On November 9, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Cellectar Biosciences, NOV 9, 2020, View Source [SID1234570367]).
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!
Third Quarter and Recent Corporate Highlights
·Held FDA Type B guidance meeting to define the registrational pathway for our priority adult hematology oncology indications and planned initiation of the pivotal study for our lead indication in the fourth quarter
·Announced CLR 131 achieved a 40% overall response rate (ORR) in Triple Class Refractory Multiple Myeloma (MM) patients with an administered total body dose (TBD) of 60mCi or greater from the Phase 2 CLOVER-1 study
·Interim results from the Phase 2 COVER-1 study at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Meeting: Advances in Malignant Lymphoma demonstrated a 100% ORR and a 75% major response rate (MRR) in LPL/WM. Mean duration of response exceeding 17 months (8.4 – 31.7 months); duration of response continues to increase for all patients
·Strengthened the management team with the appointment of Dr. John Friend, chief medical officer
"We continue to make good progress towards the fourth quarter initiation of the CLR 131 pivotal study in our lead heme-oncology indication. Our recent FDA guidance meeting was most encouraging and we look forward to providing greater details in the near-term," said James Caruso, president and CEO of Cellectar. "Additional data from our Phase 2 CLOVER-1 study remain strong, with patients in WM achieving a 100% ORR and a 75% MRR in patients failing a BTKi and a 40% ORR in the challenging to treat triple class refractory MM patient population."
Third Quarter 2020 Financial Highlights
·Cash and Cash Equivalents: As of September 30, 2020, the company had cash and cash equivalents of $18.8 million compared to $10.6 million at December 31, 2019. Cash used in operating activities was approximately $10.1 million during the nine months ended September 30, 2020 as compared to $9.0 million during the nine months ended September 30, 2019.
·Research and Development Expense: R&D expense for the three months ended September 30, 2020 was $2.7 million, compared to $2.7 million for the three months ended September 30, 2019. The cumulative R&D spending for the first nine months of 2020 was $7.8 million as compared to $6.8 million for the first nine months of 2019. The increase in R&D expense year-to-date in 2020 was primarily a result of higher general research and development costs resulting from increased personnel related costs and clinical study costs. Manufacturing and related costs decreased because of a reduction in materials production processes and related costs.
·General and Administrative Expense: G&A expense for the three months ended September 30, 2020 was $1.2 million compared to $1.3 million for the three months ended September 30, 2019. The cumulative G&A spending for the first nine months of 2020 were of $3.7 million as compared to $4.0 million for the first nine months of 2019. The decrease in G&A expense year-to-date in 2020 was primarily a result of lower stock-based compensation expense.
·Net Loss: The net loss attributable to common stockholders for the three months ended September 30, 2020 was ($3.9) million, or ($0.15) per share, compared to ($3.9) million, or ($0.42) per share, in 2019. Net loss attributable to common stockholders for the nine months ended September 30, 2020 was ($11.5) million, or ($0.69) per share, compared to ($10.7) million, or ($1.51) per share, in 2019.