MORRIS PLAINS, N.J., Nov. 7 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU), a leading biopharmaceutical company focused on developing
monoclonal antibody-based products, today reported revenues of $0.4 million
and a net loss of $8.5 million, or $0.16 per share, for the first quarter of
fiscal year 2006, which ended September 30, 2005. This compares to revenues
of $1.1 million and a net loss of $4.2 million, or $0.08 per share, for the
same period last year. Cash used to fund operations for the first three
months was $8.9 million as compared to $5.0 million for the same period last
year. The increased use of cash of $3.9 million is due primarily to the
ALLEVIATE trials evaluating epratuzumab in patients with lupus, and lower
sales revenue from diagnostic imaging products. At September 30, 2005, the
Company had $20.7 million in cash and marketable securities, in addition to
$3.5 million of restricted securities that collateralize the New Jersey
Economic Development Authority financing completed in May 2003 for the
construction of the Company's expanded manufacturing facilities.
"Currently, our highest priority is to successfully complete patient
enrollment into our ALLEVIATE trials, to which we will continue to devote
resources. While we are placing strong emphasis on a worldwide partnership
for the development of epratuzumab in all indications, we have implemented a
cost savings program to maintain a burn rate consistent with our available
resources," commented Gerard G. Gorman, the Company's Vice President, Finance,
and Chief Financial Officer.
Salary compensation for the Chairman of the Board & Chief Strategic
Officer and certain senior executives will voluntarily be deferred until the
Company's financial condition improves as a result of our out-licensing
efforts. Additionally, the Company has eliminated certain staff positions and
reduced other positions to a part-time basis. The staff reduction program
became effective November 1, 2005 and included employee severance costs of
approximately $21,000.
The Company continues to transition away from the development of
diagnostic imaging products toward the accelerated development of therapeutic
product candidates. As a result, the Company will no longer commercialize
CEA-Scan in the near future. LeukoScan will continue to be manufactured and
sold by the Company in territories where regulatory approvals have been
granted.
"We are proud to be in late-stage clinical testing with epratuzumab in
patients with lupus. This market is not only significant in the number of
patients but also has a high unmet medical need. Furthermore, the launch of
our ALLEVIATE trials has elevated us from an early research and development
company to a late-stage development company. Finally, we believe we have also
successfully resolved the listing issue with the Nasdaq Stock Market," said
Cynthia L. Sullivan, President and Chief Executive Officer of the Company.
On September 2, 2005 the Nasdaq Listing and Qualifications Panel issued a
written decision to grant the request by the Company for continued listing on
the Nasdaq National Market. In accordance with Nasdaq's procedure, the Nasdaq
Listing and Hearing Review Council had 45 calendar days to review the panel
decision at their option. The 45-day period has expired without notification
from the Nasdaq Stock Market. Consequently, we believe the Company's stock
will remain listed on the Nasdaq National Market, subject to our continued
compliance with the Nasdaq Stock Market's continued listing requirements.
Another development of note during the first quarter of fiscal year 2006
was that the Company and its subsidiary, IBC Pharmaceuticals, Inc., have been
awarded two research grants by The National Institutes of Health for the
development of an antibody-drug conjugate for the treatment of B-cell
malignancies that express the CD74 antigen, and the development of an imaging
method based on bispecific antibody pretargeting used in combination with
Fluorine-18 labeled peptides.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company focused on
the development of monoclonal, antibody-based products for the targeted
treatment of cancer, autoimmune and other serious diseases. We have developed
a number of advanced proprietary technologies that allow us to create
humanized antibodies that can be used either alone in unlabeled or "naked"
form, or conjugated with radioactive isotopes, chemotherapeutics or toxins, in
each case to create highly targeted agents. Using these technologies, we have
built a pipeline of therapeutic product candidates that utilize several
different mechanisms of action. Our lead product candidate, epratuzumab, is
currently in two pivotal Phase III trials for the treatment of patients with
moderate and severe lupus (ALLEVIATE A and B). At present, there is no cure
for lupus and no new lupus drug has been approved in the U.S. in the last 40
years. We believe that our portfolio of intellectual property, which includes
approximately 90 patents issued in the United States, and more than 250 other
issued patents worldwide, protects our product candidates and technologies.
Visit our web site at http://www.immunomedics.com.
This release, in addition to historical information, may contain forward-
looking statements made pursuant to the Private Securities Litigation Reform
Act of 1995. Such statements, including statements regarding clinical trials,
out-licensing arrangements, and capital raising activities, involve
significant risks and uncertainties and actual results could differ materially
from those expressed or implied herein. Factors that could cause such
differences include, but are not limited to, risks associated with new product
development (including clinical trials outcome and regulatory
requirements/actions), competitive risks to marketed products and availability
of required financing and other sources of funds on acceptable terms, if at
all, as well as the risks discussed in the Company's filings with the
Securities and Exchange Commission. The Company is not under any obligation,
and the Company expressly disclaims any obligation, to update or alter any
forward-looking statements, whether as a result of new information, future
events or otherwise.
For More Information:
Dr. Chau Cheng Associate Director, Investor Relations & Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com
IMMUNOMEDICS, INC.
Condensed Consolidated Balance Sheets
September 30, June 30,
2005 2005
ASSETS
Current Assets:
Cash and cash equivalents $18,526,227 $11,937,483
Marketable securities 2,162,457 3,547,507
Accounts receivable 219,464 409,458
Inventory 760,590 493,603
Other current assets 1,273,113 785,677
Restricted securities 1,275,200 15,575,200
24,217,051 32,748,928
Property and equipment, net 9,813,194 10,152,115
Restricted securities 2,231,600 2,550,400
Other long-term assets 2,309,909 2,471,706
$38,571,754 $47,923,149
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities $8,364,868 $9,422,923
Long-term debt 36,731,683 36,743,233
Other Liabilities - 2,748,240
Minority interest 247,704 272,160
Stockholders' deficit (6,772,501) (1,263,407)
$38,571,754 $47,923,149
Condensed Consolidated Statements of Operations
Three Months Ended
September 30,
2005 2004
Revenues:
Product sales 280,074 1,062,693
License fee and other revenues 98,077 52,914
Research & development 44,762 -
Revenues 422,913 1,115,607
Costs and Expenses 7,898,863 6,429,803
Operating Loss (7,475,950) (5,314,196)
Interest and Other Income (Expense) (1,067,378) 1,195,624
Net Loss before Income Tax Expense (8,543,328) (4,118,572)
Income Tax Expense - (130,088)
Net Loss $(8,543,328) $(4,248,660)
Net Loss per Common Share,
Basic and Diluted (0.16) (0.08)
Weighted average number of common
shares outstanding 54,073,059 52,528,850
SOURCE Immunomedics, Inc.
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Related links:
http://www.Immunomedics.com
Company News On-Call:
http://www.prnewswire.com/comp/113121.html
CONTACT:
Dr. Chau Cheng, Associate Director, Investor
Relations & Business Analysis, +1-973-605-8200, extension 123,
ccheng@immunomedics.com, of Immunomedics, Inc.
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