Minerva Neurosciences(NERV) - 2024 Q1 - Quarterly Report

Financial Performance - The company reported an accumulated deficit of $405.4 million as of March 31, 2024, compared to$396.8 million as of December 31, 2023[70]. - For the three months ended March 31, 2024, the company recorded a net loss of $8.6 million, an increase from a net loss of$7.0 million for the same period in 2023[70]. - The company has not generated any revenue from the sales or licensing of its product candidates, and it anticipates continuing to incur net losses for the foreseeable future[70]. - Net cash used in operating activities for Q1 2024 was approximately $6.1 million, compared to$0.1 million in Q1 2023, primarily due to a net loss of $8.6 million[102][103]. - The company reported a net loss of$8.6 million for the three months ended March 31, 2024, which was higher than the net loss of $7.0 million for the same period in 2023[102][103]. - There were no cash flows from investing or financing activities during the three months ended March 31, 2024 and 2023, resulting in a net decrease in cash of$6.1 million for Q1 2024[101][104][105]. Expenses - Research and development expenses increased to $4.2 million for the three months ended March 31, 2024, up from$2.7 million in the same period in 2023, primarily due to costs associated with the FDA's review of the NDA and the MIN-101C18 study[83]. - General and administrative expenses decreased to $2.5 million for the three months ended March 31, 2024, down from$2.7 million in the same period in 2023, mainly due to lower professional service fees[84]. Cash Position - As of March 31, 2024, the company had approximately $34.9 million in cash, cash equivalents, and restricted cash, expected to meet operating commitments for the next 12 months[89]. - The company expects to finance its cash needs through equity offerings, debt financings, and collaborations, but additional funding may dilute existing stockholder interests[99]. - Existing cash, cash equivalents, and restricted cash are believed to be sufficient to meet cash commitments for at least the next 12 months[99]. Regulatory and Clinical Developments - The FDA issued a Complete Response Letter on February 26, 2024, citing clinical deficiencies in the NDA for roluperidone, requiring additional studies to support its safety and effectiveness[71]. - The company completed a Phase 1b clinical trial in Q1 2024, enrolling 17 patients to evaluate the safety and pharmacokinetics of roluperidone co-administered with olanzapine[74]. Funding Activities - The company raised$20.0 million in gross proceeds from a private placement of common stock and warrants on June 30, 2023[92]. - The company sold its royalty interest in seltorexant to Royalty Pharma for an upfront payment of $60 million, with potential future milestone payments of up to$95 million[96]. Accounting and Reporting - The company identified critical accounting policies related to research and development costs and the liability for the sale of future royalties as significant for its financial status[106]. - The company is classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures as long as certain market value and revenue thresholds are met[108].