Full Press Release Details
Cellectar Reports Financial
Results for Year Ended 2022 and Provides a Corporate Update
Mar. 9, 2023 -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery,
development and commercialization of targeted treatments for cancer, today announced financial results for the year ended December 31,
2022 and provided a corporate update.
Recent Corporate Highlights
productive for Cellectar. We currently have 43 global sites actively recruiting patients for our pivotal study in Waldenstrom's
macroglobulinemia (WM). In parallel, our technology demonstrated consistently positive outcomes across multiple indications. At the American
Society of Hematology Conference, we presented a 50% response rate achieved by iopofosine in post BCMA multiple myeloma patients and successfully
concluded our phase 1a pediatric study and will initiate a phase 1b for High Grade Gliomas supported by a $2 million NCI grant. We also
reported the extraordinary complete response in a patient with relapsed/refractory CNS lymphoma further demonstrating iopofosine's
ability to cross the blood/brain barrier and target cancer," said James Caruso, president and CEO of Cellectar. "Importantly,
we strengthened our commercial leadership with several key hires, including Shane Lea, who has launched six new hematology/oncology products,
and Dr. Andrei Shustov, who provides a wealth of hematology/oncology clinical as well as study experience."
Financial Highlights
About Cellectar Biosciences,
Cellectar Biosciences
is focused on the discovery and development of drugs for the treatment of cancer. The company is developing proprietary drugs independently
and through research and development collaborations. 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 it plans to develop PDCs independently and through research and development
The company's product
pipeline includes iopofosine, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical
PDC chemotherapeutic programs and multiple partnered PDC assets. The company is currently investigating iopofosine in a global, open-label,
pivotal expansion cohort in relapsed or refractory WM patients who have received at least two prior lines of therapy, including those
who have failed or had a suboptimal response to Bruton tyrosine kinase inhibitors. The WM cohort will enroll up to 50 patients to evaluate
the efficacy and safety of iopofosine for marketing approval. The company is also evaluating iopofosine in highly refractory multiple
myeloma patients in its Phase 2 CLOVER-1 study and relapsed/refractory pediatric cancer patients with sarcomas or brain tumors in the
Phase 1 CLOVER-2 study.
The Phase 1 pediatric
study is an open-label, sequential-group, dose-escalation study to evaluate the safety and tolerability of iopofosine in children and
adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin's
lymphoma). The Phase 1 study is being conducted internationally at seven leading pediatric cancer centers.
The company has established
exclusivity on a broad U.S. and international intellectual property rights portfolio around its proprietary cancer-targeting PLE technology
platform, including iopofosine and its PDC programs.
In addition to the company's
exclusivity to iopofosine and its phospholipid ethers conjugated to small molecules, peptides, and oligos, the company now has non-exclusive
rights to the use of the phospholipid ether platform when conjugating with a chelator to bind select metal radioisotopes.
For more information,
please visit www.cellectar.com and www.wmclinicaltrial.com or join the conversation by liking and following us on
the company's social media channels: Twitter, LinkedIn, and Facebook.
Forward-Looking Statement
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 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, 2022. These forward-looking
statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
+++ TABLES TO FOLLOW +++
CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 19,866,358 | $ | 35,703,975 | ||||
| Prepaid expenses and other current assets | 663,243 | 867,485 | ||||||
| Total current assets | 20,529,601 | 36,571,460 | ||||||
| Fixed assets, net | 418,641 | 344,491 | ||||||
| Right-of-use asset, net | 560,334 | 204,644 | ||||||
| Long-term assets | 75,000 | 75,000 | ||||||
| Other assets | 6,214 | 6,214 | ||||||
| TOTAL ASSETS | $ | 21,589,790 | $ | 37,201,809 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued liabilities | $ | 5,478,443 | $ | 3,854,914 | ||||
| Lease liability | 50,847 | 135,449 | ||||||
| Total current liabilities | 5,529,290 | 3,990,363 | ||||||
| Lease liability, net of current portion | 552,981 | 166,292 | ||||||
| TOTAL LIABILITIES | 6,082,271 | 4,156,655 | ||||||
| COMMITMENTS AND CONTINGENCIES (Note 10) | ||||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Series D preferred stock: 111 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 1,382,023 | 1,382,023 | ||||||
| Common stock, $0.00001 par value; 160,000,000 shares authorized; 9,385,272 and 6,110,125 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 94 | 61 | ||||||
| Additional paid-in capital | 193,624,445 | 182,560,859 | ||||||
| Accumulated deficit | (179,499,043 | ) | (150,897,789 | ) | ||||
| Total stockholders' equity | 15,507,519 | 33,045,154 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 21,589,790 | $ | 37,201,809 |
CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| Year Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| COSTS AND EXPENSES: | ||||||||
| Research and development | $ | 19,219,603 | $ | 17,586,469 | ||||
| General and administrative | 9,594,170 | 6,544,811 | ||||||
| Total costs and expenses | 28,813,773 | 24,131,280 | ||||||
| LOSS FROM OPERATIONS | (28,813,773 | ) | (24,131,280 | ) | ||||
| OTHER INCOME: | ||||||||
| Other income | - | 6,634 | ||||||
| Interest income, net | 152,519 | 2,284 | ||||||
| Total other income, net | 152,519 | 8,918 | ||||||
| LOSS BEFORE INCOME TAXES | (28,661,254 | ) | (24,122,362 | ) | ||||
| INCOME TAX BENEFIT | (60,000 | ) | - | |||||
| NET LOSS | $ | (28,601,254 | ) | $ | (24,122,362 | ) | ||
| BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ | (4.05 | ) | $ | (4.35 | ) | ||
| SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 7,055,665 | 5,551,572 |