Full Press Release Details
Third Quarter 2019 Financial Results and Provides a Corporate Update
N.J., November 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
third quarter ended September 30, 2019, and provided a corporate update.
and Recent Corporate Highlights
to effectively manage our financial resources to fund our budgeted operations into 2021 while advancing multiple clinical and preclinical
programs. The third quarter proved to be highly productive for Cellectar with CLR 131 receiving FDA Fast Track Designation for
DLBCL and Orphan Drug Designation for multiple myeloma from the European Commission. In addition, we presented incremental positive
data at international scientific conferences," said Jim Caruso, CEO of Cellectar. "We continue to anticipate data from
our ongoing clinical studies by the end of this year and in early 2020."
and Nine Months Summary of Financial Results
Cash and Cash Equivalents: As of
September 30, 2019, cash and cash equivalents were approximately $13.3 million compared to $13.3 million as of December 31, 2018.
The company believes the cash balance is adequate to fund its budgeted operations into the first quarter 2021. Cash used in operating
activities was approximately $9.0 million during the nine months ended September 30, 2019 as compared to $8.7 million used during
the nine months ended September 30, 2018.
Development Expense: Research and development (R&D) expense for the three months ended September 30, 2019 was $2.7 million
compared to $2.0 million in the three months ended September 30, 2018. The cumulative R&D spending for the first nine months
of 2019 was $6.8 million as compared to $5.8 million for the first nine months of 2018. The majority of the company's R&D
spend for year-to-date 2019 was dedicated to the start-up costs and support of our pediatric study. Clinical project costs and
manufacturing expenses were $2.1 million and $5.0 million for the three and nine months ending September 30, 2019, respectively.
Administrative Expense: General and administrative (G&A) expense for the three months ended September 30, 2019 was approximately
$1.3 million compared to approximately $1.1 million in the three months ended September 30, 2018. The cumulative G&A spending
for the first nine months of 2019 were of $4.0 million as compared to $3.6 million for the first nine months of 2018.
Net loss attributable to common stockholders for the three months ended September 30, 2019 was $(3.9) million, or a loss of $(0.42)
per diluted share, compared to a net loss of $(5.3) million, or a loss of $(1.65) per diluted share, in the three months ended
September 30, 2018. Net loss attributable to common stockholders for the nine months ended September 30, 2019 was $(10.7) million,
or a loss of $(1.51) per diluted share, compared to a net loss of $(11.7) million, or a loss of $(5.29) per diluted share, in the
nine months ended September 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 Phospholipid Drug ConjugateTM (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. 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 collaborations.
lead PDC therapeutic, CLR 131, is currently in three clinical studies - one Phase 2 study, and two Phase 1 studies. The Phase 2
clinical study (CLOVER-1) is in relapsed/refractory (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 lymphomas.
product pipeline also includes one preclinical PDC chemotherapeutic program (CLR 1900) and several partnered PDC assets.
For more information,
please visit www.cellectar.com or join the conversation by liking and following us on
the company's social media channels: Twitter, LinkedIn,
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 studies, 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, June 30, 2019 and September 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
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2019 (Unaudited) | December 31, 2018 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 13,301,612 | $ | 13,255,616 | ||||
| Restricted cash | - | 55,000 | ||||||
| Prepaid expenses and other current assets | 1,450,364 | 641,218 | ||||||
| Total current assets | 14,751,976 | 13,951,834 | ||||||
| Fixed assets, net | 461,940 | 543,339 | ||||||
| Right-of-use asset, net | 363,861 | - | ||||||
| Long-term assets | 75,000 | 540.823 | ||||||
| Other assets | 6,214 | 18,086 | ||||||
| TOTAL ASSETS | $ | 15,658,991 | $ | 15,054,082 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued liabilities | $ | 2,875,342 | $ | 1,543,819 | ||||
| Derivative liability | - | 43,000 | ||||||
| Capital lease obligations, current portion | - | 2,213 | ||||||
| Deferred rent | - | 33,090 | ||||||
| Lease liability | 102,597 | - | ||||||
| Total current liabilities | 2,977,939 | 1,622,122 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Deferred rent, less current portion | - | 170,999 | ||||||
| Lease liability | 449,632 | - | ||||||
| Total long-term liabilities | 449,632 | 170,999 | ||||||
| TOTAL LIABILITIES | 3,427,571 | 1,793,121 | ||||||
| COMMITMENTS AND CONTINGENCIES (Note 7) | ||||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Series C preferred stock: 215 and 473 issued and outstanding as of September 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 September 30, 2019 and December 31, 2018, respectively | 94 | 47 | ||||||
| Additional paid-in capital | 119,384,474 | 108,323,208 | ||||||
| Accumulated deficit | (108,301,352 | ) | (97,588,343 | ) | ||||
| Total stockholders' equity | 12,231,420 | 13,260,961 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 15,658,991 | $ | 15,054,082 |
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| COSTS AND EXPENSES: | ||||||||||||||||
| Research and development | $ | 2,703,831 | $ | 1,995,571 | $ | 6,821,775 | $ | 5,798,526 | ||||||||
| General and administrative | 1,260,048 | 1,091,921 | 3,972,275 | 3,647,412 | ||||||||||||
| Total costs and expenses | 3,963,879 | 3,087,492 | 10,794,050 | 9,445,938 | ||||||||||||
| LOSS FROM OPERATIONS | (3,963,879 | ) | (3,087,492 | ) | (10,794,050 | ) | (9,445,938 | ) | ||||||||
| OTHER INCOME: | ||||||||||||||||
| Gain on revaluation of derivative warrants | 46,000 | 66,000 | 43,000 | 19,050 | ||||||||||||
| Interest income, net | 14,072 | 6,558 | 38,041 | 15,440 | ||||||||||||
| Total other income, net | 60,072 | 72,558 | 81,041 | 34,490 | ||||||||||||
| NET LOSS | (3,903,807 | ) | (3,014,934 | ) | (10,713,009 | ) | (9,411,448 | ) | ||||||||
| DEEMED DIVIDEND ON PREFERRED STOCK | - | (2,241,795 | ) | - | (2,241,795 | ) | ||||||||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (3,903,807 | ) | $ | (5,256,729 | ) | $ | (10,713,009 | ) | $ | (11,653,243 | ) | ||||
| BASIC AND DILUTED NET LOSS PER COMMON SHARE | $ | (0.42 | ) | $ | (1.65 | ) | $ | (1.51 | ) | $ | (5.29 | ) | ||||
| SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 9,386,703 | 3,184,856 | 7,098,285 | 2,204,554 |