— Minerva Neurosciences Inc. (NASDAQ: NERV) reported a fourth-quarter 2019 loss of $29.9 million or $0.77 per share, wider than a loss of $13.2 million or $0.34 per share a year ago. Analysts estimated a loss of $0.38 per share.
— Research and development expenses jumped by 217% due to non-cash impairment expense for discontinued development of MIN-117 as well as higher development expenses for the phase 3 clinical trial of roluperidone and the phase 2b clinical trial of MIN-117.
— Cash, cash equivalents, marketable securities and restricted cash as of December 31, 2019, decreased by 48% to $46 million from a year earlier.
— The company confirmed its previous forecast that top-line results from the Phase 3 trial with roluperidone are expected in the second quarter of 2020.
— Minerva announced positive data readouts in three-phase 2b studies and one phase 1b trial with seltorexant (MIN-202) during 2019. Three of these trials were in major depressive disorder (MDD) and one was in insomnia disorder.
— The company is currently in discussions with its partner, Janssen Pharmaceutica NV, regarding the phase 3 strategic development program for seltorexant, with a target indication of adjunctive treatment of MDD in patients with insomnia symptoms.
— The company is developing MIN-301, a pre-clinical candidate for the potential treatment of Parkinson’s disease and other neurodegenerative disorders. The company is continuing to conduct pre-clinical studies in preparation for regulatory filings leading toward entry into humans.