H 2028.
•
See “About the Phase 3 MIN-101C19 Trial” below for more information.
•
Roluperidone remains the only late-stage drug candidate for this high-need population.
Scientific Advisory Board
•
Minerva previously announced the formation of its Scientific Advisory Board (SAB) on June 1, 2026, comprising eight members with significant experience in psychiatry and neuroscience research, who will advise on the ongoing Phase 3 confirmatory trial of roluperidone as well as potential future pipeline programs.
•
Minerva recently added three additional members to its SAB, bringing the total to eleven members:
Christoph Correll, MD – Clinical Professor of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra University;
Stefan Leucht, MD – Head of the Section for Evidence-Based Medicine in Psychiatry and Psychotherapy at the Department of Psychiatry and Psychotherapy, Technical University of Munich; and
Michael Sand, PhD, MPH – S2 Consulting LLC; formerly a board observer on the Minerva board of directors representing Boehringer Ingelheim.
Scientific Publication – Minerva team advancing thought leadership in schizophrenia research
•
Remy Luthringer, Ph.D. (Chief Executive Officer), Michael Davidson, MD (Chief Medical Officer) and Jonathan Rabinowitz, PhD (biostatistical consultant) continue to advance thought leadership in schizophrenia research through coauthoring findings from a longitudinal analysis of 1,139 patients enrolled in the CATIE trial, one of the largest and most influential studies conducted in schizophrenia (Speyer et al., 2026). The analysis found that patients with greater negative symptom severity experienced a lower likelihood of short-term worsening of positive symptoms.
•
The findings suggest a relatively stable illness course among individuals with more severe negative symptoms. These results have implications for prognosis and treatment planning, while underscoring the persistent functional burden imposed by negative symptoms despite lower exacerbation risk.
Second Quarter and Six Months 2026 Financial Results
Research and development (R&D) expense: For the three months ended June 30, 2026 and 2025, R&D expense was $7.2 million and $1.3 million, respectively. For the six months ended June 30, 2026 and 2025, R&D expense was $12.4 million and $2.7 million, respectively. R&D expense was higher versus the prior year period in both the three and six months ended June 30 primarily due to expenses related to the C19 trial as well as higher compensation co
May 5, 2026
SEC.gov | Request Rate Threshold Exceeded
U.S. Securities and Exchange Commission
You’ve Exceeded the SEC’s Traffic Limit
Your request rate has exceeded the SEC’s maximum allowable requests per second. Your access to SEC.gov will be limited for 10 minutes.
Current guidelines limit each user to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests. To ensure that SEC.gov remains available to all users, we reserve the right to block IP addresses that submit excessive requests.
The block will be lifted automatically by waiting 10 minutes. Continuing to exceed the SEC’s maximum allowable request rate during the time-out period will extend the duration of the time-out period. To ensure fair access for all users, please reduce the rate of your requests and visit SEC.gov again after the 10 minute time-out period has passed.
For best practices on efficiently downloading information from SEC.gov, including the latest EDGAR filings, visit sec.gov/developer. You can also sign up for email updates on the SEC open data program, including best practices that make it more efficient to download data, and SEC.gov enhancements that may impact scripted downloading processes. For more information, contact opendata@sec.gov.
For more information, please see the SEC’s Web Site Privacy and Security Policy. Thank you for your interest in the U.S. Securities and Exchange Commission.
Reference ID: 0.ce06d217.1784556285.c0702563
More Information
Internet Security Policy
By using this site, you are agreeing to security monitoring and auditing. For security purposes, and to ensure that the public service remains available to users, this government computer system employs programs to monitor network traffic to identify unauthorized attempts to upload or change information or to otherwise cause damage, including attempts to deny service to users.
Unauthorized attempts to upload information and/or change information on any portion of this site are strictly prohibited and are subject to prosecution under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act of 1996 (see Title 18 U.S.C. §§ 1001 and 1030).
To ensure our website performs well for all users, the SEC monitors the frequency of requests for SEC.gov content to ensure automated searches do not impact the ability of others to access SEC.gov content. We reserve the right to block IP addresses that submit excessive requests. Current guidelines limit users to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests.
If a user or application submits more than 10 requests per second, further requests from the IP address(es) may be limited for a brief period. Once the rate of requests has dropped below the threshold for 10 minutes, the user may resume accessing content on SEC.gov. This SEC practice is designed to limit excessive automated searches on SEC.gov and is not intended or expected to impact individuals browsing the SEC.gov website.
Note that this policy may change as the SEC manages SEC.gov to ensure that the website performs efficiently and remains available to all users.
Note: We do not offer technical support for developing or debugging scripted downloading processes.
This page provides Minerva Neurosciences Inc (NERV) earnings call transcripts from SEC 8-K filings along with AI-powered predictions for post-earnings price movements. Our machine learning models analyze historical earnings data, pre-earnings price patterns, volume changes, and volatility to predict 1-day, 5-day, and 20-day returns after each earnings release.
Earnings transcripts are sourced directly from SEC EDGAR filings. Predictions are generated using gradient boosting models trained on NERV's historical earnings reactions. All predicted returns are shown as percentages, and predicted prices are calculated from the closing price at the time of prediction. Past performance does not guarantee future results.