Full Press Release Details
Cellectar Reports 2018 Second Quarter
Financial Results and Provides Business Update
MADISON, Wis. (August 10, 2018) - Cellectar Biosciences
(Nasdaq: CLRB)("Cellectar or "the Company"), a clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of drugs for the treatment of cancer, today reported financial results for the three and six
months ended June 30, 2018 and provided a business update.
Second quarter 2018 and recent highlights:
CLR 131 Supply Update
On August 7, 2018, the Company was informed by Centre for Probe
Development and Commercialization ("CPDC"), the Company's sole supplier of CLR 131, that it is subject to an
Import Alert 66-40 (the "Import Alert") by the United States Food and Drug Administration ("FDA"). While
the basis for the Import Alert was not related to CLR 131, or CPDC's production facility associated with CLR 131, CPDC informed
the Company on August 8, 2018 that CPDC would not be able to supply CLR 131 to the Company until the Import Alert is lifted or
alternative agreements are reached with the FDA. The Company intends to work with CPDC to resolve this issue as soon as practical.
As a result of the supply disruption, the Company expects delays in enrollment in its ongoing clinical trials. At this time, the
Company is not able to assess the extent of the delays or what impact the supply disruption will have on the Company, but the inability
of CPDC to supply CLR 131 on a prolonged basis would result in further delayed patient enrollment in current and planned clinical
"The second quarter was highly productive for the company
as we executed on our corporate plan and achieved multiple clinical, regulatory and financial milestones. However, due to our supplier
being placed on an import alert for activities unrelated to CLR 131 we are experiencing an unexpected interruption in drug supply
and are working to resolve this as rapidly as possible" said James Caruso, president and CEO of Cellectar Biosciences. "On
the clinical front, we announced positive DLBCL interim data from our Phase 2 trial and expanded the cohort. We received important
FDA designations that underscore the potential of our rare pediatric disease portfolio. Also, in late July we raised capital that
materially strengthened our balance sheet which we believe provides a runway into the first quarter of 2020".
2018 Second Quarter and First Half Financial Results
Research and development expenses for the second quarter of
2018 were $1.7 million, compared with $2.2 million for the second quarter of 2017. Research and development expenses for the first
half of 2018 were $3.8 million, compared with $4.0 million for the first half of 2017. The year-over-year decrease in both periods
is attributable to lower clinical project costs and manufacturing-related costs.
General and administrative expenses for the second quarter of
2018 were $1.2 million, compared with $1.0 million for the second quarter of 2017, and were $2.6 million for the first half of
2018, compared with $2.0 million for the first half of 2017. The year-over-year increase in both periods is attributable to higher
consulting, legal and marketing expenses, as well as one-time personnel costs incurred in connection with the decision to outsource
The net loss attributable to common stockholders for the second
quarter of 2018 was $2.9 million, or $1.69 per share, compared with a net loss attributable to common stockholders for the second
quarter of 2017 of $3.1 million, or $2.32 per share. The net loss attributable to common stockholders for the first half of 2018
was $6.4 million, or $3.75 per share, compared with a net loss attributable to common stockholders of $6.0 million, or $4.72 per
share, for the first half of 2017.
Cash and cash equivalents as of June 30, 2018 were $4.2 million,
compared with $10.0 million as of December 31, 2017. As noted above, subsequent to the close of the second quarter the company
raised gross proceeds of $16.56 million from an underwritten public offering. The Company expects net proceeds from this financing,
after deducting underwriting discounts and commissions and estimated offering expenses, will be approximately $14.9 million. The
Company's pro forma cash balance at June 30, 2018 was approximately $19.1 million.
About Cellectar Biosciences, Inc.
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 broaden our proprietary and partnered product pipelines.
The Company's lead PDC therapeutic, CLR 131, is in a Phase
1 clinical study in patients with relapsed or refractory (R/R) MM and a Phase 2 clinical study in R/R MM and a range of B-cell
malignancies. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma and is planning
a second Phase 1 study in combination with external beam radiation for head and neck cancer. The company's
product pipeline also includes two preclinical PDC chemotherapeutic programs (CLR 1700 and 1900) and partnered assets include
PDCs from multiple R&D collaborations.
For more information please visit www.cellectar.com.
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 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, 2017. These forward-looking statements
are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
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