World News: 13:00 GMT Friday 10th August 2018. [Cellectar Biosciences, Inc. via Globe Newswire via SPi World News]
MADISON, Wis., Aug. 10, 2018 (GLOBE NEWSWIRE) -- Cellectar Biosciences (Nasdaq: CLRB)(“Cellectar or “the Company”), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today reported financial results for the three and six months ended June 30, 2018 and provided a business update.
On August 7, 2018, the Company was informed by Centre for Probe Development and Commercialization (“CPDC”), the Company’s sole supplier of CLR 131, that it is subject to an Import Alert 66-40 (the “Import Alert”) by the United States Food and Drug Administration (“FDA”). While the basis for the Import Alert was not related to CLR 131, or CPDC’s production facility associated with CLR 131, CPDC informed the Company on August 8, 2018 that CPDC would not be able to supply CLR 131 to the Company until the Import Alert is lifted or alternative agreements are reached with the FDA. The Company intends to work with CPDC to resolve this issue as soon as practical. As a result of the supply disruption, the Company expects delays in enrollment in its ongoing clinical trials. At this time, the Company is not able to assess the extent of the delays or what impact the supply disruption will have on the Company, but the inability of CPDC to supply CLR 131 on a prolonged basis would result in further delayed patient enrollment in current and planned clinical trials for CLR 131.
“The second quarter was highly productive for the company as we executed on our corporate plan and achieved multiple clinical, regulatory and financial milestones. However, due to our supplier being placed on an import alert for activities unrelated to CLR 131 we are experiencing an unexpected interruption in drug supply and are working to resolve this as rapidly as possible” said James Caruso, president and CEO of Cellectar Biosciences. “On the clinical front, we announced positive DLBCL interim data from our Phase 2 trial and expanded the cohort. We received important FDA designations that underscore the potential of our rare pediatric disease portfolio. Also, in late July we raised capital that materially strengthened our balance sheet which we believe provides a runway into the first quarter of 2020”.
Research and development expenses for the second quarter of 2018 were $1.7 million, compared with $2.2 million for the second quarter of 2017. Research and development expenses for the first half of 2018 were $3.8 million, compared with $4.0 million for the first half of 2017. The year-over-year decrease in both periods is attributable to lower clinical project costs and manufacturing-related costs.
General and administrative expenses for the second quarter of 2018 were $1.2 million, compared with $1.0 million for the second quarter of 2017, and were $2.6 million for the first half of 2018, compared with $2.0 million for the first half of 2017. The year-over-year increase in both periods is attributable to higher consulting, legal and marketing expenses, as well as one-time personnel costs incurred in connection with the decision to outsource manufacturing.
The net loss attributable to common stockholders for the second quarter of 2018 was $2.9 million, or $1.69 per share, compared with a net loss attributable to common stockholders for the second quarter of 2017 of $3.1 million, or $2.32 per share. The net loss attributable to common stockholders for the first half of 2018 was $6.4 million, or $3.75 per share, compared with a net loss attributable to common stockholders of $6.0 million, or $4.72 per share, for the first half of 2017.
Cash and cash equivalents as of June 30, 2018 were $4.2 million, compared with $10.0 million as of December 31, 2017. As noted above, subsequent to the close of the second quarter the company raised gross proceeds of $16.56 million from an underwritten public offering. The Company expects net proceeds from this financing, after deducting underwriting discounts and commissions and estimated offering expenses, will be approximately $14.9 million. The Company’s pro forma cash balance at June 30, 2018 was approximately $19.1 million.
The Company's lead PDC therapeutic, CLR 131, is in a Phase 1 clinical study in patients with relapsed or refractory (R/R) MM and a Phase 2 clinical study in R/R MM and a range of B-cell malignancies. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer. The company’s product pipeline also includes two preclinical PDC chemotherapeutic programs (CLR 1700 and 1900) and partnered assets include PDCs from multiple R&D collaborations.
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Globe Newswire: 13:00 GMT Friday 10th August 2018
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