Telik Announces Fourth Quarter And 2012 Year End Financial Results And 2013 Financial Guidance

Fri Mar 15, 2013 4:30pm EDT

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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
expenses.

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,
2011.

2012 Highlights  

Regulatory:

* Telik'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:

* "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.  
* "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.  
* "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 54th  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 a corporate partnership and
licensing agreement, funding from a non- profit agency, or other financing
sources.



Financial Outlook

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.

About Telik

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.

 Telik, Inc.                                                                                                                                                                         
 Statements of Operations                                                                                                                                                            
 (In thousands, except per share amounts)                                                                                                                                            
 (Unaudited)                                                                                                                                                                         
                                                                                                                                                                            
                                                                                                                                                                            
                                                                                               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 and expenses  1,768                  2,503                7,979               12,057       
                                                                                                                                                                            
 Loss from operations                                                                            (1,768)                (2,503)              (7,979)             (12,057)     
                                                                                                                                                                            
 Interest and other income (expense), net                                                        2                      4                    8                   35           
 Net loss                                                                                        $(1,766)               $  (2,499)           $(7,971)            $(12,022)    
                                                                                                                                                                            
 Basic and diluted net loss per share*                                                           $  (0.66)              $    (1.38)          $  (3.64)           $    (6.69)  
                                                                                                                                                                            
 Weighted average shares used to calculate basic and diluted net loss per share*                                                                                              
 2,687                                                     1,805                                             2,188                  1,798  
                                                                                                                                                                            
 *  Adjusted for the 1-for-30 reverse split of the company's common stock effected on March 30, 2012                                                                                 
                                                                                                                                                                            
                                                                                                                                                                            
                                                                                                                                                                            
                                                                                                                                                                            
 Selected Balance Sheet Data                                                                                                                                                     
 (In thousands)                                                                                                                                                                  
 (Unaudited)                                                                                                                                                                     
                                                                                                                                                                            
                                                                                               December 31,           December 31,                                          
                                                                                               2012                   2011                                                  
                                                                                                                                                                            
 Cash, cash equivalents, investments and restricted investments                                  $ 4,997                $ 11,700                                              
                                                                                                                                                                            
 Total assets                                                                                    5,628                  12,412                                                
                                                                                                                                                                            
 Stockholders' equity                                                                            3,062                  8,299                                                 


SOURCE  Telik, Inc.


Denise San Bartolome, Corporate Communications, Telik, Inc., +1-650-845-7712,
denisesb@telik.com

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