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Palo Alto, CA, - February 19, 2004 — Telik, Inc.
(Nasdaq: TELK) reported a net loss of $14.5 million, or $0.36 per
share, for the fourth quarter ended December 31, 2003, compared
with a net loss of $12.6 million, or $0.36 per share, for the comparable
period in 2002. For the fiscal year ended December 31, 2003, the
company reported a net loss of $50.6 million, or $1.38 per share,
compared with a net loss of $34.8 million, or $1.17 per share, for
the fiscal year ended December 31, 2002.
For the quarter ended December 31, 2003, total operating expenses
increased to $14.9 million, from $13.4 million for the same quarter
in 2002. Total operating expenses increased to $52.2 million for
the year ended December 31, 2003, from $37.2 million for the year
ended December 31, 2002. The increase in operating expenses for
the year ended December 31, 2003 compared to the year ended December
31, 2002 was due to expanded clinical development of TELCYTA™
(TLK286) and TELINTRA™ (TLK199), increased headcount and higher
facility expenses as a result of our new facility in Palo Alto.
At December 31, 2003, Telik had $201.1 million in cash, cash equivalents
and investments including restricted investments, compared to $104.3
million at December 31, 2002. The increase in the company’s
cash balances was due to the successful completion of a follow-on
offering in the fourth quarter of 2003, which resulted in net proceeds
to Telik of approximately $142.8 million.
Highlights during 2003 included:
TELCYTA™
- Telik reported positive, confirmatory results from additional
Phase 2 studies of TELCYTA™ administered as a single agent
in ovarian and non-small cell lung cancer at the American Society
of Clinical Oncology meeting in June.
- Also at the ASCO meeting, Telik reported positive preliminary
data from the first clinical trial of TELCYTA™ in advanced
metastatic breast cancer. An extension of this trial is in progress
in women with metastatic breast cancer who have not previously
received chemotherapy.
- The Phase 3 registration trial of TELCYTA™ in ovarian
cancer was initiated. The trial is designed to enroll approximately
440 women with platinum refractory or resistant ovarian cancer
who have also failed treatment with one of the approved second
line agents.
- A Phase 3 registration trial of TELCYTA™ in platinum resistant
non-small cell lung cancer was announced and is scheduled to begin
in the current quarter.
- The protocols for the TELCYTA™ Phase 3 registration trials
were reviewed by the FDA under Special Protocol Assessments, and
the FDA granted Fast Track status for TELCYTA™ for the treatment
of ovarian and non-small cell lung cancer in the third line setting.
- Positive interim clinical results were reported using TELCYTA™
in combination treatment regimens with carboplatin, Taxotere®
and Doxil®, drugs that are used in current front line and
second line chemotherapy.
TELINTRA™
- At the American Society of Hematology meeting in December, Telik
reported positive interim results from the ongoing Phase 1-2a
clinical trial of TELINTRA™ in myelodysplastic syndrome.
PIPELINE AND TRAP TECHNOLOGY
- Telik’s pipeline, generated through the application of
its proprietary TRAP drug discovery technology, continued to advance
in development. In November at the AACR-NCI-EORTC conference,
Telik reported new data on its small molecule c-raf kinase inhibitors.
Also at the AACR-NCI-EORTC meeting, Telik reported on several
TRAP-generated lead compounds developed through its collaborations
with leading academic cancer institutions.
- In April, Telik announced a TRAP collaboration with Roche under
which Telik identifies drug candidates active against a pharmaceutical
target selected by Roche.
Conference Call and Webcast
Telik will host its quarterly conference call at 4:30 p.m. Eastern
time (1:30 pm. Pacific time) today. During the conference call,
Telik management will review the company’s recent progress
and provide guidance with respect to its currently anticipated financial
results for 2004. A live webcast of the conference call will be
available by logging on to www.telik.com. A replay of the webcast
will be will be available from approximately 8:30 p.m. Eastern time
February 19 through February 26, 2004. Access to the live teleconference
call is also available by calling 612-332-0819.
About Telik
Telik, Inc. of Palo Alto, CA is a biopharmaceutical company working
to discover, develop and commercialize small molecule drugs to treat
serious diseases for which there is significant demand for new therapies.
The company’s most advanced drug development candidate is
TELCYTA™ (TLK286), a tumor-activated small molecule product
candidate that is in a Phase 3 registration trial in advanced ovarian
cancer and in Phase 2 clinical trials in ovarian, non-small cell
lung and breast cancer. Telik’s product candidates were discovered
using its proprietary drug discovery technology, TRAP, which enables
the rapid and efficient discovery of small molecule drug candidates.
Additional information is available at www.telik.com.
This press release contains “forward-looking” statements.
For this purpose, any statements contained in this press release
that are not statements of historical fact may be deemed to be forward-looking
statements, including any statements regarding the potential for
TELCYTA™ (TLK286) or TELINTRA™ (TLK199) to treat one
or more types of cancer. There are a number of important factors
that could cause Telik's results to differ materially from those
indicated by these forward-looking statements, including, among
others, the following: none of Telik’s product candidates,
including TELCYTA™, has been determined to be safe or effective
in humans or received regulatory approval for marketing; it may
take us several years to complete clinical trials of our product
candidates, including TELCYTA™, prior to seeking regulatory
approval for any indication; success in preclinical testing and
early clinical trials does not ensure that later clinical trials
will be successful, and interim results of clinical trials do not
necessarily predict final results; if our competitors develop and
market products that are more effective than our product candidates,
or obtain regulatory approval before we do, our commercial opportunity
will be reduced or eliminated; if we do not obtain regulatory approval
to market products in the United States and foreign countries, we
will not be permitted to commercialize our product candidates; if
we are unable to contract with third parties to manufacture our
product candidates in sufficient quantities and at an acceptable
cost, clinical development of product candidates could be delayed;
and if we are unable to raise adequate funds in the future, we will
not be able to continue to fund our operations and clinical trials
to develop our product candidates. These and other risks are detailed
from time to time in our SEC reports, including our Annual Report
on Form 10-K for the year ended December 31, 2002 and our most recent
Quarterly Report on Form 10-Q for the quarter ended September 30,
2003. Telik does not undertake any obligation to update forward-looking
statements.
Click here for Q4 and Year End 2003
Statements of Operations
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Contact:
Carol DeGuzman
Senior Director, Corporate Communications
Telik, Inc.
Tel 650-845-7728
Email cdeguzman@telik.com
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