On August 10, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress and second quarter 2022 financial results (Press release, Nuvalent, AUG 10, 2022, View Source [SID1234618012]).

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"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 and expansion trial evaluating NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors. NVL-655, Nuvalent’s parallel lead product candidate, is an ALK-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 ALK kinase inhibitors.
New NVL-655 Preclinical Data Presented at IASLC 2022 World Conference on Lung Cancer Annual Meeting: A poster characterizing NVL-655 alongside other ALK inhibitors in a patient-derived model of lorlatinib-resistant ALK-positive NSCLC with the treatment-emergent G1202R/T1151M compound resistance mutation was presented at the IASLC 2022 World Conference on Lung Cancer (WCLC) Annual Meeting. The preclinical activity of NVL-655, as described in the poster presented, continues to support the potential for a best-in-class profile.
On-Track to Select Two Additional Development Candidates from Discovery Pipeline in 2022: Nuvalent continues to advance its pipeline expansion efforts with multiple discovery-stage research programs. The company expects to select development candidates for its programs directed toward ALK IXDN compound resistance mutations and HER2 Exon 20 insertions in the second half of 2022.
Second Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $257.0 million as of June 30, 2022. Nuvalent continues to expect the existing cash and cash equivalents to be sufficient to fund its planned operations into 2024.
R&D Expenses: Research and development (R&D) expenses were $13.6 million for the second quarter of 2022.
G&A Expenses: General and administrative (G&A) expenses were $5.2 million for the second quarter of 2022.
Net Loss: Net loss for the second quarter of 2022 was $18.5 million, or $0.38 per share.