Confirmatory Phase 3 trial of roluperidone (MIN-101C19) ongoing with topline efficacy data expected 2H 2027
Roluperidone remains the only late-stage drug candidate for this high-need population
“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
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.
- Minerva previously announced the formation of its
Scientific Advisory Board (SAB) onJune 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:
Scientific Publication – Minerva team advancing thought leadership in schizophrenia research
Remy Luthringer , Ph.D. (Chief Executive Officer),Michael Davidson , MD (Chief Medical Officer) andJonathan 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
General and administrative (G&A) expense: For the three months ended
Other income and expense: For the three months ended
Change in Fair Value of Warrant Liability1: For the three months ended
Total Liabilities: Under
Net Income (Loss): For the three months ended
For the six months ended
Cash Position: Cash, cash equivalents, marketable securities and restricted cash at
| * | 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
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 rigorous, 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 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 June 30, 2026, filed with the SEC on August 7, 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) | ||||||
| (in thousands) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | ||||||
| Marketable securities | 50,615 | - | ||||
| Restricted cash | 100 | 100 | ||||
| Prepaid expenses and other current assets | 4,366 | 698 | ||||
| Total current assets | 79,733 | 83,100 | ||||
| 14,869 | 14,869 | |||||
| Deferred public offering costs | 487 | - | ||||
| Total assets | $95,089 | $97,969 | ||||
| LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT | ||||||
| Current liabilities: | ||||||
| Accounts payable | ||||||
| Accrued expenses and other current liabilities | 2,511 | 1,651 | ||||
| Total current liabilities | 3,958 | 2,290 | ||||
| Long-term liabilities: | ||||||
| Warrant liability | 232,690 | 171,465 | ||||
| Liability related to the sale of future royalties | 60,000 | 60,000 | ||||
| Total liabilities | 296,648 | 233,755 | ||||
| Redeemable preferred stock: | ||||||
| Series A convertible preferred stock | 11,741 | 4,962 | ||||
| Stockholders' deficit: | ||||||
| Common stock | 5 | 4 | ||||
| Additional paid-in capital | 583,432 | 548,047 | ||||
| Accumulated deficit | (796,737 | ) | (688,799 | ) | ||
| Total stockholders' deficit | (213,300 | ) | (140,748 | ) | ||
| Total liabilities, redeemable preferred stock and stockholders' deficit | $95,089 | $97,969 | ||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
| (Unaudited) | ||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | ||||||||||||
| General and administrative | 3,455 | 2,076 | 14,872 | 4,617 | ||||||||
| Total operating expenses | 10,642 | 3,374 | 27,314 | 7,277 | ||||||||
| Loss from operations | (10,642 | ) | (3,374 | ) | (27,314 | ) | (7,277 | ) | ||||
| Foreign exchange losses | (14 | ) | (21 | ) | (16 | ) | (30 | ) | ||||
| Investment income | 569 | 136 | 1,199 | 295 | ||||||||
| Change in fair value of warrant liability | 27,553 | - | (81,807 | ) | - | |||||||
| Net income (loss) | $ 17,466 | $ (3,259 | ) | $ (107,938 | ) | $ (7,012 | ) | |||||
| Undistributed earnings attributable to participating preferred stock | (819 | ) | - | - | - | |||||||
| Net income (loss) attributable to common stockholders | $ 16,647 | $ (3,259 | ) | $ (107,938 | ) | $ (7,012 | ) | |||||
| Net income (loss) per share, basic | $(0.43 | ) | $(2.38 | ) | $(0.93 | ) | ||||||
| Weighted average shares outstanding, basic | 46,599 | 7,569 | 45,257 | 7,569 | ||||||||
| Net income (loss) per share, diluted | $(0.14 | ) | $(0.43 | ) | $(2.38 | ) | $(0.93 | ) | ||||
| Weighted average shares outstanding, diluted | 79,105 | 7,569 | 45,257 | 7,569 | ||||||||
| RECONCILIATION OF TOTAL LIABILITIES - NON-GAAP | ||||||
| (Unaudited) | ||||||
| Current liabilities: | ||||||
| Accounts payable | ||||||
| Accrued expenses and other current liabilities | 2,511 | 1,651 | ||||
| Total current liabilities | 3,958 | 2,290 | ||||
| Long-term liabilities: | ||||||
| Warrant liability | 232,690 | 171,465 | ||||
| Liability related to the sale of future royalties | 60,000 | 60,000 | ||||
| Total liabilities - GAAP | 296,648 | 233,755 | ||||
| Reconciling items: | ||||||
| Warrant liability | (232,690 | ) | (171,465 | ) | ||
| Liability related to the sale of future royalties | (60,000 | ) | (60,000 | ) | ||
| Total liabilities - non-GAAP | $3,958 | $2,290 | ||||
| RECONCILIATION OF ADJUSTED NET (LOSS) INCOME - NON-GAAP | ||||||||||||
| (Unaudited) | ||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||
| Net income (loss) - GAAP | $(3,259 | ) | $(107,938 | ) | $(7,012 | ) | ||||||
| Reconciling items: | ||||||||||||
| Stock-based compensation expense | 2,273 | 298 | 10,983 | 595 | ||||||||
| Changes in fair value of warrant liability | (27,553 | ) | - | 81,807 | - | |||||||
| Adjusted net (loss) income - non-GAAP | $ (7,814 | ) | $ (2,961 | ) | $ (15,148 | ) | $ (6,417 | ) | ||||
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.
