Full Press Release Details
Financial Results for Year Ended December 31, 2019 and Provides a Corporate Update
N.J., March 9, 2020 -- 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 year ended December 31, 2019 and provided a corporate update.
and Recent Corporate Highlights
"Data from our CLR 131 Phase 1 dose
escalation study and the Phase 2 CLOVER-1 study demonstrated a unique safety profile and an encouraging response rate of nearly
43% as a sixth-line treatment for relapsed/refractory multiple myeloma," said James Caruso, President and CEO of Cellectar.
"Importantly, the 75mCi dose demonstrated excellent activity in very challenging to treat subpopulations, high-risk, triple
class refractory and penta-refractory. We plan to enroll additional patients at 100mCi of CLR 131 in the two-cycle dosing optimization
regimen, which we believe will further increase response rates, the durability of responses and will likely be used in our pivotal
study planned for initiation in Q4 of this year."
Cash and Cash Equivalents: As of
December 31, 2019, the company had cash, cash equivalents and restricted cash of $10.6 million compared to $13.3 million at December
31, 2018. Cash provided by financing activities was $9.0 million, offset by cash used in operating activities of $11.7 million.
Consistent with prior guidance, the company believes its cash on hand is adequate to fund operations into the first quarter of
Research and Development Expense: Research
and development expense for the year ended December 31, 2019 was $9.0 million, compared to $6.8 million for the year ended December
31, 2018. The overall increase in research and development expense of approximately 32% was primarily attributable to an increase
in clinical project costs largely related to the startup of the pediatric study, as well as an increase in patient recruitment
for the ongoing clinical studies.
Administrative Expense: General and administrative expense for the year ended December 31, 2019 was $5.2 million, compared
to $4.8 million for the year ended December 31, 2018. The increase of 8% in general and administrative costs was primarily related
to an increase in personnel and consulting costs and an increase related to public company expenses, rent and depreciation. These
costs were offset by a decrease in accounting fees and restructuring charges.
net loss attributable to common stockholders for the year ended December 31, 2019 was ($14.1) million, or ($1.84) per share, compared
to ($15.5) million, or ($5.23) per share, in 2018.
About Cellectar Biosciences, Inc.
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 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, 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 two clinical studies - one Phase 2 study and one Phase 1 study, having just completed
their Phase 1 relapsed/refractory multiple myeloma Dose Escalation study. 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/Waldenstrom's macroglobulinemia (LPL/WM), 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 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
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. 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, our ability to maintain orphan drug designation
in the United States for CLR 131,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 our Form 10-K for
the year ended December 31, 2019, when filed. 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.
CONSOLIDATED BALANCE SHEETS
| December 31, 2019 | December 31, 2018 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 10,614,722 | $ | 13,255,616 | ||||
| Restricted cash | - | 55,000 | ||||||
| Prepaid expenses and other current assets | 770,951 | 641,218 | ||||||
| Total current assets | 11,385,673 | 13,951,834 | ||||||
| Fixed assets, net | 435,083 | 543,339 | ||||||
| Right-of-use asset, net | 348,841 | - | ||||||
| Long-term assets | 75,000 | 540,823 | ||||||
| Other assets | 6,214 | 18,086 | ||||||
| TOTAL ASSETS | $ | 12,250,811 | $ | 15,054,082 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued liabilities | $ | 2,663,873 | $ | 1,543,819 | ||||
| Derivative liability | - | 43,000 | ||||||
| Capital lease obligations, current portion | - | 2,213 | ||||||
| Deferred rent | - | 33,090 | ||||||
| Lease liability | 105,885 | - | ||||||
| Total current liabilities | 2,769,758 | 1,622,122 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Deferred rent, less current portion | - | 170,999 | ||||||
| Lease liability | 421,644 | - | ||||||
| Total long-term liabilities | 421,644 | 170,999 | ||||||
| TOTAL LIABILITIES | 3,191,402 | 1,793,121 | ||||||
| COMMITMENTS AND CONTINGENCIES (Note 11) | ||||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Preferred stock, $0.00001 par value; 7,000 shares authorized; Series C preferred stock: 215 and 473 issued and outstanding as of December 31, 2019 and 2018, respectively | 1,148,204 | 2,526,049 | ||||||
| Common stock, $0.00001 par value; 80,000,000 shares authorized; 9,386,689 and 4,732,387 shares issued and outstanding at December 31, 2019 and 2018, respectively | 94 | 47 | ||||||
| Additional paid-in capital | 119,592,366 | 108,323,208 | ||||||
| Accumulated deficit | (111,681,255 | ) | (97,588,343 | ) | ||||
| Total stockholders' equity | 9,059,409 | 13,260,961 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 12,250,811 | $ | 15,054,082 |
CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| Year Ended December 31, | ||||||||
| 2019 | 2018 | |||||||
| COSTS AND EXPENSES: | ||||||||
| Research and development | $ | 8,996,058 | $ | 6,835,229 | ||||
| General and administrative | 5,182,566 | 4,820,073 | ||||||
| Impairment of goodwill | - | 1,675,462 | ||||||
| Total costs and expenses | 14,178,624 | 13,330,764 | ||||||
| LOSS FROM OPERATIONS | (14,178,624 | ) | (13,330,764 | ) | ||||
| OTHER INCOME: | ||||||||
| Gain on revaluation of derivative warrants | 43,000 | 62,050 | ||||||
| Interest income, net | 42,712 | 29,687 | ||||||
| Total other income, net | 85,712 | 91,737 | ||||||
| NET LOSS | (14,092,912 | ) | (13,239,027 | ) | ||||
| DEEMED DIVIDEND ON PREFERRED STOCK | - | (2,241,795 | ) | |||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | (14,092,912 | ) | (15,480,822 | ) | ||||
| BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ | (1.84 | ) | $ | (5.23 | ) | ||
| SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 7,675,092 | 2,961,972 |