Full Press Release Details
Second Quarter 2019 Financial Results and Provides a Corporate Update
N.J., August 12, 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
second quarter ended June 30, 2019, and provided a corporate update.
considerable progress on both the clinical and regulatory fronts during the second quarter and subsequent period. CLR 131 continues
to advance, delivering encouraging preliminary data with improving efficacy and a clear dose response in our ongoing Phase 1 study.
In addition, the company received FDA Fast Track Designation for CLR 131 in two separate indications and believe that we continue
to track toward a registrational study in at least one B-cell hematologic malignancy from our ongoing Phase 2 CLOVER-1 study,"
said Jim Caruso, CEO of Cellectar. "Our recently adopted fractionated dosing schedule of CLR 131 has led to the improved
efficacy and tolerability observed in our latest cohorts and we are moving forward with this dosing strategy in our recently initiated
pediatric Phase 1 trial for the treatment of life-threatening cancers."
and Recent Corporate Highlights
Summary of Financial Results
Cash and Cash Equivalents: As of
June 30, 2019, cash and cash equivalents were approximately $16.8 million compared to $13.3 million as of December 31, 2018. We
believe that our cash balance is adequate to fund our basic budgeted operations through the fourth quarter of 2020. Cash used in
operating activities was approximately $5.5 million during the six months ended June 30, 2019 as compared to $5.7 million used
during the six months ended June 30, 2018.
Development Expense: R&D expense for the three months ended June 30, 2019 was $1.8 million compared to $1.7 million in
the three months ended June 30, 2018. The cumulative R&D spending for the first six months of 2019 was $4.1 million as compared
to $3.8 million for the first six months of 2018. The majority of the company's R&D spend for year-to-date 2019 was dedicated
to the start-up and support of our pediatric study with $1.3 million and $2.9 million spent for the three and six months ending
June 30, 2019, respectively, related to clinical project costs and manufacturing expenses.
Administrative Expense: General and administrative (G&A) expense for the three months ended June 30, 2019 was approximately
$1.4 million compared to approximately $1.2 million in the three months ended June 30, 2018. The cumulative G&A spending for
the first six months of 2019 were of $2.7 million as compared to $2.6 million for the first six months of 2018.
Net loss for the three months ended June 30, 2019 was $(3.2) million, or a loss of $(0.46) per diluted share, compared to a net
loss of $(2.9) million, or a loss of $(1.69) per diluted share, in the three months ended June 30, 2018. Net loss for the six months
ended June 30, 2019 was $(6.8) million, or a loss of $(1.15) per diluted share, compared to a net loss of $(6.4) million, or a
loss of $(3.75) per diluted share, in the six months ended June 30, 2018.
CLR 131 is a small-molecule, targeted Phospholipid
Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly to cancer cells, while limiting exposure to healthy
cells. CLR 131 is the company's lead product candidate and is currently being evaluated in a Phase 2 study in B-Cell lymphomas,
and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. CLR 131
was granted Orphan Drug designation for the treatment of multiple myeloma, and was granted Orphan Drug and Rare Pediatric Disease
designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma.
Cellectar Biosciences
is focused on the discovery, development, and commercialization of drugs for the treatment of cancer. The company is developing
proprietary drugs independently and through research and development (R&D) collaborations. The company's core objective
is to leverage its proprietary PDC delivery platform to develop PDCs that specifically target cancer cells, delivering improved
efficacy and better safety as a result of fewer off-target effects. Our PDC platform possesses the potential for the discovery
and development of the next-generation of cancer-targeting treatments, and we plan to develop PDCs independently and through research
and development collaborations.
lead PDC therapeutic, CLR 131, is currently in three clinical studies - a Phase 2 study, and two Phase 1 studies. The Phase
2 clinical study (CLOVER-1) is in refractory/relapsing (R/R) B-Cell malignancies, including multiple myeloma (MM), chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma
(MCL), and diffuse large B-Cell lymphoma (DLBCL). The company is also conducting a Phase 1 dose escalation study in patients with
R/R multiple myeloma (MM) and a Phase 1 study 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 and Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019. 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
| June 30, 2019 (Unaudited) | December 31, 2018 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 16,849,631 | $ | 13,255,616 | ||||
| Restricted cash | - | 55,000 | ||||||
| Prepaid expenses and other current assets | 1,333,846 | 641,218 | ||||||
| Total current assets | 18,183,477 | 13,951,834 | ||||||
| Fixed assets, net | 492,716 | 543,339 | ||||||
| Right-of-use asset, net | 378,280 | - | ||||||
| Long-term assets | 75,000 | 540,823 | ||||||
| Other assets | 6,214 | 18,086 | ||||||
| TOTAL ASSETS | $ | 19,135,687 | $ | 15,054,082 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued liabilities | $ | 2,528,017 | $ | 1,543,819 | ||||
| Derivative liability | 46,000 | 43,000 | ||||||
| Capital lease obligations, current portion | 568 | 2,213 | ||||||
| Deferred rent | - | 33,090 | ||||||
| Lease liability | 99,402 | - | ||||||
| Total current liabilities | 2,673,987 | 1,622,122 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Deferred rent, less current portion | - | 170,999 | ||||||
| Lease liability | 476,247 | - | ||||||
| Total long-term liabilities | 476,247 | 170,999 | ||||||
| TOTAL LIABILITIES | 3,150,234 | 1,793,121 | ||||||
| COMMITMENTS AND CONTINGENCIES (Note 7) | ||||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Series C preferred stock: 215 and 473 issued and outstanding as of June 30, 2019 and December 31, 2018, respectively | 1,148,204 | 2,526,049 | ||||||
| Common stock, $0.00001 par value; 80,000,000 shares authorized; 9,386,703 and 4,732,387 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively | 94 | 47 | ||||||
| Additional paid-in capital | 119,234,700 | 108,323,208 | ||||||
| Accumulated deficit | (104,397,545 | ) | (97,588,343 | ) | ||||
| Total stockholders' equity | 15,985,453 | 13,260,961 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 19,135,687 | $ | 15,054,082 |
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| COSTS AND EXPENSES: | ||||||||||||||||
| Research and development | $ | 1,809,547 | $ | 1,723,087 | $ | 4,117,944 | $ | 3,802,955 | ||||||||
| General and administrative | 1,390,812 | 1,181,832 | 2,712,227 | 2,555,491 | ||||||||||||
| Total costs and expenses | 3,200,359 | 2,904,919 | 6,830,171 | 6,358,446 | ||||||||||||
| LOSS FROM OPERATIONS | (3,200,359 | ) | (2,904,919 | ) | (6,830,171 | ) | (6,358,446 | ) | ||||||||
| OTHER INCOME: | ||||||||||||||||
| Gain/(Loss) on revaluation of derivative warrants | 1,000 | (20,000 | ) | (3,000 | ) | (46,950 | ) | |||||||||
| Interest income, net | 11,798 | 4,228 | 23,969 | 8,882 | ||||||||||||
| Total other income (expense), net | 12,798 | (15,772 | ) | 20,969 | (38,068 | ) | ||||||||||
| NET LOSS | $ | (3,187,561 | ) | $ | (2,920,691 | ) | $ | (6,809,202 | ) | $ | (6,396,514 | ) | ||||
| BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ | (0.46 | ) | $ | (1.69 | ) | $ | (1.15 | ) | $ | (3.75 | ) | ||||
| SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 6,963,301 | 1,731,561 | 5,935,111 | 1,706,278 |