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NextCure (NXTC) Presents At The 19th Annual Morgan Stanley Virtual Global Healthcare Conference - Slideshow
2021-09-11 02:44
产品管线进展 - NC318(S15)处于2期单药和联合疗法阶段,单药疗法预计2021年4季度更新数据,联合抗PD - 1疗法预计2022年上半年出初始数据[10][13] - NC410(LAIR - 1)处于1期单药疗法阶段,预计2021年下半年出初始数据[10][13] - NC762(B7 - H4)处于1期单药疗法阶段,预计2022年年中出初始数据[10][13] 产品研发情况 - NC318 1/2期单药试验1期有49名患者、15种肿瘤类型,2期恢复NSCLC腺癌队列入组,有相关病例确认缓解[20][21] - NC410是靶向TME的诱饵人融合蛋白,1/2期1期部分有8个剂量组,3mg至400mg,预计2021年4季度出初始数据[32][49] - NC762是人源化B7 - H4单克隆抗体,1/2期1期部分预计2022年年中出初始数据[51][55] 其他情况 - 公司GMP制造设施容量为2000L,使用CMO会增加约8个月时间线[56][57][58] - 2021年Q2现金头寸为2.495亿美元,资金可支撑到2023年下半年[66]
NextCure(NXTC) - 2021 Q2 - Quarterly Report
2021-08-06 04:29
Washington, D.C. 20549 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 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: 001-38905 NextCure, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of ...
NextCure (NXTC) Presents at 7th Annual Truist Securities Life Sciences Summit - Slideshow
2021-05-11 01:41
公司亮点 - 产品管线有NC318(S15)处于2期、NC410(LAIR - 1)处于1期、NC762(B7 - H4)处于IND阶段,制造设施产能2000L[6] - 拥有FIND - IO功能筛选发现引擎,验证新型癌症靶点和新作用机制[6] - 团队完全整合,管理团队经验丰富,有强大免疫学能力[6] 产品开发进度 - NC318(S15)单药疗法2021年4季度报告更新,与抗PD - 1联合疗法2021年2季度开始2期试验[8] - NC410(LAIR - 1)2021年下半年公布初始数据[8] - NC762(B7 - H4)2021年2季度开始1期试验,2022年有多个项目进行IND申报[8] 财务与里程碑 - 2021年Q2现金头寸2.834亿美元,资金可支撑到2023年下半年[30] - NC318(S15)单药疗法2021年进入2期更新阶段,与抗PD - 1联合疗法预计2022年有初始数据[30] - NC410(LAIR - 1)2021年有初始数据,NC762(B7 - H4)2022年有初始数据[30]
NextCure(NXTC) - 2021 Q1 - Quarterly Report
2021-05-07 04:39
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ⌧ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents For the quarterly period ended March 31, 2021 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: 001-38905 NextCure, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of ...
NextCure (NXTC) Presents At 20th Annual Needham Healthcare Conference - Slideshow
2021-04-16 06:01
公司亮点 - 产品管线有NC318(S15)处于2期、NC410(LAIR - 1)处于1期、NC762(B7 - H4)处于IND阶段,制造有2000L容量的先进设施[6] - 拥有FIND - IO功能筛选发现引擎,可验证新型癌症靶点和新作用机制[6] - 团队完全整合,管理经验丰富,有强大免疫学能力[6] 产品进展 - NC318单药治疗1期试验完成剂量递增、安全性和耐受性测试,49名患者中1例确认完全缓解(118 +周)、1例确认部分缓解(92 +周);2期试验截至2021年3月4日,头颈癌和三阴性乳腺癌有部分缓解,目标病灶分别减少37%和82% [22][23][26][28] - NC410 1/2期人体试验1期部分预计2021年下半年出初始数据,临床前模型显示有协同活性[38][43] - NC762已提交IND申请,2021年2季度开始1期试验,体内可抑制人黑色素瘤肿瘤生长[47][49] 近期待达里程碑 - 2021年2季度NC318(S15)抗PD - 1联合疗法开始2期试验,NC762(B7 - H4)开始1期试验[11][56] - 2021年下半年NC318(S15)单药治疗进行2期更新,NC410(LAIR - 1)出初始数据[11][56] - 2022年预计NC318(S15)抗PD - 1联合疗法出初始数据,NC762(B7 - H4)出初始数据[56]
NextCure(NXTC) - 2020 Q4 - Annual Report
2021-03-05 05:34
Table of Contents 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, 2020 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: 001-38905 NextCure, Inc. (Exact name of registrant as specified in its charter) Delaware 04-5231247 (State or other ...
NextCure(NXTC) - 2020 Q3 - Quarterly Report
2020-11-06 05:18
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ⌧ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 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: 001-38905 NextCure, Inc. (Exact name of registrant as specified in its charter) Delaware 04-5231247 (State ...
NextCure(NXTC) - 2020 Q2 - Quarterly Report
2020-08-07 04:14
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ⌧ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 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: 001-38905 NextCure, Inc. (Exact name of registrant as specified in its charter) Delaware 04-5231247 (State or ot ...
NextCure (NXTC) Investor Presentation - Slideshow
2020-05-30 01:33
公司亮点 - 拥有NC318(S15)处于2期、NC410(LAIR - 1)已提交IND并获FDA批准的产品管线,还有专用先进制造设施[6] - 具备FIND - IO功能筛选发现引擎,可验证新型癌症靶点并拓展至自身免疫疾病领域[6] - 管理团队经验丰富,创始人发现PD - L1,具备强大免疫学能力[6] 产品研发 - NC318单药疗法预计2020年Q4末完成2期数据,与化疗联合预计2020年年中启动1期;NC410预计2020年Q2启动1期,多个项目预计2021年初首次提交IND,FIND - IO平台预计2022年末首次提交IND,部分因疫情有延迟[17] NC318情况 - 是靶向Siglec - 15的人源化单克隆抗体,用于NSCLC等多种癌症,可阻断S15诱导的免疫抑制[19] - 1期试验49名患者,800mg无剂量限制性毒性(DLTs),1600mg有1例3级肺炎DLT;有1例确认完全缓解(CR)、1例确认部分缓解(PR)、14例持久疾病稳定(SD)[39] - 2期试验正在招募NSCLC、H&N、卵巢、三阴性乳腺癌患者,预计因疫情延迟公布初始数据[48] NC410情况 - 是靶向肿瘤微环境(TME)的诱饵人融合蛋白,2020年Q1已提交IND[52] - 可防止免疫抑制,促进T细胞功能和树突状细胞(DC)激活,临床前研究显示增强T细胞扩增并减轻免疫抑制[57][60] FIND - IO平台 - 是功能性、综合性的免疫肿瘤学发现引擎,有多种功能读数和细胞类型,筛选方法独特[63][65] 近期里程碑 - NC318启动与标准护理化疗的2期联合试验及公布初始2期数据预计因疫情延迟 - NC410启动1期预计因疫情延迟 - FIND - IO平台识别新靶点并启动验证
NextCure(NXTC) - 2020 Q1 - Quarterly Report
2020-05-08 05:30
Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended March 31, 2020 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: 001-38905 NextCure, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of ...