On May 11, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported recent corporate highlights and financial results for the three months ended March 31, 2018 (Press release, Cellectar Biosciences, MAY 11, 2018, View Source [SID1234526526]).

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Recent Corporate Highlights

·Received orphan drug designation and rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for CLR 131 to treat neuroblastoma.

·Received orphan drug designation from the FDA for CLR 131 to treat rhabdomyosarcoma, a rare pediatric cancer.

·Presented Phase 1 study results at the 12th World Congress of the World Federation of Nuclear Medicine and Biology demonstrating that CLR 124 is able to cross the blood-brain barrier and achieve uptake in brain tumors. The company believes these data have positive read through for CLR 131 which varies only by the radionuclide delivered.

·Initiated the diffuse large B-cell lymphoma cohort of the company’s Phase 2 clinical trial of CLR 131. This cohort is the fourth and final in the study for patients with R/R B-cell hematologic cancers.

·Initiated cohort 5 in the Phase 1 study of CLR 131 in highly pretreated R/R multiple myeloma patients. This is the first cohort in the trial to use a fractionated dosing schedule.

·Presented two late-breaking poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting. The posters highlighted the potential benefits of fractionated dosing regimens of CLR 131 and the ability of the company’s Phospholipid Drug Conjugates (PDCs) to provide improved targeting of tumor cells and the intracellular trafficking of these molecules.

·Granted seminal U.S. patent for phospholipid-ether analogs covering composition of matter and method of use for proprietary PDCs in combination with anti-cancer agents.

·Issued U.S. patent entitled "Alkylphosphocholine analogs for multiple myeloma imaging and therapy," covering the use of CLR 131 in multiple MM and received a composition of matter patent in Japan.

"The first quarter and recent weeks brought significant progress on both the clinical and regulatory fronts. We advanced both Phase 1 and Phase 2 studies for CLR 131, presented new data at major scientific conferences, and received orphan drug designation and rare pediatric disease designation from the FDA to treat neuroblastoma in pediatric patients, as well as an orphan drug designation to treat rhabdomyosarcoma," said James Caruso, president and CEO of Cellectar Biosciences. "We are particularly excited to begin our upcoming Phase 1 study to explore CLR 131 as a treatment option for children with life-threatening rare pediatric cancers."

First Quarter 2018 Financial Results

Research and development expense for the first quarter of 2018 was $2.1 million, compared with $1.9 million for the first quarter of 2017. The year over year increase is attributable to higher preclinical and clinical project costs, manufacturing, and general research and development costs.

General and administrative expense for the first quarter of 2018 was $1.3 million, compared with $1.0 million for the first quarter of 2017. The year over year increase is attributable to higher consulting, legal and marketing fees, as well as one-time personnel costs incurred in connection with the decision to outsource our manufacturing.

The net loss attributable to common stockholders for the first quarter of 2018 was $3.5 million, or $0.21 per share based on 16.8 million shares outstanding, compared with a net loss attributable to common stockholders for the first quarter of 2017 of $2.9 million, or $0.24 per share based on 12.0 million shares outstanding.

Cash and cash equivalents as of March 31, 2018 were $6.8 million, compared with $10.0 million as of December 31, 2017.