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Company also Announces Lower Net Loss Per
Share for Fiscal Year Ended December 31, 2001 Due to Recalculation
of Weighted Number of Shares Outstanding
South San Francisco, CA, - February 13, 2003 — Telik,
Inc. (Nasdaq: TELK) reported a net loss of $12.6 million, or $0.36
per share, for the fourth quarter ended December 31, 2002, and a
net loss for the year ended December 31, 2002 of $34.8 million,
or $1.17 per share. This compares with a net loss of $6.3 million,
or $0.23 per share, and $18.6 million, or $0.77 per share, for the
fourth quarter and year ended December 31, 2001, respectively. The
company’s net loss in 2002 is due primarily to increases
in research and development spending as the company’s lead
compounds, TLK286 and TLK199, advanced in clinical development.
The $0.77 net loss per share for fiscal year 2001 reflects a recalculation
of the weighted number of shares outstanding during that period,
versus the previously reported net loss of $0.81 per share.
The company ended 2002 with $104.3 million in cash, cash equivalents
and investments including restricted cash, compared to $55.2 million
at December 31, 2001. The increase in the company’s cash
balances is due to the successful completion of a follow-on offering
in October 2002, which resulted in net proceeds of approximately
$80.3 million.
Research and development expenses were $11.7 million and $31.6
million in the fourth quarter and year ended December 31, 2002,
respectively, compared with $6.6 million and $18.8 million for the
comparable periods in 2001. The increase in research and development
expenses reflects investment in the clinical development of Telik’s
lead product candidates, TLK286 and TLK199, and the ramp-up of manufacturing
of clinical supplies for both products.
"Fiscal year 2002 was a transforming year for Telik. We announced
strong, positive clinical results with TLK286 in three cancer indications,
held a successful pre-Phase 3 meeting with the FDA for TLK286, initiated
clinical development of a second drug cancer drug candidate, TLK199,
and expanded our cancer drug pipeline through the selection of drug
candidates from our collaboration with the Arizona Cancer Center,"
said Michael M. Wick, M.D., Ph.D., chairman and chief executive
officer. "We begin 2003 focused on our most important goal
of advancing TLK286 into a Phase 3 registration trial for the treatment
of ovarian cancer."
In addition to the equity offering, key accomplishments at Telik
during 2002 and early 2003 have included:
Clinical Progress
- Data were presented demonstrating significant clinical activity
of TLK286 in Phase 2 trials in ovarian, non-small cell lung and
colorectal cancer at the American Society of Clinical Oncology
meeting in May and the EORTC/NCI/AACR meeting in November.
- A successful pre-Phase 3 meeting with the FDA for TLK286 led
to the announcement of plans to begin pivotal Phase 3 registration
trials in advanced ovarian and non-small cell lung cancer patients.
The ovarian cancer trial is expected to initiate in the first
quarter of 2003.
- The TLK286 clinical development program was expanded to include
advanced breast cancer, and a total of six new clinical trials
were initiated using a weekly dose schedule and combination chemotherapy
regimens. Telik plans to present results from several of these
trials at medical conferences during 2003.
- A Phase 1-2a clinical trial began with Telik’s second
product candidate, TLK199, in patients with myelodysplastic syndrome,
a form of pre-leukemia. Early data from this trial were presented
at the American Society of Hematology meeting in December; additional
data are expected to be presented at a medical conference during
2003.
Pipeline Advancement and TRAP Collaborations
- TLK19781 was selected as Telik’s next product candidate
for clinical development. This orally available small molecule
drug has shown evidence of efficacy in several animal models of
type 2 diabetes and insulin resistance, including HIV protease
inhibitor-induced insulin resistance. Data were presented at the
American Diabetes Association meeting in June.
- Two new TRAP collaborations focused on discovering and developing
novel cancer treatments for Telik’s pipeline were begun
at the Fox Chase Cancer Center and Vanderbilt Ingram Cancer Center.
- Early success in the TRAP collaboration with the Arizona Cancer
Center at the University of Arizona led to the selection by Telik
of four new candidates for potential development.
- Telik’s TRAP collaboration with Sanwa Kagaku Kenkyusho
was extended to identify and select a small molecule drug candidate
for inflammatory disorders.
In addition, the company’s senior management team was expanded
with addition of Marc Steuer, senior vice president, business development;
David Lair, vice president, finance; Carlos Parra, vice president,
quality; and Jay Shepard, vice president, commercial operations.
Conference Call
Telik will host its quarterly conference call at 4:30 p.m. Eastern
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 2003. 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 13 through February
20, 2003. Access to the live teleconference call is also available
by calling 612 332-0228.
About Telik, Inc.
Telik, Inc. of South San Francisco, 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 TLK286, a tumor activated small molecule drug that
is in Phase 2 clinical trials in ovarian, non-small cell lung, colorectal
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.
You should not rely on forward-looking statements contained in
this press release, including statements regarding the tolerability
or potential efficacy of TLK286, or its potential in the treatment
of one or more types of cancer. Telik can give no assurance with
regard to these statements, as they are subject to various risks
and uncertainties. Past financial results may not be indicative
of future results. Factors that could affect our future financial
results include but are not limited to the numerous technical, operational
and financial uncertainties associated with drug development. All
of our product candidates, including TLK286, are in the early stages
of development, and the potential benefits of each product must
still be proven. To date, TLK286 has been tested only in open-label
uncontrolled clinical trials. Substantial additional testing, including
randomized, controlled clinical trials, will be necessary prior
to seeking regulatory approval to market TLK286, and there can be
no assurance that such trials will be initiated, have a successful
outcome, or that regulatory approval of TLK286 will be obtained.
Telik is reliant on external manufacturing of TLK286. More detailed
information regarding factors that may cause actual results to differ
materially from the results expressed or implied by statements in
this press release may be found in Telik's periodic filings with
the Securities and Exchange Commission. Telik assumes no obligation
to update any information provided in this press release or during
its conference call.
Q4 and Year End 2002 Statements
of Operations (PDF)
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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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