Minerva Neurosciences(US:NERV)2023-08-01 11:01Financial Position - As of June 30, 2023, the company had an accumulated deficit of approximately $380.0 million and net cash used in operating activities was approximately $4.0 million during the six months ended June 30, 2023[28]. - The company had cash, cash equivalents, and restricted cash of $51.9 million as of June 30, 2023, which is expected to be sufficient to meet operating commitments for the next 12 months[29]. - The company needs to raise additional capital to continue funding operations and potential later-stage clinical development programs[30]. - As of June 30, 2023, accrued expenses and other current liabilities totaled approximately $1.6 million, with significant increases in accrued bonuses and professional fees compared to December 31, 2022[46]. - The company has no commercially approved products and is subject to significant risks and uncertainties related to clinical testing and regulatory approvals[39]. Stock and Securities - The company’s common stock regained compliance with Nasdaq Listing Rule 5550(b)(2) on June 16, 2023, maintaining a minimum market value of listed securities of $35 million or greater[31]. - The Company issued pre-funded warrants for an aggregate of 575,575 shares of common stock at a purchase price of $9.99 per share, with an exercise price of $0.01 per share[48]. - The Company received gross proceeds of $20.0 million from a private placement of common stock and warrants on June 30, 2023, with net proceeds amounting to $19.7 million after offering expenses[56]. - The Company has not issued or sold any shares under the at-the-market equity offering program during the six months ended June 30, 2023, with $22.6 million still eligible for sale[59]. - The Company has agreed to file a registration statement covering the resale of securities from the private placement within 45 days of closing[57]. Financial Performance - The net loss for the three months ended June 30, 2023, was $6,192,036, compared to a net loss of $8,717,714 for the same period in 2022, representing a 29% improvement[49]. - The basic and diluted net loss per share for the three months ended June 30, 2023, was $(1.12), compared to $(1.63) for the same period in 2022, indicating a 31% reduction in loss per share[49]. - Total stock-based compensation expense for the three months ended June 30, 2023, was $608,915, a decrease of 43.2% compared to $1,071,605 for the same period in 2022[69]. - Research and development expenses for the three months ended June 30, 2023, were $297,756, down 42.2% from $514,806 in the same period of 2022[69]. - General and administrative expenses for the three months ended June 30, 2023, were $311,159, a decrease of 44.2% compared to $556,799 for the same period in 2022[69]. Clinical Development - The company received a refusal to file letter from the FDA for its NDA for roluperidone in October 2022, but the NDA was filed again on April 27, 2023, with a Prescription Drug User Fee Act goal date of February 26, 2024[26]. - The company has exclusive rights to develop and commercialize MIN-301 for Parkinson's disease and previously sold rights to royalties from seltorexant for $60 million upfront and up to $95 million in potential future milestone payments[27]. - The Company has two ongoing Phase 3 studies for seltorexant, while a third study was discontinued in 2022[52]. Compensation and Stock Options - The Company has 700,929 common stock options outstanding as of June 30, 2023, with a weighted average exercise price of $15.69 and an intrinsic value of $2,022,000[62]. - The Company has 118,666 stock options available for future grant as of June 30, 2023[62]. - As of June 30, 2023, the total unrecognized compensation costs related to non-vested stock options were approximately $0.5 million, expected to be recognized over a weighted-average period of 0.5 year[67]. - The Company recognized approximately $0.2 million in non-cash compensation expense for the period ending June 30, 2023, due to the vesting of 50% of the PRSUs following FDA acceptance of the NDA for roluperidone[68]. - As of June 30, 2023, 228,213 PRSUs have vested, with 20,218 cancelled and 228,209 remaining outstanding[68]. Lease and Legal Matters - The Company entered into a month-to-month office lease agreement on February 1, 2023, with a monthly payment of $8,290 for approximately 491 rentable square feet[71]. - The Company is not aware of any legal claims or litigation that would materially affect its financial position or results of operations[70].