Trius Therapeutics Reports First Quarter 2013 Financial Results

Trius Therapeutics Reports First Quarter 2013 Financial Results

SAN DIEGO, May 7, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc.
(Nasdaq:TSRX), a biopharmaceutical company focused on the discovery,
development and commercialization of innovative antibiotics for serious
infections, announced today its financial results for the first quarter ended
March 31, 2013.

"After successfully completing and reporting positive top-line results for our
ESTABLISH 2 study, we are preparing to file our New Drug Application (NDA) for
tedizolid later this year and, if approved, to potentially launch in the U.S.
in the second half of 2014," said John Schmid, Chief Financial Officer at
Trius.

At March 31, 2013, Trius had cash, cash equivalents and investments totaling
$83.6 million. As of May 1, 2013, Trius had 47,872,124 shares outstanding.

For the first quarter of 2013, Trius reported a net loss of $17.3 million
versus a net loss of $7.6 million in the comparable period in 2012. The
increase in the net loss in the first quarter of 2013 was primarily due to
lower collaboration revenues from our partnership with Bayer Pharma AG (Bayer)
as well as from our federal contracts. In addition, we recognized a $2.0
million non-cash expense during the three months ended March 31, 2013 related
to the valuation of our common stock warrant liability versus the non-cash
benefit recognized during the comparable period in 2012. As a result, Trius
reported a net loss per share of $0.38 for the first quarter of 2013 versus
$0.22 in the first quarter of 2012.

Revenues for the three months ended March 31, 2013 were $1.7 million compared
to $9.8 million for the same period in 2012. In the first quarter of 2012, the
Company earned a $5.0 million milestone payment from Bayer, but received no
similar payments in the current year. Federal contract revenues also decreased
from the prior year due to reduced funding for our biodefense pathogen
research programs.

Research and development expenses for the three months ended March 31, 2013
were $12.5 million compared to $16.8 million for the same period in 2012. The
decrease in research and development expenses was primarily related to lower
clinical trial and development costs for tedizolid phosphate.

General and administrative expenses for the three months ended March 31, 2013
increased to $4.5 million compared to $3.0 million for the same period in
2012. The increase in general and administrative expenses was primarily due to
an increase in commercial activities for tedizolid phosphate in connection
with launch planning.

Program Updates & Upcoming Events

In March 2013, Trius announced positive top-line data for its ESTABLISH 2
study, the second Phase 3 trial in acute bacterial skin and skin structure
infection, or ABSSSI. Tedizolid achieved all primary and secondary efficacy
outcomes after a short course of therapy using one-tenth the amount of total
drug versus the comparator linezolid (Zyvox®). Patients receiving tedizolid
also showed numerical improvements in key safety and tolerability measurements
in the complete study population. We plan to file a New Drug Application (NDA)
for tedizolid phosphate in the second half of 2013.

In January 2013, Trius completed a public offering of 7,169,135 shares of
Trius common stock and raised net proceeds of $31.6 million.

Pending final agreement with regulatory authorities, Trius plans to initiate a
Phase 3 program for the treatment of pneumonia in the second half of 2013
using the same 200 mg, once daily dose of tedizolid phosphate that is
currently being tested to treat skin infections. In addition, the Company is
progressing with enabling studies for an Investigational New Drug (IND)
application for its Gyrase-B development candidate with potent activity
against Gram-negative and Gram-positive bacterial pathogens. A Phase 1
clinical trial is expected to start in 2014.

About Trius Therapeutics

Trius Therapeutics, Inc. is a biopharmaceutical company focused on the
discovery, development and commercialization of innovative antibiotics for
serious infections. The Company's lead investigational drug, tedizolid
phosphate, is a new, novel antibiotic for the treatment of ABSSSI and serious
Gram-positive infections, including those caused by methicillin-resistant
staphylococcus aureus (MRSA). Trius has completed two Phase 3 ABSSSI trials
for which it has Special Protocol Assessments with the FDA and has partnered
with Bayer Pharma for the development and commercialization of tedizolid
phosphate outside of the U.S., Canada and the European Union. In addition to
the Company's tedizolid phosphate clinical program, Trius has initiated
IND-enabling studies for its Gyrase-B development candidate with potent
activity against Gram-negative bacterial pathogens including multi-drug
resistant strains of E. coli, Klebsiella, Acinetobacter and Pseudomonas. For
more information, visit www.triusrx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not
historical facts are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Because such statements are
subject to risks and uncertainties, actual results may differ materially from
those expressed or implied by such forward-looking statements. Such statements
include, but are not limited to, statements regarding Trius' ability to
successfully complete its ongoing clinical trials and development programs,
the timing of Trius' NDA filing and commercial launch of tedizolid for the
treatment of ABSSSI, the timing of the initiation of a Phase 3 program for
tedizolid for the treatment of pneumonia and the timing of the initiation of a
Phase 1 clinical trial for Trius' Gyrase-B development candidate. Risks that
contribute to the uncertain nature of the forward-looking statements include:
the accuracy of Trius' estimates regarding expenses, future revenues and
capital requirements; the success and timing of Trius' preclinical studies and
clinical trials; regulatory developments in the United States and foreign
countries; changes in Trius' plans to develop and commercialize its product
candidates; Trius' ability to obtain additional financing; Trius' ability to
obtain and maintain intellectual property protection for its product
candidates; and the loss of key scientific or management personnel. These and
other risks and uncertainties are described more fully in Trius' most recently
filed SEC documents, including its Form 10-K, Forms 10-Q and other documents
filed with the United States Securities and Exchange Commission, including
those factors discussed under the caption "Risk Factors" in such filings. All
forward-looking statements contained in this press release speak only as of
the date on which they were made. Trius undertakes no obligation to update
such statements to reflect events that occur or circumstances that exist after
the date on which they were made.


Trius Therapeutics, Inc.
Statements of Operations
(In thousands except per share data)

                                                      ThreeMonthsEnded
                                                       March 31,
                                                      2013       2012
                                                      (Unaudited)
Revenues:                                                        
Collaboration and license fees                         $1,198    $6,821
Contract research                                      529       3,011
                                                                
Total revenues                                         1,727     9,832
                                                                
Operating expenses:                                              
Research and development                               12,545    16,846
General and administrative                             4,504     3,004
                                                                
Total operating expenses                               17,049    19,850
                                                                
Loss from operations                                   (15,322)  (10,018 )
                                                                
Other income (expense):                                          
Interest income                                        11        —
Fair value adjustment of stock warrant liability       (1,969)   2,417
Other income (expense)                                 —        (3)
                                                                
Total other income (expense)                           (1,958)   2,414
                                                                
Net loss                                               $ (17,280) $(7,604 )
Net loss per share, basic and diluted                  $(0.38)   $(0.22 )
Weighted-average shares outstanding, basic and diluted 46,021    35,195

                                      


Trius Therapeutics, Inc.
Balance Sheets
(In thousands except share and per share data)

                                                     March 31,   December 31,
                                                      2013        2012
                                                     (Unaudited) 
Assets                                                           
Current assets:                                                  
Cash and cash equivalents                             $20,086    $16,370
Short-term investments, available-for-sale            63,562     49,659
Accounts receivable                                   2,337      5,698
Prepaid expenses and other current assets             2,698      2,254
Total current assets                                  88,683     73,981
Property and equipment, net                           820        990
Restricted cash                                       151         151
Other assets                                          164        152
Total assets                                          $89,818    $75,274
Liabilities and stockholders' equity                             
Current liabilities:                                             
Accounts payable                                      $5,046     $6,761
Accrued liabilities                                   6,514      7,762
Common stock warrant liability                        5,817       3,848
Current portion of deferred revenue                   171        116
Total liabilities                                     17,548     18,487
                                                                
Stockholders' equity:                                            
Preferred stock, $0.0001 par value; 10,000,000 shares
authorized at March 31, 2013 and December 31, 2012;   —          —
no shares issued and outstanding at March 31, 2013
and December 31, 2012
Common stock, $0.0001 par value; 200,000,000 shares
authorized at March 31, 2013 and December 31, 2012;
47,868,166 and 40,661,360 shares issued and           5          5
outstanding at March 31, 2013 and December 31, 2012,
respectively
Additional paid-in capital                            238,858    206,093
Accumulated other comprehensive income                7          9
Accumulated deficit                                   (166,600)  (149,320)
Total stockholders' equity                            72,270     56,787
Total liabilities and stockholders' equity            $89,818    $75,274

CONTACT: Public Relations Contact:
         Laura Kempke/Andrew Law at MSLGROUP
         trius@mslgroup.com
         781-684-0770
        
         Investor Relations Contact:
         Stefan Loren at Westwicke Partners, LLC
         sloren@westwicke.com
         443-213-0507