Trovagene, Inc., Announces Fourth Quarter and Year End 2012 Earnings

Mon Apr 1, 2013 5:23pm EDT

* Reuters is not responsible for the content in this press release.

For best results when printing this announcement, please click on the link
below:

http://pdf.reuters.com/pdfnews/pdfnews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20130401:nPnLA86119


SAN DIEGO,  April 1, 2013  /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a
developer of transrenal molecular diagnostics, today reported its financial
results for the three months and the year ended  December 31, 2012.  

(Logo:  http://photos.prnewswire.com/prnh/20120620/LA28014LOGO)

Fourth Quarter 2012 Financial Results

For the fourth quarter ended  December 31, 2012, Trovagene reported a net loss
of  $6.3 million, or  $0.43  per share, as compared to a net loss of  $1.3
million, or  $0.12  per share, for the three months ended  December 31, 2011.
The increase in net loss is primarily due to a change in fair value of
derivative instruments related to warrants of  $4.9 million,  $0.33  per share,
as well as an increase in the total research and development costs and general
and administrative expenses of  $0.7 million, or  $0.05  per share, during the
fourth quarter of 2012 as compared to the prior year comparable period.  

Year End 2012 Financial Results

For the year ended  December 31, 2012, Trovagene reported a net loss of  $11.6
million  or  $0.89  per share, as compared to a net loss of  $2.3 million, or 
$0.23  per share, for the twelve months ended  December 31, 2011. The increase
in net loss is primarily due to a change in fair value of derivative instruments
related to warrants of  $6.7 million, or  $0.51  per share, as well as an
increase in the total research and development costs and general and
administrative expenses of  $2.1 million,  $0.16  per share, as compared to the
prior year comparable period.

Cash and Cash Equivalents

Trovagene had cash and cash equivalents of  $10.8 million  at  December 31,
2012, as compared to  $0.7 million  at  December 31, 2011. The increase in cash
is primarily the net result of cash provided by financing activities, including
net proceeds of  $9.1 million  received from an underwritten public offering of
our common stock and warrants in the second quarter of 2012. In addition,
Trovagene closed a private placement which provided net proceeds of  $4.4
million  in the fourth quarter of 2012.

Review of 2012 and 2013 Announcements Demonstrate Progress in Development
Programs

* Launched HPV-HR assay, a urine-base molecular human papillomavirus (HPV) test
in 2013.  
* Extended planned offering of urine-based oncogene mutation tests to include a
test for the detection of a specific  p53  mutation and a specific double
mutation in the hepatitis B virus in 2013.  
* Expanded clinical collaboration with the  University of Texas  MD Anderson
Cancer Center to include the detection of transrenal  BRAF  mutations in the
urine of patients with advanced or metastatic cancers in 2013 from an initial
collaboration for the detection transrenal  KRAS  mutation in the urine of
patients with pancreatic cancer in 2012.  
* Entered into research collaboration with  Brazil's Barretos Cancer Hospital to
evaluate Trovagene's urine-based HPV assay as a potential Pap smear replacement
in 2012.  
* Entered into an agreement with  India's Strand Life Sciences to validate and
commercialize the HPV assay in  India  and  South Asia  in 2012.  
* Granted licenses for NPM1 marker for acute myelogenous leukemia to Quest
Diagnostics,  Duke University  and Genoptix, Inc. in 2012. Received a milestone
payment related to the NPM1 patent issuance from Ipsogen, S.A.  
* Strengthened patent portfolio. Received notification of issuance of two U.S.
patents in 2012. Trovagene now has 60 issued patents and 47 pending patents.  
* Acquired a CLIA-certified, CAP-approved laboratory in 2012.

About Trovagene, Inc.

Headquartered in  San Diego, California, Trovagene is developing its patented
technology for the detection of transrenal DNA and RNA, short nucleic acid
fragments, originating from normal and diseased cell death that cross the kidney
barrier and can be detected in urine. Trovagene has a strong patent position as
it relates to transrenal molecular testing. It has U.S. and European patent
applications and issued patents that cover testing for HPV and other infectious
diseases, cancer, transplantation, prenatal and genetic testing. In addition, it
owns worldwide rights to nucleophosmin-1 (NPM1), an informative biomarker for
acute myeloid leukemia (AML) and mutations in the SF3B1 gene, which have been
shown to be associated with chemotherapy response in chronic lymphocytic
leukemia (CLL) patients.

Certain statements in this press release are forward-looking within the meaning
of the Private Securities Litigation Reform Act of 1995. These statements may be
identified by the use of forward-looking words such as "anticipate," "believe,"
"forecast," "estimated" and "intend," among others. These forward-looking
statements are based on Trovagene's current expectations and actual results
could differ materially. There are a number of factors that could cause actual
events to differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, substantial
competition; our ability to continue as a going concern; our need for additional
financing; uncertainties of patent protection and litigation; uncertainties of
government or fourth party payer reimbursement; limited sales and marketing
efforts and dependence upon fourth parties; and risks related to failure to
obtain FDA clearances or approvals and noncompliance with FDA regulations. As
with any medical diagnostic tests under development, there are significant risks
in the development, regulatory approval and commercialization of new products.
There are no guarantees that future clinical trials discussed in this press
release will be completed or successful or that any product will receive
regulatory approval for any indication or prove to be commercially successful.
Trovagene does not undertake an obligation to update or revise any
forward-looking statement.  Investors should read the risk factors set forth in
Trovagene's Form 10-K for the year ended  December 31, 2012  and other periodic
reports filed with the Securities and Exchange Commission.

(Financial Information to Follow)

Contact

 Trovagene, Inc.                                      
 Financial                   Investor Relations       
 Stephen Zaniboni            Amy Caterina             
 
Chief Financial Officer    
Investor Relations      
 Trovagene, Inc.             Trovagene, Inc.          
 858-952-7594                858-952-7593             
 szaniboni@trovagene.com     acaterina@trovagene.com  


 Trovagene, Inc. and Subsidiaries                                                                                                                                                                                                                                                 
 
(A Development Stage Company)                                                                                                                                                                                                                                                   
 
Selected Financial Information                                                                                                                                                                                                                                                  
 
Consolidated Condensed Statements of Operations                                                                                                                                                                                                                                 
 
                                                                                                                                                                                                                                                                                
 
                                                                                                                                                                                                                                                                                
 
(in thousands, except for per share amounts)                                                                                                                                                                                                                                    
                                                                                                                                                                                                                                                                              
                                                                 Quarter Ended                                                                                 Year Ended                                                                   
                                                                 
December 31,                                                                                 December 31,                                                                 
                                                                2012                         2011                                        2012                                             2011                                            
 Revenues                                                       $    163                         $   34                          $             450                                 $           257                                                                   
                                                                                                                                                                                                                                                                    
 Operating expenses:                                                                                                                                                                                                                                           
 Research and development                                       594                          308                                        1,920                                                     910                                                                   
 General and administrative                                     1,003                        603                                        3,379                                                     2,324                                                                 
 Total operating expenses                                       1,597                        911                                        5,299                                                     3,234                                                                 
                                                                                                                                                                                                                                                                    
 Loss from operations                                           (1,434)                      (877)                                      (4,849)                                                   (2,977)                                                               
                                                                                                                                                                                                                                                                    
 Other income (expense)                                         4                            -                                          4                                                         (56)                                                                  
 Gain on extinguishment of debt                                 -                            -                                          -                                                         623                                                                   
 Change in fair value of derivative instruments - warrants      (4,896)                      (370)                                      (6,721)                                                   171                                                                    
 Net (loss) and comprehensive  (loss)                           $    (6,326)                     $   (1,247)                           $          (11,566)                                 $       (2,239)                                                          
                                                                                                                                                                                                                                                                     
 Preferred stock dividend                                       (10)                         (10)                                             (38)                                           (38)                                                                   
                                                                                                                                                                                                                                                                    
 Net loss available to common shareholders                      $    (6,336)                     $   (1,257)                           $    (11,604)                                  $       (2,277)                                                              
                                                                                                                                                                                                                                                                    
 Basic and diluted net loss per share                           $    (0.43)                      $         (0.12)                      $    (0.89)                                    $         (0.23)                                                             
                                                                                                                                                                                                                                                                    
 Weighted average shares outstanding - basic and diluted                    14,716           10,632                                           13,067                                                      9,712                                                     
                                                                                                                                                                                                                                                                     
                                                                                                                                                                                                                                                                     
                                                                                                                                                                                                                                                                     


 Trovagene, Inc. and Subsidiaries                                                                           
 
(A Development Stage Company)                                                                             
 
Consolidated Condensed Balance Sheet Information                                                          
 
(in thousands)                                                                                            
                                                                                                       
                                                             December 31,         December 31,         
                                                             
2012                
2011                
                                                                                                       
 Cash and cash equivalents                                   $        10,820     $        700        
 Other assets                                                590                  316                  
 Property and equipment, net                                 255                  23                   
 Total assets                                                $        11,665     $        1,039      
                                                                                                       
 Accounts payable, accrued expenses and other liabilities    $        730        $        1,430      
 Derivative financial instruments                            8,766                3,840                
 Stockholders' equity (deficiency)                           2,169                (4,231)              
 Total liabilities and stockholders' equity (deficiency)     $        11,665     $        1,039      
                                                                                                       


SOURCE  Trovagene, Inc.

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.