Nuvalent Highlights Execution Across Pipeline of Novel Kinase Inhibitors and Reports 2nd Quarter 2022 Financial Results.

CAMBRIDGE, Mass: Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today reported pipeline progress and second quarter 2022 financial results.

"Our focus for 2022 is on execution across our pipeline of novel kinase inhibitors, and the Nuvalent team has continued to deliver. In the past quarter, we announced our plan to share preliminary dose escalation data in the second half of 2022 from the Phase 1 portion of our Phase 1/2 ARROS-1 trial for patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors, and dosed the first patient in our Phase 1/2 ALKOVE-1 trial for patients with advanced ALK-positive NSCLC and other solid tumors," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "Additionally, we've continued to advance our discovery pipeline and remain poised to nominate two additional development candidates by the end of this year - a testament to the strength, ingenuity, and efficiency of the Nuvalent team, our capabilities, and approach. This is an exciting time for our company, and I'm confident in our ability to deliver on our goal of precisely targeted therapies that can enable deep and durable responses for patients with cancer."

Recent Pipeline Achievements and Anticipated Near-Term Milestones

Preliminary Dose-Escalation Data from Ongoing ARROS-1 Trial Anticipated in the Second Half of 2022: Nuvalent's Phase 1/2 ARROS-1 clinical trial evaluating NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors, is progressing well and is continuing to enroll patients in the Phase 1 portion of the study. NVL-520 is a ROS1-selective inhibitor designed to address the clinical challenges of emergent treatment resistance, off-target CNS adverse events, and brain metastases that may limit the use of currently available ROS1 kinase inhibitors. The company plans to share preliminary data from the dose-escalation portion of the trial in the second half of 2022.

Dosing Initiated and Enrollment Ongoing in ALKOVE-1 Trial: Nuvalent is actively dosing patients in the Phase 1 portion of its ALKOVE-1 trial, a Phase 1/2, multicenter, open-label, dose-escalation...