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DARA Reports Second Quarter 2013 Financial Results and Operational Overview

DARA Reports Second Quarter 2013 Financial Results and Operational Overview 
Company's Priority Remains Focusing Expertise and Resources on
Commercialization of Its Oncology Treatment and Oncology Supportive
Care Pharmaceutical Products: Soltamox(R), Gelclair(R) and Bionect(R) 
RALEIGH, NC  -- (Marketwired) -- 08/14/13 --   DARA BioSciences, Inc.
(NASDAQ: DARA), a specialty pharmaceutical company focused on the
commercialization of its complementary product portfolio of oncology
and oncology supportive care products, announced today its financial
results for the second quarter ended June 30, 2013. The Company also
summarized second quarter 2013 operational highlights and recent
developments. 
For the second quarter ended June 30, 2013, DARA reported a net loss
attributable to controlling interest of ($2,554,204), or ($0.10) per
share as compared to a net loss attributable to controlling interest
of ($1,472,521), or ($0.14) per share for the second quarter ended
June 30, 2012. The increase in loss was primarily a result of the
costs incurred in the establishment of a sales and marketing,
distribution and regulatory infrastructure to support the promotion
of the Company's oncology and oncology supportive care products. As
of June 30, 2013, cash and cash equivalents totaled $4,940,899.  
DARA believes that its currently available funds, together with
projected sales of Soltamox®, Gelclair® and Bionect® in 2013 will
enable the Company to fund its planned operations and to meet its
obligations through December 31, 2013.  
Second Quarter 2013 Operational Overview and Recent Developments 


 
--  Launched Gelclair in late April 2013, representing the Company's third
    product launch;
--  Implemented new commercial strategies and focused additional expertise
    and resources to increase and improve upon the first quarter 2013
    revenues of Soltamox and its ongoing launch, as well as in support of
    the Gelclair product launch;
--  Employed a multi-disciplinary approach to directly reach and educate
    health care providers, patient advocacy groups, caregivers and patients.
    DARA believes it can accomplish this through utilizing a combination of
    its own specialized sales organization, tele-detailing campaigns,
    appropriate levels of 
product sampling, innovative marketing programs,
    partnerships with Specialty Pharmacy Providers, working with Patient
    Advocacy Groups and Foundations as well as collaborative arrangements
    with companies that promote synergistic products within the oncology
    market;
--  Enrolled thirteen U.S. oncology centers and completed nearly fifty
    percent of the patient surveys in the Company's IRB-approved breast
    cancer patient registry study, CAPTURE (Compliance and Preference for
    Tamoxifen Registry). The registry is designed to gain valuable insight
    into adherence to prescribed tamoxifen treatment; patient preference for
    a liquid formulation of tamoxifen; and prevalence of difficulties in
    swallowing among breast cancer patients taking tamoxifen tablets; 
--  Granted T3D Therapeutics, Inc. the exclusive worldwide rights to develop
    and commercialize DB959. DB959 is an oral, highly selective, dual PPAR
    (peroxisome proliferator-activated receptor) nuclear receptor agonist.
    DARA had previously developed DB959 through Phase 1 clinical trials for
    the treatment of diabetes and dyslipidemia; and
--  Provided U.S. Food and Drug Administration (FDA), on August 8, 2013,
    with additional information requested in support of DARA's request for
    orphan drug designation for the Company's Phase 2 development asset,
    KRN5500 for the treatment of painful, treatment-refractory, chronic
    chemotherapy-induced peripheral neuropathy ("CCIPN"). 

 
"In the second quarter we commenced the launch of Gelclair,
representing our third product launch in less than one year. We are
pleased with the initial uptake in sales and believe this launch is
off to a promising start," stated David J. Drutz, MD, DARA
BioSciences' chief executive officer and chief medical officer. 
Dr. Drutz continued, "Following the disappointing first quarter 2013
sales reported for Soltamox, we made very deliberate adjustments to
our marketing plan, utilizing what we had learned from the initial
launch phase. We are observing positive uptake on Soltamox since
making our commercial adjustments, and although still modest, the
trend is moving in the right direction. The full impact of these
initiatives will take time, and we will continue to communicate our
progress on this front. Going forward, our number one priority is to
continue to work diligently, focus our expertise and commit the
necessary resources towards achieving the expectations we have for
our commercial product portfolio."  
Financial Highlights 
A summary of key financial highlights for the three and six months
ended June 30, 2013 and 2012 is as follows ($ in thousands): 


 
                    For the three  For the three  For the six  For the six  
                    months ended   months ended   months ended months ended 
                    June 30,       June 30,       June 30,     June 30,     
                    2013           2012           2013         2012         
                    $              $              $            $            
                                                                            
Net Product Revenues          76.9              -         98.1            - 
                                                                            
Gross Margin                  68.2              -         71.9            - 
                                                                            
Operating Expenses         2,804.4        1,898.8      5,535.5      3,964.1 
                                                                            
Net Loss Attributed                                                         
 to Controlling                                                             
 Interest                 (2,554.2)      (1,472.5)    (5,076.8)    (3,456.4)
 

 
                                                                            
                                                                            
                                As of June 30, 2013  As of December 31, 2012
                                                                            
Cash and Cash Equivalents                   4,940.9                  6,496.5
                                                                            
Current Assets                              5,566.1                  7,044.8
                                                                            
Current Liabilities                         1,351.6                  2,038.9
                                                                            
Working Capital                             4,214.5                  5,005.9

 
About DARA BioSciences, Inc. 
DARA is a specialty pharmaceutical company focused on the
commercialization of its complementary product portfolio of oncology
and oncology supportive care products.  
DARA increased its focus in oncology through its January 2012
acquisition of Oncogenerix, Inc., which holds the exclusive U.S.
marketing rights to Soltamox®, a novel oral liquid formulation of
tamoxifen citrate, which is widely used in the treatment and
prevention of breast cancer. Soltamox is 
the only FDA-approved oral
liquid version of tamoxifen citrate and fulfills an important
clinical need for patients who prefer a liquid formulation or cannot
tolerate existing solid tablet formulations of this drug. DARA has
exclusive U.S. rights to Soltamox through a license from Rosemont
Pharmaceuticals, Ltd.  
In June 2012, DARA launched its first product, Bionect®, a topical
treatment for skin irritation and burns associated with radiation
therapy. DARA has rights to market Bionect in the US
oncology/radiology markets under license from Innocutis. Soltamox was
launched formally as DARA's second commercial product in December
2012, coincident in timing with the 35th Annual San Antonio Breast
Cancer Symposium. In late April, 2013, DARA launched its third
product, Gelclair®, an FDA-cleared product for the treatment of oral
mucositis for which DARA also has exclusive U.S. commercial rights
through a license from Helsinn Group in Switzerland. 
DARA is also developing a cancer-support therapeutic compound,
KRN5500, for the treatment of chronic chemotherapy-induced peripheral
neuropathy (CCIPN) in patients with cancer. This product is an
excellent fit with DARA's strategic oncology focus, has successfully
completed a Phase 2a clinical trial, and has been designated a Fast
Track Drug by the FDA. DARA has created an improved, potentially
commercializable formulation of this drug and is in active partnering
discussions regarding further clinical development. DARA has also
submitted an Orphan Drug Application to the FDA for the use of this
drug in refractory painful CCIPN.  
For more information please visit our web site at www.darabio.com.  
Safe Harbor Statement 
All statements in this news release that are not historical are
forward-looking statements within the meaning of the Securities
Exchange Act of 1934, as amended. Such forward-looking statements are
subject to factors that could cause actual results to differ
materially for DARA from those projected. Important factors that
could cause actual results to differ materially from the expectations
described in these forward-looking statements are set forth under the
caption "Risk Factors" in DARA's most recent Annual Report on Form
10-K, filed with the SEC on March 28, 2013. Those factors include
risks and uncertainties relating to DARA's ability to timely
commercialize and generate revenues or profits from Bionect®,
Soltamox®, Gelclair® or other products and DARA's lack of history as
a revenue-generating company, FDA and other regulatory risks relating
to DARA's ability to market Bionect, Soltamox, Gelclair or other
products in the U.S. or elsewhere, DARA's current cash position and
its need to raise additional capital in order to be able to continue
to fund its operations, the current regulatory environment in which
DARA sells its products, the market acceptance of those products,
dependence on partners, successful performance under collaborative
and other commercial agreements, competition, the strength of DARA's
intellectual property and the intellectual property of others, the
potential delisting of DARA's common stock from the NASDAQ Capital
Market, risks and uncertainties relating to DARA's ability to
successfully integrate Oncogenerix and other risk factors identified
in the documents DARA has filed, or will file, with the Securities
and Exchange Commission ("SEC"). Copies of DARA's filings with the
SEC may be obtained from the SEC Internet site at http://www.sec.gov.
DARA expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in DARA's expectations with
regard thereto or any change in events, conditions, or circumstances
on which any such statements are based. DARA BioSciences and the DARA
logo are trademarks of DARA BioSciences, Inc. 
Investor contact: 
Jenene Thomas 
DARA BioSciences 
908-938-1475 
jthomas@darabio.com  
Media contact:
David Connolly or Samantha Stenbeck
LaVoie Group
617-374-8800 
dconnolly@lavoiegroup.com
sstenbeck@lavoiegroup.com