UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File No. 001-36517 Minerva Neurosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 26-0784194 (State or Other Jurisdiction of ...

财务数据和关键指标变化 - 2022年12月31日的现金、现金等价物和受限现金约为3620万美元,相比2021年12月31日的6090万美元减少了[15] - 2022年第四季度和2021年第四季度的研发费用分别为320万美元和1870万美元,减少了1550万美元,主要是由于2021年第四季度计提了1520万美元的MIN-301研发项目减值[17][19] - 2022年和2021年全年的研发费用分别为1460万美元和3200万美元,减少了1740万美元,主要是由于2021年第四季度计提了1520万美元的MIN-301研发项目减值以及2022年临床试验成本较低[18][19] - 2022年和2021年全年的管理费用分别为1060万美元和1330万美元,减少了270万美元,主要是由于薪酬费用和法律保险费用较低[21] 各条业务线数据和关键指标变化 - 公司没有披露各业务线的具体数据和指标变化 各个市场数据和关键指标变化 - 公司没有披露各市场的具体数据和指标变化 公司战略和发展方向及行业竞争 - 公司正在开发roluperidone作为治疗精神分裂症患者阴性症状的潜在创新性治疗方法[7][8][9][10][11] - 公司已于2022年8月提交了roluperidone的新药申请,但FDA发出了拒绝受理通知,公司正在与FDA进行进一步沟通[12] - FDA的主要关切包括:1)第2b期临床试验没有美国患者,FDA需要确保美国和非美国患者的可比性;2)第3期临床试验中只有最高剂量达到统计学显著性,FDA对此有一些技术性担忧[26][27][28] - 公司认为已经提供了大量数据来解决FDA的担忧,包括美国和非美国患者的可比性以及功能改善等,正在与FDA进一步沟通[29][30][31][34][35] - 公司表示,如果需要进行额外的临床试验,将会在获得FDA的完全认可后再进行,目前公司正专注于与FDA的对话,以获得对现有数据包的全面审查[43][44][45][46][47][48][53][54][57][58] 管理层对经营环境和未来前景的评论 - 公司表示,现有现金和现金等价物足以满足未来至少12个月的预期资本需求[16] - 公司对roluperidone的未来发展前景保持信心,认为现有的临床试验数据足以支持FDA的全面审查,并期待与FDA进一步沟通以获得更多明确[60][61] 问答环节重要的提问和回答 问题1 **Andrew Tsai 提问** FDA提出的最新问题是什么,导致公司收到拒绝受理通知并在后续会议中维持原决定[25] **Remy Luthringer 回答** 1) FDA对第2b期临床试验中没有美国患者的适用性存在疑虑,需要确保美国和非美国患者在疾病、阴性症状等方面的可比性[26][27] 2) FDA对第3期临床试验使用Hochberg校正的统计分析方法存在一些技术性担忧,因为只有最高剂量达到统计学显著性[28] 公司正在继续与FDA沟通,提供更多数据来解决这些问题[29][30][31][34][35] 问题2 **Douglas Tsao 提问** 公司是否考虑再进行一项新的临床试验,是单药还是联合用药,以更有效地解决FDA的担忧[42] **Remy Luthringer 回答** 1) FDA目前没有要求公司进行额外的临床试验,公司正专注于与FDA就现有数据包进行深入沟通和分析[43][44][53][54][57] 2) 公司之前考虑过单药和联合用药的临床试验设计,但目前认为这应该是获得FDA全面审查后的后续工作[45][46][47][48] 3) 公司希望通过与FDA的进一步对话,获得对现有数据包的清晰指引,再决定是否需要进行额外的临床试验[58]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-36517 Minerva Neurosciences, Inc. (Exact name of Registrant as specified in its Charter) Delaware 26-0784194 (State or other jurisdic ...

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q3 2022 Earnings Conference Call November 9, 2022 8:30 AM ET Company Participants Geoff Race - President Remy Luthringer - CEO Frederick Ahlholm - CFO Conference Call Participants Andrew Tsai - Jefferies Douglas Tsao - H.C. Wainwright Myles Minter - William Blair Operator Thank you for standing by. Welcome to the Minerva Neurosciences Third Quarter 2022 Conference Call. At this time, all participants are in a listen-only mode. After the speakersÂ' presentation, ther ...

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q3 2021 Results Earnings Conference Call November 8, 2021 8:30 AM ET Company Participants Geoff Race - President Remy Luthringer - Chief Executive Officer Frederick Ahlholm - Chief Financial Officer Conference Call Participants Andrew Tsai - Jefferies Thomas Shrader - BTIG Jason Butler - JMP Securities Douglas Tsao - H.C. Wainwright Operator Welcome to the Minerva Neurosciences Third Quarter 2021 Call. At this time, all participants are in a listenonly mode. There w ...

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q2 2021 Results Conference Call August 2, 2021 8:30 AM ET Company Participants William Boni - Vice President, Investor Relations & Corporate Communications Remy Luthringer - Executive Chairman & Chief Executive Officer Geoff Race - Executive Vice President, Chief Financial Officer & Chief Business Officer Conference Call Participants Andrew Tsai - Jefferies Myles Minter - William Blair Jason Butler - JMP Securities Douglas Tsao - H.C. Wainwright Operator Welcome to ...

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q1 2021 Earnings Conference Call May 12, 2021 8:30 AM ET Company Participants William Boni - Vice President, Investor Relations & Corporate Communications Remy Luthringer - Executive Chairman & Chief Executive Officer Geoff Race - Executive Vice President, Chief Financial Officer & Chief Business Officer Conference Call Participants Jason Butler - JMP Securities Tom Shrader - BTIG Jay Olson - Oppenheimer Douglas Tsao - H.C. Wainwright Myles Minter - William Blair Op ...

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q4 2020 Earnings Conference Call March 8, 2021 8:30 AM ET Company Participants William Boni - VP, IR and Corporate Communications Remy Luthringer - Executive Chairman and Chief Executive Officer Geoff Race - Executive Vice President, Chief Financial Officer and Chief Business Officer Conference Call Participants Jason Butler - JMP Jeet Mukherjee - Jefferies Joel Beatty - Citi Myles Minter - William Blair Douglas Tsao - H.C. Wainwright Operator Welcome to the Minerva ...

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q3 2020 Results Earnings Conference Call November 2, 2020 8:30 AM ET Company Participants William Boni - VP, IR & Corporate Communications Remy Luthringer - Executive Chairman and Chief Executive Officer Geoff Race - Executive Vice President, Chief Financial Officer and Chief Business Officer Conference Call Participants Joel Beatty - Citi Douglas Tsao - H.C. Wainwright Myles Minter - William Blair Jeet Mukherjee - Jefferies Operator Welcome to the Minerva Neuroscie ...

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q2 2020 Earnings Conference Call August 3, 2020 8:30 AM ET Company Participants William Boni - VP, IR & Corporate Communications Remy Luthringer - Executive Chairman and CEO Geoff Race - EVP, CFO and Chief Business Officer Conference Call Participants Shawn Egan - Citi Unidentified Analyst - Jefferies Unidentified Analyst - BTIG Jason Butler - JMP Securities Myles Minter - William Blair Douglas Tsao - H.C. Wainwright Operator Welcome to the Minerva Neurosciences Sec ...