Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical stage
biopharmaceutical company developing innovative agents for the
detection and treatment of cancer, is providing an update on its
development programs and financial results for the first quarter
2015.
Clinical Development Program Updates:
I-124-CLR1404
- After activating five large new centers this year, Cellectar
has seen an increase in patient screening and anticipates a
significant increase in enrollment in its Phase II trial of
I-124-CLR1404 in glioblastoma. However, enrollment remains slower
than expected and the company is evaluating potential strategies to
leverage existing data from investigator-sponsored studies to
modify its ongoing Phase II trial of I-124-CLR1404 in glioblastoma
and reduce the time to successful trial completion.
- Progress in investigator-sponsored clinical trials of
I-124-CLR1404, including imaging of 30 patients with various brain
cancers, should provide meaningful evidence for the optimal dose
and imaging time-point for the use of I-124-CLR1404 in
glioblastoma, the primary objective of the on-going
company-sponsored Phase II trial in glioblastoma.
I-131-CLR1404
- In April 2015, Cellectar initiated patient dosing in a
proof-of-concept trial of I-131-CLR1404 in patients with relapsed
or refractory multiple myeloma, an indication for which
I-131-CLR1404 previously received orphan drug designation from the
U.S. Food and Drug Administration. Based on data from the company's
Phase Ib trial, Cellectar anticipates that evidence of clinical
activity will be assessable relatively early in the dose escalation
process.
- Cellectar continues to expect data from this program to be
available by year-end 2015.
CLR1502
- In February 2015, a publication featured on the cover of
Neurosurgery, Official Journal of the Congress of Neurological
Surgeons - the largest neurosurgical society in the world,
demonstrated that Cellectar's fluorescent, cancer-selective agents
successfully provide visualization of glioma cells with high
fidelity, and suggest their practical and promising potential to
optimize tumor surgery.
- During the first quarter of 2015, Cellectar submitted an
investigational new drug (IND) application to the FDA to allow for
initiation of a Phase I proof-of-concept trial of CLR1502 in breast
cancer patients undergoing lumpectomy. The trial is intended to
establish the safety and tolerability of CLR1502 while
demonstrating its utility in the real-time identification of
malignant tissue.
- Cellectar is currently working with the FDA to determine if
CLR1502 should be evaluated as an imaging agent through the Center
for Drug Evaluation and Research (CDER) or as a combination product
along with an imaging system (light source) through the Center for
Devices and Radiological Health (CDRH).
- Cellectar is working closely with the FDA to resolve this
matter and expects to initiate its planned proof-of-concept study
in the second half of 2015.
"Having recently initiated our proof-of-concept therapeutic
trial in multiple myeloma, Cellectar now has two promising product
candidates in registration-enabling clinical trials, both of which
leverage the company's proprietary broad-spectrum cancer targeting
and retention technology and seek to address significant unmet
medical needs in cancer care," commented Dr. Simon Pedder,
Cellectar's president and chief executive officer. "We look forward
to advancing both programs, reporting preliminary data from each,
and initiating our fluorescence-guided surgery program with our
tumor illuminating agent, CLR1502."
Financial Results for the Quarter Ended March 31,
2015:
Cellectar reported a net loss for the quarter ended March 31,
2015 of $2.3 million or ($0.30) per share versus a net loss of $2.9
million or ($1.03) per share for the comparable period in 2014.
Research and development (R&D) expenses for the quarter
ended March 31, 2015 were $1.6 million, compared to $1.7 million
for the first quarter of 2014. The decrease in first quarter
2015 R&D expense reflects a decrease in costs associated with
supporting investigator-sponsored clinical studies partially offset
by increases in personnel related costs.
Cellectar's general and administrative (G&A) expenses for
first quarter 2015 totaled $0.9 million reflecting a 13% decrease
from the $1.1 reported for the comparable prior year period. The
decrease reflects a reduction in consulting charges and legal fees,
partially offset by a slight increase in travel-related
activities.
Cellectar ended the quarter with $7.0 million in cash and cash
equivalents compared to $9.4 million in cash and cash equivalents
at December 31, 2014. Cellectar anticipates that available cash and
cash equivalents should fund the company's planned operations into
the fourth quarter 2015 and that additional capital will be
required to complete all ongoing and planned clinical and
preclinical trials of its product candidates.
Restatement of Prior Financial Statements:
As disclosed in a Form 8-K filed by the Company on May 18, 2015,
the Audit Committee of the Board of Directors of Cellectar, in
connection with an internal review conducted by Cellectar's
management, concluded that, because of a misapplication of the
accounting guidance related to certain of the Company's warrants,
Cellectar's previously issued unaudited condensed consolidated
financial statements for the three and nine months ended September
30, 2014 and audited consolidated financial statements for the
twelve months ended December 31, 2014 should no longer be relied
upon. Cellectar has filed an amended Form 10-Q/A for the third
quarter of 2014 and an amended 2014 Form 10-K/A for the year ended
December 31, 2014 reflecting the restatements which result in
non-cash, non-operating financial statement corrections and have no
impact on the Cellectar's current or previously reported cash
position, operating expenses or total operating, investing or
financing cash flows.
On August 20, 2014, in addition to other securities, Cellectar
issued 3,833,333 warrants to purchase shares of our common stock at
an exercise price of $4.68 per share as part of an underwritten
offering. In connection with the election to participate in
this offering by the holders of debentures representing $4,000,000
principal amount and related accrued interest of $172,435,
Cellectar issued an additional 1,109,690 warrants. These warrants
contain a cash settlement feature in the event there is no current
prospectus to support the issuance of stock and warrant holder
wishing to exercise the warrant, requests gross settlement rather
than net settlement via cashless exercise.
The Audit Committee, together with management, determined that
the financial statements subsequent to this issuance should be
restated to reflect the warrants issued in August 2014 as
liabilities, with subsequent changes in their estimated fair value
recorded as non-cash income or expense in each affected period.
Conference Call and Webcast Today at 5:00 PM
EDT:
Interested investors may participate in the conference call by
dialing 888-646-8293 (domestic) or 973-453-3065 (international).
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 Phase I and Phase II product candidates
engineered to leverage the unique characteristics of cancer cells
to "find, treat and follow" malignancies in a highly selective way.
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/A for the year ended December 31, 2014. These
forward-looking statements are made only as of the date hereof, and
we disclaim any obligation to update any such forward-looking
statements.
CONTACT: INVESTOR CONTACT
Kate McNeil, Vice President of IR, PR & Corporate Communications
Cellectar Biosciences, Inc.
Phone: (347) 204-4226
Email: kmcneil@cellectar.com
Cellectar Biosciences (NASDAQ:CLRBW)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
Cellectar Biosciences (NASDAQ:CLRBW)
Historical Stock Chart
Von Jul 2023 bis Jul 2024