Minerva Neurosciences(US:NERV)2023-11-07 12:00Financial Position - As of September 30, 2023, Minerva Neurosciences, Inc. had an accumulated deficit of approximately $387.8 million and net cash used in operating activities was approximately $8.8 million during the nine months ended September 30, 2023[23]. - The Company had cash, cash equivalents, and restricted cash of $47.0 million, which is expected to be sufficient to meet operating commitments for the next 12 months[24]. - The Company has incurred recurring operating losses and negative cash flows from operations since inception, indicating ongoing financial challenges[23]. - The Company will need to raise additional capital to continue funding operations and later stage clinical development programs[25]. - As of September 30, 2023, accrued expenses and other liabilities totaled approximately $1.95 million, with significant increases in research and development costs and accrued bonuses compared to December 31, 2022[40]. Regulatory and Development Updates - The FDA confirmed that the NDA for roluperidone was assigned a standard review classification with a Prescription Drug User Fee Act goal date of February 26, 2024[21]. - Minerva has exclusive rights to develop and commercialize MIN-301 for Parkinson's disease and previously co-developed seltorexant, from which it is entitled to collect mid-single digit royalties on future sales[22]. - The Company has no commercially approved products and faces significant risks related to regulatory approvals and competition[34]. - The Company has two ongoing Phase 3 studies for seltorexant, with a third study discontinued in 2022, impacting future royalty revenues[46]. Stock and Compensation - The reverse stock split on June 17, 2022, reduced the number of outstanding shares from 42,721,566 to 5,340,193[30]. - The weighted average shares of common stock outstanding increased to 7,568,981 in Q3 2023 from 5,340,193 in Q3 2022[43]. - The Company received gross proceeds of $20 million from a private placement of common stock and warrants on June 30, 2023, with net proceeds of $19.6 million after offering expenses[50]. - The Royalty Obligation related to the sale of future royalties amounted to $79,826,671 as of September 30, 2023, including a non-cash interest expense of $19,826,671[47]. - The effective annual interest rate for the Royalty Obligation was estimated at approximately 10.7% as of September 30, 2023, up from 10.5% at the time of execution[46]. - The Company has 735,929 stock options outstanding as of September 30, 2023, with a weighted average exercise price of $14.19 and an intrinsic value of $1,037,000[56]. - The weighted average grant-date fair value of stock options outstanding on September 30, 2023, was $9.88 per share, with total unrecognized compensation costs of approximately $1.6 million[57]. - The Company has not issued any shares under its at-the-market equity offering program during the nine months ended September 30, 2023, with $22.6 million still eligible for sale[53]. - The Company has 228,213 PRSUs vested, 20,218 cancelled, and 228,209 outstanding as of September 30, 2023[62]. - 50% of the shares of common stock underlying the Company's PRSUs vested following FDA acceptance of the NDA for roluperidone, resulting in the recognition of approximately $0.2 million in non-cash compensation expense for the period ending September 30, 2023[62]. - For the three months ended September 30, 2023, total stock-based compensation expense was $371,943, a decrease from $1,036,874 in the same period of 2022[63]. - For the nine months ended September 30, 2023, total stock-based compensation expense was $1,357,317, compared to $3,161,135 for the same period in 2022[63]. Lease and Legal Matters - The Company entered into a month-to-month office lease agreement with a monthly payment of $8,290, commencing February 1, 2023[65]. - The Company has not recognized the lease agreement on the balance sheet as the term is 12 months or less[65]. - The Company is not aware of any legal claims or litigation that would materially affect its financial position or results of operations[64]. Research and Development Expenses - The Company’s research and development expenses for the three months ended September 30, 2023, were $185,075, down from $518,920 in the same period of 2022[63].