With the Acquisition of Oncogenerix, Inc., DARA Accelerates its Portfolio with Two FDA-Approved Products
RALEIGH, N.C., May 21, 2012 — DARA BioSciences, Inc. (Nasdaq:DARA) (the “Company” or “DARA”) today announced the financial results for the period ending March 31, 2012. The Company also detailed the quarter’s key corporate activities, including an overview of the commercial portfolio, which includes two FDA-registered products for the oncology and oncology supportive care markets.
The first of these compounds, Soltamox(R), the only FDA-approved oral liquid formulation of tamoxifen citrate, is first line therapy for the prevention and treatment of breast cancer and has been licensed for the U.S. from Rosemont Pharmaceuticals, Ltd., U.K. DARA is preparing for the launch of Soltamox to the oncology market later this year. Some breast cancer patients have difficulty in swallowing pills, which leaves them with few alternatives other than crushing pills (not recommended) or mixing them with food. With the introduction of the liquid version of tamoxifen citrate, patients will finally have a simple solution for this problematic issue.
As announced in January, DARA acquired the privately held company Oncogenerix, Inc., which included exclusive U.S. rights to Soltamox. In the first quarter, the Company also acquired U.S. oncology market rights to a topical sodium hyaluronate product, Bionect(R), from Innocutis. The Company is in the final stages of preparing for the introduction of Bionect. It is expected that the product will be launched in June as a topical treatment for the management of skin irritation and burns caused by radiation therapy.
In addition, the U.S. rights to a widely used generic chemotherapeutic cancer drug, gemcitabine, have been licensed from another partner, Uman Pharma. The Abbreviated New Drug Application (ANDA) for gemcitabine is expected to be filed with the FDA later this year.
Subsequent to the close of the quarter, DARA also completed $10.25 million in financing with institutional and accredited investors, thus regaining compliance with NASDAQ’s Stockholders Equity Requirement. These funds will be used for the marketing of the company’s two FDA-cleared products, activities associated with the U.S. FDA filing of the gemcitabine ANDA, the development of the pain compound KRN5500, and general working capital.
The net loss for the period totaled $2.0 million, or 29 cents per share, vs. a net loss of $1.3 million, or 26 cents per share, in the same period in 2011. The higher net loss was due primarily to business acquisition costs and the hiring of experienced staff to help execute the new oncology-focused business strategy.
Cash and cash equivalents stood at $1.4 million at March 31, 2012. On April 26, 2012 the company received gross proceeds of $10.25 million from a public offering of preferred stock and warrants.
“With the acquisition of Oncogenerix in January 2012, DARA has now become a commercial company keenly focused on markets for both high value oncology and related supportive care products,” said David J. Drutz, MD, DARA’s Chief Executive Officer.
“With the addition of Soltamox and other exciting products included in the Oncogenerix portfolio acquisition, we believe we are on our way to generating revenues and becoming profitable,” he added. “Our portfolio includes two products ready for marketing and a third soon to be filed with the FDA,” he said. “This well-balanced mix of cancer treatment and supportive care products is just a start. In addition, we have an experimental candidate for chemotherapy-induced neuropathic pain, KRN5500.” Dr. Drutz also added that the Company is currently engaged in discussions with potential partners to identify products that complement the existing portfolio.
|Statement of Operations Data:|
|Three months ended March 31,||Period from
June 22, 2002
|Sales, general and administrative||$ 1,731,480||$ 922,651||$ 28,457,599|
|Research and development||315,836||396,392||25,550,337|
|Total operating expenses||2,047,316||1,319,043||54,007,936|
|Total other income, net||(10)||(103)||12,986,145|
|Undistributed loss in equity method investments||—||—||(2,374,422)|
|Net loss before benefit from income taxes||(2,047,326)||(1,319,146)||(43,396,213)|
|Income tax benefit||—||—||194,445|
|Loss attributable to noncontrolling interest||63,450||70,497||1,720,691|
|Net loss attributable to common stockholders||$ (1,983,876)||$ (1,248,649)||$ (41,481,077)|
|Basic and diluted net loss per common share attributable to controlling interest||$ (0.29)||$ (0.26)|
|Shares used in computing basic and diluted net loss per common share attributable to controlling interest||6,804,994||4,721,948|
|Balance Sheet Data:|
|Cash, cash equivalents and short-term investments||$ 1,817,667||$ 1,462,866|
|Deficit accumulated during the development stage||(41,700,424)||(39,716,548)|
|Total stockholders’ equity||3,837,425||959,148|
About DARA BioSciences, Inc.
DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA holds the exclusive U.S. marketing rights to Soltamox(R), a novel oral liquid formulation of tamoxifen citrate, a product used widely 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 cannot tolerate existing tablet formulations of this drug. DARA plans to begin marketing Soltamox in the U.S. in Q3 2012.
DARA has also obtained exclusive U.S. commercial rights from Innocutis Holdings, LLC for Bionect(R) (hyaluronic acid sodium salt, 0.2%) within the oncology and radiation oncology marketplace. Bionect is an FDA-cleared product indicated for the management of irritation of the skin as well as first and second degree burns. Bionect is currently being promoted and sold by Innocutis in the dermatology market. DARA plans to launch this product in 2Q 2012.
DARA has obtained, in addition, the U.S. right to gemcitabine, a widely used generic chemotherapeutic cancer drug, from Uman Pharma. The Abbreviated New Drug Application (ANDA) for gemcitabine is expected to be filed with the FDA later this year.
DARA is also developing KRN5500 for the treatment of neuropathic pain in patients with cancer. KRN5500 has successfully completed a Phase 2a study and has been designated as a Fast Track Drug by the FDA. We are working with the National Cancer Institute (NCI) to design an additional clinical trial under joint DARA-NCI auspices while considering further internal Phase 2 development.
In addition, DARA’s pipeline includes DB959, a novel, non-TZD dual delta/gamma PPAR agonist for the treatment of type 2 diabetes and dyslipidemia. DARA has completed Phase 1 testing of DB959 and is presently pursuing opportunities to out-license this product. DARA also has rights to other PPAR and DPPIV-inhibitor compounds for which it intends to seek out-licensing or partnering opportunities.
For more information please visit our web site at http://www.darabio.com.
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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. Those factors include risks and uncertainties relating to DARA’s ability to timely commercialize and generate revenues or profits from Bionect(R), Soltamox(R) 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, Soltamoxor 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 the company 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.