Cellectar Biosciences Full-Year 2014 Financial Results and Recent Highlights
24 März 2015 - 9:15PM
Cellectar Biosciences, Inc. (Nasdaq: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 year ended
December 31, 2014.
"Last year, we set our sights on implementing meaningful change
at Cellectar with the goal of strengthening the fundamentals of our
business, focusing our clinical development efforts on
cost-effective trials intended to support regulatory approval in
the US, and increasing awareness of the company and its
highly-selective, cancer-targeting delivery and retention
technology," commented Cellectar's chief executive officer, Dr.
Simon Pedder. "Over the past year, we have executed against this
goal by building out a new management team, securing a Nasdaq
listing, attracting new institutional investors, obtaining FDA
approval to initiate clinical trials in two different orphan
indications and publishing multiple high profile manuscripts
detailing the groundbreaking nature of our product candidates and
underscoring their potential utility in the marketplace. With a new
course chartered and a strong foundation laid in 2014, Cellectar is
poised to make 2015 another year of achievement as we look to
complete a Phase II trial of our PET imaging agent in glioblastoma,
obtain data from our proof-of-concept trial of our therapeutic
agent in multiple myeloma and initiate a proof-of-concept trial of
our tumor margin illumination agent for image guided surgery."
Highlights from 2014:
Development Highlights
- Granted orphan drug designation from U.S. Food and Drug
Administration (FDA) for I-124-CLR1404 as a diagnostic agent for
the management of glioma, the most common and aggressive form of
brain cancer
- Initiated Phase II imaging trial of I-124-CLR1404 in patients
with glioblastoma, a type of glioma
- Granted orphan drug designation from FDA for I-131-CLR1404 for
the treatment of multiple myeloma, an incurable cancer of plasma
cells
- Received acceptance from the FDA of the Company's
investigational new drug (IND) application to evaluate
I-131-CLR1404 in clinical trials in relapsed or refractory multiple
myeloma, an incurable cancer of plasma cells
Key Presentations and Publications
- Science Translational Medicine: Publication by lead author Dr.
Jamey Weichert, Cellectar's chief scientific officer and founder,
detailing cancer-selective uptake and retention of Cellectar's
delivery platform, PET imaging and therapeutic agents selected as
cover story for June 11, 2014 issue
- PLOS ONE: Publication detailing efficacy of Cellectar's
proprietary phospholipid ether (PLE) analog agents for the
detection, imaging and real-time visualization of colorectal
cancer
- PLOS ONE: Publication detailing the results from Cellectar's
Phase Ia trial of I-131-CLR1404 in Patients with Relapsed or
Refractory Advanced Solid Tumors
- American Society of Clinical Oncology (ASCO) 2014 Annual
Meeting: Presented data from Phase Ib trial of I-131-CLR1404 at the
American Society of Clinical Oncology (ASCO) 2014 Annual
Meeting
Operational Highlights
- Changed company name to Cellectar Biosciences, Inc. and
completed the relocation of our principal executive offices,
previously in Newton, Massachusetts, to existing Madison, Wisconsin
corporate office and manufacturing facility
- Executed leadership transition, including appointment of Dr.
Simon Pedder as chief executive officer, Chad J. Kolean as chief
financial officer and Dr. Cameron Szakacs as vice president of
clinical development
- Completed underwritten public offering generating gross
proceeds of $13.5 million, before deducting underwriting discounts
and commissions and other offering expenses
- Extinguished all $4.2 million outstanding debt (principal
amount and accrued interest) of convertible debentures issued in
February 2014 in exchange for common shares and warrants in
conjunction with the August 2014 underwritten offering
- Secured listing of common stock on Nasdaq Capital Market under
the ticker CLRB
2014 Financial Results:
Cellectar reported a net loss attributable to common
stockholders for the year ended December 31, 2014 of approximately
$8.1 million or ($1.77) per share compared to a net loss
attributable to common stockholders of approximately $10.8 million
or ($3.86) per share for the year ended December 31, 2013.
Research and development expense for the year ended December 31,
2014 was approximately $6.0 million compared to approximately $6.9
million for 2013. This decrease was primarily attributable to a
reduction in salaries and stock-based compensation associated with
the restructuring efforts initiated in late 2013.
General and administrative expense for the year ended December
31, 2014 was approximately $3.7 million compared to approximately
$4.4 million in 2013. The decrease in general and
administrative costs was primarily related to decreased stock-based
compensation salaries associated with board and management changes
initiated in 2013.
As a result of management restructuring initiated in 2013,
Cellectar recorded approximately $0.2 million in 2014 as compared
to the $1.1 million in restructuring expenses recorded in 2013.
For the year ended December 31, 2014, total operating expenses
were approximately $9.9 million compared to $12.4 million for
fiscal year 2013. Cellectar's cash and cash equivalents totaled
$9.4 million as of December 31, 2014, as compared to $2.4 million
on December 31, 2013.
Conference Call and Webcast:
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 8981874 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 presented at 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, 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
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