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Cellectar Reports Recent Corporate Highlights and 2018 First Quarter Financial Results
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
FDAfor CLR 131 to treat rhabdomyosarcoma, a rare pediatric cancer.
- Presented Phase 1 study results at the 12th World
Congressof the World Federation of Nuclear Medicine and Biologydemonstrating 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 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
“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
First Quarter 2018 Financial Results
Research and development expense for the first quarter of 2018 was
General and administrative expense for the first quarter of 2018 was
The net loss attributable to common stockholders for the first quarter of 2018 was
Cash and cash equivalents as of
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. In 2018 the company plans to initiate a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and 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.
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 ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the
LHA Investor Relations
Source: Cellectar Biosciences, Inc.