Minerva Neurosciences(NERV) - 2024 Q3 - Quarterly Report

Financial Performance - As of September 30, 2024, the accumulated deficit was approximately $391.1 million, down from$396.8 million as of December 31, 2023[64]. - For the nine months ended September 30, 2024, research and development expenses increased to $9.9 million from$8.0 million for the same period in 2023, an increase of approximately 23.8%[85]. - General and administrative expenses decreased to $7.4 million for the nine months ended September 30, 2024, from$8.0 million in 2023, a decrease of approximately 7.5%[86]. - The company recorded other income of $26.6 million for the three months ended September 30, 2024, compared to zero for the same period in 2023, an increase of$26.6 million[84]. - Investment income for the three months ended September 30, 2024, was $314 thousand, down from$349 thousand in 2023, a decrease of approximately 10%[81]. - Non-cash interest expense for the sale of future royalties was zero for the three months ended September 30, 2024, down from $2.1 million in 2023, a decrease of 100$14.4 million for the nine months ended September 30, 2024, compared to $8.8 million for the same period in 2023[104][105]. - Net cash provided by financing activities was approximately$19.6 million during the nine months ended September 30, 2023, primarily from the Private Placement[106]. Revenue Generation - The company has not generated any revenue from the sales or licensing of its product candidates to date[70]. - The company has not generated any revenue from product sales to date, relying on collaborative revenue from the sale of royalty interests in seltorexant[99]. - The company sold its royalty interest in seltorexant for an upfront payment of $60 million, with potential future milestone payments of up to$95 million[98]. - The company has not generated significant revenue from product sales and does not expect to do so until regulatory approval is obtained[99]. Cash Position and Financing - The company had approximately $26.6 million in cash, cash equivalents, and restricted cash as of September 30, 2024, sufficient to meet operating commitments for the next 12 months[90]. - The company received aggregate gross proceeds of$20.0 million from a Private Placement, incurring approximately $0.4 million in offering expenses[94]. - As of September 30, 2024, an aggregate of$22.6 million was eligible for sale under the At-the-Market Equity Offering Program[96]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholder interests[101]. Development and Regulatory Matters - The FDA issued a Complete Response Letter for the NDA of roluperidone on February 26, 2024, citing clinical deficiencies that need to be addressed[63]. - The company anticipates increased expenses related to ongoing development activities and commercialization efforts for product candidates[99]. - The company is classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures[109].