Nuvalent Reports Q2 2024 Financials & Pipeline Progress

By Tamara Parker • Thursday, August 08 08:09 • Permanent Link

Nuvalent, Inc. (NASDAQ: NUVL), a clinical-stage biopharmaceutical company, has reported its second quarter 2024 financial results and highlighted progress in its pipeline. The company had $658.0 million in cash, cash equivalents, and marketable securities as of June 30, 2024, which is expected to support its operating runway into 2027.

In the second quarter of 2024: Research and development (R&D) expenses were $49.2 million. General and administrative (G&A) expenses were $16.0 million. * The net loss was $57.2 million.

Pipeline Progress and Anticipated Milestones: 1. ALK Program: * Enrollment is ongoing in the phase 2 portion of the ALKOVE-1 trial of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC). * The U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC. * Nuvalent plans to outline its broader front-line development strategy for its ALK program in 2024.

ROS1 Program:
Enrollment is ongoing in the phase 2 portion of the ARROS-1 trial of zidesamtinib for patients with advanced ROS1-positive NSCLC.
The company will present new preclinical data characterizing the intracranial activity of zidesamtinib at the ESMO Congress 2024.
HER2 Program:
Enrollment is ongoing in the HEROEX-1 phase 1a/1b clinical trial evaluating NVL-330 for pre-treated patients with HER2-altered NSCLC.

The company plans to provide updates on the status of the global phase 2 portions of the ALKOVE-1 and ARROS-1 trials, along with presentations of updated phase 1 dose-escalation datasets at the ESMO Congress 2024 in Barcelona, Spain, on September 14, 2024.

Additionally, Nuvalent aims to execute on global registrational strategies and progress the phase 2 portions of its ARROS-1 and ALKOVE-1 trials, leading to the company's first potential pivotal data in 2025 and the first potential approved product in 2026 as part of its ONTARGET 2026 operating plan.

Following these announcements, the company's shares moved -5.2%, and are now trading at a price of $67.44. For the full picture, make sure to review Nuvalent's 8-K report.

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