On August 8, 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 announced second quarter 2024 financial results (Press release, Nuvalent, AUG 8, 2024, View Source [SID1234645618]).

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"The focused efforts of our team have led to strong execution across our pipeline in 2024 to date, including the initiation of the Phase 2 portion of our ALKOVE-1 trial for NVL-655 with registrational intent, receipt of FDA breakthrough therapy designation for both zidesamtinib and NVL-655, and initiation of the HEROEX-1 trial for our third development program, NVL-330," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We’ve entered the second half of 2024 with significant enrollment progress in the global Phase 2 portions of our ARROS-1 and ALKOVE-1 clinical trials, and plan to provide a status update for both trials concurrent with the presentations of updated Phase 1 dose-escalation datasets at ESMO (Free ESMO Whitepaper). We also expect to outline our broader front-line development strategy for our ALK program later this year. Guided by our OnTarget 2026 operating plan and an unwavering commitment to our goal of bringing precisely targeted therapies to patients with cancer, we remain confident in our ability to deliver at least one pivotal dataset in 2025 towards our first potential approved product in 2026."

Recent Pipeline Progress and Anticipated Milestones

ALK Program

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Enrollment is ongoing in the Phase 2 portion of the ALKOVE-1 Phase 1/2 trial of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors, which is designed with registrational intent. At the ESMO (Free ESMO Whitepaper) Congress 2024, the company plans to provide an update on the status of the global Phase 2 portion of the trial in conjunction with an oral presentation of updated Phase 1 dose-escalation data on Saturday, September 14, 2024, 9:40 – 9:50 a.m. CEST.
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The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs). NVL-655 was previously granted FDA Orphan Drug Designation for the treatment of ALK-positive NSCLC.
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Nuvalent plans to outline its broader front-line development strategy for its ALK program in 2024.

ROS1 Program

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Enrollment is ongoing in the Phase 2 portion of the ARROS-1 Phase 1/2 trial of zidesamtinib for patients with advanced ROS1-positive NSCLC and other solid tumors, which is designed with registrational intent. At the ESMO (Free ESMO Whitepaper) Congress 2024, the company plans to provide an update on the status of the global Phase 2 portion of the trial in conjunction with an oral presentation of updated Phase 1 dose-escalation data on Saturday, September 14, 2024, 10:30 – 10:35 a.m. CEST.
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Additionally, at the ESMO (Free ESMO Whitepaper) Congress 2024, the company will present new preclinical data further characterizing the intracranial activity of zidesamtinib during a poster session on Sunday, September 15, 2024.

HER2 Program

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Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating NVL-330 for pre-treated patients with HER2-altered NSCLC (NCT06521554). The trial will evaluate the overall safety and tolerability of NVL-330. Additional objectives include determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.

ESMO Conference Call Information

Management will host a live webcast and conference call in conjunction with its data presentations at the ESMO (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain on Saturday, September 14, 2024, at 8:30 a.m. ET/2:30 p.m. CEST.

To access the call, register online here for the live webcast or dial +1 (800) 836-8184 (domestic) or +1 (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined to the Nuvalent call. Accompanying slides and a live video webcast will be available in the Investors section of the Nuvalent website at https://investors.nuvalent.com/events. A replay and accompanying slides will be archived on the Nuvalent website for 30 days.

Second Quarter 2024 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $658.0 million as of June 30, 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 $49.2 million for the second quarter of 2024.
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G&A Expenses: General and administrative (G&A) expenses were $16.0 million for the second quarter of 2024.
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Net Loss: Net loss was $57.2 million for the second 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