NERV

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. 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, [email protected] Corey Davis, Ph.D.LifeSci Advisors, [email protected] 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.

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 $5.3 million, compared to $1.4 million in the prior‑year period. The increase was primarily due to expenses related to the initiation of the C19 trial as well as higher compensation costs. General and Administrative (G&A) Expenses: G&A expenses were $11.4 million, compared to $2.5 million in the prior‑year period. The increase of $8.9 million was primarily due to non-cash stock compensation expense of $8.0 million, as well as higher professional service fees and compensation costs. Non-cash stock compensation expense included a one-time charge of $6.6 million for the modification of the terms of previously granted stock options related to Mr. Race’s settlement agreement. Change in Fair Value of Warrant Liability: For the three months ended March 31, 2026, the Company recorded a non‑cash expense of $109.4 million for both the change in the fair value of the warrant liability and losses recognized upon the exercise of warrants during 2026. Total Liabilities: Under U.S. Generally Accepted Accounting Principles (“GAAP”), for the periods ended March 31, 2026 and December 31, 2025, total liabilities were $343.1 million and $233.8 million, respectively. Excluding the warrant liability and liability related to the sale of future royalties, non-GAAP total liabilities* were $4.5 million and $2.3 million for the periods ended March 31, 2026 and December 31, 2025, respectively. Net loss: Under GAAP, Net loss for the three months ended March 31, 2026 was $125.4 million, or $2.86 per basic and diluted share, compared to a net loss of $3.8 million, or $0.50 per basic and diluted share, for the three months ended March 31, 2025. On a non‑GAAP basis, adjusted net loss* was $7.3 million, or an adjusted net loss per share* of $0.17, compared to a non-GAAP adjusted net loss* of $3.5 million, or an adjusted net loss per share* of $0.46 per share, in the prior‑year period. Cash Position: As of March 31, 2026, Minerva had approximately $78.2 million in cash, cash equivalents, marketable securities and restricted cash, 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 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. [email protected] Corey Davis, Ph.D. LifeSci Advisors, LLC 212-915-2577 [email protected]

Initiation of confirmatory Phase 3 trial with roluperidone for negative symptoms of schizophrenia is planned for Q2 2026, with topline data anticipated in 2H 2027 BURLINGTON, Mass., March 11, 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 provided business updates and reported financial results for the fourth quarter and year ended December 31, 2025. Business Updates Strategic Financing On October 23, 2025, Minerva received $80.0 million in gross proceeds from a private placement, before deducting fees and other expenses. The financing included initial upfront funding of $80.0 million and up to an additional $80.0 million if all Tranche A warrants are exercised, subject to the terms and conditions specified therein. Additional proceeds of $40.0 million may be received if all Tranche B warrants are exercised by cash payment upon the achievement of the primary endpoint of Minerva’s Phase 3 confirmatory trial of roluperidone in schizophrenia at the 12-week efficacy endpoint expected in 2H 2027. “Strengthened by the recent financing and our general alignment with the U.S. Food and Drug Administration (“FDA”) on trial design, we are working towards initiation of the confirmatory Phase 3 trial with roluperidone for the treatment of negative symptoms of schizophrenia in the second quarter,” said Dr. Remy Luthringer, Chairman and CEO of Minerva Neurosciences. “With the $80 million upfront proceeds and the exercise proceeds from the Tranche A warrants, we anticipate sufficient funds to complete the Phase 3 trial and resubmission of the New Drug Application (“NDA”) ahead of the launch of roluperidone in the United States, if approved.” Roluperidone - Potentially the First Treatment for Negative Symptoms of Schizophrenia Roluperidone is the only investigational therapy, to date, to demonstrate significant and clinically meaningful improvements on the primary negative symptoms of schizophrenia. Minerva has achieved general alignment with FDA on the confirmatory Phase 3 trial design. The Phase 3 trial remains on track to initiate in the second quarter of 2026, with a trial design similar to Minerva's two previous studies. The first phase of the trial has a primary efficacy endpoint to evaluate the improvement in negative symptoms with roluperidone 64 mg against placebo in approximately 380 patients over a 12-week period, with results expected in 2H 2027. This will be followed by a safety phase to evaluate relapse rates in patients treated with roluperidone 64 mg compared to patients treated with antipsychotics, as discussed with FDA. Minerva believes roluperidone could potentially shift the treatment paradigm for negative symptoms of schizophrenia. Minerva hosted a live discussion with key opinion leaders (KOLs) on February 3, 2026, “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. Topics included patient burden, assessment challenges, and the upcoming confirmatory Phase 3 trial of roluperidone. The webcast is available at: https://ir.minervaneurosciences.com/static-files/23ad74a8-ed16-4c15-bc03-f00d18704126 Fourth Quarter 2025 and Year End Financial Results Research and development (R&D) expense: For the three months ended December 31, 2025 and 2024, R&D expense was $2.2 million and $2.0 million, respectively. R&D expense was higher versus the prior year period primarily due to higher consultant fees. For the years ended December 31, 2025 and 2024, R&D expense was $5.8 million and $11.9 million, respectively. R&D expense was lower versus the prior year primarily due to costs incurred during 2024 for a drug substance validation campaign and safety study, as well as lower consultant fees and compensation expenses during 2025. General and administrative (G&A) expense: For the three months ended December 31, 2025 and 2024, G&A expense was $2.8 million and $2.5 million, respectively. G&A expense was higher versus the prior year period primarily due to higher compensation expenses, partially offset by lower insurance costs. For the years ended December 31, 2025 and 2024, G&A expense was $9.3 million and $9.9 million, respectively. G&A expense was lower versus the prior year primarily due to lower professional service fees and insurance costs. Non-cash interest expense: For the years ended December 31, 2025 and 2024, non-cash interest expense was zero and $4.6 million, respectively. During the third quarter of 2024 based on available data, a revision was made to the assumptions used to calculate estimated future cash flows to be received by Minerva under the Royalty Purchase Agreement with Royalty Pharma. Due to the reduction in future cash flow estimates, the carrying amount of the Liability related to the sale of Future Royalties was reduced from $86.6 million to the initial cash payment received of $60.0 million. This adjustment resulted in the recognition of $26.6 million in non-cash other income during the third quarter of 2024, which represented the amount of non-cash interest expense previously recognized through June 30, 2024. No further non-cash interest expense associated with the Liability related to the sale of Future Royalties has been recognized, and as a result, no interest expense was recognized in the fourth quarter of 2024 or full year 2025. Other income: For the years ended December 31, 2025 and 2024, Other income was zero and $26.6 million, respectively. As discussed above, Minerva recognized $26.6 million in non-cash other income during the third quarter of 2024 due to a reduction in the carrying amount of the Liability related to the sale of Future Royalties. Loss on issuance of convertible preferred stock and warrants: In conjunction with the October 2025 private placement, Minerva issued 80,000 shares of Series A Convertible Preferred Stock, which was convertible into 37.8 million shares of common stock. The fair value of the Series A Convertible Preferred Stock on the date of issuance was $184.6 million, based upon the conversion ratio of the preferred shares and the closing price of the common stock on the date of issuance. In addition, Minerva issued warrants for up to 120,000 shares of Series A Convertible Preferred Stock which, if fully exercised, are convertible into 56.8 million shares of common stock. Based on the valuation model used, the fair value of the warrants on the date of issuance was calculated to be $216.9 million, which was recorded as a non-cash Warrant Liability. As these warrants have been classified as a liability, any unexercised and outstanding warrants are revalued at each reporting period, with subsequent changes in fair value recognized in the statement of operations. For the year ended December 31, 2025, Minerva recorded a loss on the issuance of convertible preferred stock and warrants of $321.5 million, reflecting the initial fair values of the warrants of $216.9 million and the Series A Convertible Preferred Stock of $184.6 million, offset by $80.0 million in gross proceeds received from investors. The Warrant Liability is decreased when warrants are exercised and the liability associated with such exercised warrants is reclassified to stockholders’ equity. The fair value of the Warrant Liability also decreases or increases based on the price of our common stock during the reporting period as well as any changes in other variables in the valuation model used to calculate the non-cash Warrant liability. Warrant issuance cost: In conjunction with the October 2025 private placement, Minerva incurred offering issuance costs of $5.7 million, of which $2.6 million was recorded in the balance sheet as a reduction to the Series A Convertible Preferred Stock and $3.1 million as warrant issuance expense during the fourth quarter of 2025. The allocation of the offering costs was based upon the relative fair values of the Series A Convertible Preferred Stock and warrants issued in the private placement on the date of issuance. Gain (Loss) on Change in Fair Value of Warrant Liability: For years ended December 31, 2025 and 2024, the change in fair value of the Warrant Liability was a gain of $45.4 million and zero, respectively. Gain (loss) on the change in fair value of the Warrant Liability is related to the warrants issued in conjunction with the October 2025 private placement. The fair value of the non-cash Warrant Liability at December 31, 2025 was calculated to be $171.5 million and, as a result, the decrease in fair value of $45.4 million for the three-month period ended December 31, 2025 was recognized as a non-cash component of other income in the statement of operations. Total Liabilities: Under U.S. Generally Accepted Accounting Principles (“GAAP”), for the years ended December 31, 2025 and 2024, total liabilities were $233.8 million and $62.8 million, respectively. Excluding the warrant liability and liability related to the sale of future royalties, non-GAAP total liabilities* were $2.3 million and $2.8 million for the years ended December 31, 2025 and 2024, respectively. Net loss for the three months ended December 31, 2025: Under GAAP, net loss for the three months ended December 31, 2025 was $283.7 million, or net loss per share of $25.51 basic and diluted, as compared to net loss of $4.3 million, or net loss per share of $0.56, basic and diluted, for the three months ended December 31, 2024. Excluding certain non-cash items, which include $321.5 million in non-cash convertible preferred stock and warrant issuance expense and a $45.4 million gain on the change in the fair value of the non-cash warrant liability, non-GAAP adjusted net loss* for the three months ended December 31, 2025 was $7.1 million, or an adjusted net loss per share* of $0.64, basic and diluted, as compared to a non-GAAP adjusted net loss* of $4.0 million, or an adjusted net loss per share* of $0.53, basic and diluted, for the three months ended December 31, 2024. Net (loss) income for the year ended December 31, 2025: Under GAAP, net loss for the year ended December 31, 2025 was $293.4 million, or net loss per share of $34.67, basic and diluted, as compared to net income of $1.4 million, or net income per share of $0.19, basic and diluted, for the year ended December 31, 2024. Excluding certain non-cash items, which include $321.5 million in non-cash convertible preferred stock and warrant issuance expense and a $45.4 million gain on the change in the fair value of the non-cash warrant liability, non-GAAP adjusted net loss* for the year ended December 31, 2025 was $16.0 million, or an adjusted net loss per share* of $1.89, basic and diluted, as compared to non-GAAP adjusted net loss* of $19.3 million, or an adjusted net loss per share* of $2.54, basic and diluted, for the year ended December 31, 2024. Cash Position: Cash, cash equivalents and restricted cash at December 31, 2025 were approximately $82.4 million, as compared to $21.5 million at December 31, 2024. The increase in cash and cash equivalents during the period resulted from the October 2025 private placement. * 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 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) income is defined as GAAP net (loss) income, adjusted to exclude non-cash items related to: (i) stock-based compensation expense, (ii) interest expense for the sale of future royalties, (iii) other non-cash income, (iv) loss on issuance of convertible preferred stock and warrants and (v) changes in fair value of warrant liability. Non-GAAP adjusted net (loss) income per share, basic and diluted, is defined as non-GAAP adjusted net (loss) income divided by weighted average shares outstanding, basic and diluted. 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 Minerva’s belief that it has reached alignment with the FDA on the path to initiate the confirmatory Phase 3 trial of roluperidone for the treatment of negative symptoms of schizophrenia; the expected timeline, design and conduct of that trial, including the timing of its results; the aggregate amount of proceeds to be received from the October 2025 financing upon warrant exercise; Minerva’s expected funding through the confirmatory Phase 3 trial for roluperidone, the resubmission of its NDA to the FDA and a commercial launch of roluperidone in the US, if approved; and Minerva’s belief that roluperidone could potentially shift the treatment paradigm for negative symptoms of schizophrenia. 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 on March 11, 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. [email protected] Corey Davis, Ph.D. LifeSci Advisors, LLC 212-915-2577 [email protected] Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures

BURLINGTON, Mass., Nov. 05, 2025 (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 business updates and financial results for the third quarter of 2025 ending September 30, 2025. Business Updates On October 23, 2025, the Company received $80 million in gross proceeds in a private placement, before deducting fees and other expenses. The financing includes an initial upfront funding of $80 million and up to an additional $80 million in gross proceeds if all Tranche A warrants are exercised, subject to the terms and conditions specified therein. Additional proceeds of $40 million may be received if all Tranche B warrants are exercised by cash payment upon the achievement of the primary endpoint of its Phase 3 confirmatory trial of roluperidone in schizophrenia at the 12-week timepoint. “Strengthened by the recent financing and our alignment with FDA on a confirmatory Phase 3 clinical trial, we are now on a path forward to advancing roluperidone for the treatment of negative symptoms of schizophrenia,” said Dr. Remy Luthringer, Chairman and CEO of Minerva Neurosciences. “While we anticipate increases in R&D, clinical and administrative expenses, we anticipate having sufficient funds for the Phase 3 study and resubmission of our NDA, and to prepare for a commercial launch of roluperidone in the US, if approved.” Third Quarter 2025 Financial Results Research and development (R&D) expense: For the three months ended September 30, 2025 and 2024, R&D expense was $0.9 million and $1.9 million, respectively. R&D expense was lower versus the prior year period primarily due to lower costs associated with our drug substance validation campaign, consultant fees, and lower compensation expenses. For the nine months ended September 30, 2025 and 2024, R&D expense was $3.6 million and $9.9 million, respectively. R&D expense was lower versus the prior year period primarily due to lower costs associated with our drug substance validation campaign, costs for the C18 study, consultant fees, and lower compensation expenses. General and administrative (G&A) expense: For the three months ended September 30, 2025 and 2024, G&A expense was $1.9 million and $2.5 million, respectively. G&A expense was lower versus the prior year period primarily due to lower professional service fees and insurance costs. For the nine months ended September 30, 2025 and 2024, G&A expense was $6.5 million and $7.4 million, respectively. G&A expense was lower versus the prior year period primarily due to lower professional service fees. Non-cash interest expense: For both the three months ended September 30, 2025 and 2024, non-cash interest expense was zero. For the nine months ended September 30, 2025 and 2024, non-cash interest expense was zero and $4.6 million, respectively. Non-cash interest expense was lower versus the prior year period due to revising our estimates for the timing and amount of future royalty payments to be received under the royalty arrangement. During the third quarter of 2024, we adjusted the carrying amount of our liability related to the sale of future royalties to the initial payment of $60 million. This adjustment resulted in the recognition of $26.6 million in other income during the third quarter of 2024, representing the amount of non-cash interest expense amortized through June 30, 2024. Other income: For the three and nine months ended September 30, 2025 and 2024, other income was zero and $26.6 million, respectively. Other income was lower versus the prior year periods due to recognizing other income in the third quarter of 2024 as a result of the adjustment to the carrying amount of the liability related to the sale of future royalties. Net (loss) income: Net loss for the three and nine months ended September 30, 2025 was $2.7 million and $9.8 million, or a basic and diluted net loss per share of $0.36 and $1.29, respectively, as compared to a net income for the three and nine months ended September 30, 2024 of $22.5 million and $5.7 million or a basic and diluted net income per share of $2.97 and $0.75, respectively. Cash Position: Cash, cash equivalents and restricted cash at September 30, 2025 were approximately $12.4 million, as compared to $21.5 million at December 31, 2024. About Minerva Neurosciences Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva’s goal is to transform the lives of patients with improved therapeutic options, including roluperidone for negative symptoms of schizophrenia. For more information, please visit the Company’s website. 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 aggregate amount of proceeds to be received from the recent financing and warrant exercise; and Minerva’s expected funding through the confirmatory Phase 3 trial for roluperidone, the resubmission of its NDA to the FDA and a commercial launch of roluperidone in the US, if approved. 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 the company 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, 2024, filed with the Securities and Exchange Commission on February 25, 2025, as updated by its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. 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 the Company as of the date hereof, and the Company disclaims any obligation to update any forward-looking statements, except as required by law. Contact: Investor inquiries: Frederick Ahlholm Chief Financial Officer Minerva Neurosciences, Inc. [email protected] Media inquiries: Helen Shik Principal Shik Communications LLC [email protected]

FDA confirms requirement for confirmatory study of roluperidone for the treatment of negative symptoms in schizophrenia Evaluation of strategic alternatives BURLINGTON, Mass., Aug. 14, 2025 (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 provided business updates. FDA Discussions & Roluperidone Update The Company has had multiple interactions with the FDA following receipt of the Complete Response Letter (CRL) for its New Drug Application (NDA) in February 2024 and the FDA has confirmed the requirement for an additional confirmatory clinical trial to address the deficiencies cited in the CRL and resubmit the NDA. As in the two previous studies (C03 and C07), the required confirmatory clinical trial would include patients diagnosed with schizophrenia who present with impairing negative symptoms and stable positive symptoms. Patients would be selected based on stable positive symptoms and impairing negative symptoms for the six months prior to entering the trial. Minerva agreed with FDA that best efforts will be made to secure 25-30% of patients from USA (subject to competitive recruitment). The FDA has confirmed that roluperidone can be studied in monotherapy where patients would receive a double-blinded single daily 64 mg dose of roluperidone or placebo. The FDA has also confirmed that, the primary endpoint would be the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks of treatment with roluperidone compared to placebo. The FDA advised that, to support a monotherapy indication, it would be necessary to assess relapses on an observational basis for at least 52 weeks in patients treated in monotherapy with roluperidone, placebo or antipsychotics. The FDA has stated that it would consider a resubmission of the NDA that included a double-blind, placebo- or active-controlled trial of roluperidone with a duration of at least 52 weeks. The trial’s potential sole key secondary endpoint would be the comparison of the change from Baseline in the Personal and Social Performance scale total score (PSP) to Week 12, which is a scale to assess patients’ social functioning. The trial will also potentially measure the change from Baseline in Clinical Global Impression of Severity (CGI-S), change from Baseline in NSFS, PSP, and CGI-S at earlier timepoints and safety & tolerability. The FDA has agreed that an adjunctive trial with antipsychotics would not be required for resubmission of the NDA if Minerva could provide robust, controlled data demonstrating the efficacy and safety of long-term monotherapy with roluperidone in subjects with negative symptoms of schizophrenia. Second Quarter 2025 Financial Results Research and development (R&D) expense: For the three months ended June 30, 2025 and 2024, R&D expense was $1.3 million and $3.9 million, respectively. R&D expense was lower versus the prior year period primarily due to lower costs associated with our drug substance validation campaign and lower consultant fees. For the six months ended June 30, 2025 and 2024, R&D expense was $2.7 million and $8.0 million, respectively. R&D expense was lower versus the prior year period primarily due to lower costs associated with our drug substance validation campaign, costs for the C18 study, consultant fees, and lower compensation expenses. General and administrative (G&A) expense: For the three months ended June 30, 2025 and 2024, G&A expense was $2.1 million and $2.4 million, respectively. For the six months ended June 30, 2025 and 2024, G&A expense was $4.6 million and $4.9 million, respectively. G&A expense was lower versus the prior year periods primarily due to lower professional service fees. Non-cash interest expense: For the three and six months ended June 30, 2025, non-cash interest expense for the sale of future royalties was zero, as compared to $2.3 million and $4.6 million for the three and six months ended June 30, 2024, respectively. Non-cash interest expense was lower versus the prior year periods due to revising our estimates for the timing and amount of future royalty payments to be received under the royalty arrangement. During the third quarter of 2024, we adjusted the carrying amount of our liability related to the sale of future royalties to the initial payment of $60 million. This adjustment resulted in the recognition of $26.6 million in other income during the third quarter of 2024, representing the amount of non-cash interest expense amortized through June 30, 2024. Net loss: Net loss for the three and six months ended June 30, 2025 was $3.3 million and $7.0 million, or a basic and diluted net loss per share of $0.43 and $0.93, respectively, as compared to a net loss for the three and six months ended June 30, 2024 of $8.2 million and $16.8 million or a basic and diluted net loss per share of $1.09 and $2.22, respectively. Cash Position: Cash, cash equivalents and restricted cash at June 30, 2025 were approximately $15.3 million, as compared to $21.5 million at December 31, 2024. Review of Strategic Alternatives As a result of the requirement for the confirmatory study and the Company’s current cash position, Minerva is taking additional steps to reduce costs. The Company has also initiated a review process to explore strategic alternatives to maximize value for its stockholders. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such agreements or transactions. Minerva does not intend to discuss or disclose further developments regarding the exploration of strategic alternatives unless and until its board of directors has approved a definitive action or otherwise determined that further disclosure is appropriate or required by law. About Minerva Neurosciences Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva’s goal is to transform the lives of patients with improved therapeutic options, including roluperidone for negative symptoms of schizophrenia. For more information, please visit the Company’s website. 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 Minerva’s expectations regarding the confirmatory clinical trial of roluperidone and related regulatory developments; and Minerva’s cost reduction measures, the exploration of strategic alternatives for the company to maximize value for stockholders, and the outcomes thereof. 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, whether the objectives of the strategic alternative review process will be achieved; the terms, structure, benefits and costs of any strategic transaction; the timing of any transaction and whether any transaction will be consummated at all; the risk of any unexpected costs or expenses resulting from the review; uncertainties associated with regulatory processes; whether Minerva will maintain compliance with Nasdaq’s listing standards and will be able to continue its listing on the Nasdaq Capital Market; 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, 2024, filed with the Securities and Exchange Commission on February 25, 2025, as updated by its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. 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 the Company as of the date hereof, and the Company disclaims any obligation to update any forward-looking statements, except as required by law. Contact: Investor inquiries: Frederick Ahlholm Chief Financial Officer Minerva Neurosciences, Inc. [email protected] Media inquiries: Helen Shik Principal Shik Communications LLC [email protected]

BURLINGTON, Mass., May 13, 2025 (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 business updates and financial results for the first quarter of 2025 ended on March 31, 2025. Corporate Update On March 17, 2025, we were formally notified by Nasdaq that we had regained compliance with Nasdaq Listing Rule 5550(b)(3), and as such, will continue to be listed on the Nasdaq Capital Market. Interactions with the FDA continue with the goal of addressing questions raised in the Complete Response Letter (CRL) to our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia as first disclosed in the first quarter of 2024. First Quarter 2025 Financial Results Research and development (R&D) expense: For the three months ended March 31, 2025 and 2024, R&D expense was $1.4 million and $4.2 million, respectively. R&D expense was lower versus the prior year period primarily due to costs associated with the FDA’s review of our NDA for roluperidone, costs for the C18 study, and lower compensation expenses. General and administrative (G&A) expense: For both the three months ended March 31, 2025 and 2024, G&A expense was $2.5 million. Non-cash interest expense: For the three months ended March 31, 2025 and 2024, non-cash interest expense for the sale of future royalties was zero and $2.3 million, respectively. Non-cash interest expense was lower versus the prior year period due to revising our estimates for the timing and amount of future royalty payments to be received under the royalty arrangement. During the third quarter of 2024, we adjusted the carrying amount of our liability related to the sale of future royalties to the initial payment of $60 million. This adjustment resulted in the recognition of $26.6 million in other income during the third quarter of 2024, representing the amount of non-cash interest expense amortized through June 30, 2024. Net loss: Net loss was $3.8 million for the three months ended March 31, 2025, or a basic and diluted net loss per share of $0.50, as compared to net loss of $8.6 million for the three months ended March 31, 2024, or a basic and diluted net loss per share of $1.13. Cash Position: Cash, cash equivalents and restricted cash at March 31, 2025 were approximately $17.4 million, as compared to $21.5 million at December 31, 2024. About Minerva Neurosciences Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva’s goal is to transform the lives of patients with improved therapeutic options, including roluperidone for negative symptoms of schizophrenia and MIN-301 for Parkinson’s disease. For more information, please visit the Company’s website. 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 Minerva’s ability to remediate or otherwise resolve issues and deficiencies identified in the CRL and the outcome of its interactions with the FDA; and Minerva’s expectation that it will maintain compliance with Nasdaq’s listing standards and will be able to continue its listing on the Nasdaq Capital Market. 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, Minerva’s ability to address FDA’s feedback and timing thereof; uncertainties associated with regulatory processes, including the content and timing of decisions by the FDA; general risks associated with developing biopharmaceutical product candidates; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund its clinical development plans, operations and corporate objectives on terms acceptable to Minerva; 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, 2024, filed with the Securities and Exchange Commission on February 25, 2025, as updated by its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. 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 the Company as of the date hereof, and the Company disclaims any obligation to update any forward-looking statements, except as required by law. Contact: Investor inquiries: Frederick Ahlholm Chief Financial Officer Minerva Neurosciences, Inc. [email protected] Media inquiries: Helen Shik Principal Shik Communications LLC [email protected]