On May 12, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline and business progress and first quarter 2022 financial results (Press release, Nuvalent, MAY 12, 2022, View Source [SID1234614378]).
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"At Nuvalent, we’re building a fully integrated biotech company with the goal to design, develop, and deliver a portfolio of best-in-class therapies for patients with cancer. We view 2022 as a critical year of execution and we have already made meaningful progress across our pipeline. Enrollment is progressing well in the ongoing Phase 1 portion of our ARROS-1 Phase 1/2 trial of NVL-520 for advanced ROS1-positive NSCLC and other solid tumors, and following the recently announced clearance of the IND for NVL-655, we are on track for planned initiation of our ALKOVE-1 Phase 1/2 study for advanced ALK-positive NSCLC and other solid tumors in the second quarter of 2022," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "By year-end, our team has the potential to have delivered four novel development candidates since company formation, with two clinical trials underway. With an exceptional team and strong foundation in place, I am confident in our ability to bring precisely targeted therapies that can enable deeper and more durable responses to patients with cancer."
Upcoming Pipeline Milestones
ALKOVE-1 Trial of NVL-655 for Patients with ALK-positive Non-Small Cell Lung Cancer (NSCLC) Expected to Begin in Second Quarter of 2022: Nuvalent has received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for NVL-655 has been cleared. The company is on track to initiate the ALKOVE-1 Phase 1/2 study of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors, anticipated in the second quarter of 2022. NVL-655 is a novel ALK-selective inhibitor designed to address the clinical challenges of emergent treatment resistance, CNS adverse events, and brain metastases that may limit the use of currently available ALK kinase inhibitors.
Selection of Two Additional Development Candidates from Discovery Pipeline Targeted in 2022: Nuvalent continues to advance its pipeline expansion efforts with multiple discovery-stage research programs. The company expects to select development candidates for its programs directed toward ALK IXDN compound resistance mutations and HER2 Exon 20 insertions in 2022.
Recent Business Highlights
Appointed Anna Protopapas as Chair of Board of Directors: Nuvalent appointed Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics, as Chair of its Board of Directors in March 2022. Ms. Protopapas joined Mersana in March 2015 and has a substantial track record of executive leadership and business growth in the field of oncology. Her broad industry experience ranges from global development to commercial expertise with a focus on building companies from start-ups to leaders in their categories.
Presented Expanded Preclinical Profiles of NVL-520 and NVL-655 at AACR (Free AACR Whitepaper) 2022: Nuvalent presented new preclinical data supporting the potential for broad clinical utility of NVL-520 and NVL-655 across an expanded set of ROS1 and ALK fusion partners, resistance mutations, and tumor types beyond NSCLC.
Upcoming Investor Conference Presentations
2022 H.C. Wainwright Hybrid Global Investment Conference: Dr. Porter will conduct an in-person corporate presentation during the 2022 H.C. Wainwright Hybrid Global Investment Conference on Wednesday May 25, 2022 at 4:00 p.m. ET. The conference is being held May 23-26, 2022, with in-person presentations and meetings in Miami, FL. A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com and will be archived for 30 days following the presentation.
First Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $272.7 million as of March 31, 2022. Nuvalent continues to expect the existing cash, cash equivalents, and marketable securities to be sufficient to fund its planned operations into 2024.
R&D Expenses: Research and development (R&D) expenses were $12.7 million for the first quarter of 2022.
G&A Expenses: General and administrative (G&A) expenses were $5.0 million for the first quarter of 2022.
Net Loss: Net loss for the first quarter of 2022 was $17.5 million, or $0.36 per share.