Press Release<< Back
Cellectar Reports Financial Results for Year Ended December 31, 2018 and Provides a Corporate Update
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).
- Cohort 6 is evaluating up to four patients with each receiving two doses of 18.75 mCi/m2 of CLR 131 administered one week apart.
- This 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.
- The 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.
- Based 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 relapsed/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
2018 Financial Highlights
Research and development expense for the year ended
General and administrative expense for the year ended
The net loss attributable to year ended
About Cellectar Biosciences, Inc.
The company’s lead PDC therapeutic, CLR 131, is in a Phase 1 clinical study in patients with R/R MM and a Phase 2 clinical study in R/R MM and a range of B-cell malignancies. The company plans to initiate a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma.
The company’s product pipeline also includes one preclinical PDC chemotherapeutic program (CLR 1900) and partnered assets including PDCs from multiple R&D collaborations.
For more information, please visit www.cellectar.com.
Forward-Looking Statement Disclaimer
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of CLR 131, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical studies, the
CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||13,255,616||$||10,006,421|
|Prepaid expenses and other current assets||641,218||412,173|
|Total current assets||13,951,834||10,473,594|
|Fixed assets, net||543,339||244,713|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and accrued liabilities||$||1,543,819||$||1,867,758|
|Capital lease obligations, current portion||2,213||3,036|
|Total current liabilities||1,622,122||2,114,788|
|Capital lease obligation, less current portion||—||2,213|
|Deferred rent, less current portion||170,999||—|
|Total long-term liabilities||170,999||2,213|
|COMMITMENTS AND CONTINGENCIES|
|Preferred stock, $0.00001 par value; 7,000 shares authorized;|
|Series B preferred stock: none and 18 issued and outstanding as of December 31, 2018 and 2017, respectively||—||995,782|
|Series C preferred stock: 473 and none issued and outstanding as of December 31, 2018 and 2017, respectively||2,526,049||—|
|Common stock, $0.00001 par value; 80,000,000 shares authorized; 4,732,387 and 1,666,144 shares issued and outstanding at December 31, 2018 and 2017, respectively||47||16|
|Additional paid-in capital||108,323,208||94,107,981|
|Total stockholders’ equity||13,260,961||10,754,463|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||15,054,082||$||12,871,464|
CONSOLIDATED STATEMENTS OF OPERATIONS
|Year Ended December 31,|
|COSTS AND EXPENSES:|
|Research and development||$||6,835,229||$||9,465,666|
|General and administrative||4,820,073||4,135,304|
|Impairment of goodwill||1,675,462||—|
|Total costs and expenses||13,330,764||13,600,970|
|LOSS FROM OPERATIONS||(13,330,764||)||(13,600,970||)|
|Gain on revaluation of derivative warrants||62,050||22,075|
|Interest income, net||29,687||16,605|
|Total other income, net||91,737||38,680|
|DEEMED DIVIDEND ON PREFERRED STOCK||(2,241,795||)||(1,448,945||)|
|NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS||(15,480,822||)||(15,011,235||)|
|BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE||$||(5.23||)||$||(10.70||)|
|SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE||2,961,972||1,403,132|
Source: Cellectar Biosciences