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Trovagene, Inc. Reports Third Quarter 2013 Financial Results



         Trovagene, Inc. Reports Third Quarter 2013 Financial Results

First clinical results presented on novel molecular diagnostics to optimize
cancer treatment; Ends quarter with approximately $28 million in cash

PR Newswire

SAN DIEGO, Nov. 14, 2013

SAN DIEGO, Nov. 14, 2013 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a
developer of cell-free molecular diagnostics, today reported financial results
for the three months and the nine months ended September 30, 2013.

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

"We have made significant corporate and scientific achievements in recent
months. We have signed multiple collaboration agreements and launched our
first oncogene mutation detection test. In addition, the first series of
clinical results were presented at a major medical conference. These data
demonstrated the detection and monitoring of cancer mutations in urine with
high rates of sensitivity," stated Antonius Schuh, Ph.D., chief executive
officer of Trovagene. "Trovagene is well positioned to leverage its investment
in its intellectual property, scientific research, and collaborations to build
a better clinical pathway for cancer monitoring."

Third Quarter 2013 Financial Results
For the three months ended September 30, 2013, Trovagene reported a net loss
available to common stockholders of $4.4 million, or $0.25 per share, as
compared to a net loss available to common stockholders of $0.66 million, or
$0.05 per share, for the three months ended September 30, 2012. The increase
in net loss available to common stockholders was primarily due to an increase
in total operating expenses of $1.87 million, or $0.10 per share, as well as
an increase in the change in fair value of derivative instruments related to
warrants of $1.71 million, $0.09 per share, during the third quarter of 2013,
as compared to the prior year comparable period.

First Nine Months Financial Results
For the nine months ended September 30, 2013, Trovagene reported a net loss
available to common stockholders of $10.8 million, or $0.66 per share, as
compared to a net loss available to common stockholders of $5.3 million, or
$0.42 per share, for the nine months ended September 30, 2012. The increase in
net loss available to common stockholders is primarily attributable to an
increase in total operating expenses of $4.4 million, or $0.27 per share, and
an increase in the change in fair value of derivative instruments related to
warrants of $1.1 million, $0.07 per share, as compared to the prior year
comparable period.

Cash and Cash Equivalents
Trovagene had cash and cash equivalents of approximately $28 million at
September 30, 2013, as compared to $11 million at December 31, 2012. The
Company completed a $15 million registered direct offering on July 31, 2013.

Review of Recent 2013 Announcements Demonstrate Progress in Development
Programs

  o Presented first prospective cancer monitoring data demonstrating that
    Trovagene's diagnostics can detect rare oncogene mutation signals in urine
    that closely correlate to tissue biopsy and response to therapy.
  o Launched cell-free BRAF oncogene diagnostic, the first urine-based cancer
    mutation monitoring test.
  o Entered into collaboration with an undisclosed pharmaceutical company to
    study oncogene detection and monitoring in lung cancer. Initiated clinical
    collaboration with USC Norris Cancer Center to study genomic
    characterizations of metastatic colorectal cancers using Trovagene's
    proprietary cell-free DNA assays.
  o Completed $15 million registered direct offering of common stock.

Webcast of Earnings Conference Call
Trovagene's management team will host an earnings conference call on Thursday,
November 14, 2013, at 5:00 p.m. Eastern Standard Time (2:00 p.m. Pacific
Standard Time). Interested parties may listen to a live audio broadcast of the
conference call on the Company's website in the Investor Room. A replay of the
call can be accessed approximately one hour after the completion of the call
and will be archived on the website for at least one year.

About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is leveraging its patented
technology for the detection of cell-free DNA and RNA, short nucleic acid
fragments, originating from normal and diseased cell death that can be
isolated and detected from urine. Trovagene has a strong intellectual property
asset as it relates to cell-free DNA and RNA testing in urine. 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.

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 and Comprehensive Loss

 

(in thousands, except for per share amounts)

 
                        Three Months Ended    Nine Months Ended
                        September 30,         September 30,
                        2013        2012      2013           2012
                        (Unaudited)           (Unaudited)
Revenues                $ 44        $  211    $ 212          $    287
Operating expenses:
Research and            916         511       2,662          1,326
development
General and             2,206       739       5,392          2,376
administrative
Total operating         3,122       1,250     8,053          3,702
expenses
Operating loss          (3,078)     (1,039)   (7,842)        (3,415)
Interest expense        (6)         -         (7)            -
Change in fair value                                          
of derivative           (1,317)     389       (2,933)
instruments - warrants                                       (1,824)
Net loss and            $ (4,401)   $  (650)  $ (10,782)     $     (5,239)
comprehensive loss
Preferred stock         (5)         (10)      (21)                    (29)
dividend
Net loss and
comprehensive loss      $ (4,406)   $ (660)   $  (10,803)  $       (5,268)
available to common
stockholders
Basic and diluted net   $ (0.25)    $ (0.05)  $  (0.66)    $       (0.42)
loss per share
Weighted average
shares outstanding-       17,871      14,178     16,330            12,507
basic and dilute

 

 

 

 

Trovagene, Inc. and Subsidiaries

(A Development Stage Company)

Consolidated Condensed Balance Sheet Information

 

(in thousands)

 
                                                  September 30,  December 31,
                                                  2013           2012
                                                  (Unaudited) 
Cash and cash equivalents                         $    27,799    $   10,820
Other assets                                      611            590
Property and equipment, net                       740            255
Total assets                                      $    29,150    $   11,665
Current portion of long-term debt                 $    148       $   -
Accounts payable, accrued expenses and other      1,213          730
liabilities
Long-term debt, less current portion              370            -
Derivative financial instruments                  6,281          8,766
Stockholders' equity                              21,138         2,169
Total liabilities and stockholders' equity        $    29,150    $   11,665

 

SOURCE Trovagene, Inc.

Website: http://www.trovagene.com
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