Trial demonstrated no safety concerns when co-administering roluperidone and olanzapine The Company continues to advance the program, with the confirmatory Phase 3 trial now enrolling and topline data anticipated in the second half of 2027 BURLINGTON, Mass., March 25, 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 announced the presentation of clinical dat ...

Summary of Minerva Neurosciences Conference Call Company Overview - **Company**: Minerva Neurosciences (NasdaqCM:NERV) - **Focus**: Development of roluperidone, a potential treatment for schizophrenia, specifically targeting negative symptoms [1][2] Industry Context - **Schizophrenia Symptoms**: Schizophrenia is characterized by three types of symptoms: positive, negative, and cognitive deficits. Negative symptoms significantly impair quality of life and are currently not effectively treated by existing antipsychotics [2][3][4] - **Negative Symptoms**: These include avolition (lack of motivation), which is crucial for patient functioning and quality of life. Current treatments do not address these symptoms adequately, leading to a significant unmet medical need [5][6][7] Core Points and Arguments - **Treatment Gap**: There is no approved treatment for negative symptoms of schizophrenia in the U.S. as of now, and existing antipsychotics may worsen these symptoms [4][5] - **Clinical Trial Design**: The company emphasizes the need for innovative trial designs to assess the efficacy of treatments for negative symptoms, suggesting that traditional methods may not be suitable [8][9] - **Pharmacology of Roluperidone**: Roluperidone works through mechanisms that do not block dopamine, which is believed to help maintain stability in positive symptoms while improving negative symptoms [16][17] - **Efficacy Data**: In clinical trials, roluperidone showed significant improvements in negative symptoms and functioning, with a low relapse rate when used as monotherapy. The drug was well-tolerated with no significant side effects [22][24][23] Important Data Points - **Clinical Trial Results**: - The primary endpoint was assessed using the PANSS scale, with significant improvements noted at week 12. The 64 mg dose showed stronger effects compared to the 32 mg dose [19][20] - The first study had a p-value of 0.0001, indicating strong efficacy, while the second study showed a nominal improvement for the 64 mg dose [20][21] - **Patient Population**: Over 800 patients participated in the trials, with a focus on those with stable positive symptoms and significant negative symptoms [17] Regulatory Considerations - **FDA Interactions**: The company has engaged in discussions with the FDA regarding trial design and endpoints, aiming to establish a clear path for approval given the lack of existing treatments for negative symptoms [25][26] - **Study Design**: The upcoming study will compare roluperidone to commonly prescribed antipsychotics, using a double-dummy design to maintain blinding [28] Future Outlook - **Timeline for Results**: The first patient in the new study is expected to be enrolled in Q2 of the current year, with top-line results anticipated in the second half of next year [41][42] - **Regulatory Submission**: Following the results, the company plans to re-engage with the FDA regarding NDA submission [42] Additional Considerations - **Clinical Meaningfulness**: The company is working to establish clinically meaningful effect sizes in collaboration with the FDA, given the absence of approved treatments for negative symptoms [30][31] - **Relapse Assessment**: The study will include psychometric endpoints and hard clinical endpoints to assess relapse rates and overall patient safety [39][40]

Company Announcement - Minerva Neurosciences, Inc. will participate in The Stifel 2026 Virtual CNS Forum on March 17-18, 2026, with Remy Luthringer, PhD, serving as Executive Chairman & CEO [1] - The presentation is scheduled for March 18 at 8:30 AM ET, and a replay will be available for ninety days following the event [2] Company Overview - Minerva Neurosciences is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system (CNS) disorders [3] - The company is initiating a confirmatory Phase 3 trial with roluperidone aimed at addressing negative symptoms of schizophrenia [3]

Financial Performance - The company incurred a net loss of $293.4 million for the fiscal year ended December 31, 2025, with an accumulated deficit of approximately $688.8 million[154]. - As of December 31, 2025, the company had cash, cash equivalents, and restricted cash of $82.4 million, expected to meet operating commitments for at least twelve months[157]. - The company anticipates significant additional capital will be needed to continue operations and product development[161]. - The company has approximately $188.2 million of federal net operating losses as of December 31, 2025, which may begin to expire in 2036 if not utilized[164]. - The company has incurred significant losses since inception and expects to continue incurring losses over the next several years[170]. Product Development and Regulatory Approval - The lead product candidate, roluperidone, is under development for treating negative symptoms in schizophrenia, with a New Drug Application submitted in August 2022[155]. - The FDA issued a Complete Response Letter for roluperidone on February 26, 2024, requiring an additional Phase 3 clinical trial to address deficiencies[155]. - The company expects to initiate the C19 trial in the second quarter of 2026, with topline efficacy results anticipated in the second half of 2027[167]. - The FDA issued a Complete Response Letter (CRL) for the NDA of roluperidone, requiring an additional Phase 3 trial, which will increase costs and delay the approval process[170]. - The FDA has assigned a standard review classification for roluperidone with a PDUFA goal date of February 26, 2024[170]. - The Phase 3 trial (C07) for roluperidone failed to meet its primary endpoint, despite earlier trials showing positive results[175]. - The timely completion of clinical trials is heavily dependent on subject enrollment, which may be affected by various factors including competition and subject health[185]. - Regulatory authorities may require additional data or trials, which could lead to increased costs and delays in obtaining approvals[171]. - The company may face challenges in demonstrating the safety and efficacy of its product candidates, which could prevent or delay regulatory approval[186]. - The results of clinical trials conducted outside the U.S. may not be accepted by the FDA, impacting the approval process[176]. - Regulatory approval for product candidates is uncertain, and even if obtained, it may be for narrower indications than expected[191]. - Approved products will be subject to ongoing regulatory obligations, which may result in significant expenses and limit commercialization[193]. - Changes in drug indications, labeling, or safety issues may require additional regulatory submissions and studies[194]. Market and Competitive Landscape - The biopharmaceutical industry is highly competitive, with major pharmaceutical companies and biotechnology firms having greater resources, posing a risk to the commercialization of product candidates[211]. - Competitors may achieve regulatory approval faster or develop more effective products, which could hinder the company's market position[212]. - Market opportunities for the company's product candidates may be smaller than anticipated, affecting revenue and business performance[207]. Commercialization and Sales Challenges - The company currently lacks a marketing and sales organization, which may impede the effective commercialization of approved product candidates[217]. - Establishing a sales and marketing organization will require significant investment and time, posing risks to product commercialization[218]. - Coverage and adequate reimbursement from third-party payors are critical for product acceptance and commercial success[229]. - The company faces challenges in obtaining consistent coverage and reimbursement across different payors, which may affect product demand and pricing[231]. - Legislative and regulatory changes may impose additional pricing pressures and affect the company's ability to commercialize products profitably[230]. - The company may face significant delays in obtaining coverage and reimbursement for newly approved drugs, which could adversely affect operating results and financial condition[234]. Regulatory and Compliance Risks - The company is subject to various healthcare laws that could impact its operations and result in penalties if not complied with[274]. - The company is subject to various stringent healthcare laws and regulations, including the Foreign Corrupt Practices Act (FCPA), which imposes significant compliance costs and risks of penalties for violations[278]. - Non-compliance with healthcare laws could result in severe consequences, including civil and criminal penalties, reputational harm, and exclusion from federal healthcare programs[277]. - The company must adhere to the federal Physician Payments Sunshine Act, requiring annual reporting of payments made to healthcare professionals, which could impact business practices[278]. Data Privacy and Cybersecurity - Data privacy and security obligations are rapidly evolving, with potential regulatory investigations and penalties for non-compliance, which could disrupt business operations and harm revenue[280]. - The company faces significant fines under the General Data Protection Regulation (GDPR), with penalties reaching up to €20 million or 4% of annual global revenue for violations[284]. - Cyberattacks and malicious activities threaten the confidentiality and integrity of the company's sensitive information and IT systems[298]. - Ransomware attacks are increasingly prevalent and can lead to significant operational disruptions and financial losses[301]. Manufacturing and Supply Chain Risks - The company does not have manufacturing facilities and relies on third parties for the production of drug candidates, which could delay commercialization efforts[312]. - Regulatory compliance and quality assurance are critical, as non-compliance by contract manufacturers could jeopardize product approval[314]. - The company relies on third-party manufacturers for drug production, which may lead to compliance issues with cGMP regulations, potentially resulting in product recalls and supply disruptions[316]. - There is a risk of sanctions, including clinical holds or fines, if the company or its manufacturers fail to comply with applicable regulations, which could adversely affect drug supplies[317]. Intellectual Property and Patent Risks - The patent prosecution process is expensive and time-consuming, and failure to secure necessary patents could limit the company's competitive position[329]. - The expiration of patents before regulatory approval could expose the company to increased competition and reduce the ability to recover development costs[331]. - The company may need to license additional patents from third parties, and failure to obtain such licenses could materially harm the business[336]. - The company has filed and in-licensed composition-of-matter patent applications for all product candidates, but the patentability of these claims is uncertain[338]. - Changes in patent law could diminish the value of patents, impacting the company's ability to protect its product candidates[341]. Organizational and Management Challenges - The company plans to grow its organization, which may impose significant added responsibilities on management and require effective growth management[252]. - The company faces risks in managing clinical trials and integrating additional personnel, which could hinder growth[253]. - Future acquisitions, mergers, or joint ventures may disrupt business operations and expose the company to various risks, including unanticipated liabilities and integration challenges[254]. - The company has limited experience in integrating acquired businesses, which could complicate future strategic transactions[258].

Clinical Trials - Minerva Neurosciences plans to initiate a confirmatory Phase 3 trial with roluperidone for negative symptoms of schizophrenia in Q2 2026, with topline data expected in 2H 2027[1]. - The company plans to focus on the successful execution of the Phase 3 trial for roluperidone, which could potentially shift the treatment paradigm for negative symptoms of schizophrenia[26]. Financial Performance - The net loss for Q4 2025 was $283.7 million, or $25.51 per share, compared to a net loss of $4.3 million, or $0.56 per share, in Q4 2024[17]. - For the year ended December 31, 2025, the net loss was $293.4 million, or $34.67 per share, compared to a net income of $1.4 million, or $0.19 per share, in 2024[18]. - Non-GAAP adjusted net loss for Q4 2025 was $7.1 million, or $0.64 per share, compared to a non-GAAP adjusted net loss of $4.0 million, or $0.53 per share, in Q4 2024[17]. - The net loss for the three months ended December 31, 2025, was $283,668,000 compared to a loss of $4,272,000 for the same period in 2024[29]. - Adjusted net loss income for the three months ended December 31, 2025, was $7,100,000, compared to a loss of $4,022,000 in 2024[31]. Expenses - Research and development (R&D) expenses for Q4 2025 were $2.2 million, up from $2.0 million in Q4 2024, while total R&D expenses for the year were $5.8 million, down from $11.9 million in 2024[8]. - General and administrative (G&A) expenses for Q4 2025 were $2.8 million, compared to $2.5 million in Q4 2024, with total G&A expenses for the year decreasing to $9.3 million from $9.9 million in 2024[9]. - Research and development expenses for the twelve months ended December 31, 2025, were $5,759,000, down from $11,899,000 in 2024, indicating a reduction of 52%[29]. Cash and Assets - Cash, cash equivalents, and restricted cash at December 31, 2025, were approximately $82.4 million, up from $21.5 million at December 31, 2024[19]. - Total current assets increased to $83,100,000 in December 2025 from $22,269,000 in December 2024, representing a growth of 273%[28]. - Total assets rose to $97,969,000 in December 2025, up from $37,144,000 in December 2024, marking a 164% increase[28]. Liabilities - Total liabilities as of December 31, 2025, were $233.8 million, significantly higher than $62.8 million in 2024[16]. - Total liabilities increased significantly to $233,755,000 in December 2025 from $62,837,000 in December 2024, reflecting a growth of 272%[30]. - The warrant liability was recorded at $171,465,000 as of December 31, 2025, indicating a new financial obligation[30]. - The accumulated deficit increased to $688,799,000 in December 2025 from $395,377,000 in December 2024, reflecting a rise of 74%[28]. Funding - The company received $80.0 million in gross proceeds from a private placement on October 23, 2025, with potential additional proceeds of up to $120.0 million if all warrants are exercised[3]. - The company recorded a loss of $321.5 million on the issuance of convertible preferred stock and warrants in 2025, reflecting the fair values of the issued securities[13].

Core Insights - Minerva Neurosciences, Inc. is set to initiate a confirmatory Phase 3 trial for roluperidone targeting negative symptoms of schizophrenia in Q2 2026, with topline data expected in the second half of 2027 [1][9] Business Updates - The company secured $80 million in gross proceeds from a private placement on October 23, 2025, with potential additional funding of up to $120 million contingent on the exercise of warrants [3][4] - Minerva has achieved alignment with the FDA regarding the trial design for the Phase 3 study of roluperidone, which aims to evaluate its efficacy against placebo in approximately 380 patients over a 12-week period [4][9] Financial Results - For Q4 2025, Minerva reported a net loss of $283.7 million, or $25.51 per share, compared to a net loss of $4.3 million, or $0.56 per share, in Q4 2024 [17][28] - Total liabilities increased to $233.8 million as of December 31, 2025, up from $62.8 million in 2024, primarily due to the issuance of convertible preferred stock and warrants [16][27] - Cash and cash equivalents rose to approximately $82.4 million at the end of 2025, compared to $21.5 million at the end of 2024, largely due to the recent financing [19]

Core Insights - Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders [3] - The company will participate in The Citizens Life Sciences Conference on March 10-11, 2026, with a presentation scheduled for March 10 at 9:35 AM ET [2] - Minerva is initiating a confirmatory Phase 3 trial with roluperidone aimed at treating negative symptoms of schizophrenia [3] Company Information - Minerva Neurosciences, Inc. is dedicated to developing product candidates specifically for CNS diseases [3] - The company’s Executive Chairman & CEO, Remy Luthringer, will represent Minerva at the upcoming conference [1] - A replay of the conference presentation will be available for ninety days on the company's Investors & Media Events webpage [2]

Company Overview - Minerva Neurosciences is focused on developing roluperidone as a treatment for negative symptoms in patients with schizophrenia, addressing a significant unmet medical need in this area [2][3]. Product Development - Roluperidone is positioned as potentially the first effective treatment specifically targeting negative symptoms associated with schizophrenia, a condition that has seen decades of research without successful drug development [3]. Leadership and Expertise - The company is supported by notable experts in the field, including Professor Gregory Strauss and Professor Brian Kirkpatrick, who have made significant contributions to the understanding and treatment of schizophrenia [4].

Summary of Minerva Neurosciences Conference Call Company Overview - **Company**: Minerva Neurosciences (NasdaqCM:NERV) - **Focus**: Development of roluperidone for treating negative symptoms in schizophrenia Key Points Discussed Industry Context - **Schizophrenia**: Affects approximately 83 million people globally, with about 3.4 million in the U.S. alone [doc id='13'][doc id='14'] - **Financial Burden**: Estimated at $34 billion annually in the U.S., making it a leading cause of functional disability [doc id='14'] - **Negative Symptoms**: These symptoms significantly impair social and occupational functioning, leading to poor quality of life [doc id='14'][doc id='18'] Roluperidone Development - **Unmet Need**: There is currently no FDA-approved treatment specifically for negative symptoms of schizophrenia, highlighting a significant treatment gap [doc id='19'] - **Clinical Trials**: Roluperidone is positioned as potentially the first effective treatment for negative symptoms, with ongoing Phase III trials [doc id='2'][doc id='5'] FDA Engagement - **Collaboration**: Minerva has had productive discussions with the FDA regarding the design of the Phase III trial, including the use of monotherapy for roluperidone [doc id='5'][doc id='10'] - **Study Design**: The trial will compare roluperidone monotherapy against standard antipsychotic care, focusing on both efficacy and safety [doc id='60'] Clinical Insights - **Negative Symptoms Definition**: Negative symptoms include avolition, asociality, anhedonia, blunted affect, and alogia, which are minimally responsive to current treatments [doc id='20'][doc id='24'] - **Avolition**: Identified as a central domain affecting other negative symptoms, with evidence suggesting that improving motivation can lead to broader improvements in negative symptoms [doc id='25'][doc id='30'] Trial Results and Efficacy - **Phase IIb Results**: Roluperidone showed significant effects on negative symptoms, particularly at the 64 mg dose, which was associated with a large effect size [doc id='48'] - **Functionality Improvement**: The Personal and Social Performance Scale (PSP) indicated improvements in functioning, although effect sizes were modest [doc id='49][doc id='50'] Future Directions - **Phase III Confirmatory Trial**: The trial will include a screening period to ensure the right patient population, focusing on those with stable positive and negative symptoms [doc id='56][doc id='58] - **Site Selection**: Emphasis on quality performance metrics and minimizing variability by limiting the number of clinical sites involved [doc id='65][doc id='68] Conclusion - **Overall Impact**: Roluperidone has demonstrated statistical significance in improving primary negative symptoms without exacerbating positive symptoms or causing significant side effects, marking a potential breakthrough in schizophrenia treatment [doc id='53][doc id='54]

From Unmet Need to Reality Roluperidone is Potentially the First Treatment for Negative Symptoms of Schizophrenia KOL Event I February 3, 2026 1 Forward-Looking Statement This presentation 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 presentation, and involve certain risks ...