Aripiprazole

Confirmatory Phase 3 trial of roluperidone (MIN-101C19) ongoing with topline efficacy data expected 2H 2027 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., Aug. 07, 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 costs. General and administrative (G&A) expense: For the three months ended June 30, 2026 and 2025, G&A expense was $3.5 million and $2.1 million, respectively. G&A expense was higher versus the prior year period primarily due to higher professional service fees and compensation costs. For the six months ended June 30, 2026 and 2025, G&A expense was $14.9 million and $4.6 million, respectively. G&A expense was higher versus the prior year period primarily due to higher professional service fees as well as costs related to a severance agreement in the first quarter, which included a $6.6 million one-time, non-cash charge for the modification of the terms of previously granted stock options. Other income and expense: For the three months ended June 30, 2026 and 2025, investment income was $0.6 million and $0.1 million, respectively. For the six months ended June 30, 2026 and 2025, investment income was $1.2 million and $0.3 million, respectively. The increase is primarily due to higher cash equivalents and marketable securities balances. Change in Fair Value of Warrant Liability1: For the three months ended June 30, 2026, the Company recorded a non-cash gain of $27.6 million related to the change in fair value of the warrant liability. For the six months ended June 30, 2026, the Company recorded a non-cash loss of $81.8 million related to the change in fair value of the warrant liability. The gain and loss, respectively, on the change in fair value of the warrant liability is related to the warrants issued in conjunction with the October 2025 private placement. Total Liabilities: Under U.S. Generally Accepted Accounting Principles ("GAAP"), for the periods ended June 30, 2026 and December 31, 2025, total liabilities were $296.6 million and $233.8 million, respectively. Excluding the warrant liability and liability related to the sale of future royalties, non-GAAP total liabilities* were $4.0 million and $2.3 million for the periods ended June 30, 2026 and December 31, 2025, respectively. Net Income (Loss): For the three months ended June 30, 2026, Minerva recorded GAAP net income of $17.5 million, or $0.36 per basic share and $(0.14) per diluted share, compared to a net loss of $3.3 million, or $(0.43) per basic and diluted share, for the three months ended June 30, 2025. The quarter's GAAP net income was driven by a $27.6 million non-cash gain on the change in fair value of the warrant liability1; excluding that gain and stock-based compensation expense, adjusted (non-GAAP) net loss* for the quarter was $7.8 million, compared to an adjusted net loss* of $3.0 million in the prior-year period. For the six months ended June 30, 2026, Minerva recorded a GAAP net loss of $107.9 million, or $2.38 per basic and diluted share, compared to a net loss of $7.0 million, or $0.93 per basic and diluted share, for the six months ended June 30, 2025. The six-month loss reflects a $81.8 million non-cash loss on the change in fair value of the warrant liability1, the inverse of the gain recorded in the second quarter, meaning the liability's fair value moved unfavorably in the first quarter by more than it moved favorably in the second. Excluding that loss and stock-based compensation expense, adjusted (non-GAAP) net loss* for the six months was $15.1 million, compared to an adjusted net loss* of $6.4 million in the prior year period. Cash Position: Cash, cash equivalents, marketable securities and restricted cash at June 30, 2026 was approximately $75.4 million, as compared to $82.4 million at December 31, 2025. *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 AhlholmChief Financial OfficerMinerva Neurosciences, Inc.fahlholm@minervaneurosciences.com Corey Davis, Ph.D.LifeSci Advisors, LLC212-915-2577cdavis@lifesciadvisors.com CONDENSED CONSOLIDATED BALANCE SHEET DATA (Unaudited) June 30, 2026December 31, 2025 (in thousands) ASSETS Current assets: Cash and cash equivalents$24,652 $82,302 Marketable securities 50,615 - Restricted cash 100 100 Prepaid expenses and other current assets 4,366 698 Total current assets 79,733 83,100 Goodwill 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$1,447 $639 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 June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development$7,187 $1,298 $12,442 $2,660 General and administrative 3,455 2,076 14,872 4,617 Total operating expenses 10,642 3,374 27,314 7,277 Loss from operations (10,642) (3,374) (27,314) (7,277) Foreign exchange losses (14) (21) (16) (30)Investment income 569 136 1,199 295 Change in fair value of warrant liability 27,553 - (81,807) - Net income (loss)$ 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$0.36 $(0.43)$(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) June 30, 2026December 31, 2025Current liabilities: Accounts payable$1,447 $639 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 June 30, Six Months Ended June 30, 2026 2025 2026 2025 Net income (loss) - GAAP$17,466 $(3,259)$(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.

The FDA has approved Otsuka Pharmaceutical’s once-daily extended-release capsule Simtriyo (centanafadine) for attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older. Approval of the first-in-class norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) gives the Japanese drugmaker its “next major CNS launch” and positions the therapy to become a potential blockbuster in a large, under-penetrated market, according to Jefferies analysts in a July 26 note. Before Simtriyo can launch in the U.S. market, it must clear controlled-substance review by the Drug Enforcement Administration (DEA), a standard, up-to-three-month procedure for all central nervous system stimulants. How the DEA classifies Simtriyo could determine its commercial potential, the Jefferies team noted. A Schedule II designation like what Adderall and Vyvanse have could restrict uptake, while a lower classification could give Simtriyo a competitive edge in a crowded ADHD market, the analysts said. During an investor Q&A in April, Otsuka said it was not clear whether a DEA review would be necessary. The FDA classifies Simtriyo as a stimulant likely because it has dopaminergic effects, the Jefferies team observed in their Sunday note. By inhibiting the reuptake of those neurotransmitters, Simtriyo works by increasing their availability in attention and behavioral pathways. A chronic neurodevelopmental disorder characterized by trouble paying attention and controlling impulsive behaviors, ADHD affects about 7 million children in the U.S. and 15.5 million adults, according to the CDC. Stimulants are the most popular treatments for ADHD, but patients often stop or cycle through different therapies due to a lack of effectiveness, troublesome side effects and changing life demands. “We therefore view the market as capable of supporting multiple treatment classes and believe Simtriyo has an opportunity to expand the overall non-stimulant segment rather than simply take share from existing products such as Qelbree or Strattera,” the Jefferies team wrote. Based on the large market, Otsuka has targeted Simtriyo peak sales of more than 100 billion Japanese yen ($610 million). The company got the drug from its 2017 acquisition of Neurovance for $100 million upfront and up to $150 million in potential development and regulatory milestone payments. Simtriyo proved its worth in four phase 3 clinical trials. It significantly improved ADHD symptoms compared with placebo as measured by the ADHD Rating Scale-5 (ADHD-RS-5) in two pediatric trials and by the Adult ADHD Investigator Symptom Rating Scale (AISRS) in two adult studies. Across the four studies, the most common adverse reactions were rash and decreased appetite in children 6 to 12 years of age; decreased appetite, nausea, rash, headache and abdominal pain in adolescents 13 to 17 years of age; and headache, decreased appetite, insomnia, nausea, dry mouth and diarrhea in adults. A month ago, Otsuka provided positive topline phase 3b results , showing Simtriyo also beat placebo on AISRS in patients with ADHD and comorbid anxiety. “The approval of Simtriyo introduces a novel mechanism of action and expands the range of options available to healthcare professionals and patients,” Lenard Adler, director of the adult ADHD program at NYU Langone Health and an investigator on the centanafadine studies, said in a July 24 statement. “Having more therapeutic choices is important because ADHD is a highly individualized condition and treatment decisions should reflect the unique needs of each patient.” The green light for Simtriyo comes less than a year after the FDA refused to approve Otsuka and partner Lundbeck’s Rexulti as part of a combination for post-traumatic stress disorder due to mixed trial data. The ADHD drug expands Otsuka’s CNS portfolio beyond Rexulti and Abilify Maintena, both atypical antipsychotics approved to treat schizophrenia and other neurological disorders. “ADHD is primarily treated in the community setting, giving Otsuka access to a broad prescriber base and an opportunity to leverage its established US commercial infrastructure,” Jefferies analysts said.