Minerva Neurosciences(NERV) - 2019 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of June 30, 2019, cash, cash equivalents, restricted cash, and marketable securities were approximately $69.4 million, sufficient to meet cash commitments for at least the next 12 months [38] - Research and Development (R&D) expenses were $8.3 million in Q2 2019, down from $9.1 million in Q2 2018, reflecting decreased nonclinical and clinical pharmacology expenses [39] - General and Administrative (G&A) expenses increased to $4.6 million in Q2 2019 from $3.9 million in Q2 2018, primarily due to increased non-cash stock-based compensation and salary costs [40] - Net loss for Q2 2019 was $12.5 million, unchanged from Q2 2018, while the net loss for the first six months of 2019 was $28.3 million compared to $24.9 million for the same period in 2018 [42] Business Line Data and Key Metrics Changes - The company reported positive top-line results in two Phase 2b trials with seltorexant for major depressive disorder (MDD) and insomnia, indicating significant improvements in symptoms [10][11] - The Phase 3 trial with roluperidone is ongoing, focusing on patients with schizophrenia and negative symptoms, with approximately 500 patients expected to be enrolled [28] Market Data and Key Metrics Changes - The recent studies indicate that seltorexant shows efficacy in both adjunctive and monotherapy treatment of MDD, with significant improvements noted in patients with insomnia [20][26] - The insomnia study demonstrated statistically significant improvements in sleep latency in elderly patients, suggesting a favorable profile for seltorexant in this demographic [24][25] Company Strategy and Development Direction - The company aims to address unmet medical needs in neuropsychiatric disorders, with a focus on developing seltorexant and roluperidone as key therapeutic options [13][35] - Preparations for a New Drug Application (NDA) for roluperidone are underway, pending positive Phase 3 results, with a focus on ensuring adherence to trial parameters [32][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of seltorexant to treat multiple patient groups in MDD and insomnia [35] - The company is optimistic about the second half of 2019, anticipating important results from late-stage clinical trials [35][89] Other Important Information - The company is co-developing seltorexant with Janssen Pharmaceutica NV, which is noted as the only late-stage specific orexin-2 antagonist in development [14] - The safety and tolerability profile of seltorexant is comparable to that of placebo, indicating a favorable risk-benefit ratio [27] Q&A Session Summary Question: Impact of Phase 2 results on seltorexant program - Management indicated that the Phase 2 results will help fine-tune the development plan but will not change the basic strategy for Phase 3 studies [46][48] Question: Breakdown of patients in the Phase 3 roluperidone program - Management confirmed efforts to achieve approximately 30% of patients from the U.S., with current enrollment aligning well with this target [50] Question: Timeline for NDA filing if Phase 3 results are successful - Management stated that preparations for the NDA are on track, with a focus on obtaining 12 months of safety data post-Phase 3 results [54][55] Question: Key takeaways from the MDD1009 study for seltorexant - The study confirmed the drug's direct effect on mood and reassured management about the drug's innovative mechanism of action [60][62] Question: Treatment effect differences with the 20 mg dose before week-5 - Management noted that differentiation between placebo and treatment was observed after two weeks, consistent with previous studies [81] Question: Evaluation of both 20 mg and 40 mg doses in the ongoing trial - The ongoing trial is a flexible dose study allowing for both 20 mg and 40 mg doses to be evaluated [85]