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Nuvalent Investors Nuvalent Reports Pipeline Progress and Third Quarter 2021 Financial Results ARROS - 1 Clinical Trial of NVL - 520 for the Treatment of Patients with Advanced ROS1 - positive NSCLC and Other Solid Tumors is Open for Enrollment Company On - track for Initiation of Clinical Trial of NVL - 655 for the Treatment of Patients with Advanced ALK - positive NSCLC and Other Cancers in First Half of 2022 CAMBRIDGE , Mass . , Nov. 10 , 2021 / PRNewswire / -- Nuvalent , Inc. , ( Nasdaq : NUVL ) , a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer , today reported recent pipeline progress and third quarter 2021 financial results . " Throughout the third quarter of 2021 , we continued to progress our novel portfolio of precisely targeted therapies for patients with cancer . Notably , our first clinical trial of NVL - 520 , the ' ARROS - 1 ' study , is now open for enrollment of patients with advanced ROS1 - positive NSCLC and other solid tumors , " said James Porter , Ph.D. , Chief Executive Officer at Nuvalent . " We anticipate a robust set of upcoming operational milestones , including the dosing of the first patient in our ARROS - 1 study in 2021 , the advancement of our parallel lead program NVL - 655 into clinical development for ALK - positive cancers , and the expansion of our portfolio with additional internally developed product candidates . With a dedicated , expert team and a strong balance sheet in place , we believe we are well - positioned to achieve the milestones ahead . " Recent Program Highlights • ARROS - 1 Phase 1/2 Clinical Trial of NVL - 520 Open for Enrollment : Nuvalent has activated multiple U.S. sites to begin enrollment in its ARROS - 1 clinical trial , a Phase 1/2 , multicenter , open - label , dose - escalation and expansion study evaluating NVL - 520 as an oral monotherapy in patients with advanced ROS1 - positive non - small cell lung cancer ( NSCLC ) and other solid tumors . NVL - 520 is a novel ROS1 - selective inhibitor designed to address the clinical challenges of emergent treatment resistance , central nervous system ( CNS ) -related adverse events , and brain metastases that may limit the use of currently available ROS1 tyrosine kinase inhibitors ( TKls ) . The Phase 2 portion of the ARROS - 1 study is designed to support potential registration of NVL - 520 in both ROS1 - positive patients with NSCLC who are kinase inhibitor - naïve and who have been previously treated with ROS1 kinase inhibitors . Clinical site expansion in the US and EU is ongoing . • Preclinical Data Supporting Lead Programs for ROS1 - Positive and ALK - Positive NSCLC Presented at 2021 AACR - NCI - EORTC Molecular Targets and Cancer Therapeutics Conference : Nuvalent presented new preclinical data at the 2021 AACR - NCI - EORTC Molecular Targets and Cancer Therapeutics Conference further demonstrating that NVL - 520 and NVL - 655 , its parallel lead product candidates , were active against both wild- type and various known resistance variants of ROS1 or ALK , respectively ; were brain - penetrant with the potential to address brain metastases ; and selectively inhibited their respective targets compared to the structurally related tropomyosin receptor kinase B ( TRKB ) , thereby minimizing the potential for off - target TRKB - related CNS adverse events . The ARROS - 1 Phase 1/2 clinical trial of NVL - 520 is open for enrollment , and Nuvalent plans to initiate a Phase 1/2 clinical trial of NVL - 655 in advanced ALK - positive NSCLC and other cancers during the first half of 2022 .