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MINERVA NEUROSCIENCES , INC . Minerva Neurosciences Reports Third Quarter 2021 Financial Results and Business Updates November 8 , 2021 Company to Host Conference Call Today at 8:30 a.m. ET WALTHAM , Mass . , Nov. 08 , 2021 ( GLOBE NEWSWIRE ) Minerva Neurosciences , Inc. ( Nasdaq : NERV ) , a clinical - stage biopharmaceutical company focused on the development of therapies to treat central nervous system ( CNS ) disorders , today reported key business updates and financial results for the quarter ended September 30 , 2021 . Roluperidone Update On November 3 , 2021 , the Company announced that the U. S. Food and Drug Administration ( FDA ) denied the company's request for a pre - NDA meeting for roluperidone and responded that a Type C guidance meeting would be more appropriate to discuss the evidence for use of roluperidone as monotherapy for the treatment of negative symptoms in schizophrenia . The Company plans to request a Type C meeting and , subject to the timing of and feedback from the FDA , continues to work towards the submission of a New Drug Application ( NDA ) in the first half of 2022 . On September 30 , 2021 , the Company completed and announced results from a pivotal bioequivalence study comparing the roluperidone formulations used in its late - stage Phase 2b and Phase 3 trials and the planned commercial formulation . The planned commercial formulation was tested under both fasted and fed conditions . The study met key pharmacokinetic ( PK ) objectives , and the data demonstrate bioequivalence across the various formulations . Management Team Update In October , the Company promoted Geoff Race , former Executive Vice President , Chief Financial Officer and Chief Business Officer of Minerva , to President . Minerva's Senior Vice President and Chief Accounting Officer , Frederick Ahlholm , was promoted to Chief Financial Officer . In September , Dr. Ramana Kuchibhatla was appointed Senior Vice President and Head of Research & Development following Dr. Jay Saoud's retirement and transition to an advisory role . This is a key addition to the Company's leadership team which will help support forthcoming interactions with the FDA . Third Quarter 2021 Financial Results • Net Income / Loss : Net loss was $ 9.2 million for the third quarter of 2021 , or net loss per share of $ 0.22 basic and diluted , as compared to net loss of $ 8.1 million , or net loss per share of $ 0.19 basic and diluted , for the third quarter of 2020. Net loss was $ 28.6 million for the nine months ended September 30 , 2021 , or net loss per share of $ 0.67 basic and diluted , as compared to net income of $ 9.3 million , or net income per share of $ 0.23 basic and diluted for the nine months ended September 30 , 2020 . The decreases in net income for both the three and nine month periods ended September 2021 , were primarily due to the Company's opting out of its joint development agreement with Janssen Pharmaceutica for seltorexant during the second quarter of 2020. As a result of opting out of the agreement , the Company immediately recognized $ 41.2 million in collaborative revenue which had previously been included on the balance sheet under deferred revenue . • R & D Expense : For the three months ended September 30 , 2021 and 2020 , research and development ( R & D ) expense was $ 4.5 million and $ 4.6 million , respectively , a decrease of approximately $ 0.1 million . For the three months ended September 30 , 2021 and 2020 , non - cash stock compensation expense included in R & D was $ 0.5 million and $ 0.8 million , respectively . For the nine months ended September 30 , 2021 and 2020 , R & D expense was $ 13.3 million and $ 18.5 million , respectively , a decrease of approximately $ 5.2 million . For the nine months ended September 30 , 2021 and 2020 , non - cash stock compensation expense included in R & D was $ 1.8 million and $ 2.2 million , respectively . The decrease in R & D expense for both the three and nine month periods ended September 30 , 2021 versus the same periods in 2020 was primarily due to lower costs for the Phase 3 clinical trial of roluperidone , for which the three - month core study portion of the trial was completed in May 2020 . • G & A Expense : For the three months ended September 30 , 2021 and 2020 , general and administrative ( G & A ) expense was $ 3.0 million and $ 3.5 million , respectively , a decrease of approximately $ 0.5 million . For the three months ended September 30 , 2021 and 2020 , non - cash stock compensation expense included in G & A was $ 0.6 million and $ 1.2 million , respectively .