Minerva Neurosciences(US:NERV)2022-11-09 15:02Financial Data and Key Metrics Changes - Cash, cash equivalents, and restricted cash as of September 30, 2022, were approximately $40.3 million, down from $60.9 million as of December 31, 2021, indicating a decrease of about 33.5% [18] - Net loss for the third quarter of 2022 was $6.9 million, or a net loss per share of $1.29, compared to a net loss of $9.2 million, or a net loss per share of $1.72 for the same period in 2021, showing an improvement in loss [27] - For the nine months ended September 30, 2022, net loss was $25.4 million, or a net loss per share of $4.75, compared to a net loss of $28.6 million, or a net loss per share of $5.36 for the same period in 2021, also indicating a reduction in loss [27] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses for the three months ended September 30, 2022, were $2.4 million, down from $4.5 million in the same period of 2021, a decrease of approximately 46.7% [20] - For the nine months ended September 30, 2022, R&D expenses were $11.5 million, down from $13.3 million in the same period of 2021, a decrease of approximately 13.5% [21] - General and administrative (G&A) expenses for the three months ended September 30, 2022, were $2.8 million, down from $3 million in the same period of 2021, a decrease of approximately 6.7% [23] - For the nine months ended September 30, 2022, G&A expenses were $8.7 million, down from $10.7 million in the same period of 2021, a decrease of approximately 18.7% [24] Company Strategy and Development Direction - The company submitted its NDA for roluperidone to treat negative symptoms in schizophrenia to the FDA, highlighting a significant unmet medical need as there are no approved drugs in the U.S. for this condition [9][12] - The company is focused on roluperidone as a monotherapy for a specific sub-population of schizophrenia patients who do not require continuous treatment with antipsychotics for positive symptoms [15] - The company plans to discuss the FDA's refusal to file letter in a Type A meeting, which is expected to clarify the path forward for the NDA submission [11][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Type A meeting with the FDA, which is expected to provide clarity on the NDA submission and the issues raised in the refusal to file letter [30][34] - The company is also working on an early-stage pipeline, although the primary focus remains on roluperidone as it is a late-stage asset and a key value driver [57] Other Important Information - The company filed a shelf registration statement on Form S-3 to register up to $200 million in new shares of common stock, indicating potential future capital raising efforts [18] - As of September 30, 2022, an aggregate of $22.6 million was eligible for sale under the effective registration statement [19] Q&A Session Summary Question: Can the company infer whether the FDA is comfortable with any of the issues previously outlined? - Management indicated that discussions with the FDA have been ongoing and that the upcoming Type A meeting will help clarify the situation [30] Question: What dynamics would need to play out before considering another study for roluperidone? - Management stated that clarity from the Type A meeting will determine the next steps, including whether another study is necessary [33] Question: Did the FDA provide specific reasons for the refusal to file letter? - Management confirmed that the FDA provided reasons, which will be discussed in the Type A meeting [43] Question: Is the company working on other assets in the pipeline? - Management confirmed that while the focus is on roluperidone, there is an early-stage pipeline that is being developed, albeit at a slower pace [57]