Minerva Neurosciences(US:NERV)2023-05-15 11:01Financial Performance - As of March 31, 2023, Minerva Neurosciences had an accumulated deficit of approximately $373.8 million and net cash used in operating activities was approximately $0.1 million for the three months ended March 31, 2023[26]. - For the three months ended March 31, 2023, the net loss was $6,970,412, resulting in a basic and diluted loss per share of $1.31, compared to a net loss of $9,764,429 and a loss per share of $1.83 for the same period in 2022[45]. - The company has incurred recurring operating losses and negative cash flows from operations since inception, financing operations through various means including equity financings and collaboration agreements[26]. - Total stock-based compensation expense for the three months ended March 31, 2023, was $376,459, a decrease from $1,052,656 in the same period of 2022[60]. Cash and Liquidity - The company had cash, cash equivalents, and restricted cash totaling $36.1 million, which is expected to be sufficient to meet operating commitments for the next 12 months[27]. - The company will need to raise additional capital to fund operations and later-stage clinical development programs, with no assurance that such financing will be available on acceptable terms[28]. - As of March 31, 2023, accrued expenses and other liabilities totaled $1,540,663, a significant increase from $407,909 as of December 31, 2022[44]. - As of March 31, 2023, the total liability related to the sale of future royalties amounted to $75.7 million, which includes $15.7 million in non-cash interest expense[49]. - The effective annual interest rate for the Royalty Obligation was estimated to be approximately 10.7% as of March 31, 2023[48]. Agreements and Collaborations - The company has exclusive rights to develop and commercialize MIN-301 for Parkinson's disease and previously co-developed seltorexant with Janssen, opting out of the agreement in 2020[25]. - The Company entered into an agreement with Royalty Pharma for an upfront payment of $60 million and potential milestone payments of up to $95 million related to seltorexant[47]. - The company sold its rights to potential royalties from seltorexant to Royalty Pharma in January 2021, entitling it to collect royalties in the mid-single digits on future sales[25]. Regulatory and Compliance - The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024, for the New Drug Application (NDA) of roluperidone, following a formal dispute resolution request[24]. - The company received a deficiency letter from Nasdaq regarding its Market Value of Listed Securities (MVLS), which was below the required $35 million, and has until May 30, 2023, to regain compliance[29]. Stock and Compensation - No shares of the Company's common stock were issued or sold under the At-the-Market Equity Offering Program during the three months ended March 31, 2023, with $22.6 million eligible for sale[50]. - The Company granted 476,640 performance-based restricted stock units (PRSUs) through an Exchange Program, with 50% vesting upon FDA acceptance of a new drug application for roluperidone[53]. - As of March 31, 2023, the total unrecognized compensation costs related to non-vested stock options were approximately $1.5 million, expected to be recognized over 2.6 years[56]. - On April 28, 2023, 50% of the shares underlying the PRSUs granted on August 6, 2021 vested following FDA acceptance of a new drug application for roluperidone[63]. Operations - The Company is currently conducting two Phase 3 studies with seltorexant, while a third study was discontinued in 2022[48]. - The Company has a month-to-month office lease agreement with a monthly payment of $8,290, commencing February 1, 2023[62].