Nuvalent announced its “OnTarget 2026” operating plan to guide efforts towards having its first potential approved product in 2026. OnTarget 2026 delineates Nuvalent’s three-year operating plan towards bringing new, potential medicines to patients with cancer. As part of this plan, Nuvalent expects to achieve the following anticipated milestones throughout 2024, leading to the company’s first potential pivotal data in 2025 and first potential approved product in 2026: 2024: execute on global registrational strategies; progress the Phase 2 portion of its ARROS-1 trial of NVL-520 in patients with advanced ROS1-positive NSCLC with registrational intent; initiate the Phase 2 portion of its ALKOVE-1 trial of NVL-655 in patients with advanced ALK-positive NSCLC with registrational intent; launch the front-line development strategy for its ALK program; initiate the Phase 1 trial for its HER2 program; and present interim data from its ongoing ARROS-1 and ALKOVE-1 clinical trials at medical meetings. 2025: first pivotal data. 2026: first approved product. Nuvalent ended 2023 with approximately $719.9M in cash, cash equivalents and marketable securities, which, based on its current operating plans, is expected to fund its operations into 2027. This amount is a preliminary, unaudited estimate only as of today, could change following completion of year-end closing procedures, and does not present all information necessary for an understanding of our financial position as of December 31, 2023.
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