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Y-mAbs(YMAB) - 2019 Q4 - Earnings Call Presentation
2020-03-14 02:00
业绩总结 - Naxitamab的滚动BLA提交于2019年11月启动,预计在2020年3月底完成[8] - Omburtamab的滚动BLA提交于2020年5月完成[8] - Naxitamab在2019年SIOP会议中显示出78%的客观反应率(ORR)和50%的两年无进展生存率(PFS)[14] - Naxitamab在计划的BLA申请中,预计24名患者的ORR超过70%[14] - GD2-GD3疫苗在高风险神经母细胞瘤患者中的两年生存率约为90%[30] - 131I-omburtamab在CNS/LM患者中的中位生存期为51个月,历史中位生存期约为6个月[54][52] 用户数据 - Naxitamab在神经母细胞瘤的市场潜力为800名患者,其中450名为可接触患者[11] - B7-H3 omburtamab针对扩散性内脏脑干胶质瘤的市场潜力为300名患者[11] 未来展望 - Naxitamab针对前线高风险神经母细胞瘤的研究正在进行中,预计在2020年启动[15] - 177Lu-omburtamab的临床试验预计在2020年第二季度开始[8] - 公司计划在2020年进行多项临床试验,以扩展治疗适应症和治疗线[75] 融资与财务状况 - 公司已确保融资至2022年底,显示出财务实力[8] - Y-mAbs至今已成功融资3.74亿美元,现金及现金等价物为2.07亿美元(截至2020年1月1日)[74] - 2017年融资9500万美元,2018年融资1.1亿美元,2019年融资1.44亿美元[73] 新产品与技术研发 - naxitamab和omburtamab为两款关键阶段候选药物,均获得突破性疗法认定(BTD)[75] - 针对GD2-GD3疫苗的二期研究正在进行中,针对高风险神经母细胞瘤患者[75] 商业策略 - 公司致力于建立高效的商业组织,以支持神经母细胞瘤的上市和推广[68]
Y-mAbs(YMAB) - 2019 Q4 - Annual Report
2020-03-13 04:38
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, 2019. 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 001‑38650 Y-mAbs Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 47‑4619612 (State ...
Y-mAbs(YMAB) - 2019 Q3 - Quarterly Report
2019-11-14 05:18
Table of Contents 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 September 30, 2019 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 001-38650 Y-mAbs Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction o ...
Y-mAbs(YMAB) - 2019 Q2 - Quarterly Report
2019-08-15 04:02
Table of Contents 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 June 30, 2019 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 001-38650 Y-mAbs Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I. ...
Y-mAbs(YMAB) - 2019 Q1 - Quarterly Report
2019-05-11 04:04
Table of Contents For the transition period from to Commission file number 001-38650 Y‑mAbs Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 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, 2019 OR ☐ TRANSITION REPORT PURSU ...
Y-mAbs(YMAB) - 2018 Q4 - Annual Report
2019-03-23 04:02
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, 2018. 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 001‑38650 Y‑mAbs Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 47‑4619612 (State ...