FDA Discussions & Roluperidone Update - The FDA has confirmed that Minerva Neurosciences must conduct an additional confirmatory clinical trial for roluperidone to address deficiencies cited in the Complete Response Letter received in February 2024 [3][4] - The trial will focus on patients diagnosed with schizophrenia who have impairing negative symptoms and stable positive symptoms, with a target of enrolling 25-30% of patients from the USA [4] - The primary endpoint of the trial will be the change from baseline in the PANSS Marder negative symptoms factor score at 12 weeks of treatment [4][5] - The FDA has indicated that a resubmission of the NDA could be considered if it includes a double-blind, placebo- or active-controlled trial lasting at least 52 weeks [4][6] Financial Results - For Q2 2025, research and development expenses were $1.3 million, down from $3.9 million in Q2 2024, primarily due to lower costs associated with drug substance validation and consultant fees [7] - General and administrative expenses for Q2 2025 were $2.1 million, compared to $2.4 million in Q2 2024, reflecting lower professional service fees [8] - The net loss for Q2 2025 was $3.3 million, or a net loss per share of $0.43, compared to a net loss of $8.2 million, or $1.09 per share, in Q2 2024 [10][17] Cash Position - As of June 30, 2025, the company had approximately $15.3 million in cash and cash equivalents, down from $21.5 million at the end of 2024 [11][16] Review of Strategic Alternatives - In light of the confirmatory study requirement and current cash position, the company is exploring strategic alternatives to maximize shareholder value [12]

Corporate Update - Minerva Neurosciences, Inc. has regained compliance with Nasdaq Listing Rule 5550(b)(3) and will continue to be listed on the Nasdaq Capital Market [2] - The company is in ongoing interactions with the FDA to address questions raised in the Complete Response Letter (CRL) regarding its New Drug Application (NDA) for roluperidone, aimed at treating negative symptoms in schizophrenia [2] First Quarter 2025 Financial Results - Research and development (R&D) expenses decreased to $1.4 million in Q1 2025 from $4.2 million in Q1 2024, primarily due to reduced costs associated with the FDA's review and lower compensation expenses [3] - General and administrative (G&A) expenses remained stable at $2.5 million for both Q1 2025 and Q1 2024 [3] - Non-cash interest expense for the sale of future royalties was zero in Q1 2025, down from $2.3 million in Q1 2024, due to revised estimates for future royalty payments [4] - The net loss for Q1 2025 was $3.8 million, or a net loss per share of $0.50, compared to a net loss of $8.6 million, or $1.13 per share, in Q1 2024 [5] Cash Position - As of March 31, 2025, the company had approximately $17.4 million in cash, cash equivalents, and restricted cash, down from $21.5 million at the end of 2024 [5] Balance Sheet Data - Total assets as of March 31, 2025, were $32.8 million, a decrease from $37.1 million at the end of 2024 [9] - Total liabilities were $61.9 million, slightly down from $62.8 million at the end of 2024 [9] - The stockholders' deficit increased to $29.1 million from $25.7 million at the end of 2024 [9] Statements of Operations - Total operating expenses for Q1 2025 were $3.9 million, down from $6.7 million in Q1 2024 [10] - The loss from operations was $3.9 million in Q1 2025 compared to $6.7 million in Q1 2024 [10]