On February 26, 2019 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 year ended December 31, 2018, and provided a corporate update (Press release, Cellectar Biosciences, FEB 26, 2019, View Source [SID1234533678]).
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Fourth Quarter and Recent Corporate Highlights
·Announced additional positive top-line results from the relapse refractory multiple myeloma cohort in its ongoing Phase 2 clinical study of CLR 131, the company’s lead product candidate. In patients with an average of 5 prior lines of systemic therapy, CLR 131 achieved a 30% overall response rate in the first 10 evaluable patients. The company previously announced an overall response rate of 33% in patients with R/R diffuse large B-cell lymphoma (DLBCL) also receiving the single, 25mCi/m2 dose of CLR 131. All patients reported here were administered one, single 30-minute infusion of 25mCi/m2, which is approximately 60% less drug than fractionated dose currently being tested in the ongoing Phase 1 study.
·Initiated Cohort 6 of its ongoing Phase 1b study evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM).
oCohort 6 is evaluating up to four patients with each receiving two doses of 18.75 mCi/m2 of CLR 131 administered one week apart.
oThis fractionated dosing regimen will result in each patient being treated with an increase in average total exposure of approximately 60% over the Phase 2 efficacious dose of 25mCi/m2.
oThe fractionated dose administered in Cohort 5 indicated enhanced tolerability and safety compared with the single dose administered in Cohort 4 despite an 18% increase in the average dose. Additionally, patients in Cohort 5 experienced fewer adverse events.
oBased on these results and the DMC recommendation, Cellectar modified the single-dose regimen of its ongoing Phase 2 study of R/R hematologic malignancies to fractionated dosing and proceeded with Cohort 6 of the Phase 1 study.
·Granted the patent titled "Phospholipid Analogs as Diapeutic Agents and Methods of Use Thereof" by the Japanese Patent Office. The patent provides composition of matter and use protection for the company’s proprietary phospholipid ether (PLE) analogs and specifically the use of CLR 131 in breast, brain, leukemias, and a variety of other cancers
·Announced median overall survival (mOS) of 22 months in the single dose Cohorts 1-4 of the company’s ongoing Phase 1 clinical study evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM). All of these patients were heavily pretreated, averaging five prior lines of systemic therapy.
"We continue to make meaningful progress with the clinical development of CLR 131 and have now reported activity in three cohorts of our ongoing Phase 2 study in challenging relapse/refractory hematologic cancers: diffuse large B cell, Waldenstrom’s lymphoma and multiple myeloma. The recently announced 30% response rate in relapsed/refractory multiple myeloma coupled with the median overall survival of 22 months in patients receiving a single dose from the Phase 1 study is very encouraging," said James Caruso, president and CEO of Cellectar. "Going forward, we believe CLR 131, with a higher and more patient-friendly fractionated dosing regimen, has the potential to further improve upon its product profile and be an effective treatment in relapsed/refractory hematologic cancers. We look forward providing further updates and data for CLR 131 during 2019."
2018 Financial Highlights
Research and development expense for the year ended December 31, 2018 was $6.8 million, compared to $9.5 million for the year ended December 31, 2017. The overall decrease in research and development expense of 28% was due primarily to a decrease in accelerated depreciation expense due to the reassessed estimated useful life of the leasehold improvements and laboratory equipment in 2017. The reassessment of the useful lives for these assets was due to the company’s decision to close its manufacturing facility and outsource all of its manufacturing.
General and administrative expense for the year ended December 31, 2018 was $4.8 million, compared to $4.1 million for the year ended December 31, 2017. The increase of 17% for 2018 was primarily related to an increase of approximately $229,000 in purchased services related to accounting, investor relations and public company costs offset by a decrease in legal fees of approximately $157,000; and an increase of approximately $510,000 in personnel related costs.
The net loss attributable to year ended December 31, 2018 was ($15.5) million, or ($5.23) per share, respectively, compared with a net loss attributable to common stockholders for the year ended December 31, 2017 of ($15.0) million, or ($10.70) per share.
As of December 31, 2018, the company had cash, cash equivalents and restricted cash of $13.3 million compared to $10.1 million at December 31, 2017. The increase was largely attributable to cash received from financing activities of approximately $15.0 million, offset by cash used in operating activities of $11.4 million and cash used in investing activities of approximately $330,000. Consistent with prior guidance, the company believes its cash on hand is adequate to fund operations into the first quarter of 2020.