Cellectar Biosciences: Reports first quarter 2014 financial


Results and Recent Highlights


Management to Host Conference Call and Webcast at 5:00 PM EDT



MADISON, Wis., May 14, 2014 (GLOBE NEWSWIRE) — Cellectar Biosciences,
Inc. (OTCQX:CLRB), a clinical stage biopharmaceutical company
developing innovative agents for the detection and treatment of cancer,
is providing an overview of its development programs and financial
results for the first quarter 2014.



“During the first quarter, we initiated our first company-sponsored
Phase II imaging trial of I-124-CLR1404 in patients with glioblastoma,
a type of glioma,” commented Dr. Simon Pedder, Cellectar’s president
and chief executive officer. “Complementing the clinical progress for
this program, we were successful in securing orphan designation from
the FDA for I-124-CLR1404 as a diagnostic for the management of glioma
that ensures seven years of marketing exclusivity upon approval in this
indication and should accelerate our development program by enabling
smaller trials and requiring fewer patients for a new drug
application.”



Dr. Pedder continued, “We have identified a low-cost, rapid development
opportunity for our radiotherapeutic, I-131-CLR1404, in multiple
myeloma. By initiating an optical imaging and therapeutic Phase I
trial, we believe we can generate meaningful data across each of our
three development programs by the end of 2015.”



Recent Highlights:




— Completed private placement of convertible debentures and warrants for
gross proceeds of $4.0 million


— Changed company name to Cellectar Biosciences, Inc.


— Dr. Simon Pedder became full-time president and chief executive officer


— Initiated Phase II imaging trial of I-124-CLR1404 in patients with
glioblastoma, a type of glioma


— Granted orphan drug designation from U.S. Food and Drug Administration


(FDA) for I-124-CLR1404 as a diagnostic for the management of glioma, the
most common and aggressive form of brain cancer


Financial Results for the Quarter Ended March 31, 2014:

Cellectar reported a net loss for the quarter ended March 31, 2014 of
$2.9 million or ($0.05) per share versus a net loss of $3.5 million or
($0.07) per share for the comparable period in 2013.



Research and development (R&D) expenses for the quarter ended March 31,
2014 were $1.7 million, compared to $1.6 million for the first quarter
of 2013. The increase in first quarter 2014 R&D expense resulted from
increases in clinical and preclinical project costs partially offset by
decreases in manufacturing and general unallocated research costs.



Cellectar’s general and administrative (G&A) expenses were essentially
unchanged year-over-year with first quarter 2014 G&A expenses totaling
approximately $1.1 million.



Cellectar ended the quarter with $3.8 million in cash and cash
equivalents compared to $2.4 million in cash and cash equivalents at
December 31, 2013. This increase reflects the completion of a private
placement in February 2014. Cellectar anticipates that available cash
and cash equivalents should fund the company’s planned operations
through July 2014 and that additional capital will be required to
complete all ongoing and planned clinical and preclinical trials of its
product candidates.



Operational Update:



I-124-CLR1404



Based on proof-of-concept demonstrated in multiple
investigator-sponsored Phase I/II trials of I-124-CLR1404 in both
primary and metastatic brain cancers, Cellectar initiated a
company-sponsored Phase II imaging trial of I-124-CLR1404 in patients
with newly diagnosed or recurrent glioblastoma during the first quarter
of 2014. This trial, being conducted at multiple NCI-designated cancer
centers in the U.S., will compare the efficacy of I-124-CLR1404
positron emission tomography (PET) imaging in detecting glioblastoma
with standard of care MRI based on pathology confirmation in
approximately 36 patients. To determine the optimal parameters for
PET/CT brain imaging, the trial is designed to evaluate up to two dose
levels of I-124-CLR1404 (5 mCi and 7.5 mCi) in conjunction with
multiple imaging time points. Cellectar expects to complete this trial
and announce top-line results in the fourth quarter of 2014.



CLR1502



During the first quarter of 2014, Cellectar reviewed the data from its
IND-enabling preclinical package for CLR1502 and determined that
additional preclinical work would likely be required to secure approval
of its planned investigational new drug (IND) application and
initiation of Phase I clinical trials. As a result, Cellectar now plans
to submit an IND application to the U.S. Food and Drug Administration
by year-end 2014 to enable patient enrollment in a Phase I
intraoperative optical imaging study of CLR1502 in approximately 20
patients undergoing lumpectomy surgery commencing during the first
quarter of 2015.



I-131-CLR1404



A Phase Ib dose escalation study of I-131-CLR1404 in patients with
advanced solid tumors was completed during the quarter and
investigators submitted the results of the Phase Ib trial of
I-131-CLR1404 to the American Society of Clinical Oncology (ASCO) 2014
Annual Meeting. Based on the results of this trial and because of the
highly radiosensitive nature, clear unmet medical need in the
relapse/refractory setting and the potential to receive orphan drug
designation Cellectar has decided to pursue multiple myeloma as an
initial target indication for future I-131-CLR1404 development and
plans to submit an IND application with the FDA in 2014. Cellectar
believes a Phase I trial in this indication could be completed by
year-end 2015 and potentially provide meaningful proof-of-concept data
supporting use of a radiotherapeutic in the treatment of multiple
myeloma.



Conference Call and Webcast:



A conference call hosted by the Cellectar management team will be
webcast live today at 5:00 pm EDT on the Cellectar Biosciences website.
Interested investors may participate in the conference call by dialing
888-646-8293 (domestic) or 973-453-3065 (international). A replay will
be available for one week following the call by dialing 855-859-2056
for domestic participants or 404-537-3406 for international
participants and entering conference ID 45707640 when prompted.
Participants may also access both the live and archived webcast of the
conference call on the investor relations section of Cellectar’s web
site, www.cellectar.com.



About Cellectar Biosciences, Inc.



Cellectar Biosciences is developing agents to detect, treat and monitor
a broad spectrum of cancers. Using a novel phospholipid ether analog
(PLE) platform technology as a targeted delivery and retention vehicle,
Cellectar’s compounds are designed to be selectively taken up and
retained in cancer cells including cancer stem cells. With the ability
to attach both imaging and therapeutic agents to its proprietary
delivery platform, Cellectar has developed a portfolio of product
candidates engineered to leverage the unique characteristics of cancer
cells to “find, treat and follow” malignancies in a highly selective
way. I-124-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted
PET imaging agent currently being evaluated in a Phase II glioblastoma
imaging trial. Additionally, multiple investigator-sponsored Phase I/II
clinical trials are ongoing across 11 solid tumor indications.
I-131-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted
molecular radiotherapeutic that delivers cytotoxic radiation directly
and selectively to cancer cells including cancer stem cells. A Phase Ib
dose-escalation trial of I-131-CLR1404 in patients with advanced solid
tumors was completed in the first quarter of 2014 and results have been
submitted to the American Society of Clinical Oncology (ASCO) 2014
Annual Meeting. CLR1502 is a preclinical, cancer-targeted,
non-radioactive optical imaging agent for intraoperative tumor margin
illumination and non-invasive tumor imaging. For additional information
please visit www.cellectar.com



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, 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, 2013. These forward-looking statements are made
only as of the date hereof, and we disclaim any obligation to update
any such forward-looking statements.