Minerva Neurosciences Provides Third Quarter 2026 Financial Results and Business Updates
A non-cash warrant valuation gain drove quarterly profit, while adjusted losses and research spending increased year over year.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Minerva Neurosciences (Nasdaq: NERV) reported third-quarter 2026 net income of $100.7 million while continuing its confirmatory Phase 3 roluperidone trial. A $109.6 million non-cash warrant valuation gain drove the profit, versus a $2.7 million loss a year earlier. Basic earnings per share were $1.94; diluted loss per share was $0.19. Adjusted net loss widened to $5.6 million from $2.5 million.
The C19 trial targets 380 patients with negative symptoms of schizophrenia. Minerva expects Phase A efficacy data in 2H 2027 and Phase B relapse data in 2H 2028. Phase A compares 64 mg roluperidone with placebo over 12 weeks; Phase B compares it with commonly prescribed antipsychotics for another 52 weeks. Cash, cash equivalents, marketable securities and restricted cash totaled approximately $77.0 million at September 30, versus $82.4 million at December 31, 2025.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointGAAP total liabilities declined to $184.1 million at September 30, 2026, from $233.8 million at December 31, 2025.
- Minor pointQ3 GAAP net income of $100.7 million reversed a $2.7 million year-earlier loss, driven by warrant revaluation.
- Minor pointNine-month GAAP net loss narrowed to $7.2 million from $9.8 million a year earlier.
- Minor point. Forward-looking: it has not happened yet and may not happen.C19 Phase A is ongoing; Minerva expects 12-week roluperidone efficacy data in 2H 2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.C19 Phase B evaluates relapse over an additional 52 weeks; Minerva expects data in 2H 2028.
- Minor pointInvestment income increased to $0.6 million in Q3 and $1.8 million over nine months, from $0.1 million and $0.4 million.
Negative
- Moderate pointNine-month adjusted net loss widened to $20.8 million from $8.9 million a year earlier.
- Moderate pointNine-month R&D expense rose to $17.6 million from $3.6 million a year earlier.
- Moderate pointNine-month G&A expense rose to $19.1 million from $6.5 million, including a $6.6 million non-cash option-modification charge. 6% of market cap
- Minor pointQ3 adjusted net loss widened to $5.6 million from $2.5 million a year earlier.
- Minor pointQ3 R&D expense rose to $5.2 million from $0.9 million a year earlier.
4 minor points
- Minor pointQ3 G&A expense rose to $4.3 million from $1.9 million a year earlier.
- Minor pointCash, equivalents, marketable securities and restricted cash fell to approximately $77.0 million from $82.4 million at December 31, 2025.
- Minor pointQ3 diluted loss per share was $0.19, versus $0.36 a year earlier, despite basic earnings of $1.94.
- Minor pointNine-month basic/diluted losses per share were $0.15/$0.45, versus $1.29/$1.29 a year earlier.
Key Figures
- Q3 R&D expense
- $5.2 million vs. $0.9 million
- Three months ended September 30, 2026 vs. 2025
- Q3 G&A expense
- $4.3 million vs. $1.9 million
- Three months ended September 30, 2026 vs. 2025
- GAAP net income
- $100.7 million
- Q3 2026; driven by a $109.6 million non-cash warrant-liability gain
- Adjusted net loss
- $5.6 million vs. $2.5 million
- Q3 2026 vs. Q3 2025
- Cash, equivalents, marketable securities and restricted cash
- $77.0 million vs. $82.4 million
- September 30, 2026 vs. December 31, 2025
- Planned C19 Study enrollment
- 380 patients
- Global Phase 3 trial
- Phase A topline data
- 2H 2027
- C19 Study efficacy data
- Phase B topline data
- 2H 2028
- C19 Study longer-term relapse data
Previous Earnings Reports
-
Q2 reported the same C19 trial design and timetable, with R&D expense of $7.2 million.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
phase 3 medical
placebo medical
double-blind medical
panss medical
bayesian analysis technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Confirmatory Phase 3 trial of roluperidone (MIN-101C19) ongoing with topline efficacy data expected 2H 2027
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 10:00 AM ET
BURLINGTON, Mass., Nov. 06, 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 σ-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
General and administrative (G&A) expense: For the three months ended September 30, 2026 and 2025, G&A expense was
Other income and expense: For the three months ended September 30, 2026 and 2025, investment income was
Changes in Fair Value of the Warrant Liability1: For the three months ended September 30, 2026, the Company recorded a non-cash gain of
Total Liabilities: Under U.S. Generally Accepted Accounting Principles (“GAAP”), for the periods ended September 30, 2026 and December 31, 2025, total liabilities were
Net Income (Loss): For the three months ended September 30, 2026, Minerva recorded GAAP net income of
For the nine months ended September 30, 2026, Minerva recorded a GAAP net loss of
Cash Position: Cash, cash equivalents, marketable securities and restricted cash at September 30, 2026 was approximately
About the Phase 3 MIN-101C19 Trial
Minerva’s Phase 3 MIN-101C19 trial (the C19 Study) is designed to enroll 380 adults aged 18–55 with moderate to severe negative symptoms of schizophrenia, confirmed by a Positive and Negative Syndrome Scale (PANSS) negative subscale score greater than 20 and stable positive symptoms for at least six months. The C19 Study utilizes a two-part design. The overall objective of the study is to confirm the effect of roluperidone on primary negative symptoms at 12 weeks compared to placebo (Phase A) and to evaluate longer-term relapse of positive symptoms compared with commonly prescribed antipsychotic medications for an additional 52 weeks (Phase B).
The trial is designed to minimize variability and maximize sensitivity to treatment effect, including standardized assessments, and comprehensive caregiver engagement. The trial’s operational model includes intensive rater training, real-time monitoring of scoring data, and structured caregiver outreach to support safety tracking, functional assessments, and adherence.
Phase A is a 12-week, randomized, double-blind, placebo-controlled phase during which patients will receive 64 mg of roluperidone or placebo to evaluate the primary endpoint: change from baseline in the Marder Negative Symptoms Factor Score (NSFS), which is a factor-analytic composite created from selected PANSS items. The sole key secondary endpoint is the change from baseline in the Personal and Social Performance (PSP) total score. Other secondary endpoints include a broad set of additional clinical measures, including PANSS subscales, Clinical Global Impression – Severity (CGI-S), Clinical Global Impression – Improvement (CGI-I), the Calgary Depression Scale, avolition-specific analyses, and patient and caregiver treatment-satisfaction ratings. Topline data from Phase A of the trial is expected in the second half of 2027.
Phase B extends the trial for an additional 52 weeks using a double-dummy, active-controlled, randomized design comparing continued roluperidone with three commonly prescribed antipsychotic medications (risperidone, aripiprazole, or olanzapine). This phase is designed to compare relapse rates between treatment groups. Relapses of positive symptoms will be evaluated using a multi-component definition incorporating psychometric endpoints based on PANSS score worsening, and clinically meaningful events such as hospitalization or dangerous behavior. Topline data from Phase B of the trial is expected in the second half of 2028.
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva is conducting a confirmatory Phase 3 trial with roluperidone for negative symptoms of schizophrenia. For more information, please visit the Company’s website.
Non-GAAP Financial Measures
In addition to the financial information presented in this release in accordance with accounting principles generally accepted in the United States of America (GAAP), Minerva also presents adjusted non-GAAP financial measures.
Non-GAAP financial measures are included with the intent of providing investors with an understanding of Minerva’s historical financial results and trends and to facilitate comparisons between periods. In addition, these non-GAAP financial measures are among the indicators that Minerva’s management uses for planning and forecasting purposes and measuring Minerva’s performance. Minerva believes that these non-GAAP financial measures, when considered together with U.S. GAAP measures, can enhance the understanding of its financial and operating performance. Non-GAAP financial measures have no standardized meaning and investors are cautioned that, unlike financial measures prepared in accordance with U.S. GAAP, non-GAAP measures may not be comparable with the calculation of similar measures for other companies. The limitations of using non-GAAP financial measures as performance measures are that they provide a view of Minerva’s results of operations without including all events during a period and may not provide a comparable view of Minerva’s performance to other companies in the biopharmaceutical industry. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, and not to rely on any single financial measure to evaluate the business.
Non-GAAP total liabilities is defined as GAAP total liabilities, excluding warrant liability and liability related to the sale of future royalties.
Non-GAAP adjusted net income (loss) is defined as GAAP net income (loss), adjusted to exclude non-cash items related to: (i) stock-based compensation expense and (ii) changes in fair value of the warrant liability.
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 implied or express statements regarding the expected timeline, design, enrollment and conduct of Minerva’s confirmatory Phase 3 trial of roluperidone for the treatment of negative symptoms of schizophrenia, including the timing of its results; the regulatory and therapeutic potential of roluperidone; clinical adoption of treatments focused on negative symptoms of schizophrenia; market opportunities; and Minerva’s plans and objectives with respect to the roluperidone program. 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, the inability to predict with certainty the level of expenditures and resources required for the confirmatory Phase 3 trial for roluperidone and other operational matters following Minerva’s plans to refocus efforts on the successful execution of the Phase 3 trial; Minerva’s future financial performance and position may not improve, resulting in difficulties in implementing Minerva’s business strategy, and plans and objectives for future operations; the expected sufficiency of Minerva’s existing cash resources and runway may not be accurate resulting in the need for additional financing sooner than anticipated or unexpected liquidity constraints; the internal and external costs required for Minerva’s ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected, which may cause Minerva to use cash more quickly than expected or to change or curtail some of Minerva’s plans or both; trials and studies may be delayed and may not have satisfactory outcomes, and earlier trials and studies may not be predictive of later trials and studies; the design and rate of enrollment for clinical trials, including the current design of the Phase 3 confirmatory trial evaluating roluperidone may not enable successful completion of the trial(s); the commercial opportunity for roluperidone in negative symptoms of Schizophrenia may be smaller than anticipated; Minerva may be unable to obtain and maintain regulatory approvals, including uncertainties associated with the development and timing of Minerva’s interactions with the FDA; Minerva may experience uncertainties inherent in the initiation and completion of clinical trials and clinical development; the need to align with collaborators or partners may hamper or delay development and regulatory efforts or increase costs; uncertainties of patent protection and litigation; general economic conditions; and other factors that are described under the caption “Risk Factors” in Minerva’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (the “SEC”) on March 11, 2026, as supplemented by Minerva’s Form 10-Q for the quarter ended September 30, 2026, filed with the SEC on November 6, 2026. Copies of reports filed with the SEC are posted on Minerva’s website at http://ir.minervaneurosciences.com/. The forward-looking statements in this press release are based on information available to Minerva as of the date hereof, and Minerva disclaims any obligation to update any forward-looking statements, except as required by law.
Contacts:
Frederick Ahlholm
Chief Financial Officer
Minerva Neurosciences, Inc.
fahlholm@minervaneurosciences.com
Corey Davis, Ph.D.
LifeSci Advisors, LLC
212-915-2577
cdavis@lifesciadvisors.com
| CONDENSED CONSOLIDATED BALANCE SHEET DATA | ||||||
| (Unaudited) | ||||||
| September 30, 2026 | December 31, 2025 | |||||
| (in thousands) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 20,216 | $ | 82,302 | ||
| Marketable securities | 56,729 | - | ||||
| Restricted cash | 100 | 100 | ||||
| Prepaid expenses and other current assets | 6,364 | 698 | ||||
| Total current assets | 83,409 | 83,100 | ||||
| Goodwill | 14,869 | 14,869 | ||||
| Total assets | $ | 98,278 | $ | 97,969 | ||
| LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 653 | $ | 639 | ||
| Accrued expenses and other current liabilities | 1,873 | 1,651 | ||||
| Total current liabilities | 2,526 | 2,290 | ||||
| Long-term liabilities: | ||||||
| Warrant liability | 121,535 | 171,465 | ||||
| Liability related to the sale of future royalties | 60,000 | 60,000 | ||||
| Total liabilities | 184,061 | 233,755 | ||||
| Redeemable preferred stock: | ||||||
| Series A convertible preferred stock | 11,741 | 4,962 | ||||
| Stockholders' deficit: | ||||||
| Common stock | 5 | 4 | ||||
| Additional paid-in capital | 598,462 | 548,047 | ||||
| Accumulated deficit | (695,991 | ) | (688,799 | ) | ||
| Total stockholders' deficit | (97,524 | ) | (140,748 | ) | ||
| Total liabilities, redeemable preferred stock and stockholders' deficit | $ | 98,278 | $ | 97,969 | ||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
| (Unaudited) | ||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 5,156 | $ | 925 | $ | 17,598 | $ | 3,586 | ||||
| General and administrative | 4,278 | 1,919 | 19,149 | 6,535 | ||||||||
| Total operating expenses | 9,434 | 2,844 | 36,747 | 10,121 | ||||||||
| Loss from operations | (9,434 | ) | (2,844 | ) | (36,747 | ) | (10,121 | ) | ||||
| Foreign exchange losses | (8 | ) | (6 | ) | (25 | ) | (36 | ) | ||||
| Investment income | 587 | 106 | 1,786 | 401 | ||||||||
| Changes in fair value of the warrant liability | 109,602 | - | 27,794 | - | ||||||||
| Net income (loss) | $ | 100,747 | $ | (2,744 | ) | $ | (7,192 | ) | $ | (9,756 | ) | |
| Undistributed earnings attributable to participating preferred stock | (5,085 | ) | - | - | - | |||||||
| Net income (loss) attributable to common stockholders | $ | 95,662 | $ | (2,744 | ) | $ | (7,192 | ) | $ | (9,756 | ) | |
| Net income (loss) per share, basic | $ | 1.94 | $ | (0.36 | ) | $ | (0.15 | ) | $ | (1.29 | ) | |
| Weighted average shares outstanding, basic | 49,293 | 7,569 | 46,617 | 7,569 | ||||||||
| Net income (loss) per share, diluted | $ | (0.19 | ) | $ | (0.36 | ) | $ | (0.45 | ) | $ | (1.29 | ) |
| Weighted average shares outstanding, diluted | 75,251 | 7,569 | 78,223 | 7,569 | ||||||||
| RECONCILIATION OF TOTAL LIABILITIES - NON-GAAP | ||||||
| (Unaudited) | ||||||
| September 30, 2026 | December 31, 2025 | |||||
| Current liabilities: | ||||||
| Accounts payable | $ | 653 | $ | 639 | ||
| Accrued expenses and other current liabilities | 1,873 | 1,651 | ||||
| Total current liabilities | 2,526 | 2,290 | ||||
| Long-term liabilities: | ||||||
| Warrant liability | 121,535 | 171,465 | ||||
| Liability related to the sale of future royalties | 60,000 | 60,000 | ||||
| Total liabilities - GAAP | 184,061 | 233,755 | ||||
| Reconciling items: | ||||||
| Warrant liability | (121,535 | ) | (171,465 | ) | ||
| Liability related to the sale of future royalties | (60,000 | ) | (60,000 | ) | ||
| Total liabilities - non-GAAP | $ | 2,526 | $ | 2,290 | ||
| RECONCILIATION OF ADJUSTED NET (LOSS) INCOME - NON-GAAP | ||||||||||||
| (Unaudited) | ||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||
| Net income (loss) - GAAP | $ | 100,747 | $ | (2,744 | ) | $ | (7,192 | ) | $ | (9,756 | ) | |
| Reconciling items: | ||||||||||||
| Stock-based compensation expense | 3,209 | 273 | 14,192 | 868 | ||||||||
| Changes in fair value of the warrant liability | (109,602 | ) | - | (27,794 | ) | - | ||||||
| Adjusted net income (loss) - non-GAAP | $ | (5,646 | ) | $ | (2,471 | ) | $ | (20,794 | ) | $ | (8,888 | ) |
1 The warrant liability is a non-cash, mark-to-market obligation revalued each period based on Minerva's stock price and other inputs; its fluctuation does not reflect the Company's operating performance or cash position.
2 Definitions of the non-GAAP measures used by Minerva and a reconciliation of such measures to the related GAAP financial measure can be found under the sections below titled “Non-GAAP Financial Measures” and “Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures.”
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What drove Minerva Neurosciences' Q3 2026 profit?
A $109.6 million non-cash gain from changes in the fair value of its warrant liability drove quarterly GAAP net income of $100.7 million. The warrants were issued with the October 2025 private placement. Excluding that gain and stock-based compensation, adjusted net loss was $5.6 million.
When does Minerva Neurosciences expect results from the roluperidone C19 trial?
Minerva expects Phase A topline data in 2H 2027 and Phase B topline data in 2H 2028. Phase A evaluates negative symptoms after 12 weeks against placebo. Phase B evaluates relapse of positive symptoms over an additional 52 weeks against commonly prescribed antipsychotic medications.
What is the primary endpoint in Minerva Neurosciences' C19 roluperidone trial?
Phase A's primary endpoint is the change from baseline in the Marder Negative Symptoms Factor Score, a composite drawn from selected Positive and Negative Syndrome Scale items. The sole key secondary endpoint measures change in personal and social functioning using the Personal and Social Performance total score.
Who is eligible for Minerva Neurosciences' C19 roluperidone trial?
C19 is designed to enroll 380 adults aged 18–55 with moderate to severe negative symptoms of schizophrenia. Eligibility includes a Positive and Negative Syndrome Scale negative subscale score greater than 20 and stable positive symptoms for at least six months. The study plans approximately 40 sites worldwide.