On May 10, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Cellectar Biosciences, MAY 10, 2021, View Source [SID1234579549]).
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First Quarter and Recent Corporate Highlights
Initiated pivotal study of CLR 131 in Waldenstrom’s macroglobulinemia (CLOVER-WaM)
Pivotal study is designed as a global, single arm, non-comparator, expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131 and its design is in alignment with feedback received from the U.S. FDA from Cellectar’s September 2020 guidance meeting
The study will enroll 50 relapsed/refractory WM patients
The primary endpoint of the study is major response rate defined as a partial response or better (a minimum of a 50% reduction in the biological marker IgM)
Received Orphan Drug Designation from the European Commission for CLR 131 in Waldenstrom’s macroglobulinemia (WM) which provides 10 years of European market exclusivity and certain benefits including protocol assistance, reduced EU regulatory filing and associated fees
Strengthened its global Intellectual Property portfolio with granted patents in Japan, Eurasia, Australia and Mexico. These patents, entitled: "Phospholipid-Ether Analogs as Cancer-Targeting Drug Vehicles," provides composition of matter and use protection for the company’s proprietary phospholipid-ether (PLE) analogs as a targeted delivery vehicle in combination with a broad range of commonly used chemotherapeutic classes such as alkaloids, nucleoside analogs, as well as other classes of small molecule chemotherapeutic agents
"During the first quarter, we focused on clinical study execution, ramped-up our pivotal study in Waldenstrom’s macroglobulinemia and further enriched our refractory multiple myeloma data set," said James Caruso, president and CEO of Cellectar. "We also continue to make progress in our pediatric study of CLR 131 in children with relapsed or refractory solid tumors or malignant brain tumors and remain well positioned financially with a cash runway supporting our current strategic plan into the third quarter of 2023."
First Quarter Financial Highlights
Cash and Cash Equivalents: As of March 31, 2021, the company had cash and cash equivalents of $53.6 million compared to $57.2 million at December 31, 2020.
Research and Development Expense: Research and development expense for the three months ended March 31, 2021 was approximately $4.6 million compared to approximately $2.6 million for the three months ended March 31, 2020. The overall increase in research and development expense of $2.0 million was primarily a result of costs related to our WM pivotal study. General research and development costs increased because of increased personnel and related costs offset by a decrease in manufacturing and related costs and preclinical study costs.
General and Administrative Expense: General and administrative expense for the three months ended March 31, 2021 was approximately $1.7 million, compared to approximately $1.3 million for the three months ended March 31, 2020. The overall increase in general and administrative expense of $384,000 was primarily a result of professional fees and insurance.
Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2021 was ($6.4) million, or ($0.13) per share, compared to ($4.0) million, or ($0.42) per share, for the three months ended March 31, 2020.