Minerva Neurosciences(US:NERV)2022-05-04 11:30Financial Performance - The company reported an accumulated deficit of approximately $344.5 million as of March 31, 2022, and anticipates continued net losses for the foreseeable future [89]. - The company has incurred significant operating losses every year since inception and expects to continue incurring negative cash flow from operating activities [68]. - Net cash used in operating activities was approximately $5.8 million for the three months ended March 31, 2022, compared to $5.2 million for the same period in 2021, primarily due to net losses of $9.8 million and $8.8 million respectively [96][97][98]. Cash and Liquidity - As of March 31, 2022, the company had approximately $55.0 million in cash, cash equivalents, and restricted cash, which is expected to meet cash commitments for at least the next 12 months [89]. - The existing cash, cash equivalents, and restricted cash are believed to be sufficient to meet cash commitments for at least the next 12 months [94]. - Net cash provided by financing activities was $60 million during the three months ended March 31, 2021, resulting from the sale of future royalties, while there was no cash provided from financing activities in the same period of 2022 [100]. Expenses - Research and development expenses increased to $5.0 million for Q1 2022, up from $3.3 million in Q1 2021, representing a 51.5% increase primarily due to higher consulting fees related to NDA support activities [84]. - General and administrative expenses decreased to $3.0 million for Q1 2022, down from $4.2 million in Q1 2021, a reduction of approximately 28.6% due to lower staffing and legal costs [85]. - Non-cash interest expense for the sale of future royalties increased to $1.8 million in Q1 2022 from $1.3 million in Q1 2021, reflecting a 38.5% increase due to a higher effective interest rate [88]. - Stock-based compensation expense was $1.1 million for the three months ended March 31, 2022, compared to $1.5 million for the same period in 2021 [97][98]. Future Outlook - The company is preparing for a potential NDA submission for roluperidone during Q3 2022, contingent on FDA feedback [77]. - The company anticipates needing to raise additional capital or seek product collaborations to complete the development and commercialization of its product candidates [80]. - Future capital requirements will depend on various factors, including the size and timing of clinical trials and strategic partnering activities [94]. - The uncertainty in capital markets due to the COVID-19 pandemic may negatively impact the availability and cost of capital for the company [94]. Operational Activities - The company has completed the Open-label extension of the Phase 3 study for roluperidone, focusing on negative symptoms of schizophrenia [70]. - The company has not generated any revenue from product sales and relies on collaborative revenue from the sale of royalty interests in seltorexant, which was sold to Royalty Pharma for an upfront payment of $60 million [92]. - The company reported a decrease in accounts payable of $0.3 million during the three months ended March 31, 2022, which contributed to the net cash used in operating activities [97]. Accounting Policies - The company has identified critical accounting policies related to research and development costs and the liability related to the sale of future royalties as significant for its financial status [101]. - There were no cash flows from investing activities for both the three months ended March 31, 2022, and 2021 [99].