Minerva Neurosciences Provides Business Updates and Second Quarter Financial Results

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]