On September 8, 2021 Nuvalent, Inc., (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported recent pipeline and business highlights and second quarter 2021 financial results (Press release, Nuvalent, SEP 8, 2021, View Source [SID1234587401]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"At Nuvalent, we are leveraging our team’s deep expertise in chemistry and structure-based drug design to advance a novel pipeline of product candidates for patients with cancer. Our therapies are specifically designed to solve for challenges limiting the activity and durability of currently available therapies, such as kinase resistance, adverse events due to off-target activity, and metastases to the brain," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "In the first half of 2021, our team has made meaningful progress to deliver on our clear vision for advancing the field of precision oncology. We have received clearance from the FDA to proceed with the Phase 1/2 study for our ROS1-selective inhibitor NVL-520, advanced our parallel lead product candidate, the ALK-selective inhibitor NVL-655, into IND-enabling studies, and progressed multiple additional discovery-stage research programs. With the recent talented additions to our team and capital raised in our upsized IPO, we stand well positioned to fuel our upcoming transition to a clinical organization and efforts to renew hope for patients in need."
Second Quarter Highlights
IND Application for NVL-520 Cleared by FDA, Enabling Clinical Trial Initiation: The U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for NVL-520, its brain-penetrant ROS1-selective inhibitor. The company is preparing to initiate the Phase 1 portion of a global, Phase 1/2 clinical trial for NVL-520 in patients with ROS1-positive NSCLC and other advanced solid tumors in the second half of 2021.
$190.6 Million Upsized Initial Public Offering (IPO) Successfully Completed: In July 2021, Nuvalent sold 11,212,500 shares of common stock at a price to the public of $17.00 per share. The gross proceeds from the offering were approximately $190.6 million, before deducting underwriting discounts and commissions and other offering expenses.
Company Leadership Strengthened through Appointments to Management and Board: Nuvalent recently appointed Deborah Miller, Ph.D., J.D., as Chief Legal Officer, and Sapna Srivastava, Ph.D., Chief Financial Officer of eGenesis, to its Board of Directors.
Dr. Miller most recently served as Senior Vice President, Deputy General Counsel and Chief IP Counsel for Sumitomo Dainippon Pharma America (SDPA). Prior to that, Dr. Miller served as Deputy General Counsel and Chief IP Counsel at Sunovion Pharmaceuticals Inc., a subsidiary of SDPA. She previously held various roles at Infinity Pharmaceuticals, Inc. including Vice President, Deputy General Counsel and Chief Patent Counsel, where she built and managed the intellectual property group and supported various in-licensing, out-licensing and financing ventures. Earlier in her career, Dr. Miller was IP corporate counsel at Sepracor Inc. (currently, Sunovion Pharmaceuticals Inc.), and an associate at the law firm Nutter McClennen & Fish LLP. Dr. Miller earned her J.D. from Suffolk University Law School, Ph.D. in biological chemistry and molecular pharmacology from Harvard University, M.S. in medical sciences from Harvard Medical School and B.S. in chemistry from Swarthmore College.
Dr. Srivastava brings over 20 years of experience as a senior executive in the biopharmaceutical industry. She has served as the Chief Financial Officer at eGenesis Bio since April 2021. Prior to eGenesis, she held similar roles as the Chief Financial and Strategy Officer at Abide Therapeutics (acquired by Lundbeck) and at Intellia Therapeutics. Before Intellia, Dr. Srivastava was a senior biotechnology analyst at Goldman Sachs, Morgan Stanley and ThinkEquity Partners, and began her career as a research associate at J.P. Morgan. Dr. Srivastava received her Ph.D. in neuroscience from the New York University School of Medicine and her B.S. in biology from St. Xavier’s College at the University of Bombay.
Second Quarter 2021 Financial Results
As of June 30, 2021, Nuvalent had cash of $138.9 million, which does not include net proceeds from its IPO, which was completed on August 2, 2021.
Research & Development expenses for the second quarter of 2021 were $7.8 million.
General & Administrative expenses for the second quarter of 2021 were $2.0 million.
Net Loss for the second quarter was $9.8 million, or $3.17 per share.