Minerva Neurosciences(NERV) - 2024 Q2 - Quarterly Report

Financial Performance - The company reported an accumulated deficit of approximately $413.6 million as of June 30, 2024, compared to$396.8 million as of December 31, 2023[56]. - The net cash used in operating activities for the six months ended June 30, 2024, was approximately $10.0 million, primarily due to a net loss of$16.8 million[83]. - The company anticipates continuing to incur net losses for the foreseeable future as it develops its product candidates[73]. Revenue Generation - The company has not generated any revenue from product sales to date and has no products approved for commercial sale[61]. - The company has not generated any revenue from product sales to date and does not expect significant revenue until regulatory approval and commercialization of product candidates[78]. - The company has not generated revenue from product sales and relies on collaborative revenue from the sale of royalty interests[78]. Expenses - Research and development expenses increased to $8.0 million for the six months ended June 30, 2024, from$4.5 million for the same period in 2023, representing an increase of approximately 77.8%[70]. - General and administrative expenses decreased to $4.9 million for the six months ended June 30, 2024, down from$5.3 million in the same period in 2023, a decrease of approximately 7.5%[71]. - Non-cash interest expense for the sale of future royalties increased to $4.6 million for the six months ended June 30, 2024, from$4.0 million in the same period in 2023, an increase of approximately 15%[72]. - The company anticipates ongoing increases in expenses related to research, development, and clinical trials[78]. Cash Position - As of June 30, 2024, the company had approximately $31.0 million in cash, cash equivalents, and restricted cash, expected to meet operating commitments for the next 12 months[73]. - The company’s existing cash and equivalents are expected to meet cash commitments for at least the next 12 months[79]. - As of June 30, 2024, an aggregate of$22.6 million was eligible for sale under the Sales Agreement[76]. Financing Activities - The net cash provided by financing activities was approximately $19.7 million during the six months ended June 30, 2023, primarily from a Private Placement[84]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholders' interests[79]. Clinical Development - The FDA issued a Complete Response Letter (CRL) for the NDA of roluperidone on February 26, 2024, citing clinical deficiencies that need to be addressed[55]. - The company completed a Phase 1b clinical trial evaluating the co-administration of roluperidone and olanzapine, enrolling 17 subjects, with 13 completing the study[60]. Company Classification - The company is classified as a "smaller reporting company" and may take advantage of scaled disclosures[87].