On November 10, 2021 Nuvalent, Inc., (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported recent pipeline progress and third quarter 2021 financial results (Press release, Nuvalent, NOV 10, 2021, View Source [SID1234595048]).
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"Throughout the third quarter of 2021, we continued to progress our novel portfolio of precisely targeted therapies for patients with cancer. Notably, our first clinical trial of NVL-520, the ‘ARROS-1’ study, is now open for enrollment of patients with advanced ROS1-positive NSCLC and other solid tumors," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We anticipate a robust set of upcoming operational milestones, including the dosing of the first patient in our ARROS-1 study in 2021, the advancement of our parallel lead program NVL-655 into clinical development for ALK-positive cancers, and the expansion of our portfolio with additional internally developed product candidates. With a dedicated, expert team and a strong balance sheet in place, we believe we are well-positioned to achieve the milestones ahead."
Recent Program Highlights
ARROS-1 Phase 1/2 Clinical Trial of NVL-520 Open for Enrollment:
Nuvalent has activated multiple U.S. sites to begin enrollment in its ARROS-1 clinical trial, a Phase 1/2, multicenter, open-label, dose-escalation and expansion study evaluating NVL-520 as an oral monotherapy in patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. NVL-520 is a novel ROS1-selective inhibitor designed to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of currently available ROS1 tyrosine kinase inhibitors (TKIs). The Phase 2 portion of the ARROS-1 study is designed to support potential registration of NVL-520 in both ROS1-positive patients with NSCLC who are kinase inhibitor-naïve and who have been previously treated with ROS1 kinase inhibitors. Clinical site expansion in the US and EU is ongoing.
Preclinical Data Supporting Lead Programs for ROS1-Positive and ALK-Positive NSCLC Presented at 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference: Nuvalent presented new preclinical data at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference further demonstrating that NVL-520 and NVL-655, its parallel lead product candidates, were active against both wild-type and various known resistance variants of ROS1 or ALK, respectively; were brain-penetrant with the potential to address brain metastases; and selectively inhibited their respective targets compared to the structurally related tropomyosin receptor kinase B (TRKB), thereby minimizing the potential for off-target TRKB-related CNS adverse events. The ARROS-1 Phase 1/2 clinical trial of NVL-520 is open for enrollment, and Nuvalent plans to initiate a Phase 1/2 clinical trial of NVL-655 in advanced ALK-positive NSCLC and other cancers during the first half of 2022.
Upcoming Investor Conference Presentations
33rd Annual Virtual Piper Healthcare Conference: Dr. Porter will participate in a pre-recorded fireside chat during the 33rd Annual Virtual Piper Healthcare Conference, being held November 30 – December 2, 2021. The fireside chat will be available to registered participants beginning on November 22, 2021, and the webcast will be available in the investor section of the company’s website at www.nuvalent.com for 30 days following the presentation.
Third Quarter 2021 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $302.4 million as of September 30, 2021, including net proceeds from the initial public offering completed on August 2, 2021, compared to $10.3 million as of December 31, 2020.
Research & Development (R&D) expenses: R&D expenses were $9.1 million for the third quarter of 2021, compared to $3.7 million for the third quarter of 2020.
General & Administrative (G&A) expenses: G&A expenses were $3.4 million for the third quarter of 2021, compared to $0.3 million for the third quarter of 2020.
Net Loss: Net loss for the third quarter of 2021 was $12.4 million, or $0.39 per share, compared to $4.8 million, or $1.57 for the third quarter of 2020.