Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 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 001-39044 _____ ...

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K 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 Commission file number: 001-39044 SPRINGWORKS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State of Other Jurisdiction of incorporation or Organization) (I.R ...

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, 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 001-39044 SPRINGWORKS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 83-4066827 (State or other jur ...

业绩总结 - SpringWorks Therapeutics目前有两个晚期罕见肿瘤项目正在进行注册试验，均得到强有力的临床数据支持[8] - 截至2020年3月31日，公司现金及现金等价物为3.111亿美元，且无债务[90] - 当前现金状况预计可支持公司运营至2022年，完成六项正在进行和计划中的临床试验[91] 用户数据 - Nirogacestat在美国每年有约5,500至7,000名患者接受治疗[19] - 在多发性骨髓瘤中，每年约有27,000名新患者在复发/难治情况下出现[36] - 59%的患者在治疗超过2年，71%的患者在治疗超过1年[30] 临床试验数据 - Nirogacestat在Desmoid肿瘤的3期试验中，顶线数据预计在2021年第二季度至第三季度发布[19] - Nirogacestat在Desmoid肿瘤的临床试验中，客观反应率（ORR）为71.4%（7名可评估患者中5名）[26] - Nirogacestat在治疗Desmoid肿瘤的患者中，疾病控制率（DCR）为100%[26] - Nirogacestat在治疗Desmoid肿瘤的患者中，治疗的中位持续时间为49.5个月[26] - Nirogacestat在治疗重度预处理患者的2期试验中，客观反应率为29.4%（17名患者中5名）[28] - Nirogacestat组的中位无进展生存期(PFS)假设为20个月，而安慰剂组为8个月[34] - Mirdametinib在NF1相关的Plexiform神经纤维瘤的2b期试验更新预计在2020年第四季度至2021年第一季度发布[14] - Mirdametinib在一项II期试验中，42%的患者实现了≥20%的肿瘤缩小[61] 新产品和技术研发 - Nirogacestat获得FDA的快速通道和突破性疗法认证，以及FDA和欧洲委员会的孤儿药认证[19] - Mirdametinib已获得FDA和欧洲委员会的孤儿药资格，并在NF1-PN中获得FDA快速通道资格[55] - BGB-3245是针对BRAF突变和融合的潜在新型抑制剂，已于2020年第一季度在澳大利亚启动1期临床试验[80] 市场扩张和合作 - Nirogacestat与BCMA抗体药物偶联物的临床合作于2019年6月签署，已在ASH 2019上展示了前临床协同作用[50] - Mirdametinib与Lifirafenib的组合在多种KRAS突变的前临床模型中显示出协同作用[68] 未来展望 - 预计2021年将获得初步临床数据[69] - 公司在2020年和2021年有多个重要的临床试验里程碑[87]

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, 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 001-39044 SPRINGWORKS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 83-4066827 (State or other jurisdic ...

临床试验更新 - Nirogacestat在Desmoid肿瘤的III期试验更新预计在2020年下半年发布[3] - Mirdametinib在NF1-PN的IIb期试验更新预计在2020年第四季度至2021年第一季度发布[3] - Mirdametinib与Lifirafenib的RAS/RAF突变实体瘤的I期b试验更新预计在2020年上半年发布[4] - BGB-3245在RAF突变实体瘤的初步临床数据预计在2021年发布[4] 新产品与技术研发 - Nirogacestat与Belamaf的BCMA ADC联合治疗的I期b试验预计在2020年第一季度启动[3] - Nirogacestat与ALLO-715的BCMA全基因组CAR T联合治疗的I期试验预计在2020年下半年启动[3]

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, 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 001-39044 SPRINGWORKS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 83-4066827 (State or other jurisdi ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ 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 Commission file number: 001‑39044 SPRINGWORKS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 83‑4066827 Indicate by check mark whether the registrant: ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x 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 001-39044 | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | --- | --- | --- | | Common Stock, p ...