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DARA Reports First Quarter 2013 Financial Results and Operational Highlights

Companies mentioned in this article: DARA BioSciences, Inc.

RALEIGH, NC--(Marketwired - May 15, 2013) - DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today its financial results for the first quarter ended March 31, 2013. The Company also summarized the first quarter 2013 operational highlights, its recent developments, and provided a commercial and development pipeline review. DARA management will host a conference call and webcast on Thursday, May 16 at 9:00 a.m. ET.

For the first quarter ended March 31, 2013, DARA reported a net loss attributable to controlling interest of ($2,522,588), or ($0.11) per share as compared to a net loss attributable to controlling interest of ($1,983,876), or ($0.29) per share for the first quarter ended March 31, 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 offset by a decrease in general and administrative expenses primarily as a result of a reduction in audit and tax fees as well as the absence of merger related costs in the first quarter of 2013. As of March 31, 2013, cash and cash equivalents totaled $7,299,984. 

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.

First Quarter 2013 Operational Highlights and Recent Developments

  • Strengthened its management team and board of directors by adding substantial financial, commercial and business development expertise with the appointment of David L. Tousley, Chief Financial Officer and Paul J. Richardson, Independent Board Director;
  • Launched CAPTURE (Compliance and Preference for Tamoxifen Registry), a breast cancer patient survey being performed at leading breast cancer centers around the country designed to gain insights into several important aspects of breast cancer treatment, including patient adherence to tamoxifen therapy, prevalence and severity of swallowing difficulties, and patient preference for Soltamox (tamoxifen citrate) oral solution vs. tamoxifen tablets;
  • Entered an agreement with Prime Therapeutics Specialty Pharmacy LLC for distribution of its two lead proprietary products, Soltamox and Gelclair;
  • Launched the Company's third product, Gelclair (oral bioadhesive gel) for the treatment of oral mucositis in April 2013; and
  • Implemented new commercial strategies to support Soltamox, Gelclair and Bionect product launches.

"It has been just over a year since we merged DARA and Oncogenerix and embarked on our new strategy with a commercial focus in oncology and oncology supportive care. Overall, I am pleased with our progress as we continue to execute on our business plan, but certainly recognize that there is much more to do to realize the potential of our assets and to fulfill our vision, which is to become a leading player in the oncology supportive care area," stated David J. Drutz, MD, chief executive officer and chief medical officer.

Drutz continued, "The past year has been one of transition and integration of the new team in implementing our new strategy, building a commercial infrastructure and launching three FDA-approved products: Bionect, Soltamox and Gelclair. Our first quarter sales results for Soltamox were disappointing, but we believe we understand why we didn't achieve better results and have taken immediate action in making the necessary adjustments to ensure we achieve the expectations we have for this product. Importantly, the adjustments we are making to our Soltamox sales and marketing plan have the potential to positively impact the performance of our other supportive care programs. In fact, early signs indicate good initial uptake for Gelclair which was launched in late April. We believe there is a significant market opportunity for each of our three products as well as longer-term growth opportunities to in-license additional supportive care products." 

"I truly believe we have positioned DARA uniquely, have assembled a strong team at the Company and have the opportunity to bring to market important supportive care therapies for cancer patients, and in turn, build significant value for our shareholders," concluded Drutz.

Commercial Business Update

Soltamox®, tamoxifen citrate oral solution for the treatment of breast cancer
DARA has exclusive commercial rights to Soltamox in the U.S., and launched the drug formally in December 2012, coinciding with the 35th Annual San Antonio Breast Cancer Symposium. Soltamox is the only liquid form of tamoxifen available in the U.S. and may help those breast cancer patients, and those at high risk for breast cancer, who prefer liquid medication to adhere to their therapy.

In April 2013, DARA launched CAPTURE (Compliance and Preference for Tamoxifen Registry), a breast cancer patient survey. The survey is being performed at leading breast cancer centers around the country, and is designed to gain insights into several important aspects of breast cancer treatment, including patient adherence to tamoxifen therapy, prevalence and severity of swallowing difficulties, and patient preference for Soltamox (tamoxifen citrate) oral solution vs. tamoxifen tablets. CAPTURE was developed in conjunction with a Scientific Steering Committee, including two highly recognized leaders in the fields of oncology and breast cancer, Stefan Gluck, M.D., Ph.D., Sylvester Distinguished Professor, Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami, FL; and Jivesh Sharma, M.D., Presbyterian Hospital of Dallas, TX, and CEO of NEXGEN Oncology, Dallas.

By collecting data on over 600 tamoxifen patients, CAPTURE is intended to enable health care providers to better understand the complexities of patent adherence, and how patient preference or need for a liquid form of tamoxifen may improve long term compliance. The Company expects to publish the CAPTURE data, present it at scientific meetings, and share the results with its key customers in order to help educate healthcare professionals nationwide.

The Company has recently implemented several new sales and marketing strategies and programs to yield the improved sales performance it expects to see from Soltamox.

Gelclair®, an oral mucosa coating agent for the treatment of oral mucositis
In late April 2013, DARA launched Gelclair to the U.S. market where it has exclusive U.S. commercial rights. Internally conducted market research involving over 100 oncology physicians and nurses indicated strong familiarity with the Gelclair brand from its earlier presence in the U.S. market and a continuing preference for Gelclair over other commercially available products used to treat oral mucositis. DARA has commenced a direct-to-patient specialty single point of contact model, the Gelclair Access Program, to provide product access and affordability for patients together with ease of prescribing for health care providers.

Bionect®, a topical low molecular weight hyaluronic acid for the treatment of radiation skin injury
DARA launched Bionect in the second quarter of 2012. Over 100 accounts have used this product for the treatment of radiation-related skin damage and a national network of cancer treatment centers is currently establishing Bionect as first-line therapy for both inpatient and outpatient usage.

Development Asset Update

KRN5500, for the treatment of painful chronic chemotherapy induced peripheral neuropathy (CCIPN)
KRN5500 is a novel, non-narcotic/non-opioid intravenous Phase 2 product candidate for the treatment of painful CCIPN. As previously reported, the U.S. Food and Drug Administration (FDA) has designated KRN5500 a Fast Track drug, based on its potential usefulness in treating a serious medical condition and in fulfilling an unmet medical need.

In November 2012, an application to the FDA for an Orphan designation for painful CCIPN was submitted for review. DARA is currently in communication with the FDA regarding its submission.

Additionally, DARA is pursuing partnering opportunities for KRN5500. The Company is currently in active discussions with potential partners to fund the further development of this asset. This will allow the Company to focus its efforts and expertise and execute on its commercial oncology and oncology supportive care strategy.

Conference Call and Webcast

DARA BioSciences will host a conference call and audio webcast tomorrow, Thursday, May 16, 2013 at 9:00 a.m. ET to provide a corporate business update and review financial results. Interested participants and investors may access this conference call by dialing 877-407-9128 (U.S./Canada) or 201-493-6752 (international). 

An audio webcast can also be accessed via the Investors section of the DARA BioSciences corporate web site at http://www.darabio.com, and will be archived for 30 days. Web participants are encouraged to go to the web site 15 minutes prior to the start of the call to register, download and install any necessary software.

A replay of the conference call will be available until May 30, 2013. To access the replay, interested parties may dial 877-660-6853 (U.S./Canada) or 201-612-7415 (International); Conference ID: 414896.

Financial Highlights

A summary of key financial highlights for the three months ended March 31, 2013 and 2012 is as follows ($ in thousands):

                                                                            
                                     As of and for the    As of and for the 
                                    three months ended   three months ended 
                                        March 31, 2013       March 31, 2012 
Net revenues                       $              21.2  $                 - 
Gross Margin                                       3.7                    - 
Operating expenses                             2,731.1              2,047.3 
Net loss attributable to                                                    
 controlling interest                         (2,522.6)            (1,983.9)
Cash and cash equivalents                      7,300.0              6,496.5 
Current assets                                 7,911.0              7,044.8 
Current liabilities                            1,326.7              2,038.9 
Working capital                                6,584.3              5,005.9 
                                                                            

About DARA BioSciences, Inc.

DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and 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 a vital clinical need for patients who prefer 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 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 given that DARA only recently hired its initial sales force 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 ability to develop and bring new products to market as anticipated, 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 develops and 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.


Contact:

CONTACT:
Jenene Thomas
Head of Investor Relations
+1-908-938-1475
jthomas@darabio.com