Minerva Neurosciences(NERV)2025-05-13 11:00Financial Performance - The company reported an accumulated deficit of approximately $399.1 million as of March 31, 2025, compared to $395.4 million as of December 31, 2024[76]. - For the three months ended March 31, 2025, the company recorded a net loss of $3.8 million, a decrease from a net loss of $8.6 million for the same period in 2024, representing a reduction of approximately 56%[76]. - Net cash used in operating activities was approximately $4.1 million for the three months ended March 31, 2025, compared to $6.1 million for the same period in 2024[107][109]. - The net loss for the three months ended March 31, 2025, was $3.8 million, down from a net loss of $8.6 million in the same period of 2024[108][109]. Expenses - Research and development expenses decreased to $1.4 million for the three months ended March 31, 2025, down from $4.2 million in the same period of 2024, a decrease of approximately 67%[90]. - General and administrative expenses remained constant at $2.5 million for both the three months ended March 31, 2025, and 2024[91]. - Investment income decreased to $158 thousand for the three months ended March 31, 2025, down from $358 thousand in the same period of 2024, a decrease of approximately 44%[93]. - The company anticipates ongoing increases in expenses related to research, development, and clinical trials as it seeks regulatory approval for product candidates[104]. Revenue Generation - The company has not generated any revenue from the sales or licensing of its product candidates, as none have been approved for commercialization[82]. - The company has not generated any revenue from product sales to date, only collaborative revenue from a licensing agreement with Janssen[104]. Cash and Financing - As of March 31, 2025, the company had approximately $17.4 million in cash, cash equivalents, and restricted cash, which is expected to meet operating commitments for the next 12 months[96]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholders' interests[105]. - The company believes its existing cash and equivalents will be sufficient to meet cash commitments for at least the next 12 months[105]. - A $60 million payment from Royalty Pharma for the sale of royalty interests in seltorexant is recorded as a liability related to future royalties[104]. Regulatory and Operational Outlook - The FDA issued a Complete Response Letter (CRL) for the NDA of roluperidone on February 26, 2024, citing the need for additional studies to support its safety and effectiveness[75]. - The company anticipates continuing to incur net losses for the foreseeable future as it develops its product candidates and supports its operations as a public company[96]. Company Classification and Accounting Policies - The company is classified as a "smaller reporting company" and may take advantage of scaled disclosures under the Securities Exchange Act[114]. - Critical accounting policies include research and development costs, goodwill, and liabilities related to future royalties[112].