Minerva Neurosciences(NERV) - 2019 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of September 30, 2019, the company reported cash, cash equivalents, restricted cash, and marketable securities of approximately $60 million, which is expected to meet cash commitments for at least the next 12 months [26] - Research and development expenses for Q3 2019 were $9.7 million, compared to $8.4 million in Q3 2018, while for the nine months ended September 30, 2019, expenses were $29.6 million compared to $25.9 million for the same period in 2018 [26] - General and administrative expenses for Q3 2019 were $4.6 million, up from $4.1 million in Q3 2018, and for the nine months ended September 30, 2019, they were $13.9 million compared to $12.2 million in the same period in 2018 [27] - The company reported a net loss of $14 million for Q3 2019, compared to a net loss of $12 million in Q3 2018, and for the nine months ended September 30, 2019, the net loss was $42.3 million compared to $37 million for the same period in 2018 [28] Business Line Data and Key Metrics Changes - The company has completed and read out top-line results from four trials with seltorexant in major depressive disorder (MDD) and insomnia [9] - Enrollment in the Phase 2b trial with MIN-117 in MDD has been concluded, with top-line results expected in Q4 2019 [9][18] - Patient enrollment in the pivotal Phase III trial with roluperidone has resumed, with expectations to complete enrollment of 501 patients by year-end [10][11] Market Data and Key Metrics Changes - Seltorexant has shown meaningful and consistent improvement in mood and sleep symptoms across trials, with the 20 mg dose demonstrating the most robust effects [20][21] - The company is currently discussing next steps in the seltorexant program with Janssen, indicating ongoing collaboration in the market [23] Company Strategy and Development Direction - The company aims to maintain the quality of patient screening and selection in clinical trials, prioritizing integrity over speed in recruitment [11] - There is a focus on advancing roluperidone, seltorexant, and MIN-117 through clinical testing, with an emphasis on differentiating these products from currently approved treatments [23] - The company is preparing for the filing of a new drug application for roluperidone, with a commercial supply agreement already in place [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their clinical-stage products to address significant unmet medical needs, particularly in treating negative symptoms of schizophrenia [14][23] - The company is optimistic about the upcoming results from clinical trials and the potential for regulatory pathways for their product candidates [65] Other Important Information - The company has completed drug-drug interaction studies for roluperidone, showing minimal interaction with cytochrome P450 enzymes, which is favorable for its use as a monotherapy or in combination [33] - A new patent application related to MIN-117 for neuropathic pain has been filed, indicating exploration of additional therapeutic areas [34] Q&A Session Summary Question: Clarification on site expansion for roluperidone Phase III - Management clarified that they are not adding new sites to counter recruitment delays, emphasizing the importance of maintaining study integrity [31] Question: Results from drug-drug interaction studies for roluperidone - Management confirmed that the studies showed minimal interaction with key cytochrome enzymes, supporting the drug's use in various treatment settings [33] Question: Timeline for seltorexant and Janssen collaboration - Management indicated that they are working closely with Janssen to finalize plans based on feedback from an upcoming end of Phase II meeting with the FDA [39] Question: Safety data requirements for roluperidone filing - Management stated that they can start filing based on the 12-week double-blind phase results, with the 12-month safety data potentially added in a rolling basis [40] Question: Proportion of US to EU patients in roluperidone trials - Management confirmed that they aim for approximately 30% of patients from the US, but this is not mandatory, and they are monitoring safety and efficacy across regions [55] Question: Powering assumptions for MIN-117 trial - Management confirmed a clinically meaningful threshold of a 2.5 point difference over placebo for the MADRS scale, with good recruitment in the US [56] Question: Interest in advancing MIN-117 into Phase III - Management indicated that they will evaluate options based on the results of the ongoing trials before making decisions on partnerships or independent advancement [60]