On May 9, 2024 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, reiterated key anticipated milestones, and reported first quarter 2024 financial results (Press release, Nuvalent, MAY 9, 2024, View Source [SID1234643011]).

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"Guided by our OnTarget 2026 operating plan, 2024 is a year of focused execution on our path towards a potential first approval in 2026 from our pipeline of novel kinase inhibitors," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We expect to share clinical updates from our parallel lead programs for ROS1-positive and ALK-positive NSCLC at a medical meeting in the second half of the year and are on-track to dose the first patient in our HER2 program this year. This is an important time for Nuvalent, and we are excited to carry this momentum forward in hopes of bringing our therapies to patients as efficiently as possible."

Recent Pipeline Progress and Anticipated Milestones

ROS1 Program

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Nuvalent presented new preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that zidesamtinib, its novel ROS1-selective inhibitor, was effective at suppressing on-target ROS1 resistance mutations in preclinical mutagenesis screens.
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The company expects to share updated data from the ARROS-1 Phase 1/2 trial at a medical meeting in the second half of 2024. Enrollment is ongoing in the global Phase 2 portion of the study.
ALK Program

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Enrollment is ongoing in the global Phase 2 portion of the ALKOVE-1 trial of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors. The Phase 2 cohorts are designed with registrational intent for TKI pre-treated patients with ALK-positive NSCLC and to enable preliminary evaluation in patients with ALK-positive NSCLC who are TKI naïve.
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The company expects to share updated data from the ALKOVE-1 trial at a medical meeting in the second half of 2024. Additionally, Nuvalent plans to outline its broader front-line development strategy for its ALK program in 2024.
HER2 Program

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Nuvalent presented new preclinical data at AACR (Free AACR Whitepaper) supporting the broad activity against HER2 oncogenic alterations, selectivity over wild-type EGFR, and differentiated brain-penetrant profile of its novel HER2-selective inhibitor, NVL-330.
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The company expects to initiate the Phase 1 trial for its HER2 program in 2024.

Upcoming Events

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TD Cowen 5th Annual Oncology Innovation Summit:Management will be participating in a virtual fireside chat on May 29, 2024 at 9:30 am ET. A live webcast will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

First Quarter 2024 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $691.8 million as of March 31, 2024. Nuvalent believes these existing cash, cash equivalents and marketable securities to be sufficient to fund its current operating plan into 2027.
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R&D Expenses: Research and development (R&D) expenses were $38.6 million for the first quarter of 2024.
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G&A Expenses: General and administrative (G&A) expenses were $14.0 million for the first quarter of 2024.
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Net Loss: Net loss was $44.5 million for the first quarter of 2024.

About OnTarget 2026

OnTarget 2026 delineates Nuvalent’s 3-year operating plan towards bringing new, potential best-in-class medicines to patients with cancer. As part of this plan announced in January 2024, Nuvalent outlined the following anticipated milestones throughout 2024, leading to the company’s first potential pivotal data in 2025 and first potential approved product in 2026:

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2024: Execute on Global Registrational Strategies
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Progress the Phase 2 portion of its ARROS-1 trial of zidesamtinib in patients with advanced ROS1-positive NSCLC with registrational intent;
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Initiate the Phase 2 portion of its ALKOVE-1 trial of NVL-655 in patients with advanced ALK-positive NSCLC with registrational intent;
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Launch the front-line development strategy for its ALK program;
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Present interim data from its ongoing ARROS-1 and ALKOVE-1 clinical trials at medical meetings; and,
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Initiate the Phase 1 trial for its HER2 program.
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2025: First Pivotal Data
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2026: First Approved Product