Minerva Neurosciences Provides First Quarter 2026 Financial Results and Business Updates
Rhea-AI Summary
Minerva Neurosciences (Nasdaq: NERV) initiated a global confirmatory Phase 3 trial of roluperidone for negative symptoms of schizophrenia and screened the first patient in March 2026. The trial will enroll ~380 patients across ~40 sites with 12-week primary efficacy readout and topline data expected in 2H 2027.
Q1 2026 GAAP net loss was $125.4M ($2.86/sh), driven largely by a $109.4M non-cash warrant liability change; cash totaled $78.2M at March 31, 2026.
Positive
- Phase 3 initiated for roluperidone targeting negative symptoms (first patient screened March 2026)
- Trial scale: ~380 patients across ~40 global sites; topline data expected 2H 2027
- Safety signal in open-label coadministration with olanzapine: no clinically meaningful interactions reported
- Non-GAAP adjusted net loss of $7.3M indicates smaller operating cash impact after non-cash adjustments
Negative
- GAAP net loss widened to $125.4M in Q1 2026 from $3.8M prior-year, a material increase
- $109.4M non-cash expense from warrant liability change materially affected reported loss and liabilities
- Cash and equivalents of $78.2M may limit runway given upcoming Phase 3 operational costs
- G&A and stock-based compensation increased materially, including a one-time $6.6M option modification charge
News Market Reaction – NERV
In the May 5 session, NERV declined 1.26%, reflecting a mild negative market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 11 | Earnings & financing | Neutral | -8.1% | Q4/FY2025 results plus $80M placement and Phase 3 planning disclosure. |
| Nov 05 | Quarterly earnings | Neutral | +4.1% | Q3 2025 results and $80M financing to support confirmatory Phase 3 trial. |
| Aug 14 | Quarterly earnings | Neutral | +25.4% | Q2 2025 results and FDA requirement for a new 52-week confirmatory study. |
| May 13 | Quarterly earnings | Neutral | -0.1% | Q1 2025 results with lower R&D and ongoing FDA interactions on NDA. |
| Feb 25 | Annual earnings | Neutral | +0.0% | FY2024 results showing reduced expenses and modest full-year net income. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings and business update releases have produced varied one-day moves, from -8.06% to +25.35%, indicating historically volatile reactions around these catalysts.
Recent earnings and business updates for Minerva have centered on financing and enabling roluperidone’s confirmatory Phase 3 program. Prior releases highlighted private placements of up to $200M, evolving cash levels from $21.5M at year-end 2024 to $12.4M at Q3 2025, and shifting R&D spend as trial requirements were clarified. Today’s Q1 2026 update continues this pattern, combining detailed financial results with confirmation that the global Phase 3 C19 trial is underway.
Key Terms
phase 3 medical
open label medical
pharmacokinetic medical
pharmacodynamic medical
marder negative symptoms factor score (nsfs) medical
clinical global impression – severity (cgi-s) medical
clinical global impression – improvement (cgi-i) medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Confirmatory Phase 3 trial of roluperidone for negative symptoms of schizophrenia initiated and first patient screened
Previous open label trial data presented at SIRS 2026 showed no safety or drug–drug interaction concerns with roluperidone and olanzapine
Roluperidone remains the only late-stage drug candidate for this high-need population
BURLINGTON, Mass., May 05, 2026 (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 financial and business updates for the first quarter ended March 31, 2026.
Business Updates
Roluperidone - potentially the First Treatment for Negative Symptoms of Schizophrenia
- Minerva initiated its global confirmatory Phase 3 clinical trial of roluperidone for the treatment of negative symptoms of schizophrenia during the first quarter of 2026 with efficacy topline data expected 2H 2027.
- The Company screened the first patient in March 2026, marking an important operational milestone for the program.
- The Phase 3 trial will enroll approximately 380 patients across roughly 40 clinical sites worldwide, including the United States (US) and multiple European countries.
- This confirmatory Phase 3 trial 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).
- The trial will evaluate roluperidone 64 mg versus placebo to confirm the effect of roluperidone on primary negative symptoms at 12 weeks.
- The trial will also evaluate on an informational basis the longer-term relapse rate of positive symptoms for roluperidone as compared with several commonly prescribed antipsychotic medications for an additional 40 weeks.
- 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 presentations - further supporting the roluperidone program and reinforcing real world applicability
- In March 2026, Minerva presented data from its open-label safety trial evaluating roluperidone co-administered with olanzapine at the Schizophrenia International Research Society (SIRS) 2026 Annual Congress.
- The data demonstrated no clinically meaningful safety concerns, no significant pharmacokinetic interactions, and no pharmacodynamic effects when roluperidone was administered with olanzapine. This supports the continued development of roluperidone in patients receiving background antipsychotic therapy.
- The presentation is available on Minerva’s website under the presentation tab: https://ir.minervaneurosciences.com/static-files/49dcf8af-fa88-428d-89c7-c35491745374
- In February 2026, Minerva hosted a live key opinion leader (KOL) webcast, “Roluperidone: From Unmet Need to Reality,” featuring Greg Strauss, PhD, Franklin Professor of Psychology at the University of Georgia, and Brian Kirkpatrick, MD, MSPH, Peters Professor of Psychiatry at the University of Arkansas for Medical Sciences.
- The discussion addressed the burden and assessment of negative symptoms, limitations of existing treatment approaches, and the rationale and design of the ongoing confirmatory Phase 3 trial. The presentation is available at: https://bit.ly/48YzdNK and the replay is also available: https://lifescievents.com/event/pkv02859/
“The initiation of our confirmatory Phase 3 trial and the screening of the first patient represent meaningful milestones for Minerva that underscore the progress of our lead program,” said Dr. Remy Luthringer, Executive Chairman and CEO of Minerva Neurosciences. “With no approved treatments for negative symptoms of schizophrenia in the United States or Europe, roluperidone remains the only late-stage candidate specifically targeting this substantial unmet medical need. Patients often live with persistent negative symptoms such as avolition and anhedonia that remain even when positive symptoms of schizophrenia are controlled, driving long-term disability and functional impairment. Building directly on consistent late-stage clinical results, this confirmatory Phase 3 trial is designed to evaluate roluperidone’s potential to improve these core drivers of disability while laying the groundwork for a broader treatment strategy.”
Corporate Updates
- During the first quarter of 2026, Minerva announced a leadership transition with the appointment of Jim O’Connor as Chief Business Officer and General Counsel, effective April 21, 2026, as Geoff Race, the Company’s President, elected to leave the company. Mr. Race will continue to be involved with Minerva as a consultant.
- During the quarter, one investor from the October private placement elected to exercise a portion of their warrants to purchase Series A preferred stock, resulting in additional proceeds to Minerva of
$1.2 million .
First Quarter Financial Results
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Change in Fair Value of Warrant Liability: For the three months ended March 31, 2026, the Company recorded a non‑cash expense of
Total Liabilities: Under U.S. Generally Accepted Accounting Principles (“GAAP”), for the periods ended March 31, 2026 and December 31, 2025, total liabilities were
Net loss: Under GAAP, Net loss for the three months ended March 31, 2026 was
Cash Position: As of March 31, 2026, Minerva had approximately
* 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.”
About the Phase 3 MIN-101C19 Trial
The global Phase 3 MIN-101C19 trial will enroll approximately 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 trial 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 and to evaluate longer-term relapse of positive symptoms compared with commonly prescribed antipsychotic medications for an additional 40 weeks.
The trial is designed to minimize variability and maximize sensitivity to treatment effect, including standardized assessments, and comprehensive caregiver engagement. Topline data from the 12-week Phase A portion (i.e., primary efficacy endpoint) of the trial are expected in the second half of 2027. 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 a12-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.
Phase B extends the trial for 40 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 rigorous, multi-component definition incorporating psychometric endpoints based on PANSS score worsening, and clinically meaningful events such as hospitalization or dangerous behavior.
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva is initiating 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 loss is defined as GAAP net loss, adjusted to exclude non-cash items related to: (i) stock-based compensation expense and (ii) changes in fair value of the warrant liability.
Non-GAAP adjusted net loss per share, basic and diluted, is defined as GAAP net loss per share, basic and diluted, 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 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 therapeutic and regulatory potential of roluperidone in the United States and Europe; 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 March 31, 2026, filed with the SEC on May 5, 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) | ||||||
| March 31, 2026 | December 31, 2025 | |||||
| (in thousands) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 32,660 | $ | 82,302 | ||
| Marketable securities | 45,405 | - | ||||
| Restricted cash | 100 | 100 | ||||
| Prepaid expenses and other current assets | 942 | 698 | ||||
| Total current assets | 79,107 | 83,100 | ||||
| Goodwill | 14,869 | 14,869 | ||||
| Deferred offering costs | 51 | - | ||||
| Total assets | $ | 94,027 | $ | 97,969 | ||
| LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 2,118 | $ | 639 | ||
| Accrued expenses and other current liabilities | 2,364 | 1,651 | ||||
| Total current liabilities | 4,482 | 2,290 | ||||
| Long-term liabilities: | ||||||
| Warrant liability | 278,597 | 171,465 | ||||
| Liability related to the sale of future royalties | 60,000 | 60,000 | ||||
| Total liabilities | 343,079 | 233,755 | ||||
| Redeemable preferred stock: | ||||||
| Series A convertible preferred stock | 4,962 | 4,962 | ||||
| Stockholders' deficit: | ||||||
| Common stock | 4 | 4 | ||||
| Additional paid-in capital | 560,186 | 548,047 | ||||
| Accumulated deficit | (814,204 | ) | (688,799 | ) | ||
| Total stockholders' deficit | (254,014 | ) | (140,748 | ) | ||
| Total liabilities, redeemable preferred stock and stockholders' deficit | $ | 94,027 | $ | 97,969 | ||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
| (Unaudited) | |||||||
| Three Months Ended March 31, (in thousands, except per share amounts) | |||||||
| 2026 | 2025 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 5,255 | $ | 1,362 | |||
| General and administrative | 11,417 | 2,541 | |||||
| Total operating expenses | 16,672 | 3,903 | |||||
| Loss from operations | (16,672 | ) | (3,903 | ) | |||
| Foreign exchange losses | (2 | ) | (8 | ) | |||
| Investment income | 630 | 158 | |||||
| Changes in fair value of the warrant liability | (109,360 | ) | - | ||||
| Net loss | $ | (125,404 | ) | $ | (3,753 | ) | |
| Net loss per share, basic and diluted | $ | (2.86 | ) | $ | (0.50 | ) | |
| Weighted average shares outstanding, basic and diluted | 43,900 | 7,569 | |||||
| Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures RECONCILIATION OF TOTAL LIABILITIES - NON-GAAP | ||||||
| (Unaudited) | ||||||
| March 31, 2026 | December 31, 2025 | |||||
| (in thousands) | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 2,118 | $ | 639 | ||
| Accrued expenses and other current liabilities | 2,364 | 1,651 | ||||
| Total current liabilities | 4,482 | 2,290 | ||||
| Long-term liabilities: | ||||||
| Warrant liability | 278,597 | 171,465 | ||||
| Liability related to the sale of future royalties | 60,000 | 60,000 | ||||
| Total liabilities - GAAP | 343,079 | 233,755 | ||||
| Reconciling items: | ||||||
| Warrant liability | (278,597 | ) | (171,465 | ) | ||
| Liability related to the sale of future royalties | (60,000 | ) | (60,000 | ) | ||
| Total liabilities - non-GAAP | $ | 4,482 | $ | 2,290 | ||
| RECONCILIATION OF ADJUSTED NET LOSS - NON-GAAP | |||||||
| (Unaudited) | |||||||
| Three Months Ended March 31, (in thousands, except per share amounts) | |||||||
| 2026 | 2025 | ||||||
| Net loss – GAAP | $ | (125,404 | ) | $ | (3,753 | ) | |
| Reconciling items: | |||||||
| Stock-based compensation expense | 8,710 | 297 | |||||
| Changes in fair value of the warrant liability | 109,360 | - | |||||
| Adjusted net loss – non-GAAP | $ | (7,334 | ) | $ | (3,456 | ) | |
| Net loss per share, basic and diluted – GAAP | $ | (2.86 | ) | $ | (0.50 | ) | |
| Weighted average shares outstanding, basic and diluted | 43,900 | 7,569 | |||||
| Reconciling items: | |||||||
| Stock-based compensation expense | 0.20 | 0.04 | |||||
| Changes in fair value of the warrant liability | 2.49 | - | |||||
| Net loss per share, basic and diluted – non-GAAP | $ | (0.17 | ) | $ | (0.46 | ) | |
| Weighted average shares outstanding, basic and diluted | 43,900 | 7,569 | |||||
