On May 7, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the three months ended March 31, 2020 and provided a corporate update (Press release, Cellectar Biosciences, MAY 7, 2020, View Source [SID1234557330]).

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First Quarter and Recent Corporate Highlights

·Announced CLR 131 achieved primary efficacy endpoints from its Phase 2 CLOVER-1 study in median third line relapsed/refractory (r/r) and Non-Hodgkin’s lymphomas (NHL) and median sixth line r/r multiple myeloma (MM) and in the Phase 1 r/r MM dose escalation study at the 50mCi and 75mCi total body doses. The 75mCi total body dose demonstrated:

§Overall response rate (ORR) 42.8% in r/r MM

§33% ORR in triple class refractory r/r MM

§50% ORR in high risk r/r MM

§43.0% ORR and 14.3% complete responses (CR) in r/r NHL

§100% ORR and 25% CR in r/r Lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LPL/WM) across all therapeutic doses tested

·Completed the pre-planned highest dose cohort of the Phase 1 r/r MM dose escalation study

·Received Orphan Drug Designation for CLR 131 in LPL/WM from the U.S. Food and Drug Administration (FDA)

·Appointed Dr. Igor Grachev, Chief Medical Officer

·Extended the Phase 2 CLOVER-1 study in relapsed/refractory B-cell lymphomas to enroll additional patients at a dose of CLR 131 delivering 100mCi in a two-cycle dosing regimen

"CLR 131 has consistently demonstrated favorable safety and tolerability across dosing levels and encouraging response rates even in a very difficult to treat sixth line patient population that included high risk, triple class refractory and daratumamab refractory patients," said James Caruso, president and CEO of Cellectar. "We continue to enroll patients at the 100mCi level and believe the two-cycle dosing regimen we now use will further increase response rates, the durability of responses and maintain or improve upon CLR 131’s predictable safety and tolerability product profile."

The health and safety of our employees has always been paramount and that does not change during this pandemic. Within our employee base, we are not aware of any confirmed cases of COVID-19 to date. We will continue taking appropriate measures to prevent the outbreak from affecting our employees, while also managing the financial well-being of the company. Furthermore, at this time, the pandemic has not caused any disruption in our supply chain or in enrollment within our ongoing clinical studies.

First Quarter 2020 Financial Highlights

·Cash and Cash Equivalents: As of March 31, 2020, the company had cash and cash equivalents of $7.1 million compared to $10.6 million at December 31, 2019. Cash used in operating activities was approximately $3.5 million during the three months ended March 31, 2020 as compared to $2.8 million during the three months ended March 31, 2019. Consistent with prior guidance, the company believes its cash on hand is adequate to fund operations into the first quarter of 2021.

·Research and Development Expense: R&D expense for the three months ended March 31, 2020 was $2.6 million, compared to $2.3 million for the three months ended March 31, 2019. The increase in R&D expense of approximately 13% was primarily a result of general R&D cost from personnel related expenses and clinical project costs. Manufacturing and related costs and pre-clinical studies were relatively consistent.

·General and Administrative Expense: G&A expense for both the three months ended March 31, 2020 and March 31, 2019 was $1.3 million and remained relatively consistent in both periods.

·Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2020 was ($4.0) million, or ($0.42) per share, compared to ($3.6) million, or ($0.76) per share, in 2019.