Full Press Release Details
First Quarter 2019 Financial Results and Provides a Corporate Update
top-line results from relapsed/refractory multiple myeloma cohort in ongoing Phase 2 clinical study of CLR 131
overall survival rate of 22 months in Cohorts 1-4 in its ongoing Phase 1 clinical study of CLR 131 in relapsed/refractory multiple
Phase 1 pediatric study for the treatment of select relapsed or refractory solid tumors, including neuroblastoma, lymphomas and
malignant brain tumors
N.J., May 06, 2019 -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the
discovery, development and commercialization of drugs for the treatment of cancer, today announced financial results for the first
quarter ended March 31, 2019, and provided a corporate update.
and Recent Corporate Highlights
we have seen thus far for CLR 131 are very compelling with demonstrated activity in at least 3 hematologic cancers. We continue
to make significant progress in the clinic and are excited to now provide this promising treatment to pediatric cancer patients,"
said James Caruso, president and CEO of Cellectar. "We believe CLR 131 has the potential to be a meaningful part of the treatment
regimine for patients battling life-threatening cancers and look forward to continuing to provide updates on our studies throughout
Financial Highlights
Development Expense: Research and development expense for the three months ended March 31, 2019 was $2.3 million, compared
to $2.1 million in the three months ended March 31, 2018. The overall increase in research and development expense of $184,000,
or 8%, was primarily a result of an increase in clinical project costs of approximately $285,000 related to the start-up of the
pediatric study. Manufacturing and related costs increased as a result of an increase in patient recruitments for the on-going
clinical trials. Pre-clinical studies decreased as some studies were concluding. The general research and development costs were
relatively consistent.
Administrative Expense: General and administrative expense for the three months ended March 31, 2019 was approximately $1,321,000,
compared to approximately $1,329,000 in the three months ended March 31, 2018 and remained relatively consistent.
Net loss for the three months ended March 31, 2019 was $(3.6) million, or a loss of $(0.76) per diluted share, compared to a net
loss of $(3.5) million, or a loss of $(2.07) per diluted share, in the three months ended March 31, 2018.
Cash and Cash Equivalents: As of
March 31, 2019, cash and cash equivalents were approximately $10.5 million compared to $13.3 million as of December 31, 2018. The
Company believes this cash balance is adequate to fund our pipeline development and operations into the first quarter 2020.
CLR 131 is a small-molecule, cancer-targeting
radiotherapeutic PDC (proprietary phospholipid drug conjugate) designed to deliver cytotoxic radiation directly and selectively
to cancer cells and cancer stem cells. CLR 131 is our lead therapeutic PDC product candidate and is currently being evaluated in
both Phase 2 and Phase 1 clinical studies. In December 2014, the FDA granted orphan drug designation for CLR 131 for the treatment
of multiple myeloma. In 2018, the FDA granted orphan drug and rare pediatric disease designations for CLR 131 for the treatment
of neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. The FDA previously accepted our IND application for
a Phase 1 open-label, dose-escalating study to evaluate the safety and tolerability of a single intravenous administration of CLR
131 in up to 30 children and adolescents with cancers including neuroblastoma, sarcomas, lymphomas (including Hodgkin's lymphoma)
and malignant brain tumors.
Cellectar Biosciences
is focused on the discovery, development, and commercialization of drugs for the treatment of cancer. The company plans to develop
proprietary drugs independently and through research and development (R&D) collaborations. The core drug development strategy
is to leverage our PDC platform to develop therapeutics that specifically target treatment to cancer cells. Through R&D collaborations,
the company's strategy is to generate near-term capital, supplement internal resources, gain access to novel molecules or
payloads, accelerate product candidate development and to broaden our proprietary and partnered product pipelines.
lead PDC therapeutic, CLR 131, is in a Phase 2 clinical study in R/R MM and select B-cell malignancies, as well as a dose escalation
Phase 1 study in patients with R/R MM. The company is initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma.
product pipeline also includes one preclinical PDC chemotherapeutic program (CLR 1900) and several partnered PDC assets.
For more information,
please visit www.cellectar.com.
Forward-Looking Statement Disclaimer
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 trials, the FDA review process and other government regulation, 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, 2018. These forward-looking statements are made only as of the date hereof, and we disclaim
any obligation to update any such forward-looking statements.
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, 2019 (Unaudited) | December 31, 2018 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 10,488,288 | $ | 13,255,616 | ||||
| Restricted cash | - | 55,000 | ||||||
| Prepaid expenses and other current assets | 604,650 | 641,218 | ||||||
| Total current assets | 11,092,938 | 13,951,834 | ||||||
| Fixed assets, net | 516,847 | 543,339 | ||||||
| Right-of-use asset, net | 392,122 | - | ||||||
| Long-term assets | 540,823 | 540,823 | ||||||
| Other assets | 6,214 | 18,086 | ||||||
| TOTAL ASSETS | $ | 12,548,944 | $ | 15,054,082 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued liabilities | $ | 2,055,074 | $ | 1,543,819 | ||||
| Derivative liability | 47,000 | 43,000 | ||||||
| Capital lease obligations, current portion | 1,402 | 2,213 | ||||||
| Deferred rent | - | 33,090 | ||||||
| Lease liability | 96,287 | - | ||||||
| Total current liabilities | 2,199,763 | 1,622,122 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Deferred rent, less current portion | - | 170,999 | ||||||
| Lease liability | 502,207 | - | ||||||
| Total long-term liabilities | 502,207 | 170,999 | ||||||
| TOTAL LIABILITIES | 2,701,970 | 1,793,121 | ||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Series C preferred stock: 335 and 473 issued and outstanding as of March 31, 2019 and December 31, 2018, respectively | 1,789,062 | 2,526,049 | ||||||
| Common stock, $0.00001 par value; 80,000,000 shares authorized; 5,086,709 and 4,732,387 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively | 51 | 47 | ||||||
| Additional paid-in capital | 109,267,845 | 108,323,208 | ||||||
| Accumulated deficit | (101,209,984 | ) | (97,588,343 | ) | ||||
| Total stockholders' equity | 9,846,974 | 13,260,961 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 12,548,944 | $ | 15,054,082 |
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
| Three Months Ended March 31, | ||||||||
| 2019 | 2018 | |||||||
| COSTS AND EXPENSES: | ||||||||
| Research and development | $ | 2,308,397 | $ | 2,124,060 | ||||
| General and administrative | 1,321,415 | 1,329,467 | ||||||
| Total costs and expenses | 3,629,812 | 3,453,527 | ||||||
| LOSS FROM OPERATIONS | (3,629,812 | ) | (3,453,527 | ) | ||||
| OTHER INCOME (EXPENSE): | ||||||||
| Loss on revaluation of derivative warrants | (4,000 | ) | (26,950 | ) | ||||
| Interest income, net | 12,171 | 4,654 | ||||||
| Total other income (expense), net | 8,171 | (22,296 | ) | |||||
| NET LOSS | $ | (3,621,641 | ) | $ | (3,475,823 | ) | ||
| BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ | (0.76 | ) | $ | (2.07 | ) | ||
| SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 4,773,500 | 1,680,818 |