I n v e s t o r F a c t s h e e t | Q 1 2 0 2 3
OVERVIEW
We are a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer. The company's core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop PDCs that specifically target cancer cells to deliver improved efficacy and better safety as a result of fewer off-target effects. The company's PDC platform possesses the potential for the discovery and development of the next- generation of cancer-targeting treatments, and the company plans to develop PDCs independently and
through research and development collaborations.
Iopofosine I 131 (CLR 131) and PDC PLATFORM
Iopofosine is a PDC designed to provide targeted delivery of iodine-131 directly to cancer cells, while limiting exposure to healthy cells. This novel, targeted radiotherapeutic provides a differentiated product profile with unique benefits. Ongoing clinical studies include:
- The pivotal Phase 2 Part B (CLOVER-WaM): A registration study currently evaluating iopofosine in Waldenstrom's macroglobulinemia (WM) patients who have received at least 2 prior lines of therapy, including in Bruton tyrosine kinase inhibitor (BTKi) failed or suboptimal-response patients.
- The Phase 2 Part A (CLOVER-1): Additional evaluation of iopofosine in highly refractory multiple myeloma patients and select B-cell malignancies.
- A Phase 1 dose-escalating pediatric clinical study in children and adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin's lymphoma). The study is being conducted internationally at seven leading pediatric cancer centers.
- A proprietary PDC chemotherapeutic program and partnered assets including an alpha emitter and small molecule cytotoxic compounds.
CURRENT PIPELINE OPPORTUNITIES & DEVELOPMENT STATUS
FAST FACTS (as of 9/30/2022) 1, 2
Ticker (Exchange) | CLRB (Nasdaq) |
Stock Price2 | $1.85 |
Market Cap | $17.4M |
Cash Available1 | $17.8M |
Outstanding | 9.4M |
Shares2 | |
52-Week Range2 | $1.25 -$7.90 |
Avg. Daily Volume2 | 59,800 (3 mo.) |
Headquarters | Florham Park,NJ |
Fiscal Year End | December 31 |
- As reported 9/30/2022
- As of 1/6/2023
PDC PROGRAM | INDICATION | DISCOVERY | PRECLINICAL | PHASE 1 | PHASE 2 | PIVOTAL | COLLABORATION PARTNER | ||
Waldenstrom's | |||||||||
Macroglobulinemia | |||||||||
Highly Refractory | |||||||||
Multiple Myeloma | |||||||||
Iopofosine | |||||||||
I 131 | Pediatric | ||||||||
HeadandNeck (IIS) | |||||||||
CLR1900 | Solid Tumors | ||||||||
PARTNERSHIPS | |||||||||
CLR2000 | Solid Tumors | ||||||||
CLR12120 | Solid Tumors | ||||||||
New PDCs | Various Targets | ||||||||
New PDCs | Various Targets | ||||||||
I n v e s t o r F a c t s h e e t | Q 1 2 0 2 3
LEADTHERAPEUTIC CANDIDATE: Iopofosine I 131 (CLR 131)
Iopofosine is a radio-labeled small molecule therapeutic that exploits the selective uptake and retention of phospholipid ethers (PLEs) by malignant cells. Iopofosine is currently in four ongoing clinical studies evaluating its safety and efficacy in a variety of hematologic and solid cancers. A pivotal study in 50 patients with WM who have received at least 2 prior lines of therapy, including those that have failed or had a suboptimal response to BTKi therapy, was initiated in January 2021. To date, iopofosine has demonstrated a 100% overall response rate in WM patients in Part A of the Phase 2 study.
PDC PLATFORM
Our PDC Platform provides selective delivery of a diverse range of oncologic molecules to cancer cells - whether it's the primary tumor, metastatic tumor and/or cancer stem cells. Due to the diversity of molecules that can be used, PDCs can treat a wide variety of cancers: both hematologic and solid tumors, including braintumors.
- The PDC platform's mechanism of entry does not rely upon specific cell surface epitopes or antigens like other targeted delivery platforms, allowing the molecules to potentially target all existing tumor cellsin the body.
- Our PDC platform takes advantage of a metabolic pathway utilized by all tumor cell types in all stages of the tumor cycle. Tumor cells modify regions on the cell surface as a result of the utilization of this metabolic pathway. Our PDCs bind to these regions and enter the intracellular compartment.
- The PDC platform has the capacity to link with almost any molecule and provide a significant increase in targeted oncologic payload delivery to potentially all tumor cells in the body. As a result, it improves the therapeutic index of oncologic drug payloads, enhancing or maintaining efficacy while reducing adverse events.
RECENT DEVELOPMENTS
November 30, 2022
Cellectar Biosciences Announces Shane Lea as Chief Commercial Officer
November 21, 2022
Cellectar Biosciences Announces Presentation of Data on CLR 12120 Series of Targeted Alpha- Emitting Therapies at the 13th Annual World ADC Conference
November 16, 2022
Cellectar Announces Resolution of Breach
of Contract and Intellectual Property
Dispute
November 3, 2022
Cellectar Reports Financial Results for Third Quarter 2022 and Provides a Corporate Update
MANAGEMENT TEAM
James Caruso
President, CEO and Director
Chad Kolean
Chief FinancialOfficer
Shane Lea
Chief Commercial Officer
Jarrod Longcor
Chief Operating Officer
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 including our expectations of the impact of the recent COVID-19 pandemic. 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 iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2021, and our Form 10-Qfor the quarter ended September 30, 2022. These forward-lookingstatements are made only as of the date hereof, and we disclaim any obligation to update any such forward-lookingstatements.
CONTACT
Cellectar Biosciences, Inc.
100 CampusDrive, Suite207 Florham Park, NJ 07932
- (608) 441-8120investors@cellectar.com
www.cellectar.com
www.wmclinicaltrial.com
@Cellectarbio
Cellectar Biosciences
Cellectar Biosciences, Inc.
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Cellectar BioSciences Inc. published this content on 13 January 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 January 2023 19:19:04 UTC.