Telik Announces Fourth Quarter And 2012 Year End Financial Results And 2013
PALO ALTO, Calif., March 15, 2013
PALO ALTO, Calif., March 15, 2013 /PRNewswire/ --Telik, Inc. (Nasdaq: TELK)
reported a net loss of $1.8 million, or $0.66 per share, for the three months
ended December 31, 2012, compared with a net loss of $2.5 million, or $1.38
per share, for the comparable period in 2011. For the year ended December 31,
2012, net loss was $8.0 million, or $3.64 per share, compared with a net loss
of $12.0 million, or $6.69 per share, for the year ended December 31, 2011.
Net loss per share for both periods were adjusted for the 1-for-30 reverse
split of the company's common stock effected on March 30, 2012.
For the quarter ended December 31, 2012, total operating costs and expenses
were $1.8 million compared with $2.5 million in the fourth quarter of 2011,
representing a reduction of approximately 29%, primarily due to lower
headcount, reduced clinical trial expenses, and lower corporate and
stock-based compensation expenses.
Operating costs and expenses for the year ended December 31, 2012 were $8.0
million, compared with $12.1 million for the same period in 2011. Operating
costs and expenses in 2012 included approximately $0.7 million in stock-based
compensation expense compared to $1.6 million in 2011. The reduction in
operating costs and expenses of approximately 34% in the year ended December
31, 2012, compared with 2011, were primarily due to lower headcount, reduced
clinical trial expenses, and lower corporate and stock-based compensation
At December 31, 2012, Telik had $5.0 million in cash, cash equivalents,
restricted cash and investments, compared with $11.7 million at December 31,
oTelik's product candidate, ezatiostat HCL (Telintra), was granted orphan
drug designation by the US Food and Drug Administration (FDA) for the
treatment of myelodysplastic syndrome (MDS). Orphan designation grants
potential US market exclusivity to a drug for the treatment of a specified
condition for a period of seven years following FDA marketing approval.
Additional potential benefits of orphan designation include development
grants, tax credits related to clinical trial expenses, protocol
development assistance and exemption from FDA user fees.
Results of clinical trials with Telintra were reported in peer reviewed
medical publications including:
o"Phase 1 dose-ranging study of ezatiostat hydrochloride in combination
with lenalidomide in patients with non-deletion (5q) low to intermediate-1
risk myelodysplastic syndrome (MDS)," Raza, A., et al., Journal of
Hematology & Oncology 2012, 5:18 doi:10.1186/1756-8722-5-18; 30 April
2012.Significant findings of the study included multilineage responses
and good tolerability, supporting the further development of the Telintra
and Revlimid® combination in MDS as well as in other hematologic
malignancies where Revlimid is a standard of care.
o"Prediction of response to therapy with ezatiostat in lower risk
myelodysplastic syndrome," Galili, N. et al., Journal of Hematology &
Oncology 2012, 5:20 doi:10.1186/1756-8722-5-20; 6 May 2012. A gene marker
analysis was performed using RNA available from 30 patients enrolled in a
Phase 2 Telintra clinical trial.Pathway analysis of the response profile
revealed that the genes comprising the jun-N-terminal kinase/c-JUN
molecular pathway, which is known to be influenced by Telintra, were
under-expressed in responders and over-expressed in non-responders,
providing additional support for the novel mechanism of action of Telintra
and a potential basis for a companion diagnostic.
o"Oral Ezatiostat HCl (Telintra), a Glutathione Analog Prodrug GSTP1-1
Inhibitor, for Treatment of Patients with Myeloid Growth Factor-Resistant
Idiopathic Chronic Neutropenia (ICN)," by Roger M. Lyons, MD; et al.
Available online at Blood (ASH 54^th Annual Meeting Abstracts) 2012 120:
Abstract 4394. This abstract reports the preliminary results of a clinical
trial of Telintra for the treatment of patients with idiopathic chronic
neutropenia (ICN), a rare group of blood disorders characterized by low
circulating white cells, recurrent fevers, inflammation and serious
infections. Telintra treatment of ICN patients with very low white blood
cell levels who were not responsive to G‑CSF led to clinically significant
reductions in serious infections. Telintra is the first targeted GSTP1-1
inhibitor that has been shown to have a positive effect on white blood
cell levels in ICN and may provide molecular insight into the
pathophysiology of ICN.
In 2013, Telik is focusing on: (1) planning and initiating a Phase 3
placebo-controlled randomized registration trial of TELINTRA for the treatment
of Low to Intermediate-1 risk MDS and (2) advancing its leading preclinical
oncology drug candidate. In order to initiate the registration trial, we need
to secure funding through the establishment of acorporate partnership and
licensing agreement, funding from a non- profit agency, or other financing
For the full year 2013, Telik anticipates total operating costs and expenses
to be in the range of $5.5 million to $6.0 million, which includes non-cash
stock-based compensation expense of approximately $0.3 million. The costs for
a Phase 3 TELINTRA registration trial are not included in this outlook and
would require additional funding. The company's cash utilization for the full
year 2013, without any Phase 3 costs, is expected to be in the range of $7.0
million to $7.5 million. The company was able to raise approximately $3.6
million through its At Market Issuance Sales Agreement in the first two months
of 2013, and its current existing cash resources will be sufficient to fund
projected operating requirements into the fourth quarter of 2013. In order to
meet its cash requirements beyond the fourth quarter of 2013, the company
would have to raise additional funds through corporate partnering or
additional financing. There is no assurance Telik will be successful in
obtaining additional funding in the near future to fund registration trial or
continue its operations.
Telik, Inc. of Palo Alto, CA, is a clinical stage drug development company
focused on discovering and developing small molecule drugs to treat cancer.
The company's most advanced drug candidate is Telintra®, a modified
glutathione analog intended for the treatment of hematologic disorders
including myelodysplastic syndrome; followed by Telcyta®, a cancer activated
prodrug for the treatment of a variety of cancers. 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.
Forward Looking Statements
This press release contains "forward looking" statements, including statements
regarding Telik's financial outlook and expected cash utilization for 2013 and
the future development of TELINTRA, preclinical drug candidates and potential
corporate partnerships. These forward looking statements are based upon
Telik's current expectations. There are important factors that could cause
Telik's results to differ materially from those indicated by these
forward-looking statements, including, among others, that Telik would be
unable to continue to fund its operations if it is unable to raise adequate
funding; if the development of its drug candidates, including clinical trials
of TELINTRA, is delayed or unsuccessful, if Telik does not enter into
collaborative arrangements to advance its programs, the rate of product
development will be delayed and expenditures may increase; if Telik is
delisted from the Nasdaq Capital Market, its ability to raise additional
financing and the liquidity of its common stock could be adversely affected.
Detailed information regarding these and other 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, including the factors described in the
section entitled "Risk Factors" in its annual report on Form 10-K for the year
ended December 31, 2012. Telik does not undertake any obligation to update
forward looking statements contained in this press release.
Telik, the Telik logo, TELINTRA, TELCYTA and TRAP are trademarks or registered
trademarks of Telik, Inc.
Statements of Operations
(In thousands, except per share amounts)
Three Months Ended Twelve Months Ended
December 31, December 31,
2012 2011 2012 2011
Operating costs and expenses:
Research and development $ 736 $ 1,102 $ 3,524 $ 5,566
General and administrative 1,032 1,401 4,455 6,491
Total operating costs 1,768 2,503 7,979 12,057
Loss from operations (1,768) (2,503) (7,979) (12,057)
Interest and other income 2 4 8 35
Net loss $(1,766) $ (2,499) $(7,971) $(12,022)
Basic and diluted net loss per $ (0.66) $ (1.38) $ (3.64) $ (6.69)
Weighted average shares used to
calculate basicand diluted net 2,687 1,805 2,188 1,798
loss per share*
* Adjusted for the 1-for-30 reverse split of the company's common stock
effected on March 30, 2012
Selected Balance Sheet Data
Cash, cash equivalents,
investments and restricted $ 4,997 $ 11,700
Total assets 5,628 12,412
Stockholders' equity 3,062 8,299
SOURCE Telik, Inc.
Contact: Denise San Bartolome, Corporate Communications, Telik, Inc.,
Press spacebar to pause and continue. Press esc to stop.