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NEW YORK--(BUSINESS WIRE)--August 14, 1997--ImClone Systems
Incorporated (Nasdaq: IMCL) today announced financial results for the
quarter ended June 30, 1997. The Company reported revenues of
$3,196,000 and a net loss of $1,038,000 or $0.04 per share. These
results compare with revenues of $75,000 and a net loss of
$4,569,000, or $0.23 per share, for the comparable period last year.
Operating expenses for the quarter ended June 30, 1997 were
$4,529,000 as compared with $3,438,000 for the quarter ended June 30,
1996.
Quarter Overview
Revenues in the quarter were recorded in connection with the
achievement of a number of development and commercial milestones
contained in agreements with two corporate partners, Abbott
Laboratories (Abbott) and Merck KGaA (Merck). In May, the Company
announced that it was entitled to receive two milestone payments
totaling $1 million from Abbott as a result of a patent issuance in
Europe for the Company's proprietary Repair Chain Reaction (RCR) DNA
probe technology, in combination with the initiation of commercial
sales by Abbott of DNA probe assays employing this technology.
In June, ImClone announced the receipt of a $500,000 milestone
payment from Merck. The payment resulted from the achievement of a
pilot-scale manufacturing run of BEC2, ImClone's lead therapeutic
compound for the treatment of small cell lung cancer. This
achievement triggered the first in a series of eight quarterly
support payments, which will total $4.7 million. The Company also
earned a second milestone payment of $1 million from Merck, as a
result of the completion of a successful manufacturing run of bulk
cGMP grade BEC2.
In May, ImClone announced at the 33rd Annual Meeting of the
American Society of Clinical Oncology (ASCO) encouraging results of
the Company's Phase Ib/IIa dose-escalation study of its lead cancer
therapeutic, C225, an epidermal growth factor receptor (EGFr)
antagonist, in combination with the chemotherapeutic agent cisplatin.
In April, at the 88th Meeting of the American Association for Cancer
Research (AACR), ImClone presented promising results of a preclinical
study of C225 in human bladder carcinoma cells, as well as
preclinical data on its anti-FLK-1/KDR monoclonal antibody program.
The Company is currently evaluating C225 in head and neck cancer
patients in three Phase Ib/IIa dose-escalation trials in combination
with other anti-cancer therapies in the treatment of head and neck
cancer. ImClone expects to initiate Phase II/III studies to evaluate
the potential of C225 in various tumor types. Two of these tumor
targets will include renal cell cancer where C225 will be used alone,
and head and neck cancers where C225 will be used in combination with
chemotherapy. These targets present opportunities for near-term
demonstration of C225 activity, effectiveness and subsequent market
approval.
In addition, ImClone intends to initiate a Phase III multinational
trial for BEC2 in the fourth quarter of this year. BEC2 is a novel
cancer vaccine designed to elicit a cancer-fighting immune response
in patients with small cell lung cancer and other GD3 expressing
tumors.
In preclinical research, the Company is evaluating the
therapeutic potential of its anti-FLK-1/KDR monoclonal antibody as an
anti-angiogenic agent, especially against tumors known to secrete
vascular endothelial growth factor (VEGF).
ImClone Systems Incorporated, headquartered in New York, is a
biopharmaceutical company developing novel therapeutic products
including interventional therapeutics, cancer vaccines and blood cell
growth factors for the treatment of cancer and cancer-related
disorders.
Except for the historical information contained herein, the
matters discussed in this news release include forward-looking
statements. Actual results may differ materially from those
predicted in such forward-looking statements due to the risks and
uncertainties inherent in the Company's business, including, without
limitation, risks and uncertainties in the progression of clinical
trials, obtaining and maintaining regulatory approval, market
acceptance of and continuing demand for the Company's products, the
impact of competitive products and pricing, and the Company's ability
to obtain additional financing to support its operations.
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